Drug-Eluting Stents: High Marks in Peripheral Artery Disease

Steven Fox

April 23, 2013

Drug-eluting stents (DES) may be superior to bare-metal stents (BMS) in the treatment of patients with chronic lower leg ischemia, according to results of a meta-analysis of 6 studies.

An article detailing the meta-analysis appears in the April issue of the Journal of Endovascular Therapy.

George A. Antoniou, MD, PhD, from the Department of Vascular and Endovascular Surgery, Central Manchester University Hospitals, United Kingdom, and colleagues note that as the prevalence of diabetes continues to increase, so likely will the prevalence of critical limb ischemia. They point out that even though surgical reconstruction of clogged arteries has historically been the most commonly used therapeutic strategy in such cases, stents might offer similar or even better outcomes with the advantage of no surgical trauma.

"Controversy exists, however, with regard to the superiority of DES over BMS in terms of the clinical benefit in [critical limb ischemia] patients," they write.

To determine whether DES or BMS provide better results, the authors conducted a meta-analysis that included 6 studies: 4 randomized trials and 2 observational studies. In all, the authors evaluated data on 544 patients.

They report that DES recipients fared significantly better than BMS patients for the main outcome measures assessed:

  • Differences in primary patency: odds ratio (OR), 4.511; 95% confidence interval [CI], 2.897 - 7.024; P < .001; number needed to treat (NNT), 3.5.

  • Freedom from target lesion revascularization: OR, 3.238; 95% CI, 2.019 - 5.192; P < .001; NNT, 6.0.

  • Clinical improvement at 1 year: OR, 1.792; 95% CI, 1.039 - 3.090; P = .036; NNT, 7.3.

No significant differences were noted in limb salvage and overall survival at 1 year.

Although the authors concede their meta-analysis only covered outcomes out 1 year, they nonetheless think the findings are important.

"This analysis has demonstrated favorable 1-year results with DES as compared with BMS, expressed by increased patency rates and freedom from [target lesion revascularization]," they write. However, they add, "It remains to be determined whether or not improvement in such outcome measures will be reflected in clinical parameters, such as limb salvage and wound healing."

In an invited commentary, Giuseppe Biondi-Zoccai, MD, from Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy, and colleagues weigh the advantages and disadvantages of meta-analyses vs large-scale singular trials.

The commentators also emphasize that not all DES produce the same outcomes, so the results cited in the current meta-analysis should not be generalized to all types of stent devices.

Despite those potential caveats, they commend Dr. Antoniou and colleagues for their contribution to the literature. "[T]he meta-analysis of Antoniou et al. is a clear example of the advantages of a systematic, comprehensive, and timely review of the evidence base concerning a specific clinical issue, aimed at informing decision making and guiding further research efforts. As such, it is recommended reading for all endovascular specialists."

Dr. Biondi-Zoccai has consulted/lectured for several companies manufacturing DES. The authors and other commentators have disclosed no relevant financial relationships.

J Endovasc Ther. 2013;20:131-144. Full text