SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Study Details
Study Description
Brief Summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TAXUS® Liberté™
|
Device: TAXUS® Liberté™
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
|
| Active Comparator: XIENCE V® EECSS
|
Device: XIENCE V® EECSS
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
|
Outcome Measures
Primary Outcome Measures
- In-stent Late Loss (LL) [270 days]
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Secondary Outcome Measures
- Clinical Device Success (Per-lesion) [immediately post-procedure]
Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
- Clinical Procedure Success (Per-patient) [immediately post-procedure]
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
- In-segment Late Loss [270 days]
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
- Proximal Late Loss [270 day]
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
- Distal Late Loss [270 days]
Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
- In-stent Angiographic Binary Restenosis Rate [270 days]
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
- In-segment Angiographic Binary Restenosis Rate [270 days]
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
- In-stent Percent Diameter Stenosis (% DS) [270 days]
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
- In-segment Percent Diameter Stenosis (% DS) [270 days]
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [0 to 37 days]
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [254 days]
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [365 days]
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement.
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [37 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [254 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
- Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [393 days]
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [37 days]
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [254 days]
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
- Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [393 days]
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs.
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) [37 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) [254 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
- Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) [393 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR) [37 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [254 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
- Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [393 days]
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
Eligibility Criteria
Criteria
Inclusion Criteria:
-
at least 18 years
-
able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
-
diagnosed with diabetes, as documented by medical history.
-
evidence of myocardial ischemia
-
acceptable candidate for coronary artery bypass grafting (CABG) surgery
-
agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
-
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
-
maximum of one, de novo, target lesion per native major epicardial vessel or side branch
-
target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
-
target lesion ≤ 28 mm in length by visual estimate
-
target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1
Exclusion Criteria:
-
known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
-
current unstable arrhythmias
-
Left ventricular ejection fraction < 30%
-
received a heart or any other organ transplant or is on a waiting list for any organ transplant
-
receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
-
receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
-
known hypersensitivity or contraindication to specific agents
-
elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
-
platelet count limits, white blood cell limits or documented or suspected liver disease
-
renal insufficiency
-
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
-
Cerebrovascular accident or transient ischemic attack within the past 6 months
-
significant GI or urinary bleed within the past 6 months
-
history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Target lesion meets any of the following criteria:
-
In-stent restenotic
-
aorto-ostial location (within 3 mm)
-
left main location
-
located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
-
located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
-
lesion involving a side branch ≥ 2.5 mm in diameter
-
lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
-
located in a major epicardial vessel that has been previously treated with brachytherapy
-
located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
-
total occlusion (TIMI flow 0), prior to wire crossing
-
excessive tortuosity proximal to or within the lesion
-
extreme angulation (≥ 90%) proximal to or within the lesion
-
heavy calcification
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Salzburger Landeskliniken | Salzburg | Austria | ||
| 2 | C.H.U. - Hopital Michallon | Grenoble | France | ||
| 3 | CHU Lille - Hôpital Cardiologique | Lille | France | ||
| 4 | Herzzentrum | Bernau | Germany | ||
| 5 | Universitätsklinikum | Heidelberg | Germany | ||
| 6 | Lukas Krankenhaus Neuss | Neuss | Germany | ||
| 7 | Herzzentrum Siegburg GmbH | Siegburg | Germany | ||
| 8 | Sheba Medical Center | Ramat Gan | Israel | ||
| 9 | Azienda Ospedaliera Riuniti | Bergamo | Italy | ||
| 10 | Ospedale Civile | Mirano | Italy | ||
| 11 | Azienda Ospedaliera di Padova | Padova | Italy | ||
| 12 | IRCCS Policlinico San Matteo | Pavia | Italy | ||
| 13 | Azienda Ospedaliera S. Gdi Dio Salerno | Salerno | Italy | ||
| 14 | Institute Jantung Negara | Kuala Lumpur | Malaysia | ||
| 15 | Medisch Centrum Alkmaar | Alkmaar | Netherlands | ||
| 16 | Maasstad Ziekenhuis | Rotterdam | Netherlands | ||
