Today in Medicine: Mixed Long-term Results for Sirolimus-Eluting Stent Implantation in Diabetic Patients
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June 29th, 2007 By Shaun Takao [1]
Madrid, Spain: Long-term results of the DIABETES (DIABETes and sirolimus Eluting Stent) trial showed a marked reduction in target lesion revascularization (TLR) with the sirolimus-eluting stent (SES) compared with the bare metal stent (BMS) at 2 year follow-up. However, there was also a significant cumulative rate of revascularization due to atherosclerosis progression in both groups as well as an increase in late stent thrombosis after clopidogrel discontinuation. The long-term clinical results were published in this month’s issue of the European Heart Journal.
The DIABETES trial was the first randomized multicenter trial examining the efficacy of SES in preventing restenosis in diabetic patients. The trial randomized 160 diabetic patients with de novo coronary stenoses to either SES or BMS. One year dual antiplatelet therapy of aspirin and clopidogrel was routinely prescribed for one year in both arms. In total, 111 lesions were treated with SES and 110 lesions with BMS.
The overall MACE rate, defined as death, MI, TLR, or stent thrombosis, was significantly lower in the SES group at the two year follow-up, though this was driven by the considerable reduction in the TLR rate after SES implantation. At the two year follow-up, the rate of TLR was just 7.7% in the SES group compared with 35.0% in the BMS group (p<0.001).
The stent thrombosis rate at the one year follow-up was 0% in the SES group while there were 2 cases of stent thrombosis in the BMS group. Following clopidogrel withdrawal, 3 patients in the SES group presented with stent thrombosis and one patient presented with thrombosis in a BMS implanted prior to the trial.
In their paper, Dr. Pilar Jiménez-Quevedo and colleagues also note that further studies are needed to evaluate the prognostic implications of microvascular complications of diabetes mellitus after SES implantation.
P.J.-Q is a recipient of a Community of Madrid-European Social Funding grant.
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Read more about PCI in the Diabetic Patient in the Living Textbook of Cardiology
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