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Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials
Massimiliano Fusaro1, Salvatore Cassese1, Gjin Ndrepepa1
1Deutsches Herzzentrum, Technische Universität, Munich, Germany.
Insights
Drug-eluting stents (DESs) significantly reduce reintervention and amputation rates in patients with infrapopliteal artery disease compared to balloon angioplasty or bare-metal stents (BMSs). This meta-analysis shows no significant impact on mortality or clinical improvement at one year.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Atherosclerotic disease of infrapopliteal arteries poses significant challenges in limb salvage.
- Drug-eluting stents (DESs) have shown promise in improving patency compared to older methods.
- The definitive clinical benefit of DES in this specific vascular territory requires further clarification.
Purpose of the Study:
- To conduct an updated meta-analysis of randomized trials on percutaneous revascularization using primary drug-eluting stenting.
- To evaluate the outcomes of DES implantation in patients with atherosclerotic disease of infrapopliteal arteries.
- To compare DES therapy against plain balloon angioplasty or bare-metal stents (BMSs).
Main Methods:
- Comprehensive literature search of MEDLINE, Embase, CENTRAL, and conference abstracts.
- Inclusion of randomized trials with intention-to-treat analysis and at least 6-month follow-up.
- Primary endpoint: target lesion revascularization; Secondary endpoints: restenosis, amputation, death, and Rutherford class.
Main Results:
- Analysis of 5 trials involving 611 patients (294 DES, 307 control).
- DES significantly reduced target lesion revascularization (OR 0.31) and restenosis (OR 0.25).
- DES also demonstrated a significant reduction in amputation risk (OR 0.50) without affecting mortality or Rutherford class improvement.
Conclusions:
- Drug-eluting stent therapy is effective in treating focal infrapopliteal artery disease.
- DES implantation reduces the need for reintervention and lowers amputation rates.
- No significant impact on mortality or functional class was observed at one-year follow-up.
Objectives:
This study sought to undertake an updated meta-analysis of randomized trials investigating the outcomes of percutaneous revascularization with primary drug-eluting stenting in patients with atherosclerotic disease of infrapopliteal arteries.
Background:
In atherosclerotic disease of infrapopliteal arteries, drug-eluting stents (DESs) improve patency rates compared with plain balloon angioplasty or bare-metal stents (BMSs). However, the clinical impact of DES placement in this vascular territory still remains uncertain.
Methods:
We searched MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), scientific session abstracts, and relevant Websites. The keywords used were "below the knee," "infrapopliteal artery," "angioplasty," "drug-eluting stent(s)," "bare metal stent(s)," "trial," and "randomized trial." Inclusion criteria were randomized design, intention-to-treat analysis, and a minimum of 6-month follow-up. Exclusion criteria were vessels treated other than infrapopliteal arteries; devices used other than DESs, plain balloons, or BMSs; and duplicated data. The primary endpoint was target lesion revascularization; secondary endpoints were restenosis, amputation, death, and improvement in Rutherford class.
Results:
A total of 611 patients from 5 trials were randomly assigned to DESs (n = 294) versus control therapy (plain balloon angioplasty/BMS implantation, n = 307). Overall, the median lesion length was 26.8 mm (interquartile range [IQR]: 18.2 to 30.0 mm) with a reference vessel diameter of 2.86 mm (IQR: 2.68 to 3.00 mm). At a median follow-up of 12 months (IQR: 12 to 36 months), DESs reduced the risk of target lesion revascularization (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.18 to 0.54; p < 0.001), restenosis (OR: 0.25; 95% CI: 0.15 to 0.43; p < 0.001), and amputation (OR: 0.50; 95% CI: 0.26 to 0.97); p = 0.04) without a significant difference in terms of death (OR: 0.81; 95% CI: 0.45 to 1.49; p = 0.50) and Rutherford class improvement (OR: 1.36; 95% CI: 0.91 to 2.04; p = 0.13) versus control therapy.
Conclusions:
In focal disease of infrapopliteal arteries, DES therapy reduces the risk of reintervention and amputation compared with plain balloon angioplasty or BMS implantation without any impact on mortality and Rutherford class at 1-year follow-up.
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