PERSEUS WH: TAXUS PERSEUS Workhorse

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00484315
• Collaborator: (none)
• Enrollment: 1,264
• Locations: 90
• Arms: 2
• Duration (Months): 75
• Patients Per Site: 14
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the TAXUS PERSEUS Workhorse trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries of 2.75 mm to 4.0 mm diameter.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation; Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement	Phase 3

Detailed Description

This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries ≥ 2.75 mm and ≤ 4.0 mm in diameter, compared to a control group of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System .

One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).

Eligible subjects will have annual follow-up until 5 years post-index procedure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1264 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAXUS Element	Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation; TAXUS Element stent placement
Active Comparator: TAXUS Express	Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement; TAXUS Express Stent Implant

Outcome Measures

Primary Outcome Measures

1. Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel. [12 months post-index procedure]

   The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.

Secondary Outcome Measures

1. In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure [9 months post-index procedure]

   The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Clinical Inclusion Criteria:

• Subject is ≥ 18 years old

• Eligible for percutaneous coronary intervention (PCI)

• Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia

• Acceptable candidate for coronary artery bypass grafting (CABG)

• Left ventricular ejection fraction (LVEF) is ≥ 30%

• Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

• Subject willing to comply with all specified follow-up evaluations

Clinical Exclusion Criteria:

• Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine

• Known hypersensitivity to paclitaxel

• Known allergy to stainless steel

• Known allergy to platinum

• Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent

• Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure

• Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure

• Previous treatment with intravascular brachytherapy in the target vessel

• Planned PCI or CABG post-index procedure

• Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement

• Myocardial infarction (MI) within 72 hours prior to index procedure

• Cerebrovascular accident (CVA) within the past 6 months

• Cardiogenic shock

• Acute or chronic renal dysfunction

• Prior anaphylactic reaction to contrast agents

• Leukopenia

• Thrombocytopenia

• Thrombocytosis

• Active peptic ulcer or active gastrointestinal (GI) bleeding

• Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents

• Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure

• Known intention to procreate within 9 months after the index procedure

• Positive pregnancy test within 7 days before the index procedure, or lactating

• Life expectancy of less than 24 months due to other medical conditions

• Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity

• Currently participating in another investigational drug or device study

Angiographic Inclusion Criteria:

• Target Lesion

• Target lesion located in native coronary artery

• Target lesion must be de novo

• Target lesion diameter stenosis ≥ 50%

• Reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 4.0 mm

• Cumulative target lesion length ≤ 28 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent)

• Target lesion is successfully pre-dilated

• One non-target lesion may be treated in a non-target vessel as follows:

• Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required

• Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s)

• Treatment must be completed prior to treatment of target vessel

Angiographic Exclusion Criteria

• Target lesion located in left main artery, whether protected or unprotected

• Target lesion is a chronic total occlusion (TIMI flow ≤ 1)

• Target lesion is restenotic

• Target lesion is located in a saphenous vein graft or mammary artery graft

• Target lesion is accessed via saphenous vein graft or mammary artery graft

• Target lesion is < 5 mm from bare metal stent (BMS)

• Target lesion < 5 mm from ostium

• Target lesion < 5 mm from side branch vessel ≥ 2.0 mm in diameter (Exceptions: subject may be enrolled if side branch is 100% occluded or if side branch is protected with a patent graft)

• Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel at a location with ≥ 2.0mm RVD

• Target lesion and/or target vessel proximal to target lesion moderately or severely calcified

