"Dual Antiplatelet Therapy Duration in High-Bleeding-Risk Patients After Stent Implantation".
The New England Journal of Medicine. 2021.
Clinical Question
What is the appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent?
Bottom Line
One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months regarding the occurrence of net adverse clinical events and major adverse cardiac or cerebral events, and resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
Major Points
Guidelines
Design
Population
Patients at high bleeding risk who had undergone implantation of a biodegradable-polymer sirolimus-eluting stent, free from adverse events during the first month post-PCI.
Interventions
- Abbreviated dual antiplatelet therapy (one month duration, n=2295)
- Standard dual antiplatelet therapy (at least three additional months, n=2284)
Outcomes
- Net adverse clinical events at 335 days.
- Major adverse cardiac or cerebral events at 335 days.
- Major or clinically relevant nonmajor bleeding at 335 days.
Criticisms
- The open-label design could introduce bias in reporting or management of outcomes.
- The results may not generalize to patients with lower bleeding risk or those who receive different stent types.
- Wide noninferiority margins could potentially miss a modest increase in incidence.
Funding
The trial was funded by Terumo.
Further Reading
The New England Journal of Medicine, DOI: 10.1056/NEJMoa2108749