Nitroaspirin

No previous studies have evaluated the effect of an aspirin-free strategy for patients undergoing staged percutaneous coronary intervention (PCI).

We conducted a post hoc subgroup analysis in patients undergoing staged PCI within 1 month in STOPDAPT-3 (n=6,002), which randomly compared prasugrel monotherapy with dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. There were 814 patients undergoing staged PCI within 1 month (no-aspirin group, n=401; DAPT group, n=413). The median interval from randomization to the first staged PCI was 8 (interquartile range 5-13) days. More than 90% of the patients received assigned antiplatelet agents at all staged PCI procedures. The effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (3.74% vs. 1.94%; HR 1.94; 95% CI 0.82-4.57) and cardiovascular (3.49% vs. 2.42%; HR 1.44; 95% CI 0.64-3.25) endpoints. The no-aspirin group compared with the DAPT group had a numerically higher incidence of the co-primary cardiovascular endpoint, which occurred after the first staged PCI procedure (2.49% vs. 1.21%; HR 2.07; 95% CI 0.71-6.05).

An aspirin-free prasugrel monotherapy relative to DAPT had numerically higher risks of cardiovascular and major bleeding events in patients undergoing staged PCI at 1 month.

Safety of aspirin-free strategy immediately after percutaneous coronary intervention (PCI) for cardiovascular events in patients with diabetes was unknown.

We conducted the prespecified subgroup analysis on diabetes in the STOPDAPT-3 trial, which randomly compared prasugrel (3.75 mg/day) monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. Of 5966 study patients, there were 2715 patients (45.5%) with diabetes. Patients with diabetes more often had chronic coronary syndrome, heart failure or cardiogenic shock, and comorbidities than those without. Patients with diabetes compared to those without had higher incidences of major bleeding and cardiovascular events. Regardless of diabetes, the effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (diabetes: 5.05% vs. 5.47%; HR, 0.92; 95%CI, 0.66–1.28 and non-diabetes: 3.99% vs. 4.07%; HR, 0.98; 95%CI, 0.69–1.38; P for interaction = 0.81) and cardiovascular (diabetes: 5.54% vs. 5.15%; HR, 1.08; 95%CI, 0.78–1.49 and non-diabetes: 2.95% vs. 2.47%; HR, 1.20; 95%CI, 0.79–1.82; P for interaction = 0.70) endpoints. The incidences of subacute definite or probable stent thrombosis and any coronary revascularization were higher in the no-aspirin group than in the DAPT group regardless of diabetes.

The effects of an aspirin-free prasugrel monotherapy (3.75 mg/day) relative to DAPT for major bleeding and cardiovascular events were not different regardless of diabetes.