• Target lesion and/or target vessel proximal to target lesion severely tortuous

• Target lesion located within or distal to a > 60° bend in target vessel

• Target vessel with angiographic presence of probable or definite thrombus

• Unprotected left main coronary artery disease

• Protected left main coronary artery disease with target lesion in Left Anterior Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if only lesion is target lesion in Right Coronary Artery (RCA)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Princeton	Birmingham	Alabama	United States	35211
2	Medical Center East	Birmingham	Alabama	United States	35235-3401
3	Bakersfield Memorial Hospital	Bakersfield	California	United States	93301
4	Alvarado Hospital	La Jolla	California	United States	92037
5	Scripps Clinic	La Jolla	California	United States	92037
6	Scripps Memorial Hospital	La Jolla	California	United States	92037
7	University of California, Davis Medical Center	Sacramento	California	United States	95817
8	Mercy General Hospital	Sacramento	California	United States	95819
9	South Denver Cardiology Associates, PC	Littleton	Colorado	United States	80120
10	Christiana Hospital	Newark	Delaware	United States	19718-0002
11	Washington Hospital Center	Washington	District of Columbia	United States	20010-3017
12	Mediquest Research at Munroe Regional Medical Center	Ocala	Florida	United States	34471
13	Florida Hospital	Orlando	Florida	United States	32803
14	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239-2940
15	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
16	Piedmont Hospital	Atlanta	Georgia	United States	30309
17	St. Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
18	Medical Center of Central Georgia	Macon	Georgia	United States	31208
19	Kaiser Foundation Hospitals	Honolulu	Hawaii	United States	96817
20	Evanston Northwestern	Evanston	Illinois	United States	60201
21	St. Anthony's Medical Center	Rockford	Illinois	United States	61107
22	St. John's Hospital	Springfield	Illinois	United States	62701
23	Northern Indiana Research Alliance / Lutheran Hospital of Indiana	Fort Wayne	Indiana	United States	46804-4140
24	Krannert Institute of Cardiology	Indianapolis	Indiana	United States	46202
25	St. Vincent's Hospital	Indianapolis	Indiana	United States	46290
26	Trinity Terrace Park	Davenport	Iowa	United States	52803
27	Iowa Heart Center	Des Moines	Iowa	United States	50134
28	Maine Medical Center	Portland	Maine	United States	04102-3134
29	Union Memorial Hospital	Baltimore	Maryland	United States	21218-2829
30	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912-6367
31	Tufts Medical Center	Boston	Massachusetts	United States	02111
32	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115
33	Cape Cod Research Institute	Hyannis	Massachusetts	United States	02601
34	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
35	Cardiac and Vascular Research Center of Northern Michigan	Petoskey	Michigan	United States	49770
36	Lakeland Hospitals at St. Joseph	St. Joseph	Michigan	United States	49085-2112
37	St. Mary's Duluth Clinic Regional Heart Center	Duluth	Minnesota	United States	55805
38	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407-1195
39	Mercy Hospital	Minneapolis	Minnesota	United States	55433
40	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
41	St. Anthony's Medical Center	St. Louis	Missouri	United States	63128-2106
42	Nebraska Heart Hospital	Lincoln	Nebraska	United States	68526
43	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
44	Heart Hospital of New Mexico	Albuquerque	New Mexico	United States	87102
45	St. Joseph's Hospital Health Center	Liverpool	New York	United States	13088
46	Lenox Hill Hospital	New York	New York	United States	10021
47	Columbia University Medical Center	New York	New York	United States	10032
48	Carolinas Medical Center	Charlotte	North Carolina	United States	28203-5866
49	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina	United States	27401
50	Wake Medical Center	Raleigh	North Carolina	United States	27610
51	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
52	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157-0001
53	The Christ Hospital	Cincinnati	Ohio	United States	45219
54	Ohio State University Medical Center	Columbus	Ohio	United States	43210
55	Riverside Methodist Hospital	Columbus	Ohio	United States	43214-3907
56	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
57	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma	United States	73120
58	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
59	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
60	Main Line Health Heart Center	Bryn Mawr	Pennsylvania	United States	19010
61	Lancaster General Hospital	Lancaster	Pennsylvania	United States	17604
62	St. Mary Medical Center	Langhorne	Pennsylvania	United States	19047
63	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104
64	Sisters of Charity Providence Hospital	Columbia	South Carolina	United States	29204-1018
65	University Medical Center-Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
66	Wellmont Holston Valley Medical Center	Kingsport	Tennessee	United States	37660-3831
67	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-7235
68	Baylor Heart & Vascular Hospital	Dallas	Texas	United States	75226
69	Methodist DeBakey Heart Center	Houston	Texas	United States	77030-2767
70	TexSAn Heart Hospital	San Antonio	Texas	United States	78229
71	Trinity Mother Frances Health System	Tyler	Texas	United States	75701
72	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
73	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
74	Lynchburg General Hospital	Lynchburg	Virginia	United States	24501
75	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507-1904
76	Swedish Medical Center	Seattle	Washington	United States	98122
77	Deaconess Medical Center	Spokane	Washington	United States	99204
78	Sacred Heart Medical Center	Spokane	Washington	United States	99204
79	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
80	University of Wisconsin	Madison	Wisconsin	United States	53792
81	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
82	CaRE Foundation, Inc.	Wausau	Wisconsin	United States	54401
83	Royal Adelaide Hospital, Adelaide, SA, Australia	Adelaide	South Australia	Australia	5000
84	Monash Medical Centre	Clayton	Victoria	Australia	3168
85	St. Vincents Public,	Fitzroy	Victoria	Australia	3065
86	Auckland City Hospital	Auckland		New Zealand	1023
87	Christchurch Hospital	Christchurch		New Zealand	8001
88	Waikato Hospital	Hamilton		New Zealand	3240
89	Wellington Hospital	Wellington		New Zealand
90	National Heart Centre	Singapore		Singapore	168752

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital
• Principal Investigator: Louis A Cannon, MD, Cardiac and Vascular Research Center of Northern Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00484315
• Other Study ID Numbers: S2037; S2037-PIVOT-2006
• First Posted: Jun 8, 2007
• Last Update Posted: May 8, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Boston Scientific Corporation: drug-eluting stent; paclitaxel-eluting stent; DES
• Additional relevant MeSH terms: Coronary Artery Disease; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Recruitment Details	Enrollment of 1264 subjects was planned; 1262 (942 TAXUS Element and 320 TAXUS Express) were enrolled and randomized at 90 centers by October 1, 2008. A total of 330 subjects were randomly assigned to protocol-mandated 9-month angiographic follow-up (angiographic subset).

