Courtesy of Dr. José Álvarez.
In patients at high bleeding risk with drug-eluting stents, the duration of dual antiplatelet therapy has been subjected to ongoing review.
Guidelines from the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) suggest shortening this treatment to a maximum of three to six months (Class IIb). The ESC establishes a difference depending on whether the condition is acute or chronic.
The Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent (MASTER DAPT), presented at the ESC Congress and simultaneously published in N Engl J Med, is a multicenter, randomized study that included patients at high bleeding risk who underwent coronary angioplasty and received Ultimaster/Tansei stents (bioresorbable-polymer sirolimus-eluting stents with with 80-μm struts). There were no restrictions regarding angioplasty complexity, and all patients met at least one criterion to be considered at high bleeding risk—including patients concurrently treated with oral anticoagulants.
The study randomized into two groups 4579 patients who had received dual antiplatelet therapy (DAPT) for 30 days.
In the abbreviated antiplatelet regimen arm, all patients interrupted DAPT at randomization and continued treatment with a single antiplatelet agent (aspirin or a P2U12 inhibitor, mainly clopidogrel) with no concomitant oral anticoagulant (OAC) for 11 months and an OAC for five months.
In the standard antiplatelet regimen arm, patients who had no concomitant OAC continued treatment with aspirin for at least a year and treatment with a P2Y12 inhibitor for at least six to 12 months after angioplasty.
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Patients concomitantly receiving OAC could maintain dual antiplatelet therapy until a year had passed (triple scheme) or discontinue it three months after angioplasty and complete the year with a single antiplatelet agent (aspirin or a P2Y12 inhibitor).
Net adverse clinical events (which included overall mortality, acute myocardial infarction, stroke, or major bleeding) occurred in 7.5% of patients in the abbreviated therapy group and in 7.7% of the standard treatment group (p < 0.001 for non-inferiority).
Major cardiac or cerebral clinical events (overall mortality, acute myocardial infarction, or stroke) occurred in 6.1% of patients in the abbreviated treatment group and in 5.9% of patients in the standard treatment group (p = 0.001 for non-inferiority).
Read also: Single or Dual Antiplatelet Therapy in Stroke or Transient Ischemic Attack?
Major or clinically relevant bleeding occurred in 6.5% of patients in the abbreviated treatment group and in 9.4% of patients in the standard treatment group (p < 0.001 for superiority).
Authors conclude that, in this group of patients treated with angioplasty and implantation of Ultimaster/Tansei stents with criteria to be considered at high bleeding risk, interrupting dual antiplatelet therapy at a mean of 34 days after angioplasty was associated with a lower incidence of major or clinically relevant bleeding events without an increase in ischemic events.
Comments:
The core message of this study is that, in these patients, a short course of dual antiplatelet therapy is safe in terms of ischemic events and beneficial in relation to bleeding events.
The patient base was broad, as regards clinical condition (stable and unstable) and the anatomical complexity of angioplasty.
The P2Y12 inhibitor selected was left to the discretion of the investigator (in most cases, clopidogrel was used).
Only patients treated with the Ultimaster drug-eluting stent (TANSEI) were included.
It is uncertain whether these results can be extrapolated to patients without high bleeding risk and to other stent platforms.
Courtesy of Dr. José Álvarez.
Original Title: Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk.
Reference: N Engl J Med August 28, 2021 DOI:10.1056/NEJMoa2108749.
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