COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.
In: European Heart Journal, Jg. 41 (2020-07-14), Heft 27, S. 2541-2552
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Zugriff:
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/mm 2 . 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%]; P non-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%); P non-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 ClinicalTrials.gov (NCT02701543). Open in new tab Download slide Open in new tab Download slide [ABSTRACT FROM AUTHOR]
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Titel: |
COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.
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Autor/in / Beteiligte Person: | Steiner, Sabine ; Schmidt, Andrej ; Zeller, Thomas ; Tepe, Gunnar ; Thieme, Marcus ; Maiwald, Lars ; Schröder, Henrik ; Euringer, Wulf ; Ulrich, Matthias ; Brechtel, Klaus ; Brucks, Steffen ; Blessing, Erwin ; Schuster, Johannes ; Langhoff, Ralf ; Schellong, Sebastian ; Weiss, Norbert ; Scheinert, Dierk |
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Zeitschrift: | European Heart Journal, Jg. 41 (2020-07-14), Heft 27, S. 2541-2552 |
Veröffentlichung: | 2020 |
Medientyp: | academicJournal |
ISSN: | 0195-668X (print) |
DOI: | 10.1093/eurheartj/ehaa049 |
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