Arm/Group Title	TAXUS Element	TAXUS Express
Arm/Group Description	Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
Period Title: 12-Month Clinical Follow-up
STARTED	942	320
COMPLETED	914	311
NOT COMPLETED	28	9
Period Title: 12-Month Clinical Follow-up
STARTED	256	74
COMPLETED	228	61
NOT COMPLETED	28	13

Baseline Characteristics

Arm/Group Title	TAXUS Element	TAXUS Express	Total
Arm/Group Description	Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)	Total of all reporting groups
Overall Participants	942	320	1262
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	540 57.3%	163 50.9%	703 55.7%
>=65 years	402 42.7%	157 49.1%	559 44.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.2 (9.6)	63.5 (9.5)	62.5 (9.6)
Sex: Female, Male (Count of Participants)
Female	275 29.2%	100 31.3%	375 29.7%
Male	667 70.8%	220 68.8%	887 70.3%
Race/Ethnicity, Customized (participants) [Number]
Hispanic or Latino	10 1.1%	6 1.9%	16 1.3%
Caucasian	872 92.6%	296 92.5%	1168 92.6%
Asian	15 1.6%	6 1.9%	21 1.7%
Black of African heritage	37 3.9%	13 4.1%	50 4%
Native Hawaiian or other Pacific Islander	4 0.4%	1 0.3%	5 0.4%
American Indian or Alaska native	3 0.3%	0 0%	3 0.2%
Other	4 0.4%	0 0%	4 0.3%
Region of Enrollment (participants) [Number]
United States	859 91.2%	290 90.6%	1149 91%
Singapore	6 0.6%	2 0.6%	8 0.6%
Australia	60 6.4%	22 6.9%	82 6.5%
New Zealand	17 1.8%	6 1.9%	23 1.8%
Cardiac History (participants) [Number]
Previous Percutaneous Coronary Intervention (PCI)	216 22.9%	80 25%	296 23.5%
Previous Coronary Artery Bypass Graft (CABG)	42 4.5%	20 6.3%	62 4.9%
Previous Myocardial Infarction (MI)	195 20.7%	60 18.8%	255 20.2%
Congestive Heart Failure	56 5.9%	24 7.5%	80 6.3%
Stable Angina	629 66.8%	213 66.6%	842 66.7%
Unstable Angina	195 20.7%	68 21.3%	263 20.8%
Silent Ischemia	117 12.4%	39 12.2%	156 12.4%
Cardiac History: Ejection Fraction (ejection fraction percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ejection fraction percent]	58.0 (9.3)	57.8 (9.8)	57.9 (9.4)
Cardiac Risk Factors (participants) [Number]
Smoking, Ever	611 64.9%	216 67.5%	827 65.5%
Medically Treated Diabetes	232 24.6%	80 25%	312 24.7%
Hyperlipidemia Requiring Medication	717 76.1%	243 75.9%	960 76.1%
Hypertension Requiring Medication	709 75.3%	256 80%	965 76.5%
Family History of Coronary Artery Disease	589 62.5%	196 61.3%	785 62.2%
Comorbidities (participants) [Number]
History of Peripheral Vascular Disease	99 10.5%	36 11.3%	135 10.7%
History of Transient Ischemic Attack	30 3.2%	14 4.4%	44 3.5%
History of Cerebrovascular Accident	30 3.2%	12 3.8%	42 3.3%
History of Renal Disease	45 4.8%	11 3.4%	56 4.4%
History of Gastrointestinal Bleeding	9 1%	7 2.2%	16 1.3%
Lesion Characteristic: Target Lesion Vessel (participants) [Number]
Left Anterior Descending Artery	406 43.1%	140 43.8%	546 43.3%
Left Circumflex Artery	217 23%	69 21.6%	286 22.7%
Right Coronary Artery	319 33.9%	111 34.7%	430 34.1%
Lesion Characteristic: Lesion Location (participants) [Number]
Ostial	25 2.7%	8 2.5%	33 2.6%
Proximal	368 39.1%	128 40%	496 39.3%
Mid	485 51.5%	154 48.1%	639 50.6%
Distal	64 6.8%	30 9.4%	94 7.4%
Lesion Characteristics (millimeter) [Mean (Standard Deviation) ]
Reference Vessel Diameter	2.8 (0.5)	2.8 (0.5)	2.8 (0.5)
Minimum Lumen Diameter	0.8 (0.3)	0.8 (0.4)	0.8 (0.3)
Lesion Length	14.2 (6.1)	14.1 (5.8)	14.2 (6.0)
Sidebranch Stenosis	24.4 (28.1)	25.7 (28.8)	24.7 (28.3)
Lesion Characteristic: Percent Diameter Stenosis (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	72.1 (10.9)	71.7 (10.9)	72.0 (10.9)
Lesion Characteristics (participants) [Number]
Eccentric Lesion	487 51.7%	161 50.3%	648 51.3%
> 45 Degree Bend	61 6.5%	22 6.9%	83 6.6%
> 90 Degree Bend	2 0.2%	1 0.3%	3 0.2%
Tortuosity, any	59 6.3%	14 4.4%	73 5.8%
Calcification, any	228 24.2%	86 26.9%	314 24.9%
Total Occlusion	6 0.6%	2 0.6%	8 0.6%
Bifurcation	343 36.4%	129 40.3%	472 37.4%
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class (participants) [Number]
Type A	79 8.4%	28 8.8%	107 8.5%
Type B1	233 24.7%	85 26.6%	318 25.2%
Type B2	384 40.8%	130 40.6%	514 40.7%
Type C	246 26.1%	77 24.1%	323 25.6%
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow (participants) [Number]
TIMI 0	2 0.2%	2 0.6%	4 0.3%
TIMI 1	4 0.4%	0 0%	4 0.3%
TIMI 2	34 3.6%	4 1.3%	38 3%
TIMI 3	902 95.8%	314 98.1%	1216 96.4%

