Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty

Fro Ge Be Lü Ra Inn Fre rec of Ma OBJECTIVES The intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years. BACKGROUND In the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years. METHODS A total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths #22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study.With a 2:1 randomization, 72 patientswere randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients. RESULTS At 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p 1⁄4 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p 1⁄4 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p 1⁄4 0.001). CONCLUSIONS PCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439) (J Am Coll Cardiol Intv 2015;8:1695–700) © 2015 by the American College of Cardiology Foundation. m the *Medizinische Klinik I, Klinikum Fuerth, Fuerth, Germany; yMedical Scientific Affairs, B. Braun Vascular Systems, Berlin, rmany; zMedizinische Klinik II, Klinikum Coburg, Coburg, Germany; xKlinik für Kardiologie, Zentralklinikum Bad Berka, Bad rka, Germany;kKlinik für Kardiologie, Klinikum Kulmbach, Kulmbach, Germany; {Medizinische Klinik II, Universitätsklinikum beck, Lübeck, Germany; #Herzklinik Ulm, Ulm, Germany; **Abteilung für Innere Medizin/Kardiologie, Krankenhaus Möllntzeburg, Mölln-Ratzeburg, Germany; yyMedizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany; zzKlinik für ere/Medizin Kardiologie, Diakonissenhaus Flensburg, Flensburg, Germany; xxKlinik für Neurologie, Universitätsklinikum iburg, Freiburg, Germany; and the kkKlinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm, Germany. Dr. Rittger has eived a research grant from B. Braun. Dr. Wöhrle has received speaker honoraria from B.Braun. Dr. Waliszewski is an employee B. Braun. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. nuscript received February 3, 2015; revised manuscript received June 3, 2015, accepted July 17, 2015. TABLE 1 Selected Basic Demog the Initial Publication (1) Baseline cardiovascular risk factors