Trial reportEuropean heart journal2020
COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.
Trial report in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02701543 (Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Diversity in randomized clinical trials for peripheral artery disease: a systematic review.International journal for equity in health · 2024Pooled it
- Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.Vascular health and risk management · 2023Trial
- The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort.Vascular medicine (London, England) · 2022Trial
- One-year results for Japanese patients in RANGER II SFA.Heart and vessels · 2022Trial
- Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.Vascular health and risk management · 2022Trial
- 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent.Cardiovascular and interventional radiology · 2021Trial
- Low-Dose Versus High-Dose Drug-Coated Balloon After Jetstream Atherectomy for Severely Calcified Femoropopliteal Lesions: A Multicenter Registry Study.Cardiovascular and interventional radiology · 2026Article
- Clinical feasibility of primary retrograde endovascular therapy via trans-ankle intervention: a retrospective single-center study.CVIR endovascular · 2026Article
- Safety of paclitaxel-coated devices in patients with peripheral artery disease: an updated systematic review and meta-analysis of randomized controlled trials.EClinicalMedicine · 2026Article
- Endovascular Treatment for Femoropopliteal Arterial Lesions with a Focus on Long-Term Limb Prognosis.Annals of vascular diseases · 2026Review
- Comparison of High-Dose versus Low-Dose Paclitaxel Drug-Coated Balloons for Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry.Yonsei medical journal · 2025Article
- The Impact of Peripheral Vascular Motion on Acute Drug Retention of Intravascular Devices.Cardiovascular engineering and technology · 2025Article
- Femoropopliteal Interventions for Peripheral Artery Disease: A Review of Current Evidence and Future Directions.Interventional cardiology clinics · 2025Review
- Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study.The International journal of angiology : official publication of the International College of Angiology, Inc · 2025Article
- Safety and Efficacy of a Paclitaxel-Coated Balloon for the Treatment of Symptomatic Patients with Long Superficial Femoral Artery Disease.Vascular health and risk management · 2025Observational
- Reply: Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
- Predicting residual pressure gradients after balloon angioplasty in patients with femoropopliteal artery lesions.Heart and vessels · 2024Article
- Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.Heart and vessels · 2024Article
- Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.Cardiovascular and interventional radiology · 2024Article
- Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsDrug-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
resultsWithin 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.
conclusionTwo 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 registrationThe trial is registered with ClinicalTrials.gov (NCT02701543).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.