Outcome Measures

1. Primary Outcome

Title	Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.
Description	The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.
Time Frame	12 months post-index procedure

Outcome Measure Data

Analysis Population Description

The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.

Arm/Group Title	TAXUS Element	TAXUS Express
Arm/Group Description	Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
Measure Participants	915	309
Number [participants]	51 5.4%	19 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAXUS Element, TAXUS Express
	Comments	Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was < 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.
Statistical Test of Hypothesis	p-Value	0.9996
	Comments	The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was < 4.1%, given the data observed.
	Method	Bayesian modeling
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.570
	Confidence Interval	(1-Sided) 95%; to 1.85
	Parameter Dispersion	Type: Standard Deviation; Value: 0.0155
	Estimation Comments	Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.

2. Secondary Outcome

Title	In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure
Description	The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.
Time Frame	9 months post-index procedure

Outcome Measure Data

Analysis Population Description

All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.

Arm/Group Title	TAXUS Element	TAXUS Express
Arm/Group Description	Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
Measure Participants	228	60
Mean (Standard Deviation) [percent diameter stenosis]	26.1 (17.71)	26.28 (17.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAXUS Element, TAXUS Express
	Comments	Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was < 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.
Statistical Test of Hypothesis	p-Value	0.9970
	Comments	P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was < 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.
	Method	Bayesian modeling
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.0294
	Confidence Interval	(1-Sided) 95%; to 0.1078
	Parameter Dispersion	Type: Standard Deviation; Value: 0.08253
	Estimation Comments	Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.

