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B. Scheller, C. Hehrlein, W. Bocksch, W. Rutsch, D. Haghi, U. Dietz, M. Böhm, U. Speck (2006)
Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter.Clinical research in cardiology : official journal of the German Cardiac Society, 97 10
P. Teirstein (2010)
Drug-eluting stent restenosis: an uncommon yet pervasive problem.Circulation, 122 1
P. Buszman, A. Tellez, M. Afari, Yanping Cheng, Gerard Conditt, Jenn McGregor, K. Milewski, M. Stenoien, G. Kaluza, J. Granada (2013)
Stent healing response following delivery of paclitaxel via durable polymeric matrix versus iopromide-based balloon coating in the familial hypercholesterolaemic swine model of coronary injury.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 9 4
P. Buszman, A. Tellez, M. Afari, A. Peppas, Gerard Conditt, S. Rousselle, Jenn McGregor, M. Stenoien, G. Kaluza, J. Granada (2013)
Tissue uptake, distribution, and healing response after delivery of paclitaxel via second-generation iopromide-based balloon coating: a comparison with the first-generation technology in the iliofemoral porcine model.JACC. Cardiovascular interventions, 6 8
G. Tepe, T. Zeller, T. Albrecht, S. Heller, U. Schwarzwälder, J. Beregi, C. Claussen, A. Oldenburg, B. Scheller, U. Speck (2008)
Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg.The New England journal of medicine, 358 7
V. Kolachalama, S. Pacetti, J. Franses, J. Stankus, Hugh Zhao, T. Shazly, A. Nikanorov, L. Schwartz, A. Tzafriri, E. Edelman (2013)
Mechanisms of Tissue Uptake and Retention in Zotarolimus-Coated Balloon TherapyCirculation, 127
P. Stella, A. Belkacemi, C. Dubois, H. Nathoe, J. Dens, C. Naber, T. Adriaenssens, E. Belle, P. Doevendans, P. Agostoni (2012)
A multicenter randomized comparison of drug‐eluting balloon plus bare‐metal stent versus bare‐metal stent versus drug‐eluting stent in bifurcation lesions treated with a single‐stenting technique: Six‐month angiographic and 12‐month clinical results of the drug‐eluting balloon in bifurcations trialCatheterization and Cardiovascular Interventions, 80
D. Mathey, I. Wendig, M. Boxberger, K. Bonaventura, F. Kleber (2011)
Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 7 Suppl K
M. Unverdorben, F. Kleber, H. Heuer, H. Figulla, C. Vallbracht, M. Leschke, B. Cremers, S. Hardt, M. Buerke, H. Ackermann, M. Boxberger, R. Degenhardt, B. Scheller (2010)
Treatment of small coronary arteries with a paclitaxel-coated balloon catheterClinical Research in Cardiology, 99
J. Wöhrle, R. Birkemeyer, S. Markovic, The-Vinh Nguyen, A. Sinha, T. Miljak, J. Spiess, W. Rottbauer, H. Rittger (2011)
Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery diseaseHeart, 97
M. Werk, S. Langner, Bianka Reinkensmeier, Hans-Frank Boettcher, G. Tepe, U. Dietz, N. Hosten, B. Hamm, U. Speck, J. Ricke (2008)
Inhibition of Restenosis in Femoropopliteal Arteries: Paclitaxel-Coated Versus Uncoated Balloon: Femoral Paclitaxel Randomized Pilot TrialCirculation, 118
Scheller (2006)
Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheterN Engl J Med, 355
B. Scheller, U. Speck, C. Abramjuk, U. Bernhardt, M. Böhm, G. Nickenig (2004)
Paclitaxel Balloon Coating, a Novel Method for Prevention and Therapy of RestenosisCirculation, 110
U. Speck, B. Cremers, B. Kelsch, M. Biedermann, Y. Clever, S. Schaffner, D. Mahnkopf, U. Hanisch, M. Böhm, B. Scheller (2012)
Do Pharmacokinetics Explain Persistent Restenosis Inhibition by a Single Dose of Paclitaxel?Circulation: Cardiovascular Interventions, 5
J. Mehilli, A. Dibra, A. Kastrati, J. Pache, J. Dirschinger, A. Schömig (2006)
Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.European heart journal, 27 3
F. Kleber, A. Schulz, Y. Clever, Telse Hauschild, U. Dietz, M. Waliszewski, B. Cremers, B. Scheller (2013)
TCT-327 Late lumen enlargement - a potential new paradigm in vascular therapyJournal of the American College of Cardiology, 62
J. Wöhrle, M. Zadura, S. Möbius‐Winkler, M. Leschke, C. Opitz, W. Ahmed, P. Barragan, J. Simon, G. Cassel, B. Scheller (2012)
SeQuentPlease 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, 60 18
F. Ribichini, M. Romano, R. Rosiello, L. Vecchia, E. Cabianca, G. Caramanno, Diego Milazzo, P. Loschiavo, S. Rigattieri, S. Musarò, Bruno Pironi, A. Fiscella, F. Amico, C. Indolfi, C. Spaccarotella, A. Bartorelli, D. Trabattoni, F. Rovere, A. Rolandi, Federico Beqaraj, R. Belli, P. Sangiorgio, R. Villani, A. Berni, I. Sheiban, M. Quijada, B. Cappi, Licia Ribaldi, C. Vassanelli (2013)
A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease).JACC. Cardiovascular interventions, 6 10
M. Unverdorben, C. Vallbracht, B. Cremers, H. Heuer, C. Hengstenberg, C. Maikowski, G. Werner, D. Antoni, F. Kleber, W. Bocksch, M. Leschke, H. Ackermann, M. Boxberger, U. Speck, R. Degenhardt, B. Scheller (2009)
Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent RestenosisCirculation, 119
M. Unverdorben, R. Degenhardt, C. Vallbracht, M. Wiemer, D. Horstkotte, H. Schneider, C. Nienaber, W. Bocksch, M. Gross, M. Boxberger (2006)
The paclitaxel‐eluting Coroflex™ please stent pilot study (PECOPS I): Acute and 6‐month clinical and angiographic follow‐upCatheterization and Cardiovascular Interventions, 67
A. Latib, A. Colombo, F. Castriota, A. Micari, A. Cremonesi, F. Felice, A. Marchese, M. Tespili, P. Presbitero, G. Sgueglia, F. Buffoli, C. Tamburino, F. Varbella, A. Menozzi (2012)
A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study.Journal of the American College of Cardiology, 60 24
U. Kaul, M. Unverdorben, R. Degenhardt, A. Seth, V. Bahl, S. Hiremath, P. Chandra, Ajit Mullesari, P. Sandhu, S. Rao, Oommen George, H. Ackermann, M. Boxberger (2013)
The paclitaxel-eluting PTCA-balloon in combination with a cobalt-chromium stent in two different sequences to treat de novo coronary artery lesions: an angiographic follow up study.Indian heart journal, 65 5
Background There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent‐polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. Methods A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non‐inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow‐up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients. Results The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in‐stent late lumen loss in BMS + PCB was comparable and non‐inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. Pnon‐inf < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3–2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4–6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4–4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5–7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38). Conclusions Paclitaxel delivery via drug coated balloon or polymer‐stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail‐out for PCB alone angioplasty.
Journal of Interventional Cardiology – Wiley
Published: Aug 1, 2015
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