Twenty-four months clinical outcomes of sirolimus-eluting stents for the treatment of small coronary arteries: the long-term SES-SMART clinical study

• Published in: European heart journal 2009-09, Vol.30 (17), p.2095-2101
• Main Authors: Menozzi, Alberto, Solinas, Emilia, Ortolani, Paolo, Repetto, Alessandra, Saia, Francesco, Piovaccari, Giancarlo, Manari, Antonio, Magagnini, Enrico, Vignali, Luigi, Bonizzoni, Erminio, Merlini, Piera Angelica, Cavallini, Claudio, Ardissino, Diego
• Format: Article
• Language: English
• Subjects: Aged; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Cardiology. Vascular system; Cerebrovascular Disorders - etiology; Cerebrovascular Disorders - mortality; Coronary heart disease; Coronary Restenosis - mortality; Coronary Restenosis - therapy; Death, Sudden, Cardiac - etiology; Drug-Eluting Stents; Female; Heart; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Myocardial infarction; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Myocardial Revascularization - mortality; Pharmacology. Drug treatments; Prospective Studies; Revascularization; Risk Factors; Single-Blind Method; Sirolimus; Sirolimus - administration & dosage; Small coronary arteries; Stents; Treatment Outcome; Tubulin Modulators - administration & dosage
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehp224

Aims It has been demonstrated that, in comparison with bare-metal stents (BMS), sirolimus-eluting stents (SES) reduce restenosis after the percutaneus revascularization of small coronary arteries, but the long-term clinical outcomes of this treatment have not yet been investigated. Methods and results The long-term SES-SMART clinical study was a multicentre, prospective, randomized, single-blind study of 257 patients receiving a SES or BMS in a small coronary artery, who were evaluated at discharge, 30 days, 8 and 24 months after stenting. The clinical endpoint of the study was a 24 months composite of major adverse cardiac and cerebrovascular events, which included death, non-fatal myocardial infarction, ischaemia-driven target lesion revascularization (TLR), and cerebrovascular accident. The 24 months follow-up was completed by 254 patients (98.8%). The use of SES was associated with a significantly lower incidence of the clinical endpoint (12.6% vs. 33.1%; HR 0.30, 95% CI: 0.17–0.55; P < 0.0001), which was not only due to a reduction in TLR (7.9% vs. 29.9%; HR 0.30, 95% CI: 0.16–0.59; P < 0.0001), but also to a reduction in myocardial infarction (1.6% vs. 10.2%; HR 0.09, 95% CI: 0.01–0.66; P = 0.018). Conclusion In comparison with BMS, the use of SES in the percutaneous revascularization of small coronary arteries is associated with improved clinical outcomes after 2 years follow-up.