Maciej Lesiak1, Aleksander Araszkiewicz1, Stefan Grajek1, Antonio Colombo2, Jacques Lalmand3, Steen Carstensen4, Atsuo Namiki5, Tetsuya Tobaru6, Béla Merkely7, Raul Moreno8, Emanuele Barbato9,10, William Wijns9, Shigeru Saito11. 1. Department of Cardiology, University of Medical Sciences, Poznan, Poland. 2. Cardiac Cath Lab and Interventional Cardiology Unit EMO GVM Centro Cuore, Columbus and San Raffaele Hospital, Milan, Italy. 3. Department of Cardiology, CHU de Charleroi, Charleroi, Belgium. 4. Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark. 5. Department of Cardiology, Kanto Rosai Hospital, Kawasaki, Japan. 6. Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan. 7. Heart and Vascular Center, Semmelweis University, Budapest, Hungary. 8. Department of Interventional Cardiology, University Hospital La Paz, Madrid, Spain. 9. Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium. 10. Departement of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 11. Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan.
Abstract
OBJECTIVES: To assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES). BACKGROUND:LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear. METHODS: In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee. RESULTS: The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44). CONCLUSIONS: Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES.
RCT Entities:
OBJECTIVES: To assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES). BACKGROUND: LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear. METHODS: In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee. RESULTS: The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44). CONCLUSIONS:Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES.
Authors: Alberto Chisari; Anna Maria Pistritto; Raffaele Piccolo; Alessio La Manna; Gian Battista Danzi Journal: Int J Mol Sci Date: 2016-09-06 Impact factor: 5.923