BACKGROUND: Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication. METHODS: One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)). The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length with a vessel diameter of 2.25-2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss. RESULTS: Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 +/- 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 +/- 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 +/- 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis. CONCLUSION: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).
BACKGROUND: Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication. METHODS: One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)). The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length with a vessel diameter of 2.25-2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss. RESULTS: Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 +/- 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 +/- 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 +/- 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis. CONCLUSION: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).
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Authors: V Verin; Y Popowski; B de Bruyne; D Baumgart; W Sauerwein; M Lins; G Kovacs; M Thomas; F Calman; C Disco; P W Serruys; W Wijns Journal: N Engl J Med Date: 2001-01-25 Impact factor: 91.245
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Authors: Klaus Bonaventura; Alexander W Leber; Christian Sohns; Mattias Roser; Leif-Hendrik Boldt; Franz X Kleber; Wilhelm Haverkamp; Marc Dorenkamp Journal: Clin Res Cardiol Date: 2012-02-21 Impact factor: 5.460
Authors: Upendra Kaul; Martin Unverdorben; Ralf Degenhardt; Ashok Seth; Vinay K Bahl; Shirish M S Hiremath; Praveen Chandra; Ajit S Mullesari; P S Sandhu; Seshagiri Rao; Oommen George; Hanns Ackermann; Michael Boxberger Journal: Indian Heart J Date: 2013-09-13
Authors: Bruno Scheller; Dieter Fischer; Yvonne P Clever; Franz X Kleber; Ulrich Speck; Michael Böhm; Bodo Cremers Journal: Clin Res Cardiol Date: 2013-03-20 Impact factor: 5.460
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