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European Heart Journal Advance Access published online on June 9, 2009
European Heart Journal, doi:10.1093/eurheartj/ehp224
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

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

Alberto Menozzi1,*, Emilia Solinas1, Paolo Ortolani2, Alessandra Repetto3, Francesco Saia2, Giancarlo Piovaccari4, Antonio Manari5, Enrico Magagnini6, Luigi Vignali1, Erminio Bonizzoni7, Piera Angelica Merlini8, Claudio Cavallini9, Diego Ardissino1 and for the SES-SMART Investigators

1 Unità Operativa di Cardiologia, Dipartimento Cardio-Polmonare, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci 14 43100, Parma, Italy
2 Istituto di Cardiologia, Università di Bologna, Policlinico Sant'Orsola-Malpighi, Via Massarenti 9 40128, Bologna, Italy
3 Divisione di Cardiologia, Fondazione IRCCS Policlinico San Matteo, P.le Golgi 2 27100, Pavia, Italy
4 Unità Operativa di Cardiologia, Ospedale degli Infermi, Via Settembrini 2 47900, Rimini, Italy
5 Unità Operativa di Cardiologia, Ospedale Santa Maria Nuova, Viale Risorgimento 80 42100, Reggio Emilia, Italy
6 Unità Operativa di Cardiologia, Ospedale Santa Chiara, Via Roma 67 56124, Pisa, Italy
7 Istituto di Statistica Medica e Biometria, Università di Milano, Via Venezian 1 20133, Milano, Italy
8 Dipartimento di Cardiologia, Ospedale Niguarda, Piazza Ospedale Maggiore 3 20162, Milano, Italy
9 Unità Operativa di Cardiologia, Ospedale Santa Maria della Misericordia, Piazzale Menghini 1 06132, Perugia, Italy

Received 25 May 2008; revised 5 April 2009; accepted 4 May 2009 * Corresponding author. Tel: +39 521 702070, Fax: +39 521 702189, Email: almenozzi{at}ao.pr.it

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.

Key Words: Stents • Sirolimus • Small coronary arteries • Revascularization • Myocardial infarction


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