Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.
OBJECTIVE
To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year.


METHODS
Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year.


RESULTS
Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up.


CONCLUSIONS
The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.
Cardiology Department, Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
K
K
Orvin
Department of Cardiology, University Toulouse-Rangueil Hospital, France.
D
D
Carrie
Segeberger Kliniken GmbH, Bad Segeberg, Germany.
G
G
Richardt
Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
W
W
Desmet
Cardiology Department, Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
A
A
Assali
Medizinische Klinik I, Klinikum Darmstadt GmbH, Darmstadt, Germany.
G
G
Werner
Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.
Y
Y
Ikari
Department of Cardiology, Sakurabashi-Watanabe Hospital, Osaka, Japan.
K
K
Fujii
Interventional Cardiology, Hospital Universitario Puerta De Hierro/Majadahonda, Madrid, Spain.
J
J
Goicolea
C H U Mont Godinne UCL, Yvoir, Belgium.
V
V
Dangoisse
Department of Interventional Cardiology, Azienda Ospedaliera-IRCCS S. Maria Nuova, Viale Risorgimento, Italy.
A
A
Manari
Shonan Kamakura General Hospital, Kanagawa, Japan.
S
S
Saito
Cardiovascular Centre Aalst, OLV Hospital, Belgium.
W
W
Wijns
Cardiology Department, Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
R
R
Kornowski
D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D003324:Coronary Artery Disease; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000601:surgery; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000494:pharmacology*; D013997:Time Factors
D007166:Immunosuppressive Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
Sirolimus eluting stent; cobalt-chromium stent; complex lesions; coronary bifurcation; drug eluting stent