The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

CORONARY INTERVENTIONS

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study

EuroIntervention 2019;14:e1836-e1842 published online June 2018. DOI: 10.4244/EIJ-D-17-01087

1. HU Virgen Arrixaca-Murcia, El Palmar, Murcia, Spain; 2. PHE University Cardiology Clinic, Skopje, Republic of North Macedonia; 3. Clinical Hospital Center Zemun, Belgrade, Serbia; 4. Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5. Hospital Universitario Central Asturias-Oviedo, Oviedo, Spain; 6. Clinical Center Nis, Nis, Serbia; 7. Complejo Hospitalario Universitario Santiago de Compostela, Santiago de Compostela, Spain; 8. Complejo Hospitalario Universitario A Coruña, A Coruña, Spain; 9. Centro Cardiologico Monzino, University of Milan, Milan, Italy; 10. Azienda Ospedaliero Universitaria Careggi, Florence, Italy; 11. Azienda Ospedaliero Universitaria, Policlinico “Vittorio Emanuele” – Ospedale Ferrarotto, Catania, Italy; 12. San Raffaele Hospital, Milan, Italy; 13. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil; 14. Interventional Cardiology Department, Cork University Hospital, Cork, Ireland; 15. MedStar Washington Hospital Center, Washington, DC, USA; 16. Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia

Aims: The MASTER study was designed to compare the performance of a new biodegradable 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, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six 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 revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had 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 revascularisation 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 the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm).

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. Clinical Trials Registration: https://clinicaltrials.gov/NCT02828683

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