Adverse Events

Time Frame	Site reported serious and non-serious adverse events were collected through 365 days.
Arm/Group Title	TAXUS Element		TAXUS Express
Arm/Group Description	Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)		Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
All Cause Mortality
	TAXUS Element		TAXUS Express
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TAXUS Element		TAXUS Express
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	334/942 (35.5%)		110/320 (34.4%)
Blood and lymphatic system disorders
Anaemia	9/942 (1%)	9	5/320 (1.6%)	5
Leukocytosis	0/942 (0%)	0	1/320 (0.3%)	1
Microcytic anaemia	1/942 (0.1%)	1	1/320 (0.3%)	1
Cardiac disorders
Acute coronary syndrome	0/942 (0%)	0	1/320 (0.3%)	1
Angina pectoris	73/942 (7.7%)	84	27/320 (8.4%)	28
Angina unstable	18/942 (1.9%)	19	6/320 (1.9%)	7
Arteriospasm coronary	1/942 (0.1%)	1	0/320 (0%)	0
Atrial fibrillation	14/942 (1.5%)	16	2/320 (0.6%)	2
Atrial flutter	1/942 (0.1%)	1	2/320 (0.6%)	2
Atrial tachycardia	2/942 (0.2%)	2	0/320 (0%)	0
Atrioventricular block complete	1/942 (0.1%)	1	0/320 (0%)	0
Bradycardia	4/942 (0.4%)	4	2/320 (0.6%)	2
Bundle branch block right	0/942 (0%)	0	1/320 (0.3%)	1
Cardiac arrest	4/942 (0.4%)	5	1/320 (0.3%)	1
Cardiac disorder	2/942 (0.2%)	2	0/320 (0%)	0
Cardiac failure congestive	7/942 (0.7%)	8	5/320 (1.6%)	9
Cardiac tamponade	1/942 (0.1%)	1	0/320 (0%)	0
Coronary artery disease	9/942 (1%)	9	3/320 (0.9%)	3
Coronary artery dissection	10/942 (1.1%)	10	10/320 (3.1%)	10
Coronary artery embolism	0/942 (0%)	0	1/320 (0.3%)	1
Coronary artery occlusion	1/942 (0.1%)	1	0/320 (0%)	0
Coronary artery stenosis	18/942 (1.9%)	19	5/320 (1.6%)	5
Coronary artery thrombosis	1/942 (0.1%)	1	1/320 (0.3%)	1
Dressler's syndrome	1/942 (0.1%)	1	0/320 (0%)	0
Intracardiac thrombus	1/942 (0.1%)	1	0/320 (0%)	0
Myocardial infarction	24/942 (2.5%)	24	5/320 (1.6%)	5
Myocardial ischaemia	1/942 (0.1%)	1	1/320 (0.3%)	1
Pericardial effusion	1/942 (0.1%)	1	0/320 (0%)	0
Pericardial haemorrhage	0/942 (0%)	0	1/320 (0.3%)	1
Pericarditis	3/942 (0.3%)	3	0/320 (0%)	0
Sick sinus syndrome	6/942 (0.6%)	6	1/320 (0.3%)	1
Sinus bradycardia	2/942 (0.2%)	2	0/320 (0%)	0
Sinus tachycardia	1/942 (0.1%)	1	0/320 (0%)	0
Supraventricular tachycardia	2/942 (0.2%)	2	0/320 (0%)	0
Tachycardia	1/942 (0.1%)	1	0/320 (0%)	0
Ventricular arrhythmia	1/942 (0.1%)	1	0/320 (0%)	0
Ventricular asystole	1/942 (0.1%)	1	0/320 (0%)	0
Ventricular extrasystoles	1/942 (0.1%)	1	0/320 (0%)	0
Ventricular fibrillation	1/942 (0.1%)	1	0/320 (0%)	0
Ventricular tachycardia	3/942 (0.3%)	5	0/320 (0%)	0
Ear and labyrinth disorders
Vertigo	0/942 (0%)	0	1/320 (0.3%)	1
Endocrine disorders
Thyroid mass	1/942 (0.1%)	1	0/320 (0%)	0
Eye disorders
Cataract	0/942 (0%)	0	1/320 (0.3%)	1
Retinal detachment	1/942 (0.1%)	1	0/320 (0%)	0
Gastrointestinal disorders
Abdominal distension	1/942 (0.1%)	1	0/320 (0%)	0
Abdominal pain	2/942 (0.2%)	2	0/320 (0%)	0
Abdominal pain lower	1/942 (0.1%)	1	0/320 (0%)	0
Abdominal pain upper	1/942 (0.1%)	1	0/320 (0%)	0
Anal fistula	1/942 (0.1%)	1	0/320 (0%)	0
Chronic gastrointestinal bleeding	1/942 (0.1%)	2	0/320 (0%)	0
Colitis	0/942 (0%)	0	1/320 (0.3%)	1
Crohn's disease	1/942 (0.1%)	1	0/320 (0%)	0
Diverticulum	0/942 (0%)	0	1/320 (0.3%)	1
Diverticulum intestinal haemorrhagic	1/942 (0.1%)	1	0/320 (0%)	0
Erosive duodenitis	1/942 (0.1%)	1	0/320 (0%)	0
Gastric ulcer	0/942 (0%)	0	1/320 (0.3%)	1
Gastritis	2/942 (0.2%)	2	1/320 (0.3%)	1
Gastritis erosive	2/942 (0.2%)	2	0/320 (0%)	0
Gastrointestinal haemorrhage	5/942 (0.5%)	6	0/320 (0%)	0
