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Study Summary

The One-Month DAPT trial was a randomized, parallel, open-label trial comparing outcomes of 1 month of dual antiplatelet therapy (DAPT) followed by aspirin monotherapy with current guideline-recommended 6-12 months of DAPT among patients undergoing percutaneous coronary interventions (PCI) with stable ischemic heart disease and amenable coronary anatomy. A total of 3,020 patients were randomized after elective PCI to either 1 month of DAPT with aspirin and a P2Y12 inhibitor followed by 11 months of aspirin monotherapy, or 6-12 months of DAPT followed by 0-6 months of aspirin alone. At 12 months, 1 month of DAPT resulted in no significant difference in a composite primary outcome measure of cardiac death, nonfatal myocardial infarction, target-vessel revascularization, stroke, or major bleeding compared to 6-12 months of DAPT (5.9% versus 6.5%, P for non-inferiority <0.001; see accompanying Hurst’s Central Illustration). Among secondary outcomes, one month of DAPT was non-inferior to 6-12 months of DAPT for stent thrombosis (0.7% versus 0.8%, P = 0.842), stroke (0.9% versus 1.1%, P = 0.581), and major bleeding (1.7% versus 2.5%, P = 0.136).

Commentary

Study Strengths: As appreciation of the delicate balance of bleeding and thrombotic risks in cardiovascular disease grows, this was a randomized, multicenter trial addressing the safety of a short DAPT duration strategy in a well-defined subset of low-risk patients undergoing PCI. Study groups were well balanced with respect to demographics and comorbidities.

Study Limitations: Critically, the study excluded patients with myocardial infarction, cardiogenic shock, and complex lesions, prohibiting extrapolation of findings to these higher risk subsets. This concern is further underscored by a significant interaction between indication for PCI (stable versus unstable disease) and findings, favoring longer-duration DAPT in patients with acute coronary syndrome. Secondly, it is notable that treatment groups differed not only in the duration of DAPT but also in the stents used — 1 month DAPT patients received a polymer-free drug-coated stent (BioFreedom) whereas longer DAPT patients received traditional drug-eluting stents (Biomatrix or Ultimaster). The safety of 1 month DAPT with traditional drug-eluting stents cannot be inferred from this trial.

Next Steps/Clinical Perspective: Results of the One-Month DAPT trial suggest that carefully-selected low-risk patients with non-complex anatomy and stable (or troponin-negative unstable) coronary artery disease might not require the full 6-12 months of DAPT recommended by current guidelines. Whether this finding holds true for traditional drug-eluting stents or whether it may only be applied to newer polymer-free drug-eluting stents is uncertain. Study findings should not be used to guide treatment of higher risk patients with myocardial infarction or shock, for whom longer usage of P2Y12 inhibitor therapy is guideline-directed and remains appropriate. The different question of whether aspirin can be stopped while continuing P2Y12 inhibitor monotherapy is a subject of separate trials (e.g., GLOBAL LEADERS and TWILIGHT). Beyond strategies for timing of discontinuation of DAPT, the findings of the One-Month DAPT trial (in particular, very low rates of stent thrombosis) may furthermore help to inform considerations for timing of non-cardiac surgery after PCI and perioperative DAPT management.

Trial Reference

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One-month dual antiplatelet therapy followed by aspirin monotherapy after drug-eluting stent implantation: Randomized One-Month DAPT trial. Presented by Dr. Myeong-Ki Hong at the American Heart Association Virtual Scientific Sessions, November 15, 2020.

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