Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty

Autor: Ulrich Dietz, Holger Hartmann, Mohammed Nabil Ahmed, Giuseppe Biondi Zoccai, Beatrix Schnorr, Christian Lange, H. Stiepani, Dirk Roelfs Meyer, Enrique Lopez Hänninen, M. Werk, Thomas Albrecht, Götz Eschenbach, Andrea Behne
Rok vydání: 2012
Předmět:
Male
Time Factors
Percutaneous
medicine.medical_treatment
Constriction
Pathologic
Kaplan-Meier Estimate
Balloon
chemistry.chemical_compound
Coated Materials
Biocompatible
Restenosis
Germany
Secondary Prevention
Popliteal Artery
Aged
80 and over
Drug Carriers
Likelihood Functions
angioplasty
Equipment Design
Middle Aged
Femoral Artery
Treatment Outcome
Paclitaxel
peripheral vascular disease
Female
revascularization
medicine.symptom
Cardiology and Cardiovascular Medicine
Vascular Access Devices
medicine.medical_specialty
Arterial Occlusive Diseases
Revascularization
Amputation
Surgical
restenosis
Angioplasty
medicine
Humans
Aged
Proportional Hazards Models
claudication
Chi-Square Distribution
business.industry
Cardiovascular Agents
medicine.disease
drug-eluting balloon
Surgery
Radiography
chemistry
Pacifier
Linear Models
Claudication
business
Angioplasty
Balloon
Zdroj: Circulation: Cardiovascular Interventions. 5:831-840
ISSN: 1941-7632
1941-7640
DOI: 10.1161/circinterventions.112.971630
Popis: Background— Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty. Methods and Results— Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0±5.3 and 6.6±5.5cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (−0.01mm [95% CI, −0.29; 0.26] versus 0.65mm [0.37; 0.93], P =0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P =0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P P =0.02). Conclusions— Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up. Clinical Trial Registration— URL http://www.clinicaltrials.gov . Unique identifier: NCT01083030.
Databáze: OpenAIRE
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