Copyright © 2004 by the European Society of Cardiology.
Clinical research
Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients
Insights from the RAVEL Trial
a Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil
b University of Florida, Shands Jacksonville, Jacksonville, FL, USA
c Clinique Saint Gatien, Tours, France
d Hôpital Charles Nicolle, Rouen, France
e Ospedali Riuniti di Bergamo, Bergamo, Italy
f Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
g Cordis, a Johnson & Johnson Company, Warren, NJ, USA
h Cardialysis, Rotterdam, The Netherlands
i Academisch Ziekenhuis Rotterdam Dijkzigt, Rotterdam, The Netherlands
j Institut Hospitalier Jacques Cartier, Massy, France
* Correspondence to: Alexandre Abizaid, MD, PhD, Av. Dr Dante Pazzanese, 500, Ibirapuera, Sao Paulo, SP, Brazil. Tel: 55-11-5085-4141; Fax: 55-11-55497807
E-mail address: aabizaid{at}uol.com.br
Received 21 March 2003; revised 30 October 2003; accepted 6 November 2003
Abstract
Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07±0.2 vs 0.82±0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (–0.03±0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)—an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007).
Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.
Key Words: Diabetes • Restenosis • Sirolimus • Drug eluting stents
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