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.


Journal

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139

Informations de publication

Date de publication:
01 02 2019
Historique:
received: 31 08 2017
revised: 02 07 2018
accepted: 12 07 2018
pubmed: 10 10 2018
medline: 11 2 2020
entrez: 10 10 2018
Statut: ppublish

Résumé

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

Sections du résumé

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.

Identifiants

pubmed: 30298593
doi: 10.1002/ccd.27809
doi:

Substances chimiques

Alloys 0
Cardiovascular Agents 0
nitinol 2EWL73IJ7F
Sirolimus W36ZG6FT64

Banques de données

ClinicalTrials.gov
['NCT02784405']

Types de publication

Comparative Study Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

208-215

Informations de copyright

© 2018 Wiley Periodicals, Inc.

Auteurs

Antonio Montefusco (A)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

Fabrizio D'Ascenzo (F)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

Sebastiano Gili (S)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

Grzegorz Smolka (G)

Division of Cardiology, Medical University of Silesia, Katowice, Poland.

Alaide Chieffo (A)

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

Andreas Baumbach (A)

Queen Mary University, London, United Kingdom.

Javier Escaned (J)

Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.
Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain.
Faculty of Medicine, Complutense University of Madrid, Madrid, Spain.

Paolo Sganzerla (P)

Division of Cardiology, AO Ospedale Treviglio-Caravaggio, Treviglio, Italy.

Francesco Tomassini (F)

Interventional Cardiology Unit, Infermi Hospital, Rivoli and San Luigi Gonzaga Hospital, Orbassano, Italy.

Gioel Gabrio Secco (GG)

Interventional Cardiology, Santi Antonio, Biagio e Cesare Arrigo Hospital, Alessandria, Italy.

Fabrizio Ugo (F)

Division of Cardiology, San Giovanni Bosco Hospital, Turin, Italy.

Corrado Tamburino (C)

Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.

Annamaria Nicolino (A)

Divison of Cardiology, Santa Corona Hospital, Pietra Ligure, Italy.

Massimo Mancone (M)

Department of Cardiovascular Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.

Arnaldo Poli (A)

Division of Cardiology, Ospedale Civile di Legnano - ASST Ovest Mi, Legnano, Italy.

Kuan-Leong Yew (KL)

Cardiology Department, Manipal Hospital, Klang, Selangor, Malaysia.

Plinio Cirillo (P)

Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.

Wojciech Wanha (W)

Division of Cardiology, Medical University of Silesia, Katowice, Poland.

Luigi Emilio Pastormerlo (LE)

Fondazione Monasterio CNR-Regione Toscana, Italy.

Roberto di Summa (R)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

Gennaro Sardella (G)

Department of Cardiovascular Respiratory, Nephrologic, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.

Antonio Colombo (A)

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

Fiorenzo Gaita (F)

Department of Medical Sciences, Division of Cardiology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.

Bernardo Cortese (B)

Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milan, Italy.
Fondazione Monasterio CNR-Regione Toscana, Italy.

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