Drug-Coated Devices in PAD Intervention (VOYAGER PAD)

Quick Takes

  • Drug-coated devices (DCDs) were not associated with mortality or major adverse limb events.
  • DCDs were associated with reduction in unplanned index limb revascularization.
  • Risk of bleeding with rivaroxaban versus placebo was similar between patients treated with and without DCDs.

Study Questions:

What is the safety and effectiveness of drug-coated devices (DCDs) in lower extremity revascularization for peripheral artery disease (PAD)?


This analysis of the VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) study evaluated the safety and effectiveness of paclitaxel DCDs on prespecified DCD outcomes that included mortality and unplanned index limb revascularization (UILR) as the primary safety and effectiveness outcomes, respectively. Major adverse limb events (MALE) were also evaluated as a secondary outcome. Only patients undergoing lower extremity revascularization were included. Because DCD use was not randomized, inverse probability treatment weighting was used to achieve balance and account for each subject’s propensity for DCD versus non-DCD treatment. Median follow-up was 31 months.


DCDs were not associated with mortality (hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.83-1.09) or MALE (HR, 1.08; 95% CI, 0.90-1.30), but were associated with reduced UILR (21.5% vs. 24.6%; HR, 0.84; 95% CI, 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (p for interaction = 0.88) and safety of rivaroxaban with respect to bleeding (p for interaction = 0.57) were observed.


DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD.


The 2018 meta-analysis that initially demonstrated an association between DCDs and mortality led to a large-scale pullback on use of this technology for lower extremity PAD interventions at many institutions. For readers who have not been following the DCD saga closely since then, the introduction section of this paper gives a succinct overview of the differences in study designs, data sources, follow-up, and outcomes from subsequent attempts to address these questions. As the authors eloquently put it, these “mixed results” have perpetuated uncertainty about the role of DCDs in lower extremity revascularization for PAD.

Results of this study suggest that unplanned repeat revascularizations are less common after revascularizations performed with DCDs. Although no difference in mortality between DCD versus non-DCD procedures was identified, it is important to remember that the median follow-up of 31 months only includes the initial portion of the period when mortality risk has been observed to unfold in previous studies (usually 2-5 years). The results therefore provide short-term reassurance.

Mortality is difficult to top when prioritizing tradeoffs, but it is possible that some patients might accept slightly increased mortality risk to avoid restenosis and need for repeat procedures. For patients with chronic limb-threatening ischemia (CLTI), who already face significant short-term mortality and amputation risk, there are no good alternatives to revascularization and the consequences of restenosis may be particularly severe. These factors may combine to tilt the balance toward more aggressive DCD use in patients with CLTI, particularly those who have already experienced patency and/or tissue loss. The majority of patients treated in this study were claudicants, however; availability of exercise and pharmacotherapy as alternatives to revascularization might also justify more selective DCD use when treating claudication.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Prevention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Interventions and Vascular Medicine, Chronic Angina

Keywords: Cardiology Interventions, Coronary Restenosis, Hemorrhage, Intermittent Claudication, Ischemia, Myocardial Revascularization, Paclitaxel, Peripheral Arterial Disease, Pharmaceutical Preparations, Risk, Rivaroxaban, Secondary Prevention, Vascular Diseases, Vascular Surgical Procedures

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