Which Anticoagulation Strategy for Patients with Atrial Fibrillation and a New Stent?

November 14, 2016

Which Anticoagulation Strategy for Patients with Atrial Fibrillation and a New Stent?

  1. Mark S. Link, MD

Low-dose rivaroxaban regimens plus either single or dual antiplatelet therapy fared well against warfarin plus DAPT in a relatively small, short-term randomized trial.

  1. Mark S. Link, MD

Anticoagulation-treated patients with atrial fibrillation (AF) often receive stents, prompting the need for dual antiplatelet therapy (DAPT). To assess how best to prevent bleeding in these patients, researchers conducted a multinational, manufacturer-funded trial (PIONEER-AF) in which they randomized 2124 patients with nonvalvular AF to one of three strategies after stent placement:

  • Low-dose rivaroxaban (15 mg/day) plus a single P2Y12 inhibitor for 12 months

  • Very-low-dose rivaroxaban (2.5 mg twice daily) plus low-dose aspirin and a P2Y12 inhibitor for an investigator-chosen period of 1, 6, or 12 months

  • Adjusted-dose warfarin plus low-dose aspirin and a P2Y12 inhibitor for an investigator-chosen period of 1, 6, or 12 months

Clinically significant bleeding was significantly less common in the 15-mg rivaroxaban group (16.8%) and the 2.5-mg rivaroxaban group (18.0%) than in the warfarin + DAPT group (26.7%). Incidence of the composite efficacy endpoint — cardiovascular death, myocardial infarction, or stroke at 1 year — was similar among the three groups: 6.5%, 5.6%, and 6.0%, respectively.

Comment

Although rivaroxaban (at a low or very low dose) plus antiplatelet therapy was as effective as — and safer than — warfarin plus DAPT after stenting, the trial's short-term follow-up and relatively small size limit the strength of its efficacy findings. In contrast, key previous trials of direct anticoagulants have each followed roughly 20,000 patients for several years. PIONEER-AF is more reassuring with regard to stent thrombosis, which generally occurs in the first year after stenting, than embolic events. I also find it unfortunate that this trial did not use standard-dose (20-mg) rivaroxaban given that that dose has been proven equivalent to warfarin for preventing embolic events. In effect, this trial provides clarity for interventional cardiologists but confusion for electrophysiologists. I am now comfortable with rivaroxaban plus a P2Y12 inhibitor for treating patients with recent stents and AF but am uncomfortable with the dose of rivaroxaban used in this trial.

Editor Disclosures at Time of Publication

  • Disclosures for Mark S. Link, MD at time of publication Grant / Research support Unequal Technologies Editorial boards UpToDate; Heart Rhythm Leadership positions in professional societies Heart Rhythm Society (Chair, CME Compliance Committee); American Heart Association (Chair, ACLS Writing Group; Member, Emergency Cardiovascular Care)

Citation(s):

Reader Comments (2)

Rajeev Gupta,MD,DM Physician, Cardiology, Al Jowhara-mediclinic Hospital, Al Ain, UAE

Caution is needed to apply the study in real-world. The shorter duration and less number of enrolled subjects are its serious limitations.The topic is trending and all of us want to know the answer, but in a reassuring way and not in a hurried way. I think editorial and further studies are timely to settle the common clinical challenge.

Hassan Khaled Nagi MD Other, Cardiology, Professor in Cairo University

Trial injustice! as they should not put Aspirin in the Coumadin arm so that it can be compared with Rivaroxban plus P2Y12 ; and if they did so, the bleeding rate will bw similar!! ( study design is biast to Rivaroxoban )

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