COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions

Eur Heart J. 2020 Jul 14;41(27):2541-2552. doi: 10.1093/eurheartj/ehaa049.


Aims: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2.

Methods and results: Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred.

Conclusion: Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths.

Clinical trial registration: The trial is registered with (NCT02701543).

Keywords: Drug-coated balloons; Patency; Peripheral vascular disease; Restenosis; Stents; Superficial femoral artery disease.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon*
  • Cardiovascular Agents*
  • Coated Materials, Biocompatible
  • Femoral Artery
  • Humans
  • Paclitaxel
  • Peripheral Arterial Disease* / therapy
  • Pharmaceutical Preparations*
  • Popliteal Artery
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Vascular Patency


  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Pharmaceutical Preparations
  • Paclitaxel

Associated data