| 17 | Medical University of Bydgoszcz | Bydgoszcz | Poland | ||
| 18 | General De Alicante | Alicante | Spain | ||
| 19 | Hospital Belvigte de Barcelona | Barcelona | Spain | ||
| 20 | Hospital Santa Creu I Sant Pau | Barcelona | Spain | ||
| 21 | Clinico San Carlos | Madrid | Spain | ||
| 22 | Hospital Puerta de Hierro | Madrid | Spain | ||
| 23 | La Paz | Madrid | Spain | ||
| 24 | Hospital Virgen de la Arrixaca | Murcia | Spain | ||
| 25 | Hospital General de Valencia | Valencia | Spain | ||
| 26 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | ||
| 27 | King's College Hospital | London | United Kingdom | ||
| 28 | Wessex Cardiac Unit | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Eberhard Grube, MD, International Heart Center Rhein-Ruhr, Essen, Germany
- Principal Investigator: Upendra Kaul, MD, Fortis Hospital, New Delhi, India
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 05-369 Diabetic Sub-study
Study Results
Participant Flow
| Recruitment Details | 324 subjects were recruited at 32 sites. Eligible subjects invited to participate, in-hospital or in-clinic and required to provide signed informed consent prior to enrollment. Final eligibility based on angiographic inclusion criteria prior to the intended procedure. Dates of recruitment: April 28, 2007 to October 6, 2008. |
|---|---|
| Pre-assignment Detail | Subjects were randomized via telephone randomization and stratified by insulin treatment status, number of lesions treated-single vs. multiple. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI) |
| Period Title: Overall Study | ||
| STARTED | 106 | 218 |
| COMPLETED | 100 | 212 |
| NOT COMPLETED | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS | Total |
|---|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI | Total of all reporting groups |
| Overall Participants | 106 | 218 | 324 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
49
46.2%
|
102
46.8%
|
151
46.6%
|
| >=65 years |
57
53.8%
|
116
53.2%
|
173
53.4%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.75
(8.95)
|
65.32
(9.61)
|
65.46
(9.39)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
35
33%
|
66
30.3%
|
101
31.2%
|
| Male |
71
67%
|
152
69.7%
|
223
68.8%
|
| Region of Enrollment (participants) [Number] | |||
| France |
2
1.9%
|
7
3.2%
|
9
2.8%
|
| Thailand |
0
0%
|
2
0.9%
|
2
0.6%
|
| Spain |
57
53.8%
|
87
39.9%
|
144
44.4%
|
| Poland |
8
7.5%
|
17
7.8%
|
25
7.7%
|
| Malaysia |
1
0.9%
|
13
6%
|
14
4.3%
|
| Austria |
2
1.9%
|
8
3.7%
|
10
3.1%
|
| Israel |
1
0.9%
|
1
0.5%
|
2
0.6%
|
| Netherlands |
1
0.9%
|
12
5.5%
|
13
4%
|
| Germany |
14
13.2%
|
22
10.1%
|
36
11.1%
|
| United Kingdom |
3
2.8%
|
6
2.8%
|
9
2.8%
|
| Italy |
17
16%
|
43
19.7%
|
60
18.5%
|
Outcome Measures
| Title | In-stent Late Loss (LL) |
|---|---|
| Description | In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 110 | 249 |
| Mean (Standard Deviation) [millimeters] |
0.39
(0.49)
|
0.19
(0.37)
|
| Title | Clinical Device Success (Per-lesion) |
|---|---|
| Description | Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy. |
| Time Frame | immediately post-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure Lesions | 133 | 289 |
| Number (95% Confidence Interval) [Percentage of lesions] |
98.50
|
97.58
|
| Title | Clinical Procedure Success (Per-patient) |
|---|---|
| Description | Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success. |
| Time Frame | immediately post-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 102 | 212 |
| Number (95% Confidence Interval) [Percentage of participants] |
93.14
87.9%
|
96.70
44.4%
|
| Title | In-segment Late Loss |
|---|---|
| Description | In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 109 | 249 |
| Mean (Standard Deviation) [millimeters] |
0.22
(0.45)
|
0.12
(0.42)
|
| Title | Proximal Late Loss |
|---|---|
| Description | Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up |
| Time Frame | 270 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 104 | 241 |
| Mean (Standard Deviation) [millimeters] |
0.17
(0.33)
|
0.13
(0.39)
|
| Title | Distal Late Loss |
|---|---|
| Description | Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 107 | 247 |
| Mean (Standard Deviation) [millimeters] |
0.0
(0.34)
|
0.0
(0.3)
|
| Title | In-stent Angiographic Binary Restenosis Rate |
|---|---|
| Description | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 115 | 261 |
| Number (95% Confidence Interval) [Percentage of participants] |
6.1
5.8%
|
3.1
1.4%
|
| Title | In-segment Angiographic Binary Restenosis Rate |
|---|---|
| Description | Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA. |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 110 | 255 |
| Number (95% Confidence Interval) [Percentage of participants] |
6.4
6%
|
7.5
3.4%
|
| Title | In-stent Percent Diameter Stenosis (% DS) |
|---|---|
| Description | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 115 | 261 |
| Mean (Standard Deviation) [Percent diameter stenosis] |
20.70
(16.02)
|
14.33
(13.34)
|
| Title | In-segment Percent Diameter Stenosis (% DS) |
|---|---|
| Description | This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA. |
| Time Frame | 270 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Measure lesions | 110 | 255 |
| Mean (Standard Deviation) [Percent diameter stenosis] |
23.87
(15.25)
|
22.42
(15.05)
|
| Title | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) |
|---|---|
| Description | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. |
| Time Frame | 0 to 37 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Number (95% Confidence Interval) [Percentage of participants] |
0.94
0.9%
|
0.00
0%
|
| Title | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) |
|---|---|
| Description | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. |
| Time Frame | 254 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 217 |
| Number (95% Confidence Interval) [Percentage of participants] |
2.83
2.7%
|
0.46
0.2%
|
| Title | Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) |
