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COMPASSIONATE USE OF A PACLITAXEL COATED BALLOON CATHETER IN PATIENTS WITH REFRACTORY CORONARY IN-STENT RESTENOSIS
E330 JACC March 27, 2012 Volume 59, Issue 13
ACC-i2 with TCT COMPASSIONATE USE OF A PACLITAXEL COATED BALLOON CATHETER IN PATIENTS WITH REFRACTORY CORONARY IN-STENT RESTENOSIS i2 Oral Contributions McCormick Place South, S103c Sunday, March 25, 2012, 11:00 a.m.-11:10 a.m.
Session Title: Prevention and Treatement of Restenosis Abstract Category: 12. PCI - Complex Lesions, Multivessel Disease Presentation Number: 2509-7 Authors: Yvonne P. Clever, Bruno Scheller, Michael Böhm, Bodo Cremers, Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany Background: Treatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after Drug Eluting Stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR DCB may be a last option therapy. This paper presents DCB therapy as compassionate use treatment before the balloons were available in Europe. Methods and Results: Compassionate use of DCB was approved by the local ethical committee. Fifteen patients with refractory ISR in 28 lesions were prospectively enrolled between 12/2006 and 04/2009. The frequency of prior ISR was 3.9±1.4. Nine patients presented with coronary threevessel disease and 6 patients with one- or two-vessel disease. Thirteen patients had DES-ISR, two patients with contraindication for prolonged dual antiplatelet therapy repeated BMS-ISR. Two or three layers of metal were present in eleven patients. Four patients had prior coronary artery bypass grafting. All lesions were treated with DCB (SeQuentTM Please, B.Braun, Germany). Angiographic follow-up was obtained in 14 patients. Clinical follow-up was available in all patients after 3.2±0.8 years (maximum 4.8 years). Target lesion revascularization was done in 2 of 28 lesions (7.1%), one patient with ischemic cardiomyopathy died after 1.5 years. No further MACE occurred. Conclusion: DCB appear to be safe and clinically useful in the treatment of ISR. DCB is a new promising option for high risk patients with refractory ISR.
ACC-i2 with TCT COMPASSIONATE USE OF A PACLITAXEL COATED BALLOON CATHETER IN PATIENTS WITH REFRACTORY CORONARY IN-STENT RESTENOSIS i2 Oral Contributions McCormick Place South, S103c Sunday, March 25, 2012, 11:00 a.m.-11:10 a.m.
Session Title: Prevention and Treatement of Restenosis Abstract Category: 12. PCI - Complex Lesions, Multivessel Disease Presentation Number: 2509-7 Authors: Yvonne P. Clever, Bruno Scheller, Michael Böhm, Bodo Cremers, Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany Background: Treatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after Drug Eluting Stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR DCB may be a last option therapy. This paper presents DCB therapy as compassionate use treatment before the balloons were available in Europe. Methods and Results: Compassionate use of DCB was approved by the local ethical committee. Fifteen patients with refractory ISR in 28 lesions were prospectively enrolled between 12/2006 and 04/2009. The frequency of prior ISR was 3.9±1.4. Nine patients presented with coronary threevessel disease and 6 patients with one- or two-vessel disease. Thirteen patients had DES-ISR, two patients with contraindication for prolonged dual antiplatelet therapy repeated BMS-ISR. Two or three layers of metal were present in eleven patients. Four patients had prior coronary artery bypass grafting. All lesions were treated with DCB (SeQuentTM Please, B.Braun, Germany). Angiographic follow-up was obtained in 14 patients. Clinical follow-up was available in all patients after 3.2±0.8 years (maximum 4.8 years). Target lesion revascularization was done in 2 of 28 lesions (7.1%), one patient with ischemic cardiomyopathy died after 1.5 years. No further MACE occurred. Conclusion: DCB appear to be safe and clinically useful in the treatment of ISR. DCB is a new promising option for high risk patients with refractory ISR.