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Early Discontinuation of Aspirin after PCI in Low-Risk Acute Myocardial Infarction
Giuseppe Tarantini1, Benjamin Honton2, Valeria Paradies3
1Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua Medical School, Padua, Italy.
Insights
For acute myocardial infarction patients, P2Y12-inhibitor monotherapy after 1 month of dual antiplatelet therapy is as effective as continuing dual therapy, while significantly reducing bleeding events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Optimal duration of dual antiplatelet therapy (DAPT) post-percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) remains debated.
- Guideline-recommended complete revascularization and contemporary drug-eluting stents are standard, yet DAPT duration is unclear.
Purpose of the Study:
- To compare P2Y12-inhibitor monotherapy versus continued DAPT in low-risk AMI patients.
- To assess noninferiority for adverse cardiovascular/cerebrovascular events and superiority for bleeding events.
Main Methods:
- A multicenter, open-label, randomized trial involving 1942 patients post-AMI and complete revascularization.
- Patients received 1 month of DAPT, then were randomized to P2Y12-inhibitor monotherapy or continued DAPT for 11 months.
- Primary outcome: composite of death, MI, stent thrombosis, or stroke. Secondary outcome: clinically relevant bleeding (BARC types 2, 3, or 5).
Main Results:
- P2Y12-inhibitor monotherapy was noninferior to DAPT for the primary composite outcome (2.1% vs. 2.2%; P=0.02).
- Monotherapy significantly reduced clinically relevant bleeding events compared to DAPT (2.6% vs. 5.6%; P=0.002).
- Incidence of stent thrombosis and serious adverse events was similar between groups.
Conclusions:
- In selected low-risk AMI patients, P2Y12-inhibitor monotherapy after an initial month of DAPT is a safe and effective strategy.
- This approach achieves similar efficacy in preventing major ischemic events while substantially lowering bleeding risk.
- Findings support de-escalation of antiplatelet therapy to reduce bleeding complications without compromising ischemic protection.
Background:
An appropriate duration of dual antiplatelet therapy after percutaneous coronary intervention for acute myocardial infarction that has been treated with guideline-recommended complete revascularization and a contemporary drug-eluting stent remains unclear.
Methods:
We conducted a multicenter, open-label, randomized trial at 40 European sites. Adults with acute myocardial infarction who had undergone successful complete revascularization within 7 days after the infarction and had subsequently completed 1 month of dual antiplatelet therapy with no ischemic or major bleeding events were randomly assigned to transition to a P2Y12 inhibitor as monotherapy or to continue dual antiplatelet therapy for an additional 11 months. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, or major bleeding (defined by the Bleeding Academic Research Consortium [BARC] as a bleeding event of type 3 or 5) at 11 months after randomization (tested for noninferiority with a margin of 1.25 percentage points). The main secondary outcome was BARC type 2, 3, or 5 bleeding (clinically relevant bleeding) at 11 months after randomization (tested for superiority).
Results:
Among the 2246 enrolled patients, 1942 underwent randomization: 961 to receive P2Y12-inhibitor monotherapy and 981 to continue dual antiplatelet therapy. A primary-outcome event occurred in 20 patients (2.1%) in the P2Y12-inhibitor monotherapy group and in 21 patients (2.2%) in the dual antiplatelet therapy group (difference, -0.09 percentage points; 95% confidence interval [CI], -1.39 to 1.20; P = 0.02 for noninferiority). BARC type 2, 3, or 5 bleeding occurred in 2.6% of the patients in the P2Y12-inhibitor monotherapy group and in 5.6% of those in the dual antiplatelet therapy group (hazard ratio, 0.46; 95% CI, 0.29 to 0.75; P = 0.002 for superiority). Stent thrombosis was infrequent, and the incidence was similar in the two groups. The incidence of serious adverse events appeared to be similar in the two groups.
Conclusions:
Among low-risk patients with acute myocardial infarction who had undergone early complete revascularization and had completed 1 month of dual antiplatelet therapy without complications, P2Y12-inhibitor monotherapy was noninferior to continued dual antiplatelet therapy with respect to the occurrence of adverse cardiovascular and cerebrovascular events and resulted in a lower incidence of bleeding events. (Funded by MicroPort [France]; TARGET-FIRST ClinicalTrials.gov number, NCT04753749.).
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