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For patients on clopidogrel (Plavix) when undergoing lower limb revascularization procedures, keeping it on board while adding rivaroxaban (Xarelto) and aspirin for preventing major adverse events increased bleeding risk to an unacceptable level, researchers said at the .

In a substudy of the VOYAGER PAD trial, reported by William Hiatt, MD, of the University of Colorado in Aurora, the primary endpoint -- a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, and cardiovascular death -- was somewhat lower in patients maintained for up to 6 months on clopidogrel with rivaroxaban plus aspirin added, versus those receiving rivaroxaban plus aspirin without clopidogrel (16.0% vs 18.7% at 3 years, respectively).

But major bleeding was more common in the clopidogrel group, at 3.0% during year 1 and 8.1% through year 3, compared with 2.5% and 5.6%, respectively, in the no-clopidogrel patients.

The overall VOYAGER PAD study was intended to evaluate rivaroxaban and aspirin against aspirin alone for event prevention after lower limb revascularization. That analysis was an overall win for the combination. The substudy was conducted to address the role of dual antiplatelet therapy (DAPT) following such procedures, which is recommended in many guidelines, in the context of add-on rivaroxaban.

Hiatt and others agreed that the combination of direct oral anticoagulant and DAPT did more harm than good -- and that DAPT may be the one to jettison in routine practice.

"More bleeding with background clopidogrel, even if not severe by adjudication, may be associated with broad consequences including discontinuation of therapies," Hiatt said in his oral late-breaker presentation. "In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimized or avoided to reduce this risk."

Discussant Sahil Parikh, MD, of Columbia University in New York City, commented, "The big question from the main VOYAGER PAD study really was this overarching question of bleeding hazard with triple therapy. As Dr. Hiatt illustrated, the data suggest the value of clopidogrel is questionable but the hazard is not questionable. Now, as an interventionalist, I am going to wonder whether I would send a patient home from the procedure on rivaroxaban and aspirin rather than dual antiplatelet therapy."

Parikh said that the substudy will challenge the dogma that DAPT needs to be on board if stents, especially drug-eluting stents, are implanted. He suggests that a deeper dive in the robust data from VOYAGER PAD could provide the answer to that question.

"This is practice changing for most of us who take care of these patients," he said, referring to the rivaroxaban-aspirin combination absent clopidogrel. "The hazard reduction is pretty clear; the risk of bleeding is acceptable, and asks the question of whether dual antiplatelet therapy should be used at all, or at least for how long."

He suggested that a bleeding risk score will be developed from the data, which will help clinicians decide which patients need more or less therapy.

VOYAGER PAD randomized 6,564 patients to aspirin plus either rivaroxaban or placebo. About half came into the study on clopidogrel, with continuation at investigators' discretion. Median post-procedure exposure to clopidogrel was 30 days, ranging up to 6 months.