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 1 year. 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.

Pompei G., Campo G., Ruggiero R., Maffeo D., Sgura F., Arrotti S., et al. (2023). Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study. INTERNATIONAL JOURNAL OF CARDIOLOGY, 383, 1-7 [10.1016/j.ijcard.2023.04.029].

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

Dall'Ara G.;Saia F.;
2023

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 1 year. 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.
2023
Pompei G., Campo G., Ruggiero R., Maffeo D., Sgura F., Arrotti S., et al. (2023). Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study. INTERNATIONAL JOURNAL OF CARDIOLOGY, 383, 1-7 [10.1016/j.ijcard.2023.04.029].
Pompei G.; Campo G.; Ruggiero R.; Maffeo D.; Sgura F.; Arrotti S.; Preti G.; Iannaccone M.; Erriquez A.; Biscaglia S.; Sganzerla P.; Capecchi A.; Pign...espandi
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S0167527323005752-main.pdf

accesso aperto

Tipo: Versione (PDF) editoriale
Licenza: Licenza per Accesso Aperto. Creative Commons Attribuzione (CCBY)
Dimensione 2.75 MB
Formato Adobe PDF
2.75 MB Adobe PDF Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/961906
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 0
  • ???jsp.display-item.citation.isi??? 0
social impact