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.
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.; D'Ascenzo, F.; Gili, S.; Smolka, G.; Chieffo, A.; Baumbach, A.; Escaned, J.; Sganzerla, P.; Tomassini, F.; Secco, G. G.; Ugo, F.; Tamburino, C.; Nicolino, A.; Mancone, M.; Poli, A.; Yew, K. -L.; Cirillo, P.; Wanha, W.; Pastormerlo, L. E.; di Summa, R.; Sardella, G.; Colombo, A.; Gaita, F.; Cortese, B.. - In: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. - ISSN 1522-1946. - 93:2(2019), pp. 208-215. [10.1002/ccd.27809]
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
Mancone M.;Sardella G.;
2019
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.File | Dimensione | Formato | |
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