Swedish Drug Elution Trial in Peripheral Arterial Disease - SWEDEPAD

Dec 21, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Swedish Research Council, Swedish Heart–Lung Foundation, and Region Västra Götaland
Date Published:
12/09/2020
Date Updated:
12/21/2020
Original Posted Date:
12/21/2020
References

Contribution To Literature:

The SWEDEPAD trial did not find an association between paclitaxel-eluting stents/balloons and increased mortality.

Description:

Meta-analyses have raised concern that paclitaxel-eluting stents/balloons are associated with increased mortality when used for the treatment of symptomatic peripheral arterial disease. The goal of the present trial was to evaluate drug-coated devices compared with uncoated devices for treatment of symptomatic peripheral arterial disease.

Study Design

  • Randomized
  • Parallel
  • Stratified
  • Open-label

Patients with symptomatic peripheral arterial disease undergoing endovascular lower extremity revascularization were randomized to a coated device (n = 1,149) versus an uncoated device (n = 1,140).

  • Total number of enrollees: 2,289
  • Duration of follow-up: 2.5 years
  • Mean patient age: 75 years
  • Percentage female: 45%
  • Percentage with diabetes: 46%

Inclusion criteria:

  • Intermittent claudication or chronic limb-threatening ischemia
  • Infrainguinal peripheral arterial disease
  • Eligible for endovascular revascularization

Exclusion criteria:

  • Acute lower limb ischemia
  • Infrainguinal aneurysmal disease
  • Participation in another peripheral arterial disease trial

Principal Findings:

The primary outcome, all-cause mortality during the entire follow-up period, occurred in 25.5% of the drug-coated device group compared with 24.6% of the uncoated device group (p = not significant). Results were the same among those with chronic limb-threatening ischemia and those with intermittent ischemia.

Secondary outcomes:

All-cause mortality at 1 year occurred in 10.2% of the drug-coated device group compared with 9.9% of the uncoated device group (p = not significant). Results were the same among those with chronic limb-threatening ischemia and those with intermittent ischemia.

Interpretation:

Among patients with symptomatic peripheral arterial disease, drug-coated devices for treatment of symptomatic peripheral arterial disease were not associated with increased mortality. There was not a clear mechanism for the previously documented harmful association. Lack of a harmful association from this study supports ongoing and future trials with the use of this technology.

References:

Nordanstig J, James S, Andersson M, et al. Mortality With Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med 2020;383:2538-46.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Vascular Medicine

Keywords: Diabetes Mellitus, Drug-Eluting Stents, Endovascular Procedures, Geriatrics, Intermittent Claudication, Ischemia, Lower Extremity, Myocardial Revascularization, Paclitaxel, Peripheral Arterial Disease, Stents, Vascular Diseases


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