|---|---|
| Description | The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement. |
| Time Frame | 365 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 104 | 215 |
| Number (95% Confidence Interval) [Percentage of participants] |
2.88
2.7%
|
0.47
0.2%
|
| Title | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. |
|---|---|
| Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. |
| Time Frame | 37 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Number (95% Confidence Interval) [Percentage of participants] |
2.83
2.7%
|
1.38
0.6%
|
| Title | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. |
|---|---|
| Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. |
| Time Frame | 254 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 217 |
| Number (95% Confidence Interval) [Percentage of participants] |
4.72
4.5%
|
6.45
3%
|
| Title | Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. |
|---|---|
| Description | TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs. |
| Time Frame | 393 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 104 | 215 |
| Number (95% Confidence Interval) [Percentage of participants] |
14.42
13.6%
|
20.93
9.6%
|
| Title | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) |
|---|---|
| Description | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. |
| Time Frame | 37 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Number (95% Confidence Interval) [Percentage of participants] |
7.55
7.1%
|
2.29
1.1%
|
| Title | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) |
|---|---|
| Description | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. |
| Time Frame | 254 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 217 |
| Number (95% Confidence Interval) [Percentage of participants] |
9.43
8.9%
|
5.53
2.5%
|
| Title | Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) |
|---|---|
| Description | Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs. |
| Time Frame | 393 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 104 | 215 |
| Number (95% Confidence Interval) [Percentage of participants] |
12.50
11.8%
|
11.16
5.1%
|
| Title | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 37 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Number (95% Confidence Interval) [Percentage of participants] |
8.49
8%
|
2.29
1.1%
|
| Title | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 254 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 217 |
| Number (95% Confidence Interval) [Percentage of participants] |
11.32
10.7%
|
6.45
3%
|
| Title | Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. |
| Time Frame | 393 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 104 | 215 |
| Number (95% Confidence Interval) [Percentage of participants] |
16.35
15.4%
|
16.28
7.5%
|
| Title | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR |
| Time Frame | 37 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 218 |
| Number (95% Confidence Interval) [Percentage of participants] |
10.38
9.8%
|
3.21
1.5%
|
| Title | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR |
| Time Frame | 254 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 106 | 217 |
| Number (95% Confidence Interval) [Percentage of participants] |
14.15
13.3%
|
9.68
4.4%
|
| Title | Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) |
|---|---|
| Description | Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR |
| Time Frame | 393 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up. |
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS |
|---|---|---|
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI |
| Measure Participants | 104 | 215 |
| Number (95% Confidence Interval) [Percentage of participants] |
23.08
21.8%
|
24.19
11.1%
|
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled. | |||
| Arm/Group Title | TAXUS® Liberté™ | XIENCE V® EECSS | ||
| Arm/Group Description | Patients receiving the TAXUS® Liberté™ stent during PCI | Patients receiving the XIENCE V® EECSS stent during PCI | ||
All Cause Mortality |
||||
| TAXUS® Liberté™ | XIENCE V® EECSS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| TAXUS® Liberté™ | XIENCE V® EECSS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 41/105 (39%) | 100/215 (46.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/105 (0%) | 0 | 2/215 (0.9%) | 3 |
| Cardiac disorders | ||||
| Angina pectoris | 13/105 (12.4%) | 14 | 25/215 (11.6%) | 29 |
| Aortic valve stenosis | 0/105 (0%) | 0 | 1/215 (0.5%) | 3 |
| Arrhythmia | 2/105 (1.9%) | 2 | 4/215 (1.9%) | 4 |
| Atrial fibrillation | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Atrial septal defect | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Atrioventricular block complete | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Bradycardia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Cardiac failure congestive | 1/105 (1%) | 1 | 1/215 (0.5%) | 1 |
| Cardiogenic shock | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Coronary artery disease | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Coronary artery dissection | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Coronary artery restenosis | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Coronary artery stenosis | 3/105 (2.9%) | 3 | 13/215 (6%) | 13 |
| In-stent coronary artery restenosis | 2/105 (1.9%) | 2 | 2/215 (0.9%) | 2 |
| Myocardial infarction | 9/105 (8.6%) | 9 | 6/215 (2.8%) | 8 |
| Myocardial infarction, acute | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Myocardial ischaemia | 2/105 (1.9%) | 2 | 4/215 (1.9%) | 4 |
| Tricuspid valve incompetence | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Ventricular extrasystoles | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Ventricular fibrillation | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Ear and labyrinth disorders | ||||