Gastrooesophageal reflux disease	0/942 (0%)	0	1/320 (0.3%)	1
Haemorrhoidal haemorrhage	1/942 (0.1%)	1	0/320 (0%)	0
Hiatus hernia	2/942 (0.2%)	2	0/320 (0%)	0
Intestinal obstruction	1/942 (0.1%)	1	0/320 (0%)	0
Intra-abdominal haematoma	0/942 (0%)	0	1/320 (0.3%)	1
Lower gastrointestinal haemorrhage	1/942 (0.1%)	1	0/320 (0%)	0
Melaena	0/942 (0%)	0	1/320 (0.3%)	1
Pancreatitis acute	1/942 (0.1%)	1	0/320 (0%)	0
Rectal haemorrhage	3/942 (0.3%)	3	1/320 (0.3%)	1
Retroperitoneal haematoma	2/942 (0.2%)	2	0/320 (0%)	0
Retroperitoneal haemorrhage	2/942 (0.2%)	2	0/320 (0%)	0
Small intestinal obstruction	3/942 (0.3%)	3	0/320 (0%)	0
Splenic artery aneurysm	1/942 (0.1%)	1	0/320 (0%)	0
Umbilical hernia, obstructive	1/942 (0.1%)	1	0/320 (0%)	0
Upper gastrointestinal haemorrhage	1/942 (0.1%)	1	1/320 (0.3%)	1
General disorders
Adverse drug reaction	2/942 (0.2%)	2	0/320 (0%)	0
Catheter site haematoma	4/942 (0.4%)	4	3/320 (0.9%)	3
Catheter site haemorrhage	4/942 (0.4%)	4	2/320 (0.6%)	2
Catheter site related reaction	0/942 (0%)	0	1/320 (0.3%)	1
Chest discomfort	1/942 (0.1%)	1	0/320 (0%)	0
Chills	0/942 (0%)	0	1/320 (0.3%)	1
Death	1/942 (0.1%)	1	0/320 (0%)	0
Non-cardiac chest pain	53/942 (5.6%)	61	15/320 (4.7%)	18
Pain	3/942 (0.3%)	3	0/320 (0%)	0
Pyrexia	2/942 (0.2%)	2	0/320 (0%)	0
Hepatobiliary disorders
Cholecystitis	0/942 (0%)	0	2/320 (0.6%)	2
Cholecystitis acute	1/942 (0.1%)	1	1/320 (0.3%)	1
Cholelithiasis	1/942 (0.1%)	1	1/320 (0.3%)	1
Immune system disorders
Anaphylactic reaction	1/942 (0.1%)	1	0/320 (0%)	0
Anaphylactoid reaction	1/942 (0.1%)	1	0/320 (0%)	0
Drug hypersensitivity	1/942 (0.1%)	1	0/320 (0%)	0
Infections and infestations
Acinetobacter bacteraemia	0/942 (0%)	0	1/320 (0.3%)	1
Beta haemolytic streptococcal infection	0/942 (0%)	0	1/320 (0.3%)	1
Bronchitis	3/942 (0.3%)	3	0/320 (0%)	0
Cellulitis	3/942 (0.3%)	3	4/320 (1.3%)	6
Device related infection	1/942 (0.1%)	1	0/320 (0%)	0
Empyema	1/942 (0.1%)	1	0/320 (0%)	0
Endocarditis	0/942 (0%)	0	1/320 (0.3%)	1
Gastroenteritis	3/942 (0.3%)	3	0/320 (0%)	0
Gastroenteritis viral	2/942 (0.2%)	2	0/320 (0%)	0
Lobar pneumonia	0/942 (0%)	0	1/320 (0.3%)	1
Orchitis	1/942 (0.1%)	1	0/320 (0%)	0
Osteomyelitis	0/942 (0%)	0	3/320 (0.9%)	4
Perirectal abscess	1/942 (0.1%)	1	0/320 (0%)	0
Pneumonia	9/942 (1%)	9	2/320 (0.6%)	2
Pneumonia bacterial	1/942 (0.1%)	1	0/320 (0%)	0
Postoperative wound infection	2/942 (0.2%)	2	0/320 (0%)	0
Sepsis	1/942 (0.1%)	1	0/320 (0%)	0
Staphylococcal infection	1/942 (0.1%)	1	0/320 (0%)	0
Tooth abscess	1/942 (0.1%)	1	0/320 (0%)	0
Urinary tract infection	2/942 (0.2%)	2	1/320 (0.3%)	1
Viral infection	1/942 (0.1%)	1	0/320 (0%)	0
Wound infection	1/942 (0.1%)	1	0/320 (0%)	0
Injury, poisoning and procedural complications
Abdominal wound dehiscence	0/942 (0%)	0	1/320 (0.3%)	1
Anaemia postoperative	0/942 (0%)	0	1/320 (0.3%)	1
Anastomotic ulcer	1/942 (0.1%)	1	0/320 (0%)	0
Back injury	1/942 (0.1%)	1	0/320 (0%)	0
Cardiac procedure complication	2/942 (0.2%)	2	3/320 (0.9%)	3
Contrast media reaction	1/942 (0.1%)	1	0/320 (0%)	0
Contusion	1/942 (0.1%)	1	0/320 (0%)	0
Facial bones fracture	3/942 (0.3%)	3	0/320 (0%)	0
Fall	1/942 (0.1%)	1	0/320 (0%)	0
Foot fracture	1/942 (0.1%)	1	0/320 (0%)	0
Hand fracture	1/942 (0.1%)	1	0/320 (0%)	0
Hip fracture	1/942 (0.1%)	1	0/320 (0%)	0
Joint injury	1/942 (0.1%)	1	0/320 (0%)	0
Laceration	1/942 (0.1%)	1	0/320 (0%)	0
Ligament rupture	1/942 (0.1%)	1	0/320 (0%)	0
Limb injury	2/942 (0.2%)	2	0/320 (0%)	0
Lumbar vertebral fracture	1/942 (0.1%)	1	0/320 (0%)	0
Meniscus lesion	1/942 (0.1%)	1	0/320 (0%)	0
