Evidence map›Paper›PMID 28851504›Full record

Trial reportLancet (London, England)2017

Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

David E Kandzari, Laura Mauri, Jacques J Koolen, Joseph M Massaro, Gheorghe Doros, Hector M Garcia-Garcia, Johan Bennett, Ariel Roguin, Elie G Gharib, Donald E Cutlip and 2 more

Erratum issued Registry-linked trialAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02389946 (BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V), which is not on this map. Cited by 88 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 7 pooled it
35.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02389946 nacompletednot on this map

BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V

TypeinterventionalSponsorBiotronik, Inc.Ran2015 to 2021Enrolled1,334ConditionsCoronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart DiseaseArmsOrsiro DES, Xience DES
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 7 syntheses or guidelines pooled it, 265 citations in OpenAlex.

  1. Pooled it
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  6. Pooled it
  7. Guideline
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  9. Everolimus-eluting versus biolimus-eluting stents with biodegradable polymers in unselected patients undergoing percutaneous coronary intervention: five-year results of the randomised, non-inferiority SORT OUT VIII trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Trial
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  12. Polymer-free biolimus-coated stents versus ultrathin-strut biodegradable polymer sirolimus-eluting stents: two-year outcomes of the randomised SORT OUT IX trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Trial
  13. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021
    Trial
  14. BioMatrix versus Orsiro biodegradable polymer stents in all-comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2021
    Trial
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  16. Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2020
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  20. Review

28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 4 countries.

David E KandzariPiedmont Heart Institute, Atlanta, GA, USA. Electronic address: david.kandzari@piedmont.org.
Laura MauriDivison of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Jacques J KoolenCatharina Hospital, Eindhoven, Netherlands.
Joseph M MassaroDepartment of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA.
Gheorghe DorosDepartment of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA.
Hector M Garcia-GarciaDivision of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.
Johan BennettDepartment of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
Ariel RoguinDepartment of Cardiology, Rambam Medical Center, Haifa, Israel.
Elie G GharibCharleston Area Medical Center, Charleston, WV, USA.
Donald E CutlipBeth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA, USA.
Ron WaksmanDivision of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.
BIOFLOW V Investigators
Boston University · USBaim Institute for Clinical Research · USBrigham and Women's Hospital · USCharleston Area Medical Center · USKU Leuven · BEMedStar Washington Hospital Center · USPiedmont Atlanta Hospital · USRadboud University Nijmegen · NLRambam Health Care Campus · ILResearch Network (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention.

methodsBIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946.

findingsBetween May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208).

interpretationThe outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology.

fundingBIOTRONIK.

Indexed as

Absorbable ImplantsDrug-Eluting StentsEverolimusPercutaneous Coronary InterventionSirolimusBayes TheoremCoronary Artery DiseaseCreatine Kinase, MB FormFemaleHumansMaleMiddle AgedMyocardial InfarctionPolymersProspective StudiesProsthesis DesignCreatine Kinase, MB FormEverolimusPolymersSirolimus

Identifiers

PMID28851504
OpenAlexW2747702104

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.