Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions

doi:10.2337/dc07-1377

Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions

A prospective, randomized, multicenter study

¹Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Rome, Italy
²Cardiology Department, Mirano Hospital, Mirano, Italy
³Division of Cardiology, Department of Internal Medicine and Systemic Disease, Ferrarotto Hospital, University of Catania, Catania, Italy
⁴Division of Cardiology, S. Eugenio Hospital, Rome, Italy
⁵Institute of Cardiology, University of Verona, Verona, Italy
⁶Catheterization Laboratory, S. Giovanni Hospital, Rome, Italy

Address correspondence and reprint requests to Fabrizio Tomai, MD, Division of Cardiology, Department of Cardiovascular Sciences, European Hospital, Via Portuense 700, 00149 Rome, Italy. E-mail: f.tomai{at}tiscali.it

Abstract

OBJECTIVE—It is still controversial whether sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) are equally effective in patients with diabetes. In these patients, multiple individual variables may be responsible for neointimal hyperplasia, thus making difficult the comparison of the two drug-eluting stents (DES).

RESEARCH DESIGN AND METHODS—We designed a prospective, randomized study to compare the efficacy in prevention of restenosis of SES and PES, both implanted in the same diabetic patient with multiple de novo coronary artery lesions undergoing elective percutaneous coronary intervention. We enrolled 60 patients with diabetes with at least two significant de novo angiographic stenoses in different coronary segments. The primary end point was in-stent late luminal loss (LLL) at 8-month angiographic follow-up.

RESULTS—A total of 120 lesions were successfully treated with the randomly assigned DES (SES, n = 60; PES, n = 60). In-stent LLL was lower in the SES than in the PES group (0.26 ± 0.4 vs. 0.50 ± 0.6 mm; P = 0.01). Coronary lesions treated with SES presented a reduced in-stent LLL in 40 (68%) patients, while PES resulted in a lower in-stent LLL in 19 (32%) patients (P = 0.0002). At multivariable analysis, the type of DES implanted was the only independent predictor of in-stent LLL (odds ratio 2.3 [95% CI 1.1–5.0]; P = 0.03).

CONCLUSIONS—SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.

Footnotes

Published ahead of print at http://care.diabetesjournals.org on 27 September 2007. DOI: 10.2337/dc07-1377.

A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

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- Accepted September 23, 2007.
- Received July 17, 2007.
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