High- vs. Low-Dose Paclitaxel Drug-Coated Balloons for Femoropopliteal Interventions - COMPARE

Contribution To Literature:

The COMPARE trial showed that a low-dose drug-coated balloon was noninferior to high-dose at maintaining vessel patency.

Description:

The goal of the trial was to evaluate high-dose compared with low-dose drug-coated balloon angioplasty among patients with moderate to severe claudication.

Study Design

  • Randomized
  • Parallel
  • Stratification

After successful lesion crossing, patients with moderate to severe claudication were randomized to low-dose paclitaxel drug-coated balloon angioplasty 2.0 μg/mm2 (n = 207) versus high-dose paclitaxel drug-coated balloon angioplasty 3.5 μg/mm2 (n = 207). The drug-coated balloon length was required to be ≥1 cm longer than the pre-dilatation balloon with an inflation time ≥120 seconds.

  • Total number of enrollees: 414
  • Duration of follow-up: 12 months
  • Mean patient age: 68 years
  • Percentage female: 38%
  • Percentage with diabetes: 31%

Inclusion criteria:

  • De novo or restenotic femoropopliteal lesions not exceeding the medial femoral epicondyle with a lesion length ≤30 cm and ≥1 patent tibial runoff vessel

Exclusion criteria:

  • Presence of thrombus or stent in the target lesion
  • Required treatment with alternative therapies, such as stenting, laser, atherectomy, cryoplasty, brachytherapy, and re-entry devices

Other salient features/characteristics:

  • >40% of lesions were totally occluded
  • >50% of lesions were moderately to severely calcified
  • Bailout stenting: 25.6% in the high-dose group vs. 30.0% in the low-dose group

Principal Findings:

The primary efficacy endpoint of primary patency (absence of clinically driven target lesion revascularization or binary restenosis) at 12 months occurred in 81.5% of the high-dose group compared with 83.0% of the low-dose group (p for noninferiority < 0.01). The results were the same according to lesion length strata.

The primary safety endpoint (composite of freedom from device and procedure-related death through 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization) at 12 months occurred in 92.6% of the high-dose group compared with 91.0% of the low-dose group (p for noninferiority < 0.01).

Secondary outcomes:

  • All-cause mortality: 1.6% of the high-dose group compared with 2.5% of the low-dose group (p = 0.73)
  • No major amputations occurred in either group

Interpretation:

Among patients with moderate to severe claudication, low-dose paclitaxel balloon angioplasty was noninferior to high-dose paclitaxel balloon angioplasty. Bailout stenting was required 25-30% of the time. Primary vessel patency was >80% and freedom from major adverse events was >90% for both groups. It is reassuring that all-cause mortality was low and there were no major amputations in either group.

References:

Steiner S, Schmidt A, Zeller T, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J 2020;Jan 28:[Epub ahead of print].

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Interventions and Vascular Medicine

Keywords: Amputation, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Balloon Occlusion, Cardiology Interventions, Dilatation, Femoral Artery, Intermittent Claudication, Paclitaxel, Stents, Vascular Diseases


< Back to Listings