Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from <scp>CENTURY</scp> II trial

BVS use for coronary bifurcation lesions in an "all-comer" population was associated with acceptable TLF rates up to midterm follow-up. However, ST rates were higher than seen with contemporary metallic stents possibly due to the low incidence of intravascular guidance and postdilation resulting in a higher likelihood of scaffold underexpansion and malapposition, further supporting the importance of meticulous implantation technique. © 2016 Wiley Periodicals, Inc.

Section: Discussionsupporting

confidence: 84%

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry

Naganuma

Colombo

Lesiak

et al. 2016

“…The RCT known as the CENTURY II trial, which enrolled 1,119 patients assigned in a 1:1 ratio to receive either BP‐SESs or the Xience stents, demonstrated that the TLR, TLF, and definite ST rates were 2.7%, 4.4%, and 0.9%, respectively, at 9 months after BP‐SES implantation . BP‐SESs also showed similar safety and effectiveness to the permanent polymer everolimus‐eluting Xience stent when used for bifurcation lesions, small vessels, and long lesions . Although the CENTURY II trial included complex lesions, patients of HD and ISR were partially excluded from that study.…”

Section: Discussionmentioning

confidence: 99%

Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus‐eluting Ultimaster stents in all‐comers: A report of 1,727 cases

Tadano

Kotani

Kashima

et al. 2019

Background Although bioresorbable polymer sirolimus‐eluting Ultimaster stents (BP‐SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real‐world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have not been fully investigated. Objectives This study evaluated the 1‐year clinical outcomes after BP‐SES implantation in real‐world PCI cases and identified the predictors of adverse outcomes. Methods In this single‐center, all‐comers study, we consecutively implanted BP‐SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow‐up assessment of these patients. Results The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1‐year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. Conclusions The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP‐SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1‐year clinical outcomes after BP‐SES implantation were found to be favorable among all‐comer PCI cases, including patients receiving HD and those with in‐stent restenosis.

“…Overall, the present study adds to the numerous published evidence from recent years on excellent performance of Ultimaster (BP‐SES) system. This includes reports of favorable outcomes in general and specific subpopulations, like STEMI patients, bifurcations, long lesions, and small vessels …”

Section: Discussionmentioning

confidence: 99%

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

Íñiguez

Chevalier

Richardt

et al. 2019

Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimuseluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial. Background: The 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. Methods: Among 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 9 months. Results: In 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 Abbreviations: (N)IDDM, (non) insulin-dependent diabetes mellitus; (N)STEMI, (non) ST-segment elevation myocardial infarction; ACC/AHA, Funding information Terumo 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.Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population. K E Y W O R D Sclinical trials, complex PCI, coronary artery disease, drug eluting, percutaneous coronary intervention, stent, stent design/structure/coating