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Meta-Analysis Comparing Drug-Coated Balloons and Percutaneous Transluminal Angioplasty for Infrapopliteal Artery

Mahmoud Barbarawi1, Abdul Haseeb Qazi2, Juyong Lee1

  • 1Division of Cardiology, University of Connecticut, Farmington, Connecticut.

The American Journal of Cardiology
|September 18, 2022
PubMed

Insights

Drug-coated balloons (DCB) significantly reduce restenosis and revascularization in critical limb ischemia patients with infrapopliteal arterial disease compared to conventional balloon angioplasty (PTA). DCB treatment showed no increased risk of mortality or amputation.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Medical Devices

Background:

  • Critical limb ischemia (CLI) due to infrapopliteal peripheral arterial disease (PAD) poses significant treatment challenges.
  • Conventional percutaneous transluminal balloon angioplasty (PTA) has limitations in managing complex infrapopliteal lesions.
  • Limited comparative data exists on drug-coated balloons (DCB) versus PTA for infrapopliteal PAD.

Purpose of the Study:

  • To conduct an updated meta-analysis assessing the safety and efficacy of DCB compared to conventional PTA.
  • To evaluate DCB's effectiveness in treating infrapopliteal arterial disease in patients with CLI.
  • To synthesize current evidence on key clinical outcomes including restenosis, revascularization, mortality, and amputation.

Main Methods:

  • Systematic database search of PubMed/MEDLINE, EMBASE, and Cochrane Library up to November 15, 2021.
  • Inclusion of randomized controlled trials comparing DCB with conventional PTA for infrapopliteal arterial disease.
  • Meta-analysis of 9 trials involving 1,501 participants, reporting risk ratios (RRs) and 95% confidence intervals (CIs).

Main Results:

  • DCB demonstrated a significantly lower incidence of restenosis (RR 0.48, p=0.0001) compared to PTA.
  • DCB usage was associated with a significant reduction in clinically driven target lesion revascularization (RR 0.54, p=0.006).
  • No significant differences were observed in all-cause mortality, major target limb amputation, or major adverse cardiovascular events between DCB and PTA.

Conclusions:

  • DCB is a safe and effective treatment option for infrapopliteal arterial disease in patients with CLI.
  • DCB significantly reduces restenosis and the need for revascularization compared to conventional PTA.
  • DCB does not increase the risk of mortality or major limb amputation, offering a favorable safety profile.

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