ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

• Sponsor: The Medicines Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01913483
• Collaborator: (none)
• Enrollment: 732
• Locations: 39
• Arms: 2
• Actual Duration (Months): 29.7
• Patients Per Site: 18.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Endovascular Interventions; Bleeding	Drug: Bivalirudin; Drug: Unfractionated Heparin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 732 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
• Actual Study Start Date: Sep 24, 2013
• Actual Primary Completion Date: Mar 16, 2016
• Actual Study Completion Date: Mar 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bivalirudin Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters/minute [mL/min]).	Drug: Bivalirudin; Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.; Other Names: AngioMAX Angiox
Active Comparator: Unfractionated Heparin UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.	Drug: Unfractionated Heparin; Unfractionated heparin is an anticoagulant.; Other Names: Heparin

Outcome Measures

Primary Outcome Measures

1. Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC) [Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first]

   BARC ≥3 includes: Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision. Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period. Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.

Secondary Outcome Measures

1. Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration [Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first]

   Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3). In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.

2. Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30 [Study drug initiation (Day 1) up to 30 days]

   Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC. In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participants ≥ 18 years of age

• Must be undergoing one of the following PEI procedures:

• Carotid artery stenting

• Lower Extremity Interventions (LEI) for Critical Limb Ischemia

• LEI for claudication

• Provide written informed consent prior to any study-specific procedure being performed

Exclusion Criteria:

• Any known contra-indication to the use of bivalirudin or UFH

• Acute limb ischemia

• Planned amputation regardless of the outcome of the PEI

• Dialysis dependent

• Weight less than 38 kg or more than 202 kg

• History of any bleeding diathesis or severe hematological disease

• History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage

• Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization

• Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization

• Concomitant percutaneous coronary intervention

• Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization

• International normalized ratio >1.7 within 24 h prior to the index procedure

• Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention)

• Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure

• Severe contrast allergy that cannot be pre-medicated

• Procedures performed by radial access when they are intended as the primary access site for the index procedure

• Known or suspected pregnant women or nursing mothers

• Previous enrollment in this study (MDCO-BIV-12-03)

• Participation in other investigational drug or device trials within 30 days prior to randomization

• Participants who, for any reason, are deemed by the investigator to be inappropriate for this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Lakes Research	Hot Springs	Arkansas	United States	71901
2	Stanford Hospital and Clinics	Stanford	California	United States	94305-5407
3	Clearwater Cardiovascular and Interventional Consultants	Clearwater	Florida	United States	33756
4	Florida Research Network	Gainesville	Florida	United States	32605
5	The Cardiac and Vascular Institute	Gainesville	Florida	United States	32605
6	Baptist Cardiac & Vascular Institute	Miami	Florida	United States	33176
7	Florida Hospital	Orlando	Florida	United States	32803
8	Peoria Radiology Research & Education Foundation	Peoria	Illinois	United States	61637
9	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52803
10	Kentucky Heart Foundation - King's Daughters Medical Center	Ashland	Kentucky	United States	41101
11	Tufts Medical Center	Boston	Massachusetts	United States	02111
12	VA Boston Healthcare System	Boston	Massachusetts	United States	02132
13	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
14	Cape Cod Research Institute	Hyannis	Massachusetts	United States	02601
15	Michigan Heart	Ypsilanti	Michigan	United States	48197
16	Mayo Clinic	Rochester	Minnesota	United States	55905
17	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
18	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
19	New Mexico Heart Institute	Albuquerque	New Mexico	United States	87102
20	Weill Cornell Medical College	New York	New York	United States	10021
21	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
22	Columbia University Medical Center	New York	New York	United States	10032
23	Stony Brook Medicine	Stony Brook	New York	United States	11794
24	Novant Health Heart and Vascular Institute	Charlotte	North Carolina	United States	28204
25	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina	United States	27401
26	University of Cincinnati	Cincinnati	Ohio	United States	45267
27	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
28	Jobst Vascular Institute	Toledo	Ohio	United States	43606
29	Integris - Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
30	Rhode Island Hospital	Providence	Rhode Island	United States	02903
31	AnMed Health	Anderson	South Carolina	United States	29621
32	Medical University of South Carolina	Charleston	South Carolina	United States	29425
33	Texas Tech University Health Science Center	Lubbock	Texas	United States	79430
34	Scott and White Hospital	Temple	Texas	United States	76508
35	Alpine Research	Ogden	Utah	United States	84403
36	INOVA Alexandria Hospital	Alexandria	Virginia	United States	22304
37	University of Virginia Health System	Charlottesville	Virginia	United States	22908
38	Swedish Medical Center	Seattle	Washington	United States	98122
39	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• The Medicines Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Medicines Company
• ClinicalTrials.gov Identifier: NCT01913483
• Other Study ID Numbers: MDCO-BIV-12-03
• First Posted: Aug 1, 2013
• Last Update Posted: May 30, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heparin; Calcium heparin; Bivalirudin

