Victor A Jiménez1, Andrés Iñiguez2, José A Baz2, Mariano Valdés3, Alberto Ortiz2, André Vuilliomenet4, Vicente Mainar5, Dariusz Dudek6, Shmuel Banai7, David Tüller8, Jean-Louis Bonnet9, Antonio De Miguel2, Guillermo Bastos2, William Wijns10, Shigeru Saito11. 1. Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain. Electronic address: victor.alfonso.jimenez.diaz@sergas.es. 2. Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain. 3. Hospital Universitario V. Arrixaca, Murcia, Spain. 4. Kantonsspital Aarau, Aarau, Switzerland. 5. Department of Cardiology, University General Hospital of Alicante, Alicante, Spain. 6. Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland. 7. Tel Aviv Sourasky Medical Centre, Tel Aviv, Israel. 8. Department of Cardiology, Stadtspital Triemli, Zürich, Switzerland. 9. Department of Cardiology, Hospital La Timone, Marseille, France. 10. Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium. 11. Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan.
Abstract
BACKGROUND: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. METHODS: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24months. RESULTS: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P=0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P=0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. CONCLUSIONS: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up.
RCT Entities:
BACKGROUND: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymereverolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. METHODS: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24months. RESULTS: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P=0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P=0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. CONCLUSIONS:BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up.
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