August 25, 2016
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PCI infrequent in patients with AF at moderate to high risk for stroke

In the ROCKET AF trial, PCI was performed in less than 1% of patients with atrial fibrillation and moderate to high risk for stroke. Most patients remained on rivaroxaban after PCI, but the use of dual antiplatelet therapy on top of oral anticoagulation was variable, according to a new analysis.

Further, rates of bleeding and thrombotic events were high after PCI and most occurred within 6 months after the procedure.

“These results highlight the need for caution in these patients and should drive further research on the combination of direct oral anticoagulants and antiplatelet therapy in the setting of PCI,” Matthew W. Sherwood, MD, MHS, from the Duke Clinical Research Institute, and fellow ROCKET AF researchers wrote.

ROCKET AF was a randomized, double blind, double-dummy, international, noninferiority study that compared fixed-dose rivaroxaban (Xarelto, Janssen) vs. dose-adjusted warfarin for prevention of stroke in patients with nonvalvular AF. The new analysis was designed to evaluate effects of combined dual antiplatelet therapy (DAPT) and direct oral anticoagulation after PCI. Sherwood and colleagues analyzed all ROCKET AF participants in the treatment group who received oral anticoagulation and divided them based on PCI status during follow-up.

In total, 152 of 14,171 patients (1.1%) underwent PCI during a median follow-up of 806 days. Of those, 61 patients were in the rivaroxaban arm and 92 in the warfarin arm.

Eighty-one percent of patients who underwent PCI received continued treatment with rivaroxaban. After PCI, 37% of patients were treated with DAPT (clopidogrel and aspirin) for 30 days or more and 34% were treated with antiplatelet monotherapy. A little more than 12% of patients changed their treatment from DAPT to monotherapy within 30 days after PCI. Fifteen percent of patients received no antiplatelet therapy, according to the findings.

When the researchers evaluated outcomes, they found that the rate of stroke or systemic embolism was 4.5 per 100 patient-years and the rate of major bleeding events was 10.2 per 100 patient-years in both treatment groups. Compared with patients who did not undergo PCI, rates of all ischemic and thrombotic events were higher among those who underwent PCI.

“Our results highlight the importance of caution in these patients, and the need for further research on the combination of non-vitamin K antagonist oral anticoagulants and antiplatelet therapy in the setting of PCI,” the researchers wrote. – by Jennifer Byrne

Disclosure: Several researchers report financial ties with Janssen. Please see the full study for a list of the researchers’ relevant financial disclosures.