Safety and effectiveness of the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease: SPARTA, a multicenter experience

Montefusco A 1 , De Filippo O 1 , Gili S 1 , Mancone M 2 , Calcagno S 2 , Cirillo P 3 Show all authors , Esposito G 3 , Poli A 4 , Ferrara E 4 , Smolka G 5 , Wanha W 5 , Palmieri C 6 , Pastormerlo LE 6 , Baumbach A 7 , Sganzerla P 8 , Tamburino C 9 , Bruno F 1 , Secco GG 10 , Nicolino A 11 , Yew KL 12 , di Palma G 13 , Wojakowski W 5 , Sardella G 2 , Rinaldi M 1 , Cortese B 6 , D'Ascenzo F 1

Affiliations 

  • 1 Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin
  • 2 Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome
  • 3 Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples
  • 4 Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi, Legnano, Italy
  • 5 Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  • 6 Fondazione Monasterio CNR-Regione Toscana, Massa, Italy
  • 7 Queen Mary University London and Barts Heart Centre, London, UK
  • 8 Division of Cardiology, AO Ospedale Treviglio-Caravaggio, Treviglio
  • 9 Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania
  • 10 Interventional Cardiology, Santi Antonio, Biagio e Cesare Arrigo Hospital, Alessandria
  • 11 Division of Cardiology, Santa Corona Hospital, Pietra Ligure, Italy
  • 12 Cardiology Department, Manipal Hospital, Klang, Selangor, Malaysia
  • 13 Department of Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy
Coron Artery Dis, 2020 01;31(1):27-34.
PMID: 31658146 DOI: 10.1097/MCA.0000000000000790

Abstract

AIMS: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting.

BACKGROUND: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available.

METHODS: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones.

RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71).

CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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