by Robert Fay

In routine clinical practice, drug-eluting stents (DES) are as safe and effective as bare-metal stents (BMS), according to a study published in the November 21, 2007 Journal of the American College of Cardiology. The authors say that the lower risk of target vessel revascularization among DES patients was "achieved without excess hazard of death or [myocardial infarction]," and the authors found a low rate of late stent thrombosis.

Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but the authors found limited data regarding whether DES provide superior outcomes compared to BMS for the full spectrum of patients treated with DES in North America. The authors evaluated the two procedures, drawing on data from the National Heart, Lung and Blood Institute Dynamic Registry to compare outcomes of 1,460 patients who received at least one DES (sirolimus or paclitaxel) in 2004 with 1,763 patients who received at least one BMS between 2001 and 2002. The researchers looked at lesion characteristics and procedural outcomes as well as in-hospital and clinical outcomes after 1 year.

For at least up to 1 year, DES in general clinical practice was not associated with any excess risk of death or myocardial infarction (MI) compared with BMS, even in patients with complex heart lesions. The cumulative death and MI rate in patients who received DES was 7.6 percent compared with 8.7 percent for BMS recipients. Patients treated with DES also had substantially reduced clinically driven target vessel revascularizations compared with patients who received BMS (5 percent versus 8.7 percent), and the durability of the initial angioplasty was enhanced by DES.

The current study provides "additional information regarding the safety and effectiveness of DES," say the authors. "For at least up to 1 year, use of DES in standard clinical practice was not associated with any excess risk of death or MI compared with BMS, even in complex lesion subsets. Furthermore, the durability of the initial percutaneous revascularization was enhanced with DES," they conclude.

"This study, which was funded by the National Institutes of Health (NIH), is one of the first to explore the comparison between DES and BMS in the United States &mdash using an extensively validated and complete data collection tool," said E. Magnus Ohman, MD, FRCPI, FACC, Professor of Medicine and Director of the Program for Advanced Coronary Disease at Duke University Medical Center. "It suggests that at least at 1 year after stent implantation that DES appear safe and are associated with lower repeat revascularization rates &mdash thus validating some of the observations from the previous randomized trials. Long-term safety remains to be explored and the next wave of this NIH registry will have the opportunity to explore this."

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Source: Abbott JD, Voss MR, Nakamura M, et al. 2007. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice. Journal of the American College of Cardiology 50:2029-2036.

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