Study Results

Participant Flow

Pre-assignment Detail	Participants who were randomized into the trial, who received at least one dose of study drug (Safety Population), and underwent the index peripheral endovascular interventions (PEI) procedure were included in the modified Intent-to-Treat (mITT) Population. This was the primary population for analyses of the primary and secondary endpoints.

Arm/Group Title	Bivalirudin	Unfractionated Heparin
Arm/Group Description	Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).	Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Period Title: Overall Study
STARTED	367	365
Received at Least 1 Dose of Study Drug	335	321
COMPLETED	346	343
NOT COMPLETED	21	22

Baseline Characteristics

Arm/Group Title	Bivalirudin	Unfractionated Heparin	Total
Arm/Group Description	Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).	UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.	Total of all reporting groups
Overall Participants	335	321	656
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	69.3 (10.3)	68.8 (10.3)	69.0 (10.3)
Sex: Female, Male (Count of Participants)
Female	133 39.7%	123 38.3%	256 39%
Male	202 60.3%	198 61.7%	400 61%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	1 0.3%	4 0.6%
Asian	1 0.3%	2 0.6%	3 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	49 14.6%	40 12.5%	89 13.6%
White	282 84.2%	278 86.6%	560 85.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	335 100%	321 100%	656 100%

Outcome Measures

1. Primary Outcome

Title	Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
Description	BARC ≥3 includes: Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision. Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period. Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.
Time Frame	Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first

Outcome Measure Data

Analysis Population Description

mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.

Arm/Group Title	Bivalirudin	Unfractionated Heparin
Arm/Group Description	Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).	UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Measure Participants	335	321
Number [percentage of participants]	1.5 0.4%	1.6 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bivalirudin, Unfractionated Heparin
	Comments	Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9458
	Comments	The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
Description	Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3). In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.
Time Frame	Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first

Outcome Measure Data

Analysis Population Description

mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.

Arm/Group Title	Bivalirudin	Unfractionated Heparin
Arm/Group Description	Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).	UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Measure Participants	335	321
Bleed (BARC ≥ Type 2)	47 14%	42 13.1%
TIMI major	0 0%	4 1.2%
TIMI minor	4 1.2%	1 0.3%
Death	0 0%	1 0.3%
MI	0 0%	0 0%
Stroke/TIA	0 0%	0 0%
Amputation	0 0%	0 0%
URV	2 0.6%	2 0.6%
NACE	7 2.1%	6 1.9%

3. Secondary Outcome

Title	Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Description	Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC. In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.
Time Frame	Study drug initiation (Day 1) up to 30 days

Outcome Measure Data

Analysis Population Description

mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.

Arm/Group Title	Bivalirudin	Unfractionated Heparin
Arm/Group Description	Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).	UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Measure Participants	335	321
Bleed (BARC ≥ Type 2)	53 15.8%	51 15.9%
Bleed (BARC ≥ Type 3)	6 1.8%	7 2.2%
Death	2 0.6%	3 0.9%
MI	0 0%	1 0.3%
Stroke/TIA	1 0.3%	2 0.6%
Amputation	8 2.4%	5 1.6%
URV	9 2.7%	11 3.4%
MACE (Death/MI/Stroke/Amputation/URV)	18 5.4%	19 5.9%
NACE	22 6.6%	23 7.2%

