One-Month Dual Antiplatelet Therapy Followed by P2Y Inhibitor Monotherapy After Biodegradable Polymer Drug-Eluting Stent Implantation - The REIWA Region-Wide Registry.

BACKGROUND

The safety and feasibility of using 1-month dual antiplatelet therapy (DAPT) followed by P2Yinhibitor monotherapy for patients after percutaneous coronary intervention (PCI) with thin-strut biodegradable polymer drug-eluting stents (BP-DES) in daily clinical practice remain uncertain.

METHODS AND RESULTS

The REIWA region-wide registry is a prospective study conducted in 1 PCI center and 9 local hospitals in northern Japan. A total of 1,202 patients who successfully underwent final PCI using BP-DES (Synergy: n=400; Ultimaster: n=401; Orsiro: n=401), were enrolled in the registry, and received 1-month DAPT followed by P2Yinhibitor (prasugrel 3.75 mg/day or clopidogrel 75 mg/day) monotherapy. The primary endpoint was a composite of cardiovascular and bleeding events at 12 months, including cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST), ischemic or hemorrhagic stroke, and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. Based on the results of a previous study, we set the performance goal at 5.0%. Over the 1-year follow-up, the primary endpoint occurred in 3.08% of patients, which was lower than the predefined performance goal (P<0.0001). Notably, definite ST occurred in only 1 patient (0.08%) within 1 year (at 258 days). No differences were observed in the primary endpoint between stent types.

CONCLUSIONS

The REIWA region-wide registry suggests that 1-month DAPT followed by P2Yinhibitor monotherapy is safe and feasible for Japanese patients with BP-DES.