Clinical Outcomes After Percutaneous Coronary Intervention in East Asian Patients　― 30-Month Results of the PENDULUM Registry ―

Abstract

Background: The 12-month results of the PENDULUM registry showed that after implantation of second-generation drug-eluting stents (DES), high P2Y₁₂reaction unit (HPR) were independently associated with ischemic but not bleeding events.

Methods and Results: This study analyzed cumulative incidences of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding (Bleeding Academic Research Consortium type 3 and 5) at 30 months after index percutaneous coronary intervention (PCI) (primary endpoints). Of 6,422 patients undergoing PCI with DES, 5,796 completed the 30-month follow up. The continuation rate of dual antiplatelet therapy decreased to 59.3% at 12 months and 26.4% at 30 months. At 30 months, the cumulative incidence of MACCE increased linearly and reached 9.5% (95% confidence interval 8.8–10.2) and that of major bleeding had the inflection point at 12 months and was 4.4% (3.9–5.0). MACCE and bleeding events were higher in HPR patients (unadjusted P value). After covariate adjustment, P2Y₁₂reactivity units measured immediately after index PCI was not an independent risk factor for MACCE or major bleeding at 30 months.

Conclusions: MACCE consistently increased after 12 months post-PCI, whereas the increase in major bleeding events slowed down after 12 months in Japanese PCI patients in a real-world clinical setting. HPR patients had increased MACCE and bleeding complications, but HPR was not an independent risk factor of events at 30 months.