Philine J Köln1, Bruno Scheller2, Houng Bang Liew3, Tuomas T Rissanen4, Wan Azman Wan Ahmad5, Ralf Weser6, Telse Hauschild7, Amin Ariff Nuruddin8, Yvonne P Clever2, Hee Hwa Ho9, Franz X Kleber10. 1. Charité - Universitätsmedizin Berlin, Berlin, Germany. 2. Universitätsklinikum des Saarlandes, Homburg, Germany. 3. Sabah Heart Centre, Kota Kinabalu, Malaysia. 4. North Karelia Central Hospital, Joensuu, Finland. 5. University of Malaya Medical Center, Kuala Lumpur, Malaysia. 6. Evangelisches Krankenhaus Paul Gerhardt Stift, Lutherstadt Wittenberg, Germany. 7. Klinikum Ernst von Bergmann, Potsdam, Germany. 8. National Heart Institute, Kuala Lumpur, Malaysia. 9. Tan Tock Seng Hospital, Tan Tock Seng, Singapore, Singapore. 10. Cardio Centrum Berlin, Academic Teaching Institution, Charité - Universitätsmedizin Berlin, Berlin, Germany. Electronic address: post@fxkleber.de.
Abstract
BACKGROUND: Chronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. METHODS: We included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. RESULTS: The recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction. CONCLUSIONS: Drug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.
BACKGROUND: Chronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. METHODS: We included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. RESULTS: The recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction. CONCLUSIONS:Drug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.