News | Stroke | May 12, 2017

Analysis Shows Increased Risk of Early Stroke with New-Onset Atrial Fibrillation Post-TAVR

Results of BRAVO-3 randomized trial show patients with new-onset AF are more than four times more likely to have a stroke than non-AF TAVR patients

Analysis Shows Increased Risk of Early Stroke with New-Onset Atrial Fibrillation Post-TAVR, SCAI 2017 late-breaking clinical trial

May 12, 2017 — More than one-third of patients undergoing transcatheter aortic valve replacement (TAVR) were observed to have atrial fibrillation (AF) either at baseline or new-onset within 30 days after TAVR, according to data from the BRAVO-3 randomized trial. Patients with new-onset AF had a greater than 4-fold greater risk of stroke within 30 days. Results from the trial were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions, May 10-13 in New Orleans.

The BRAVO-3 trial included 802 patients with a mean age of 82 years randomized to bivalirudin (BIV) or unfractionated heparin (UFH) for transfemoral TAVR. In this sub-study, 41.4 percent (n=332) of patients were noted to have baseline AF or new AF within 30 days of TAVR, and 58.6 percent (n=470) had no AF. Patients with existing or new AF had a greater occurrence of pre-existing comorbidities, including renal dysfunction, lower left ventricular ejection fraction and a higher euroSCORE I.

“Previous studies have shown that AF patients undergoing TAVR have a greater risk for ischemic as well as bleeding events,” said the study’s principal investigator George D. Dangas, M.D., Ph.D., professor of medicine at the Icahn School of Medicine at Mount Sinai and director of cardiovascular innovation at the Zena and Michael A. Weiner Cardiovascular Institute of the Mount Sinai Medical Health System in New York City. “We wanted to study these associations using a more contemporary population, in the context of overall improved devices, techniques and post-TAVR management to see if the results were similar. We were also interested in studying the antithrombotic prescription patterns in this high-risk patient population, as there is currently no consensus on the optimal strategy following TAVR.”

The primary endpoint of the BRAVO-3 trial was 48h Bleeding Academic Research Consortium (BARC) type 3b bleeding. For this sub-study, the two main outcomes of interest were stroke and death at 30-days in patients with AF versus no AF. Outcomes were also examined by treatment with bivalirudin (BIV) or unfractionated heparin (UFH).

Unadjusted 30-day clinical outcomes for AF patients were stroke (3.9 percent), death (6 percent) and BARC major bleeding (10.2 percent). Outcomes for non-AF patients were stroke (2.6 percent), death (4.5 percent) and BARC major bleeding (9.4 percent). The unadjusted odds of early stroke in patients with new-onset AF were 4.49 times greater compared to odds in patients with no AF. No significant differences were noted in 30-day outcomes by AF status and anticoagulant strategy.

“Our study showed that a large percentage of patients have AF, either baseline or new-onset,” said study investigator Usman Baber, M.D., assistant professor, medicine, cardiology, Icahn School of Medicine at Mount Sinai. “New-onset AF lends a significantly higher risk of early stroke, nearly five-fold. Moreover, although nearlyall AF patients had a high calculated predictive stroke risk score (CHA2DS2VASc) of ≥ 4, we found that around two-thirds went home on an oral anticoagulant. We need to better risk stratify AF patients during follow-up, when acute risk of bleeding has abated, for prescription of anticoagulants where appropriate.”

Another interesting finding of the BRAVO-3 trial was that the design of the device also plays a role in outcomes. Read the article “Analysis Looks at Role Type of Valve Plays in Patient Outcomes Post-TAVR,” which was also presented at SCAI 2017.

Dangas’s disclosed grants or research support from The Medicines Company. Baber reported no disclosures.

Watch the VIDEO "TAVR Stands Equal to Surgical Valve Replacement," an interview with Michael Reardon, M.D.

For more information:

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Overlay Init