Multiple fractures	1/942 (0.1%)	1	0/320 (0%)	0
Post procedural bile leak	0/942 (0%)	0	1/320 (0.3%)	1
Renal injury	0/942 (0%)	0	1/320 (0.3%)	1
Road traffic accident	1/942 (0.1%)	1	0/320 (0%)	0
Skin laceration	2/942 (0.2%)	2	0/320 (0%)	0
Subdural haematoma	1/942 (0.1%)	2	0/320 (0%)	0
Tendon rupture	2/942 (0.2%)	2	0/320 (0%)	0
Thoracic vertebral fracture	1/942 (0.1%)	1	0/320 (0%)	0
Wound	1/942 (0.1%)	1	0/320 (0%)	0
Wound complication	0/942 (0%)	0	1/320 (0.3%)	1
Investigations
Blood creatine phosphokinase MB increased	1/942 (0.1%)	1	0/320 (0%)	0
Blood creatine phosphokinase increased	2/942 (0.2%)	2	0/320 (0%)	0
Blood pressure increased	1/942 (0.1%)	1	0/320 (0%)	0
Cardiac enzymes increased	3/942 (0.3%)	3	2/320 (0.6%)	2
Ejection fraction decreased	1/942 (0.1%)	1	0/320 (0%)	0
International normalised ratio increased	1/942 (0.1%)	1	1/320 (0.3%)	1
Troponin I increased	1/942 (0.1%)	1	0/320 (0%)	0
Troponin increased	0/942 (0%)	0	1/320 (0.3%)	1
White blood cell count increased	1/942 (0.1%)	1	0/320 (0%)	0
Metabolism and nutrition disorders
Dehydration	2/942 (0.2%)	2	0/320 (0%)	0
Diabetes mellitus inadequate control	1/942 (0.1%)	2	1/320 (0.3%)	1
Diabetic foot	1/942 (0.1%)	2	0/320 (0%)	0
Gout	1/942 (0.1%)	1	0/320 (0%)	0
Hyperglycaemia	0/942 (0%)	0	1/320 (0.3%)	1
Hyperkalaemia	1/942 (0.1%)	1	0/320 (0%)	0
Hypoglycaemia	1/942 (0.1%)	1	1/320 (0.3%)	1
Hypokalaemia	0/942 (0%)	0	1/320 (0.3%)	1
Obesity	1/942 (0.1%)	1	0/320 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/942 (0.2%)	2	0/320 (0%)	0
Arthritis	1/942 (0.1%)	1	0/320 (0%)	0
Arthropathy	1/942 (0.1%)	1	0/320 (0%)	0
Back pain	2/942 (0.2%)	2	1/320 (0.3%)	1
Dupuytren's contracture	1/942 (0.1%)	1	0/320 (0%)	0
Lumbar spinal stenosis	1/942 (0.1%)	1	0/320 (0%)	0
Mobility decreased	0/942 (0%)	0	1/320 (0.3%)	1
Muscle spasms	1/942 (0.1%)	1	0/320 (0%)	0
Muscular weakness	1/942 (0.1%)	1	0/320 (0%)	0
Musculoskeletal chest pain	1/942 (0.1%)	1	0/320 (0%)	0
Musculoskeletal pain	1/942 (0.1%)	1	0/320 (0%)	0
Osteoarthritis	3/942 (0.3%)	3	0/320 (0%)	0
Pain in extremity	2/942 (0.2%)	2	0/320 (0%)	0
Pain in jaw	0/942 (0%)	0	1/320 (0.3%)	1
Rotator cuff syndrome	2/942 (0.2%)	3	0/320 (0%)	0
Sensation of heaviness	1/942 (0.1%)	1	0/320 (0%)	0
Spinal column stenosis	2/942 (0.2%)	2	0/320 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm	1/942 (0.1%)	1	0/320 (0%)	0
Bladder cancer	2/942 (0.2%)	2	0/320 (0%)	0
Brain cancer metastatic	0/942 (0%)	0	1/320 (0.3%)	1
Brain neoplasm benign	0/942 (0%)	0	1/320 (0.3%)	1
Breast cancer	3/942 (0.3%)	3	1/320 (0.3%)	1
Colon cancer	0/942 (0%)	0	1/320 (0.3%)	1
Lymphoma	0/942 (0%)	0	1/320 (0.3%)	1
Metastases to lung	1/942 (0.1%)	1	0/320 (0%)	0
Metastatic carcinoma of the bladder	1/942 (0.1%)	1	0/320 (0%)	0
Papillary thyroid cancer	1/942 (0.1%)	1	0/320 (0%)	0
Rectosigmoid cancer	1/942 (0.1%)	1	0/320 (0%)	0
Renal neoplasm	1/942 (0.1%)	1	0/320 (0%)	0
Skin cancer	0/942 (0%)	0	1/320 (0.3%)	1
Tongue neoplasm malignant stage unspecified	1/942 (0.1%)	1	0/320 (0%)	0
Transitional cell carcinoma	1/942 (0.1%)	1	0/320 (0%)	0
Nervous system disorders
Carotid artery stenosis	4/942 (0.4%)	5	2/320 (0.6%)	3
Cerebrovascular accident	0/942 (0%)	0	1/320 (0.3%)	1
Convulsion	1/942 (0.1%)	1	0/320 (0%)	0
Dizziness	2/942 (0.2%)	2	0/320 (0%)	0
Embolic stroke	0/942 (0%)	0	1/320 (0.3%)	1
Haemorrhage intracranial	0/942 (0%)	0	1/320 (0.3%)	1
Headache	1/942 (0.1%)	1	0/320 (0%)	0
Hydrocephalus	1/942 (0.1%)	1	0/320 (0%)	0
Loss of consciousness	1/942 (0.1%)	1	0/320 (0%)	0
Nerve compression	1/942 (0.1%)	1	0/320 (0%)	0
Presyncope	1/942 (0.1%)	1	1/320 (0.3%)	1
