Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS-2 registries

Montefusco A 1 , D'Ascenzo F 1 , Gili S 1 , Smolka G 2 , Chieffo A 3 , Baumbach A 4 Show all authors , Escaned J 5 , Sganzerla P 6 , Tomassini F 7 , Secco GG 8 , Ugo F 9 , Tamburino C 10 , Nicolino A 11 , Mancone M 12 , Poli A 13 , Yew KL 14 , Cirillo P 15 , Wanha W 2 , Pastormerlo LE 16 , di Summa R 1 , Sardella G 12 , Colombo A 3 , Gaita F 1 , Cortese B 17

Affiliations 

  • 1 Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy
  • 2 Division of Cardiology, Medical University of Silesia, Katowice, Poland
  • 3 Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
  • 4 Queen Mary University, London, United Kingdom
  • 5 Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain
  • 6 Division of Cardiology, AO Ospedale Treviglio-Caravaggio, Treviglio, Italy
  • 7 Interventional Cardiology Unit, Infermi Hospital, Rivoli and San Luigi Gonzaga Hospital, Orbassano, Italy
  • 8 Interventional Cardiology, Santi Antonio, Biagio e Cesare Arrigo Hospital, Alessandria, Italy
  • 9 Division of Cardiology, San Giovanni Bosco Hospital, Turin, Italy
  • 10 Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy
  • 11 Divison of Cardiology, Santa Corona Hospital, Pietra Ligure, Italy
  • 12 Department of Cardiovascular Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy
  • 13 Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi, Legnano, Italy
  • 14 Cardiology Department, Manipal Hospital, Klang, Selangor, Malaysia
  • 15 Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
  • 16 Fondazione Monasterio CNR-Regione Toscana, Italy
  • 17 Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milan, Italy
Catheter Cardiovasc Interv, 2019 02 01;93(2):208-215.
PMID: 30298593 DOI: 10.1002/ccd.27809

Abstract

OBJECTIVES: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).

BACKGROUND: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.

METHODS: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.

RESULTS: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.

CONCLUSION: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

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

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