Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial

Birgelen, Clemens von; Kok, Marlies M.; Heijden, Liefke C. van der; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Gin, R. Melvyn Tjon Joe; Somi, Samer; Houwelingen, K. Gert van; Stoel, Martin G.; Man, Frits H.A.F. de; Louwerenburg, J. W.; Hartmann, Marc; Zocca, Paolo; Linssen, Gerard C.M.; Palen, Job van der; Doggen, Carine J.M.; Löwik, Marije M.

doi:10.1016/s0140-6736(16)31920-1

Cited by 220 publications

(159 citation statements)

References 35 publications

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“…The safety of the Synergy stent is supported also by our mortality results up to 1 year showing no significant differences when compared with the other n‐DES. The overall mortality rates are similarly low, considering the clinical profile risk and the higher average age of our study population, when compared with previous randomized studies on newer stent devices . The patients in the Synergy stent group had a higher mean age, a higher proportion with diabetes and prior cardiovascular risk factors as well as more three vessel and left main disease, longer stents with smaller diameter and more bifurcation lesions.…”

Section: Discussionsupporting

confidence: 55%

“…Definite ST rates at 9 months were similarly low in the CENTURY II study that has randomized a selected population of 1,100 patients between PCI with a sirolimus bioabsorbable polymer stent and everolimus permanent polymer stent . Recent results from the BIORESORT randomized study have confirmed the non‐inferiority at 12 months follow‐up of the thin very thin strut drug‐eluting stents with two different biodegradable polymers eluting either everolimus (Synergy) or sirolimus (Orsiro) when compared with the durable polymer stent eluting zotarolimus (Resolute Integrity)in all comers with a high proportion of patients with acute coronary syndromes.…”

Section: Discussionmentioning

confidence: 97%

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Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Sarno

Lagerqvist

Olivecrona

et al. 2017

Cathet Cardio Intervent

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 97%

Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Sarno

Lagerqvist

Olivecrona

et al. 2017

Cathet Cardio Intervent

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“…The thin‐strut (≤81 μm) bioabsorbable abluminal polymer‐coated SYNERGY DES (Boston Scientific, Natick, MA, USA) eluting everolimus was implanted according to routine local clinical practice. The use of SYNERGY DES was supported by the favorable results of the EVOLVE II pivotal and the BIO‐RESORT all‐comer trials …”

Section: Methodsmentioning

confidence: 99%

Impact of post‐procedural minimal stent area on 2‐year clinical outcomes in the SYNTAX II trial

Katagiri

Maria

Kogame

et al. 2019

Cathet Cardio Intervent

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Objectives To investigate the impact of minimal stent area (MSA) evaluated by post‐procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three‐vessel disease (TVD). Background The impact of post‐procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD. Methods The SYNTAX II study is a multicenter, all‐comers, open‐label, single arm study that investigated the impact of a state‐of‐the‐art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post‐procedural MSA and lesion‐level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion‐oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target‐vessel myocardial infarction, and ischemia‐driven target lesion revascularization. Results Eight hundred and nineteen lesions with post‐procedural MSA available in 367 patients were included in the analysis. The post‐procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2, intermediate tercile: 5.0–6.7 mm2, and largest tercile: >6.7 mm2). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post‐procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR. Conclusions In the SYNTAX II trial, larger post‐procedural MSA was independently associated with the lower rate of TLR at 2 years.

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“…PCI with newer‐generation DESs in patients with previous CABG is safe, but the high long‐term rate of target vessel revascularization shows that after treatment with newer‐generation DESs, the risk of repeat revascularizations remains high. In times of increasingly low adverse event rates of randomized all‐comer trials,35 it will be of paramount importance to keep enrolling patients with a history of CABG to ensure adequate statistical power. In clinical practice, knowledge of the safety but increased risk of repeat target vessel revascularization following PCI in patients with previous coronary bypass surgery—particularly if a diseased SVG requires treatment—will be relevant to cardiologists and other physicians involved in heart team discussions and informed consent.…”

Section: Discussionmentioning

confidence: 99%

Long‐Term Outcome of Consecutive Patients With Previous Coronary Bypass Surgery, Treated With Newer‐Generation Drug‐Eluting Stents

Heijden

Kok

Zocca

et al. 2018

JAHA

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BackgroundPercutaneous coronary intervention (PCI) in patients with previous coronary artery bypass grafting (CABG) is associated with adverse clinical events. Although newer generation drug‐eluting stents showed favorable short‐term safety profiles, there is a lack of long‐term outcome data. We evaluated the impact of previous CABG on 5‐year clinical outcomes of patients treated with PCI using newer‐generation drug‐eluting stents.Methods and ResultsIn this patient‐level pooled analysis of the prospective TWENTE (The Real‐World Endeavor Resolute versus Xience V Drug‐Eluting Stent Study in Twente) trial and nonenrolled TWENTE registry, we assessed a consecutive series of patients who underwent PCI with newer‐generation drug‐eluting stents for non–ST‐segment–elevation acute coronary syndromes or stable angina. Of all 1709 patients, 202 (11.8%) had a history of CABG. Patients with previous CABG had significantly higher 5‐year rates of cardiac death (10.4% versus 4.3%; P<0.001) and target vessel revascularization (25.0% versus 8.1%; P<0.001). These differences remained statistically significant after adjustment for differences in baseline characteristics. Landmark analysis revealed that from 1‐ to 5‐year follow‐up, the rates of cardiac death (8.1% versus 3.2%; P<0.001) and target vessel revascularization (17.1% versus 5.9%; P<0.001) were significantly higher in patients with previous CABG. Among patients with a history of CABG, PCI of an obstructed vein graft was associated with a higher rate of 5‐year target vessel revascularization (P=0.003).ConclusionsAt 5‐year follow‐up after PCI with newer‐generation drug‐eluting stents, the risk of cardiac death and target vessel revascularization was significantly higher in patients with previous CABG. The target vessel revascularization rate was highest in patients who underwent PCI of obstructed vein grafts.

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Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial

Cited by 220 publications

References 35 publications

Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Impact of post‐procedural minimal stent area on 2‐year clinical outcomes in the SYNTAX II trial

Long‐Term Outcome of Consecutive Patients With Previous Coronary Bypass Surgery, Treated With Newer‐Generation Drug‐Eluting Stents

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