Subarachnoid haemorrhage	1/942 (0.1%)	1	1/320 (0.3%)	1
Syncope	3/942 (0.3%)	3	0/320 (0%)	0
Syncope vasovagal	2/942 (0.2%)	2	0/320 (0%)	0
Transient ischaemic attack	0/942 (0%)	0	3/320 (0.9%)	4
Psychiatric disorders
Mental status changes	4/942 (0.4%)	4	1/320 (0.3%)	1
Renal and urinary disorders
Haematuria	4/942 (0.4%)	4	0/320 (0%)	0
Nephrolithiasis	2/942 (0.2%)	2	1/320 (0.3%)	1
Nephropathy toxic	0/942 (0%)	0	1/320 (0.3%)	1
Renal artery stenosis	1/942 (0.1%)	1	2/320 (0.6%)	2
Renal failure	2/942 (0.2%)	2	0/320 (0%)	0
Renal failure acute	4/942 (0.4%)	4	2/320 (0.6%)	2
Urinary retention	2/942 (0.2%)	2	0/320 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/942 (0.1%)	1	0/320 (0%)	0
Prostatitis	0/942 (0%)	0	1/320 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/942 (0.1%)	1	0/320 (0%)	0
Chronic obstructive pulmonary disease	5/942 (0.5%)	5	1/320 (0.3%)	1
Dyspnoea	7/942 (0.7%)	7	3/320 (0.9%)	3
Dyspnoea exertional	0/942 (0%)	0	1/320 (0.3%)	1
Epistaxis	1/942 (0.1%)	2	2/320 (0.6%)	3
Laryngeal mass	1/942 (0.1%)	1	0/320 (0%)	0
Pleural effusion	1/942 (0.1%)	2	0/320 (0%)	0
Pleuritic pain	0/942 (0%)	0	1/320 (0.3%)	1
Pneumonia aspiration	1/942 (0.1%)	1	0/320 (0%)	0
Pneumonitis	0/942 (0%)	0	1/320 (0.3%)	1
Pneumothorax	1/942 (0.1%)	1	0/320 (0%)	0
Pulmonary embolism	2/942 (0.2%)	2	3/320 (0.9%)	3
Pulmonary fibrosis	0/942 (0%)	0	1/320 (0.3%)	1
Respiratory arrest	0/942 (0%)	0	1/320 (0.3%)	1
Respiratory distress	1/942 (0.1%)	1	0/320 (0%)	0
Respiratory failure	2/942 (0.2%)	3	2/320 (0.6%)	2
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/942 (0%)	0	1/320 (0.3%)	1
Skin ulcer	0/942 (0%)	0	1/320 (0.3%)	1
Surgical and medical procedures
Spinal decompression	1/942 (0.1%)	1	0/320 (0%)	0
Vascular disorders
Aortic aneurysm	2/942 (0.2%)	3	0/320 (0%)	0
Aortic stenosis	1/942 (0.1%)	1	0/320 (0%)	0
Arterial thrombosis limb	1/942 (0.1%)	1	0/320 (0%)	0
Coronary artery stenosis	1/942 (0.1%)	1	1/320 (0.3%)	1
Deep vein thrombosis	4/942 (0.4%)	4	1/320 (0.3%)	1
Femoral arterial stenosis	1/942 (0.1%)	1	0/320 (0%)	0
Haematoma	3/942 (0.3%)	3	0/320 (0%)	0
Hypertension	4/942 (0.4%)	4	0/320 (0%)	0
Hypotension	4/942 (0.4%)	4	1/320 (0.3%)	1
Intermittent claudication	10/942 (1.1%)	11	0/320 (0%)	0
Myocardial infarction	1/942 (0.1%)	1	0/320 (0%)	0
Orthostatic hypotension	0/942 (0%)	0	1/320 (0.3%)	1
Peripheral artery dissection	1/942 (0.1%)	1	0/320 (0%)	0
Peripheral vascular disorder	4/942 (0.4%)	5	4/320 (1.3%)	4
Phlebitis	0/942 (0%)	0	1/320 (0.3%)	1
Phlebitis superficial	0/942 (0%)	0	1/320 (0.3%)	1
Subclavian artery stenosis	1/942 (0.1%)	1	0/320 (0%)	0
Thrombophlebitis superficial	1/942 (0.1%)	1	0/320 (0%)	0
Vascular pseudoaneurysm	7/942 (0.7%)	7	2/320 (0.6%)	2
Other (Not Including Serious) Adverse Events
	TAXUS Element		TAXUS Express
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	277/942 (29.4%)		97/320 (30.3%)
Cardiac disorders
Angina pectoris	98/942 (10.4%)	114	40/320 (12.5%)	44
General disorders
Catheter site haematoma	46/942 (4.9%)	47	19/320 (5.9%)	22
Catheter site haemorrhage	28/942 (3%)	28	16/320 (5%)	18
Non-cardiac chest pain	120/942 (12.7%)	150	32/320 (10%)	36
Musculoskeletal and connective tissue disorders
Back pain	55/942 (5.8%)	56	18/320 (5.6%)	19

Limitations/Caveats

The comparator control for PERSEUS Workhorse study was chosen based on commercially available stent (TAXUS Express) at the time of study enrollment. Thus, the comparator group does not represent the most recently available paclitaxel-eluting stent.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.