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

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

Bikdeli, Behnood (författare): 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 USA,New York Presbyterian Hospital/Columbia University Medical Center,Yale University,Cardiovascular Research Foundation, New York

McAndrew, Thomas (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Crowley, Aaron (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

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Chen, Shmuel (författare): Columbia 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

Mehdipoor, Ghazaleh (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Redfors, Bjorn (författare): Columbia 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,Cardiovascular Research Foundation, New York,New York Presbyterian Hospital/Columbia University Medical Center,Sahlgrenska University Hospital

Liu, Yangbo (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Zhang, Zixuan (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Liu, Mengdan (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Zhang, Yiran (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Francese, Dominic P. (författare): Cardiovasc Res Fdn, Clin Trials Ctr, New York, NY 10019 USA,Cardiovascular Research Foundation, New York

Erlinge, David (författare): Lund University,Lunds universitet,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Molecular Cardiology,Lund University Research Groups

James, Stefan, 1964- (författare): Uppsala University,Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)

Han, Yaling (författare): Gen Hosp Northern Theater Command, Dept Cardiol, Shenyang, Peoples R China,Shenyang General Hospital of PLA

Li, Yi (författare): Gen Hosp Northern Theater Command, Dept Cardiol, Shenyang, Peoples R China,Shenyang General Hospital of PLA

Kastrati, Adnan (författare): Tech Univ, Deutsch Herzzentrum Munchen, Dept Cardiol, Munich, Germany,Technical University of Munich,German Heart Centre, Munich

Schuepke, Stefanie (författare): Tech Univ, Deutsch Herzzentrum Munchen, Dept Cardiol, Munich, Germany,German Heart Centre, Munich,Technical University of Munich

Stables, Rod H. (författare): