Trial Procedures
diabetes
ADVERSE EVENT, DIABETES
Patients were randomly assigned in a 1:1 ratio to receive open-label the biodegradable-polymer sirolimus-eluting stent (Orsiro Mission; Biotronik) or the durable-polymer, slow-release zotarolimus-eluting stent (Resolute Onyx; Medtronic) after successful lesion preparation. Randomization was concealed using a web-based system; randomization sequences were computer-generated, blocked with randomly selected block sizes of 2 or 4, and were stratified by country, site, diabetes status, and intended use of a single antiplatelet drug (aspirin or a P2YPatients eligible for follow-up visits were those who received at least 1 study stent. During follow-up visits, which occurred preferably on-site, at 30 (range, −2 to 7), 180 (±30), and 365 (±30) days after randomization, ischemic status, quality-of-life questionnaires, self-reported adherence to antiplatelet medications, and any adverse event data were collected.Complete source data verification was implemented in 541 patients (28.2%), including the first 2 patients enrolled at each site and a randomly selected cohort of 25% of the remaining patients per site.