The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
803
Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
Unfractionated heparin is an anticoagulant.
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Major bleeding (Bleeding Academic Research Consortium \[BARC\] type ≥3b) was defined as follows: * Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade. * BARC 3c includes intracranial or intraocular bleeds that compromised vision. * BARC type 4 (Coronary Artery Bypass Grafting \[CABG\]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period. * BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause.
Time frame: at 48 hours or discharge, whichever occurs first
Net Adverse Clinical Events (NACE) at up to 30 Days
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
Time frame: up to 30 days after procedure
NACE at 48 Hours or Before Hospital Discharge
NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.
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Montreal Heart Institute
Montreal, Quebec, Canada
St. Paul´s Hospital Providence Health Care
Vancouver, Canada
Clinique Pasteur, Unité de Cardiologie Interventionnelle
Toulouse, Cedex 3, France
CHU de Toulouse
Toulouse, Cedex 9, France
CHU Jean Minjoz, Service de Cardiologie
Besançon, France
Centre Hospitalier de Lyon
Bron, France
Department of Cardiology, CHRU Lille
Lille, France
Institut Hospitalier Jacques Cartier
Massy, France
Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle
Rouen, France
University Heart Centre, Clinic of Inner Medicine 1 Cardiology
Jena, Lobeda Ost, Germany
...and 23 more locations
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
Percentage of participants with major bleeding according to the following scales: * Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding * Thrombolysis in Myocardial Infarction (TIMI)=major bleeding * Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate * Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Transient Ischemic Attack
The percentage of participants reporting transient ischemic attack is presented.
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acute Kidney Injury
The percentage of participants reporting acute kidney injury is presented.
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
Major Vascular Complications
The percentage of participants reporting a major vascular complications as defined by VARC is presented.
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Acquired Thrombocytopenia
The percentage of participants reporting acquired thrombocytopenia is presented.
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
New Onset Atrial Fibrillation/Flutter
The percentage of participants reporting new onset atrial fibrillation/flutter is presented.
Time frame: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.
Time frame: Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.
Time frame: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up