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Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk
Marco Valgimigli1, Enrico Frigoli1, Dik Heg1
1From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) - all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) - all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) - all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) - both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III-Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) - all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).
Insights
One month of dual antiplatelet therapy is as effective as longer durations for high-risk patients receiving drug-eluting stents. Abbreviated therapy also significantly reduces bleeding events, offering a safer alternative for coronary stent patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Determining optimal dual antiplatelet therapy (DAPT) duration post-drug-eluting stent (DES) implantation in high bleeding risk (HBR) patients is critical.
- Current guidelines offer limited clarity on balancing ischemic event prevention with bleeding risk in HBR populations.
Purpose of the Study:
- To compare the efficacy and safety of abbreviated DAPT (1 month) versus standard DAPT (≥3 months) in HBR patients undergoing DES implantation.
- To evaluate if a shorter DAPT regimen is non-inferior for major adverse cardiac or cerebral events (MACCE) and superior for reducing bleeding.
Main Methods:
- A randomized controlled trial involving HBR patients who received a biodegradable-polymer sirolimus-eluting stent.
- Patients were assigned to either 1-month abbreviated DAPT or standard DAPT (≥3 months).
- Primary outcomes included net adverse clinical events (NACE), MACCE, and major or clinically relevant nonmajor bleeding, assessed at 335 days.
Main Results:
- One-month DAPT was non-inferior to standard DAPT for NACE (7.5% vs. 7.7%) and MACCE (6.1% vs. 5.9%) in the per-protocol population.
- Abbreviated DAPT significantly reduced major or clinically relevant nonmajor bleeding compared to standard DAPT (6.5% vs. 9.4%) in the intention-to-treat population.
- All primary efficacy and safety endpoints met their respective noninferiority or superiority criteria.
Conclusions:
- One month of DAPT is a safe and effective strategy for HBR patients after DES implantation, demonstrating non-inferiority to longer durations for ischemic events.
- Abbreviated DAPT significantly lowers bleeding risk, suggesting it as a preferred treatment duration in this population.
- Findings support shorter DAPT durations in select HBR patients to mitigate bleeding complications without compromising ischemic protection.
Background:
The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear.
Methods:
One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population.
Results:
Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority).
Conclusions:
One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020.).
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