Trial Outcomes & Findings for ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial (NCT NCT01913483)
NCT ID: NCT01913483
Last Updated: 2017-05-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
732 participants
Primary outcome timeframe
Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
Results posted on
2017-05-30
Participant Flow
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.
Participant milestones
| Measure |
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 per minute \[mL/min\]).
|
Unfractionated Heparin
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.
|
|---|---|---|
|
Overall Study
STARTED
|
367
|
365
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
335
|
321
|
|
Overall Study
COMPLETED
|
346
|
343
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
| Measure |
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 per minute \[mL/min\]).
|
Unfractionated Heparin
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Death
|
14
|
17
|
Baseline Characteristics
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Baseline characteristics by cohort
| Measure |
Bivalirudin
n=335 Participants
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).
|
Unfractionated Heparin
n=321 Participants
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
n=656 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 Years
STANDARD_DEVIATION 10.3 • n=93 Participants
|
68.8 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
69.0 Years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=93 Participants
|
123 Participants
n=4 Participants
|
256 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=93 Participants
|
198 Participants
n=4 Participants
|
400 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
282 Participants
n=93 Participants
|
278 Participants
n=4 Participants
|
560 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
335 participants
n=93 Participants
|
321 participants
n=4 Participants
|
656 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs firstPopulation: mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.
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.
Outcome measures
| Measure |
Bivalirudin
n=335 Participants
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).
|
Unfractionated Heparin
n=321 Participants
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.
|
|---|---|---|
|
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)
|
1.5 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs firstPopulation: mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.
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.
Outcome measures
| Measure |
Bivalirudin
n=335 Participants
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).
|
Unfractionated Heparin
n=321 Participants
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.
|
|---|---|---|
|
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
Bleed (BARC ≥ Type 2)
|
47 participants
|
42 participants
|
|
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
TIMI major
|
0 participants
|
4 participants
|
|
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
TIMI minor
|
4 participants
|
1 participants
|
|
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
Death
|
0 participants
|
1 participants
|
|
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
MI
|
0 participants
|
0 participants
|
|
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
Stroke/TIA
|
0 participants
|
0 participants
|
|
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
Amputation
|
0 participants
|
0 participants
|
|
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
URV
|
2 participants
|
2 participants
|
|
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
NACE
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Study drug initiation (Day 1) up to 30 daysPopulation: mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.
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.
Outcome measures
| Measure |
Bivalirudin
n=335 Participants
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).
|
Unfractionated Heparin
n=321 Participants
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.
|
|---|---|---|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Bleed (BARC ≥ Type 2)
|
53 participants
|
51 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Bleed (BARC ≥ Type 3)
|
6 participants
|
7 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Death
|
2 participants
|
3 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
MI
|
0 participants
|
1 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Stroke/TIA
|
1 participants
|
2 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
Amputation
|
8 participants
|
5 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
URV
|
9 participants
|
11 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
MACE (Death/MI/Stroke/Amputation/URV)
|
18 participants
|
19 participants
|
|
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
NACE
|
22 participants
|
23 participants
|
Adverse Events
Bivalirudin
Serious events: 25 serious events
Other events: 81 other events
Deaths: 13 deaths
Unfractionated Heparin
Serious events: 27 serious events
Other events: 70 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Bivalirudin
n=335 participants at risk
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).
|
Unfractionated Heparin
n=321 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.60%
2/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.62%
2/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.93%
3/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.62%
2/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Sepsis
|
0.60%
2/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Groin infection
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Femoral artery embolism
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Femoral artery occlusion
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Hypotension
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Peripheral artery dissection
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.62%
2/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendon necrosis
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
2/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Asthenia
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Ischaemic ulcer
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Local swelling
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Thrombosis in device
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Vessel puncture site pain
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.60%
2/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.62%
2/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Surgical and medical procedures
Aortic aneurysm
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Nervous system disorders
Syncope
|
0.30%
1/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.00%
0/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
Other adverse events
| Measure |
Bivalirudin
n=335 participants at risk
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).
|
Unfractionated Heparin
n=321 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
4.5%
15/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
4.0%
13/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Vascular disorders
Hypotension
|
3.0%
10/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
4.7%
15/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
12/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
4.7%
15/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
11/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
2.5%
8/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
6/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.31%
1/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Vessel puncture site pain
|
2.7%
9/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
1.6%
5/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
General disorders
Pain
|
2.1%
7/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.93%
3/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
8/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
1.6%
5/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
5/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
0.62%
2/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/335 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
1.2%
4/321 • Randomization up to 30 days (±7 days)
Does not include 2 participants who died before receiving study drug.
|
Additional Information
Chief Medical Executive
Miami Cardiac & Vascular Institute, Baptist Health South Florida
Phone: 800-273-2700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place