Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial

Pilgrim, Thomas; Roffi, Marco; Tüller, David; Müller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Heg, Dik; Jüni, Peter; Windecker, Stephan

doi:10.1016/j.ahj.2014.06.004

Cited by 16 publications

(12 citation statements)

References 17 publications

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“…BIOSCIENCE was an investigator‐initiated, single‐blind, multicenter, randomized noninferiority trial with minimal exclusion criteria (ClinicalTrials.gov, NCT01443104). The study design and the principal features of the study devices have been detailed previously . Study enrollment was performed between February 2012 and May 2013 at 9 centers in Switzerland.…”

Section: Methodsmentioning

confidence: 99%

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Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial

Zbinden

Piccolo

Heg

et al. 2016

JAHA

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BackgroundNo data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents (BP‐SES). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP‐SES with durable‐polymer everolimus‐eluting stents (DP‐EES) in patients undergoing percutaneous coronary intervention.Methods and ResultsA total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP‐SES (n=1063) or DP‐EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP‐SES arm and 107 patients (10.4%) in the DP‐EES arm (risk ratio [RR] 1.00, 95% CI 0.77–1.31, P=0.979). There were no significant differences between BP‐SES and DP‐EES with respect to cardiac death (RR 1.01, 95% CI 0.62–1.63, P=0.984), target‐vessel myocardial infarction (RR 0.91, 95% CI 0.60–1.39, P=0.669), target‐lesion revascularization (RR 1.17, 95% CI 0.81–1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56–3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP‐SES arm and 4 cases (0.4%) in the DP‐EES arm (P=0.423). In the prespecified subgroup of patients with ST‐segment elevation myocardial infarction, BP‐SES was associated with a lower risk of target‐lesion failure compared with DP‐EES (RR 0.48, 95% CI 0.23–0.99, P=0.043, P interaction=0.026).ConclusionsComparable safety and efficacy profiles of BP‐SES and DP‐EES were maintained throughout 2 years of follow‐up.Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

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Section: Methodsmentioning

confidence: 99%

“…The study design and the principal features of the study devices have been detailed previously. 8 Study enrollment was performed between February 2012 and May 2013 at 9 centers in Switzerland. Patients were randomly assigned to treatment with BP-SES or DP-EES (Xience Prime or Xpedition stent; Abbott Vascular).…”

Section: Study Design and Patient Populationmentioning

confidence: 99%

Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial

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Heg

et al. 2016

JAHA

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“…The trial design and criteria for inclusion and exclusion have previously been described 8 . The study complied with the Declaration of Helsinki.…”

Section: Methods Study Population and Proceduresmentioning

confidence: 99%

Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial

Franzone¹,

Taniwaki²,

Rigamonti³

et al. 2016

EuroIntervention

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Aims: We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS). Methods and results:Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low <8, medium 8-15, high >15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS.Conclusions: Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity. KEYWORDS• biodegradable polymer sirolimuseluting stents • coronary artery disease • durable polymer everolimus-eluting stents • SYNTAX score

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“…The BIOSCIENCE was an investigator-initiated, multicenter, single-blind, randomized trial assessing the noninferiority of the Orsiro BP-SES (Biotronik AG, Bülach, Switzerland) relative to the Xience DP-EES (Abbott Vascular, Abbott Park, IL, USA) [11]. Eligibility was defined by: age above 18 years, presence of stable coronary artery disease (CAD) or acute coronary syndromes (ACS), de novo or restenotic lesions in native coronary arteries or bypass grafts.…”

Section: Study Populationmentioning

confidence: 99%

External validity of the “all-comers” design: insights from the BIOSCIENCE trial

et al. 2016

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Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial

Cited by 16 publications

References 17 publications

Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial

Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial

Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial

External validity of the “all-comers” design: insights from the BIOSCIENCE trial

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