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  • Bikdeli, BehnoodColumbia Univ, Dept Med, NewYork Presbyterian Hosp, Med Ctr,Div Cardiol, New York, NY USA;Yale Univ, Yale Sch Med, Ctr Outcomes Res & Evaluat, New Haven, CT USA;Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Yale University,Cardiovascular Research Foundation, New York,New York Presbyterian Hospital/Columbia University Medical Center (author)

Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction : Rationale and Methodology

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2019-12-09
  • Georg Thieme Verlag KG,2020
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-407324
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-407324URI
  • https://doi.org/10.1055/s-0039-1700872DOI
  • https://lup.lub.lu.se/record/6bf267f4-4d5f-45b8-94f8-5dbcb9e788c9URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Background Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed.Objective To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin.Methods We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin.Results From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin).Conclusion We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results..

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • McAndrew, ThomasCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Crowley, AaronCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Chen, ShmuelColumbia Univ, Dept Med, NewYork Presbyterian Hosp, Med Ctr,Div Cardiol, New York, NY USA;Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York,New York Presbyterian Hospital/Columbia University Medical Center (author)
  • Mehdipoor, GhazalehCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Redfors, BjornColumbia Univ, Dept Med, NewYork Presbyterian Hosp, Med Ctr,Div Cardiol, New York, NY USA;Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden,New York Presbyterian Hospital/Columbia University Medical Center,Sahlgrenska University Hospital,Cardiovascular Research Foundation, New York (author)
  • Liu, YangboCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Zhang, ZixuanCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Liu, MengdanCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Zhang, YiranCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Francese, Dominic P.Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York (author)
  • Erlinge, DavidLund University,Lunds universitet,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Molecular Cardiology,Lund University Research Groups(Swepub:lu)kard-der (author)
  • James, Stefan,1964-Uppsala University,Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367 (author)
  • Han, YalingGen Hosp Northern Theater Command, Dept Cardiol, Shenyang, Peoples R China,Shenyang General Hospital of PLA (author)
  • Li, YiGen Hosp Northern Theater Command, Dept Cardiol, Shenyang, Peoples R China,Shenyang General Hospital of PLA (author)
  • Kastrati, AdnanTech Univ, Deutsch Herzzentrum Munchen, Dept Cardiol, Munich, Germany,German Heart Centre, Munich,Technical University of Munich (author)
  • Schuepke, StefanieTech Univ, Deutsch Herzzentrum Munchen, Dept Cardiol, Munich, Germany,German Heart Centre, Munich,Technical University of Munich (author)
  • Stables, Rod H.Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England;Univ Liverpool, Liverpool, Merseyside, England,Liverpool Heart and Chest Hospital,University of Liverpool (author)
  • Shahzad, AdeelLiverpool Heart & Chest Hosp, Liverpool, Merseyside, England,Liverpool Heart and Chest Hospital (author)
  • Steg, Philippe GabrielHop Bichat Claude Bernard, Paris, France;Royal Brompton Hosp, Imperial Coll, London, England,Hopital Bichat-Claude-Bernard AP-HP,Royal Brompton Hospital (author)
  • Goldstein, PatrickLille Univ Hosp, Lille, France,Lille University Hospital (author)
  • Frigoli, EnricoUniv Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland,Bern University Hospital,University of Bern (author)
  • Mehran, RoxanaCardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA;Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA,Icahn School of Medicine at Mount Sinai,Cardiovascular Research Foundation, New York (author)
  • Valgimigli, MarcoUniv Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland,University of Bern,Bern University Hospital (author)
  • Stone, Gregg W.Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA;Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA,Cardiovascular Research Foundation, New York,Icahn School of Medicine at Mount Sinai (author)
  • Columbia Univ, Dept Med, NewYork Presbyterian Hosp, Med Ctr,Div Cardiol, New York, NY USA;Yale Univ, Yale Sch Med, Ctr Outcomes Res & Evaluat, New Haven, CT USA;Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USAYale University (creator_code:org_t)

Related titles

  • In:Thrombosis and Haemostasis: Georg Thieme Verlag KG120:2, s. 348-3610340-62452567-689X

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