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.
Aged
Aged, 80 and over
Alloys
Cardiovascular Agents
/ administration & dosage
Comparative Effectiveness Research
Coronary Artery Disease
/ diagnostic imaging
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
/ adverse effects
Prosthesis Design
Registries
Retrospective Studies
Risk Assessment
Risk Factors
Self Expandable Metallic Stents
Sirolimus
/ administration & dosage
Time Factors
Treatment Outcome
percutaneous coronary intervention
second-generation drug-eluting stent
self-expandable stent
unprotected left main
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
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.
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
208-215Informations de copyright
© 2018 Wiley Periodicals, Inc.