Prolonged DAPT after Bioresorbable Scaffold

All subjects will take a loading dose of 300 mg clopidogrel or 180 mg ticagrelor plus 300 mg aspirin within 24 h before intervention. After the index procedure, a daily dose of a P2Y12 inhibitor (75 mg clopidogrel per day or 180 mg ticagrelor twice a day) as well as 100 mg aspirin per day will be administered over 12 months after the index procedure (observational period). Aspirin can be replaced by cilostazol (50 mg twice a day) or indobufen (100 mg twice a day) if subjects have a history of a gastric ulcer or bleeding. For the subjects who are eligible for randomization at 12 months (± 1 month), the prerandomization daily dose of the P2Y12 inhibitor will be continued or discontinued based on the randomization arm. Aspirin will be maintained for the duration of treatment. Subjects who switch from one type of P2Y12 inhibitor to another are eligible for enrollment if they have not changed within 6 months before randomization. All drugs will be prescribed to subjects routinely at the outpatient department of each center. Regular records of drug usage will be made throughout the entire study by investigators. Compliance will be reviewed by phone calls to subjects every 3 months from physicians to reconfirm the daily dose of each drug. Prasugrel has not yet been approved for the treatment of coronary artery disease in China.
All XINSORB BRS-treated subjects who are receiving 12 months (± 1 month) of the DAPT post index procedure and who are event-free (from death, MI, stroke, repeat revascularization, scaffold thrombosis, and BARC type 3 or 5 bleeding events) and who are compliant with DAPT (defined as no interruption more than 14 days) are eligible for randomization. The subjects will be randomized at a 1:1 ratio to receive either aspirin alone or a continuation of DAPT for an additional 24 months.