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Submitted on July 9, 2004
Revised on October 31, 2004
Accepted on November 5, 2004

Early and Mid-Term Results of Drug-Eluting Stent Implantation in Unprotected Left Main

Alaide Chieffo MD, Goran Stankovic MD, Erminio Bonizzoni PhD, Eleftheria Tsagalou MD, Ioannis Iakovou MD, Matteo Montorfano MD, Flavio Airoldi MD, Iassen Michev MD, Massimo Giuseppe Sangiorgi MD, Mauro Carlino MD, Giancarlo Vitrella MD, and Antonio Colombo MD^*

From San Raffaele Hospital (A.C., E.T., M.M., F.A., I.M., M.C., G.V., A.C.) and Columbus Hospital (I.I., M.S., A.C.) and Institute of Medical Statistics and Biometry, University of Milan (E.B.), Milan, Italy; and the Institute for Cardiovascular Disease (G.S.), Clinical Center of Serbia, Belgrade, Serbia and Montenegro.

^* To whom correspondence should be addressed. E-mail: colombo{at}emocolumbus.it.

Background--The safety and efficacy of percutaneous coronary intervention in unprotected left main (ULM) coronary arteries are still a matter of debate.

Methods and Results--All consecutive patients who had a sirolimus-eluting stent (Cypher, Cordis, Johnson and Johnson Co) or a paclitaxel-eluting stent (Taxus, Boston Scientific) electively implanted in de novo lesions on unprotected left main were analyzed. Patients treated with a drug-eluting stent (DES) were compared with the historical group of consecutive patients treated with bare metal stent (BMS). Eighty-five patients were treated with DES; 64 had BMS implantation. Patients treated with DES had lower ejection fractions (51.1±11% versus 57.4±13%, P=0.002) and were more often diabetics (21.2% versus 10.9%, P=0.12) with more frequent distal left main involvement (81.2% versus 57.8%, P=0.003). Furthermore, in the DES group, smaller vessels (3.33±0.6 versus 3.7±0.7 mm, respectively; P=0.0001) with more lesions (2.94±1.6 versus 2.25±1.3, P=0.004) and vessels (2.03±0.69 versus 1.8±0.72, P=0.05) were treated with longer stents (24.3±12 versus 15.8±8.6 mm, P=0.0001). Despite the higher-risk patients and lesion profiles in the DES group, the incidence of major cardiac events at a 6-month clinical follow-up was lower in the DES than in the BMS group (20.0% versus 35.9%, respectively; P=0.039). Moreover, cardiac deaths occurred in 3 DES patients (3.5%), as compared with 6 (9.3%) in the BMS group (P=0.17).

Conclusions--In this early experience with DES in unprotected left main, this procedure appears safe with favorable and improved clinical results as compared with historical control subjects with a BMS. A randomized study comparing surgery appears justified at present.

Key words: revascularization • stents, drug-eluting • arteries

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