Early Aspirin Withdrawal After PCI in ACS

By CAFMI AI From New England Journal of Medicine

Background and Study Rationale

Dual antiplatelet therapy (DAPT) combining aspirin and a P2Y12 inhibitor has been the cornerstone treatment strategy following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). This combined approach is aimed at reducing the risk of thrombotic events such as stent thrombosis and myocardial infarction. However, the prolonged use of aspirin is associated with an increased risk of bleeding complications, which can negatively impact patient outcomes and quality of life. The motivation for the recent study centered on whether early discontinuation of aspirin, while continuing P2Y12 inhibitor monotherapy, could maintain ischemic protection while significantly reducing bleeding risk. This question addresses a critical balance clinicians strive to achieve in managing antiplatelet therapy post-PCI, especially in a US-based healthcare setting where bleeding consequences can lead to hospitalization and increased healthcare costs. The investigation was a rigorously designed, multicenter randomized controlled trial enrolling 3,500 patients with ACS undergoing PCI, making it one of the largest studies to evaluate this clinical dilemma comprehensively. Given the widespread use of DAPT in the US, these findings have immediate relevance for refining guideline recommendations and optimizing individualized patient care strategies.

Key Findings and Clinical Implications

The trial compared two patient groups: one undergoing early aspirin withdrawal after just 1 month of DAPT, continuing only the P2Y12 inhibitor, against the standard approach involving 12 months of combined DAPT. Primary endpoints were major adverse cardiovascular events (MACE), encompassing cardiovascular death, myocardial infarction, stroke, and urgent revascularization, alongside major bleeding defined by stringent clinical criteria. Results demonstrated that the early aspirin withdrawal strategy was non-inferior to the standard regimen in preventing ischemic events, with MACE rates nearly identical between groups (5.4% vs. 5.1%, hazard ratio 1.05; 95% confidence interval 0.85 to 1.29; P=0.65). Remarkably, the bleeding rates were significantly reduced by more than half in the early aspirin withdrawal group (1.7% compared to 3.5%, hazard ratio 0.48; 95% confidence interval 0.29 to 0.78; P=0.003). These findings imply that clinicians can safely consider aspirin discontinuation after the first month post-PCI, reducing bleeding complications without compromising ischemic protection. Such an approach could lead to fewer bleeding-related hospitalizations and complications, streamline medication regimens, and may improve adherence, especially in populations at heightened bleeding risk such as elderly patients or those with prior bleeding history.

Study Design, Limitations, and Future Directions

The study’s robust design included 3,500 patients randomized across multiple centers, enhancing the generalizability of results to diverse real-world populations, including US clinical settings. Patients with ACS undergoing PCI were enrolled, reflecting typical clinical presentations. The intervention’s timing—stopping aspirin after 1 month—was selected to maintain early critical ischemic protection while mitigating bleeding risk thereafter. Limitations include the open-label design and relatively short follow-up period of 12 months, which may not capture very late thrombotic events or long-term safety. Moreover, the trial excluded certain high-risk subgroups, such as those with prior stroke or hemorrhagic events, so caution is needed when applying results universally. From a clinical workflow perspective, the findings encourage reevaluation of standard DAPT protocols in primary care and cardiology practices, prompting clinicians to individualize therapy based on bleeding risk stratification. Patient counseling should emphasize adherence to P2Y12 inhibitor therapy after aspirin discontinuation and the importance of monitoring for ischemic symptoms. Future studies may explore even shorter aspirin durations or differing P2Y12 inhibitors. These insights are poised to influence upcoming guideline updates and promote safer, patient-centered antiplatelet management strategies post-PCI in ACS patients.

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