Marlene Busko

May 12, 2017

NEW ORLEANS, LA — Among patients who had transfemoral transcatheter aortic-valve replacement (TAVR) for aortic stenosis, those with new-onset atrial fibrillation (AF) had a fourfold greater risk of early stroke compared with patients without AF[1].

Moreover, a third of patients with existing or new AF were discharged without a prescription for an oral anticoagulant, even though all patients had a CHA2DS2VASc score of 2 or more and most had a score of 4 or more, placing them at high risk of bleeding.

These findings are from a post hoc analysis of the previously reported BRAVO 3 trial, which did not find an advantage with bivalirudin (Angiomax, the Medicines Company) vs heparin during transfemoral TAVR.

Dr Usman Baber (Icahn School of Medicine at Mount Sinai, New York) presented these results in a press briefing before a late-breaking clinical-trial session here at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions.

"It's another piece of evidence that highlights the importance of new-onset AF" in a contemporary cohort of patients undergoing TAVR, Baber told heartwire from Medscape.

What is new is that "we still see no advantage for bivalirudin compared with heparin in patients with AF, although they are at higher risk," he added.

Another novel finding is the tremendous heterogeneity in discharge therapies for patients who had AF. "Almost one-third got no anticoagulation," he pointed out. The differences in discharge therapies "highlight the lack of a standardized approach or standardized evidence with respect to choices of antithrombotics and antiplatelets in patients with AF" in contemporary practice, according to Baber.

"The variety of the different anticoagulation or lack of oral anticoagulation for these patients with CHA2DS2VASc scores of 4 and above," where most had scores of 4, 5, or 6, indicating a high risk of bleeding, really stood out, and that a good number of patients went home without an oral anticoagulant was "incredible," session comoderator Roxanne Mehran (Icahn School of Medicine at Mount Sinai) commented to heartwire .

"I think the novel oral anticoagulants could have an important role" for such patients, she said.

802 Patients From BRAVO 3

Patients with AF who undergo TAVR have worse outcomes, and new-onset AF, reported to occur in 1% to 38% of such patients, increases the risk of stroke or death, Baber noted.

To explore this, the researchers analyzed data from BRAVO 3, a phase 3b, open-label study that randomized 802 high-risk patients in seven European and North American countries to receive transfemoral TAVR, in which unfractionated heparin or bivalirudin was used during the procedure.

As previously reported, there was no advantage with bivalirudin vs heparin for bleeding outcomes or net adverse clinical events (NACE; death, MI, stroke, and major bleeding) up to 30 days.

The current analysis compared outcomes in the 332 patients who had AF (of whom 294 had AF at baseline and 38 had new-onset AF) vs the 470 patients who did not.

Patients in both groups had a similar mean age (82), weight, and rates of diabetes, CAD, and prior stroke/transient ischemic attack (TIA). However, patients with AF had a higher EuroSCORE and a lower mean glomerular filtration rate (GFR) and mean left ventricular ejection fraction (LVEF).

Both groups had procedures that used similar sheath sizes, anesthesia types, and valve types, with similar success rates.

Among the patients with AF, only 0.1% and 0.9% had CHA2DS2VASc scores of 2 and 3, respectively. Most had scores of 4 (10%), 5 (35%), and 6 (31%), and the rest had scores of 7 (16%), 8 (6%), or 9 (1%).

Of the patients with AF, 30% were discharged with dual antiplatelet therapy and no anticoagulant. The rest received aspirin and an oral anticoagulant (32%) or a P2Y12 inhibitor and an oral anticoagulant (22%) or triple therapy (13%) or other therapy (3%).

Most patients without AF (80%) received dual antiplatelet therapy when they were discharged.

The adjusted odds of having major bleeding, death, stroke, MACE, NACE, or a major vascular event were similar in patients with vs without AF.

However, in the 30 days after TAVR, patients with new-onset AF had a much greater likelihood of having a stroke compared with patients who did not have AF (unadjusted odds ratio 4.49; 95% CI 1.37–14.67).

The study was not powered to evaluate treatment outcomes of bivalirudin vs heparin in patients with or without AF; the findings cannot be generalized to other approaches; and there was only 30-day follow-up, Baber acknowledged.

It also suggests further research directions. "Do we need to pay very close attention to or think about monitoring post-TAVR for a longer period? Are there strategies that we can do to try to mitigate that risk? Finally, is the relationship between new-onset AF and risk because of the AF, or is that simply a marker?"

Baber reported that he has no relevant financial relationships.  Mehran reported that she received research grants that were paid to her institution from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, the Medicines Company, OrbusNeich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis, Medtronic, AUM Cardiovascular, and Beth Israel Deaconess Medical Center. She received consulting and other fees from Janssen Pharmaceuticals, Osprey Medical, Watermark Research Partners, Medscape, the Medicines Company, Boston Scientific, Merck, Cardiovascular Systems, Sanofi, Shanghai BraccoSinePharmaceutical, and AstraZeneca, and she owns stock in Claret Medical and Elixir Medical.

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