Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial
Por:
Iniguez, A, Chevalier, B, Richardt, G, Neylon, A, Jimenez, VA, Kornowski, R, Carrie, D, Moreno, R, Barbato, E, Serra-Penaranda, A, Guiducci, V, Valdes-Chavarri, M, Yajima, J, Wijns, W, Saito, S, CENTURY II Study Investigators
Publicada:
1 feb 2020
Resumen:
ObjectivesTo assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.
BackgroundThe use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.
MethodsAmong 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n =225) or PP-EES (n =231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9months.
ResultsIn this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p =.29 and 10.2 vs. 13.4%; p =.29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p =.33 and 0.9 vs. 1.7%; p =.43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.
ConclusionsThese results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.
Filiaciones:
Iniguez, A:
Univ Hosp Vigo, Hosp Alvaro Cunqueiro, Cardiol Dept, Estr Clara Campoamor 341, Vigo 36312, Pontevedra, Spain
Chevalier, B:
Inst Cardiovasc Paris Sud, Intervent Cardiol Dept, Massy, France
Richardt, G:
Segeberger Kliniken, Dept Cardiol, Bad Segeberg, Germany
Neylon, A:
Galway Univ Hosp, SAOLTA Hlth Care Grp, Galway, Ireland
NUI, Galway, Ireland
Jimenez, VA:
Univ Hosp Vigo, Hosp Alvaro Cunqueiro, Cardiol Dept, Estr Clara Campoamor 341, Vigo 36312, Pontevedra, Spain
Kornowski, R:
Rabin Med Ctr, Cardiol Dept, Petah Tiqwa, Israel
Tel Aviv Univ, Sackler Fac Med, Tel Aviv, Israel
Carrie, D:
Rangueil Univ Hosp, Dept Cardiol, Toulouse, France
Moreno, R:
La Paz Univ Hosp, Intervent Cardiol Dept, Madrid, Spain
Barbato, E:
Onze Lieve Vrouwe Ziekenhuis, Cardiovasc Ctr, Aalst, Belgium
Univ Naples Federico II, Dept Adv Biomed Sci, Div Cardiol, Naples, Italy
Serra-Penaranda, A:
Univ Autonoma Barcelona, Cardiol Dept, Hosp Santa Creu & St Pau, IIB SantPau CIBERCV, Barcelona, Spain
Guiducci, V:
Santa Maria Nuova Hosp, Intervent Cardiol Unit, Reggio Emilia, Italy
Valdes-Chavarri, M:
Hosp Univ Virgende la Arrixaca, Cardiol Dept, IMIB Arrixaca, Murcia, Spain
Yajima, J:
Cardiovasc Inst, Dept Cardiovasc Med, Tokyo, Japan
Wijns, W:
NUI Galway, Lambe Inst, Galway, Ireland
Saito, S:
Shonan Kamakura Gen Hosp, Dept Cardiol, Kamakura, Kanagawa, Japan
Shonan Kamakura Gen Hosp, Catheterizat Lab, Kamakura, Kanagawa, Japan
Green Published, Hybrid Gold
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