Key result
Sirolimus-eluting Stentys stent is associated with a ~14% MACE rate at 13 months.
Why the study?
Few data were available regarding the safety and effectiveness of the self-apposing sirolimus-eluting Stentys stent in a real-life setting.
Observational (n=278)
Yes
The sirolimus-eluting Stentys stent demonstrated a 14% MACE rate at 13 months in a real-world registry, highlighting that stent thrombosis risk is associated with STEMI presentation and specific anatomic features.
Stent thrombosis risk in STEMI warrants caution with Stentys; leaves open randomized confirmation of safety and efficacy.
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.
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Montefusco et al. (2019) conducted an observational in coronary artery disease (n=278). sirolimus-eluting Stentys stent was evaluated on Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis). In 278 patients treated with the sirolimus-eluting Stentys stent, the rate of major adverse cardiovascular events was 14% at 13 months, with stent thrombosis occurring in 3.9%.
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