Adverse Events

Time Frame	Randomization up to 30 days (±7 days)
Adverse Event Reporting Description	Does not include 2 participants who died before receiving study drug.
Arm/Group Title	Bivalirudin		Unfractionated Heparin
Arm/Group Description	Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).		UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
All Cause Mortality
	Bivalirudin		Unfractionated Heparin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/335 (3.9%)		16/321 (5%)
Serious Adverse Events
	Bivalirudin		Unfractionated Heparin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/335 (7.5%)		27/321 (8.4%)
Cardiac disorders
Cardiac failure congestive	2/335 (0.6%)		1/321 (0.3%)
Acute coronary syndrome	1/335 (0.3%)		0/321 (0%)
Bradycardia	0/335 (0%)		1/321 (0.3%)
Cardiac arrest	0/335 (0%)		1/321 (0.3%)
Ear and labyrinth disorders
Vertigo	1/335 (0.3%)		0/321 (0%)
Gastrointestinal disorders
Retroperitoneal haemorrhage	0/335 (0%)		1/321 (0.3%)
General disorders
Asthenia	0/335 (0%)		1/321 (0.3%)
Ischaemic ulcer	1/335 (0.3%)		0/321 (0%)
Local swelling	0/335 (0%)		1/321 (0.3%)
Thrombosis in device	0/335 (0%)		1/321 (0.3%)
Vessel puncture site pain	1/335 (0.3%)		0/321 (0%)
Infections and infestations
Cellulitis	2/335 (0.6%)		2/321 (0.6%)
Urinary tract infection	0/335 (0%)		3/321 (0.9%)
Postoperative wound infection	0/335 (0%)		2/321 (0.6%)
Sepsis	2/335 (0.6%)		0/321 (0%)
Groin infection	0/335 (0%)		1/321 (0.3%)
Lobar pneumonia	0/335 (0%)		1/321 (0.3%)
Localised infection	0/335 (0%)		1/321 (0.3%)
Injury, poisoning and procedural complications
Procedural pain	0/335 (0%)		1/321 (0.3%)
Rib fracture	1/335 (0.3%)		0/321 (0%)
Vascular graft thrombosis	0/335 (0%)		1/321 (0.3%)
Vascular pseudoaneurysm	1/335 (0.3%)		0/321 (0%)
Metabolism and nutrition disorders
Failure to thrive	1/335 (0.3%)		0/321 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/335 (0.3%)		2/321 (0.6%)
Back pain	1/335 (0.3%)		0/321 (0%)
Compartment syndrome	0/335 (0%)		1/321 (0.3%)
Osteoarthritis	1/335 (0.3%)		0/321 (0%)
Tendon necrosis	1/335 (0.3%)		0/321 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma	0/335 (0%)		1/321 (0.3%)
Nervous system disorders
Syncope	1/335 (0.3%)		0/321 (0%)
Psychiatric disorders
Mental status change	0/335 (0%)		1/321 (0.3%)
Renal and urinary disorders
Renal failure acute	2/335 (0.6%)		2/321 (0.6%)
Urinary retention	0/335 (0%)		1/321 (0.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/335 (0.3%)		1/321 (0.3%)
Dyspnoea	1/335 (0.3%)		0/321 (0%)
Wheezing	1/335 (0.3%)		0/321 (0%)
Surgical and medical procedures
Aortic aneurysm	0/335 (0%)		1/321 (0.3%)
Peripheral artery bypass	0/335 (0%)		1/321 (0.3%)
Vascular disorders
Deep vein thrombosis	1/335 (0.3%)		0/321 (0%)
Femoral artery dissection	0/335 (0%)		1/321 (0.3%)
Femoral artery embolism	1/335 (0.3%)		0/321 (0%)
Femoral artery occlusion	1/335 (0.3%)		0/321 (0%)
Hypotension	1/335 (0.3%)		0/321 (0%)
Peripheral artery dissection	1/335 (0.3%)		0/321 (0%)
Peripheral artery stenosis	1/335 (0.3%)		0/321 (0%)
Peripheral artery thrombosis	0/335 (0%)		1/321 (0.3%)
Peripheral vascular disorder	0/335 (0%)		1/321 (0.3%)
Other (Not Including Serious) Adverse Events
	Bivalirudin		Unfractionated Heparin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/335 (24.2%)		70/321 (21.8%)
Gastrointestinal disorders
Nausea	8/335 (2.4%)		5/321 (1.6%)
Vomiting	5/335 (1.5%)		2/321 (0.6%)
Abdominal pain	0/335 (0%)		4/321 (1.2%)
General disorders
Vessel puncture site pain	9/335 (2.7%)		5/321 (1.6%)
Pain	7/335 (2.1%)		3/321 (0.9%)
Musculoskeletal and connective tissue disorders
Back pain	12/335 (3.6%)		15/321 (4.7%)
Pain in extremity	11/335 (3.3%)		8/321 (2.5%)
Groin pain	6/335 (1.8%)		1/321 (0.3%)
Vascular disorders
Hypertension	15/335 (4.5%)		13/321 (4%)
Hypotension	10/335 (3%)		15/321 (4.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.