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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
SeQuent please world wide registry: Clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study
Journal of the American College of Cardiology, Volume 60, No. 18, Year 2012
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Description
Objectives: This study sought to assess the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an international, multicenter, prospective, large-scale registry study. Background: In small randomized trials, PCB angioplasty was superior to uncoated balloon angioplasty for treatment of bare-metal stent (BMS) and drug-eluting stent (DES) restenosis. Methods: Patients treated with SeQuent Please PCBs were included. The primary outcome measure was the clinically driven target lesion revascularization (TLR) rate at 9 months. Results: At 75 centers, 2,095 patients with 2,234 lesions were included. The TLR rate was 5.2% after 9.4 months. Definite vessel thrombosis occurred in 0.1%. PCB angioplasty was performed in 1,523 patients (72.7%) with DES or BMS restenosis and 572 patients (27.3%) with de novo lesions. The TLR rate was significantly lower in patients with PCB angioplasty for BMS restenosis compared with DES restenosis (3.8% vs. 9.6%, p < 0.001). The TLR rate did not differ for PCB angioplasty of paclitaxel-eluting stent and non-paclitaxel-eluting sten restenosis (8.3% vs. 10.8%, p = 0.46). In de novo lesions (small vessels), the TLR rate was low and did not differ between PCB angioplasty with and without additional BMS implantation (p = 0.31). Conclusions: PCB angioplasty in an all-comers, prospective, multicenter registry was safe and confirmed in a large population the low TLR rates seen in randomized clinical trials. PCB angioplasty was more effective in BMS restenosis compared with DES restenosis, with no difference regarding the type of DES. © 2012 American College of Cardiology Foundation.
Authors & Co-Authors
Wöhrle, Jochen
Germany, Ulm
Universität Ulm
Zadura, Mariusz
Germany, Bad Oeynhausen
Herz- Und Diabeteszentrum Nordrhein-westfalen Universitätsklinik Der Ruhr-universität Bochum
Möbius-Winkler, Sven
Germany, Leipzig
Universität Leipzig
Leschke, Matthias
Germany, Esslingen
Clinic Esslingen
Opitz, Christian F.
Germany, Berlin
Deutsches Rotes Kreuz Kliniken Berlin
Germany, Greifswald
Universität Greifswald
Ahmed, Waqas
Pakistan, Islamabad
Shifa International Hospital
Barragan, Paul
Unknown Affiliation
Simon, Jean Philippe
Unknown Affiliation
Cassel, Graham
South Africa, Johannesburg
Milpark Hospital
Scheller, Bruno
Germany, Homburg
Universitätsklinikum Des Saarlandes Medizinische Fakultät Der Universität Des Saarlandes
Statistics
Citations: 198
Authors: 10
Affiliations: 9
Identifiers
Doi:
10.1016/j.jacc.2012.07.040
ISSN:
07351097
e-ISSN:
15583597
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study