Abstract
Background: P2Y12 inhibitor monotherapy after a brief period of dual antiplatelet therapy (DAPT) can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). We sought to examine the effect of P2Y12 inhibitor monotherapy vs. prolonged DAPT among patients with hypertension undergoing PCI. Methods: This is a post-hoc analysis of the SMART-CHOICE trial, in which patients undergoing PCI were randomly assigned to either P2Y12 inhibitor monotherapy after 3-month DAPT (n=1495) or DAPT for 12 months or longer (n=1498). The primary endpoint was Bleeding Academic Research Consortium (BARC) 2~5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. Treatment effects were estimated according to the presence of hypertension with formal interaction testing. Results: Patients with hypertension comprised 61.5% of the randomized cohort, and were characterized by more frequent comorbidities, a higher PRECISE-DAPT score, and a higher prevalence of the multivessel disease. At 3 years, patients with hypertension experienced higher rates of all-cause death (3.9% vs 2.5%; p=0.039), stroke (1.6% vs 0.6%; p=0.014), or a composite ischemic endpoint (6.8% vs 3.8%; p<0.001), but similar BARC 2~5 bleeding (5.4% vs 4.9%; p=0.601) compared with patients without hypertension. The incidence of BARC 2~5 bleeding was 2.9% and 7.8% among patients with hypertension randomized to P2Y12 inhibitor monotherapy versus DAPT [hazard ratio (HR), 0.382; 95% confidence interval (CI), 0.243 to 0.600; p<0.001]. However, P2Y12 inhibitor monotherapy was not associated with an increase in ischemic events compared with DAPT (7.2% vs. 6.5%; HR: 1.135; 95% CI: 0.767 to 1.679; p=0.527) in patients with hypertension. In the overall population, there was no significant interaction between hypertension and treatment for the primary bleeding (adjusted p for interaction 0.835) or ischemic endpoints (adjusted p for interaction 0.707). Conclusions: P2Y12 inhibitor monotherapy is associated with a significantly lower risk for bleeding events compared with DAPT, without any compromise in ischemic prevention, among patients with hypertension undergoing PCI.
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