Randomized Evaluation of a Novel Biodegradable Polymer-Based Sirolimus-Eluting Stent in ST-Segment Elevation Myocardial Infarction: The MASTER Study

Mariano Valdes-Chavarri, Sasko Kedev, Aleksandar N Neskovic, Cesar Morís de la Tassa, Milan Zivkovic, Ramiro Trillo Nouche, Nicolas Vázquez González, Antonio L Bartorelli, David Antoniucci, Corrado Tamburino, Antonio Colombo, Alexandre A Abizaid, Eugene McFadden, Hector M Garcia-Garcia, Dejan Milasinovic, Goran Stankovic

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Abstract

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.

Original languageEnglish
JournalEuroIntervention
DOIs
Publication statusE-pub ahead of print - Jun 26 2018

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Valdes-Chavarri, M., Kedev, S., Neskovic, A. N., Morís de la Tassa, C., Zivkovic, M., Trillo Nouche, R., Vázquez González, N., Bartorelli, A. L., Antoniucci, D., Tamburino, C., Colombo, A., Abizaid, A. A., McFadden, E., Garcia-Garcia, H. M., Milasinovic, D., & Stankovic, G. (2018). Randomized Evaluation of a Novel Biodegradable Polymer-Based Sirolimus-Eluting Stent in ST-Segment Elevation Myocardial Infarction: The MASTER Study. EuroIntervention. https://doi.org/10.4244/EIJ-D-17-01087