| Vertigo | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Abdominal pain upper | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Catheter site haematoma | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| General disorders | ||||
| Asthenia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Catheter site related reaction | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Chest pain | 1/105 (1%) | 1 | 3/215 (1.4%) | 4 |
| Noncardiac chest pain | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Hepatobiliary disorders | ||||
| Cholangitis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Infections and infestations | ||||
| Abscess | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Appendicitis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Diverticulitis | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Gastroenteritis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Haematoma infection | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Lobar pneumonia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Sepsis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Animal bite | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Arteriovenous graft thrombosis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Coronary artery restenosis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Incisional hernia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Instent coronary artery restenosis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Joint injury | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Radius fracture | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Spinal fracture | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Tendon rupture | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Upper limb fracture | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Vascular graft occlusion | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Investigations | ||||
| Cardiac stress test abnormal | 1/105 (1%) | 1 | 2/215 (0.9%) | 2 |
| Ejection fraction decreased | 2/105 (1.9%) | 2 | 0/215 (0%) | 0 |
| Troponin T | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Diabetic foot | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 0/105 (0%) | 0 | 1/215 (0.5%) | 2 |
| Hyperkalaemia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Hypoglycaemia | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Intervertebral disc protrusion | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Meniscus lesion | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Osteoarthritis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Brain neoplasm | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Colon cancer | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Hepatic cancer metastatic | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Hodgkins disease | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Leukaemia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Lip andor oral cavity cancer | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Lung neoplasm malignant | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Peritoneal carcinoma | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Nervous system disorders | ||||
| Cerebellar infarction | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Encephalopathy | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Ischaemic stroke | 1/105 (1%) | 1 | 1/215 (0.5%) | 1 |
| Neuralgia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Syncope vasovagal | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Transient ischaemic attack | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Psychiatric disorders | ||||
| Panic attack | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Renal and urinary disorders | ||||
| Nephropathy | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Renal artery stenosis | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Renal failure | 0/105 (0%) | 0 | 4/215 (1.9%) | 5 |
| Renal failure acute | 1/105 (1%) | 1 | 1/215 (0.5%) | 1 |
| Urinary retention | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 0/105 (0%) | 0 | 4/215 (1.9%) | 4 |
| Pneumothorax | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Pulmonary oedema | 1/105 (1%) | 1 | 1/215 (0.5%) | 1 |
| Vocal cord disorder | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Surgical and medical procedures | ||||
| Coronary angioplasty | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Coronary arterial stent insertion | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Coronary revascularisation | 1/105 (1%) | 1 | 2/215 (0.9%) | 2 |
| Diabetes mellitus management | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Vascular disorders | ||||
| Coronary artery dissection | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Femoral arterial stenosis | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Haematoma | 2/105 (1.9%) | 2 | 3/215 (1.4%) | 4 |
| Haemorrhage | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Hypertension | 2/105 (1.9%) | 2 | 2/215 (0.9%) | 2 |
| Hypovolaemic shock | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Peripheral arterial occlusive disease | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
| Peripheral ischaemia | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Peripheral vascular disorder | 0/105 (0%) | 0 | 2/215 (0.9%) | 2 |
| Retroperitoneal haemorrhage | 0/105 (0%) | 0 | 1/215 (0.5%) | 1 |
| Vascular pseudoaneurysm | 1/105 (1%) | 1 | 0/215 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| TAXUS® Liberté™ | XIENCE V® EECSS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/105 (12.4%) | 26/215 (12.1%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 12/105 (11.4%) | 13 | 14/215 (6.5%) | 14 |
| Coronary artery dissection | 1/105 (1%) | 1 | 12/215 (5.6%) | 12 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Robert Smith Jr, Ph.D., Sr Clinical Research Scientist |
|---|---|
| Organization | Abbott Vascular |
| Phone | 408-845-8265 |
| robert.smithjr@av.abbott.com |
- 05-369 Diabetic Sub-study