Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study. (2024)

Affiliation

• Pompei G; Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, FE, Italy.
• Campo G; Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, FE, Italy. Electronic address: cmpglc@unife.it.
• Ruggiero R; Cardiovascular Department, Infermi Hospital, Rimini, Italy.
• Maffeo D; Cardiology Unit, Fondazione Poliambulanza Istituto Ospedaliero Brescia, Brescia, Italy.
• Sgura F; Cardiology Unit, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
• Arrotti S; Cardiology Unit, Azienda Ospedaliero Universitaria di Modena, Modena, Italy.
• Preti G; Interventional Cardiology Unit, AULSS2 Marca Trevigiana, Ospedale di Conegliano, Conegliano, Italy.
• Iannaccone M; Cardiology Unit, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy.
• Erriquez A; Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, FE, Italy.
• Biscaglia S; Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, FE, Italy.
• Sganzerla P; Interventional Cardiology Unit, IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Milano, Italy.
• Capecchi A; Cardiology Unit, Maggiore Hospital, Bologna, Italy.
• Pignatelli G; Cardiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
• Dall'Ara G; Cardiology Unit, Morgagni-Pierantoni Hospital, Forlì, Italy.
• Saia F; Cardiology Unit, St. Orsola Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
• Tomassini F; Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Rivoli Infermi Hospital ASLTO3, Rivoli, Turin, Italy.
• Rolfo C; Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Rivoli Infermi Hospital ASLTO3, Rivoli, Turin, Italy.
• Varbella F; Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Rivoli Infermi Hospital ASLTO3, Rivoli, Turin, Italy.
• Cerrato E; Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, Rivoli Infermi Hospital ASLTO3, Rivoli, Turin, Italy.

ABSTRACT

BACKGROUND:

The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population.

METHODS:

SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization.

RESULTS:

Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis.

CONCLUSIONS:

These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.