AIMS: The MASTER study was designed to compare performance of a new biode-gradable polymer sirolimus-eluting stent (BP-SES) with a bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).
METHODS AND RESULTS: The study was a prospective, randomized (3:1), controlled, single-blind multi-center trial that enrolled 500 STEMI patients within 24h of symptom onset, during 2013-2015. 375 were treated with BP-SES and 125 with BMS. 104 randomized patients underwent angiographic follow-up at 6 months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascu-larization (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at 6 months in the angiographic cohort. The major secondary end-point for safety was a composite of all-cause death, recurrent MI, unplanned infarct related artery revascularization, stroke, definite stent thrombosis (ST) or major bleeding at 1 month. At 12 months, TVF occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascu-larization in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated superiority (p=0.0125) of BP-SES (0.09±0.43mm) over BMS (0.79±0.67mm).
CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.