Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge

Time frame · at 48 hours or discharge, whichever occurs first

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.

Net Adverse Clinical Events (NACE) at up to 30 Days

Time frame · up to 30 days after procedure

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.

NACE at 48 Hours or Before Hospital Discharge

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier

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.

Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.

Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)

Time frame · at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

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

Transient Ischemic Attack

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

The percentage of participants reporting transient ischemic attack is presented.

Acute Kidney Injury

Time frame · at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

The percentage of participants reporting acute kidney injury is presented.

Major Vascular Complications

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

The percentage of participants reporting a major vascular complications as defined by VARC is presented.

Acquired Thrombocytopenia

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

The percentage of participants reporting acquired thrombocytopenia is presented.

New Onset Atrial Fibrillation/Flutter

Time frame · at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)

The percentage of participants reporting new onset atrial fibrillation/flutter is presented.

Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge

Time frame · Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)

The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.

Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor

Time frame · at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up

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.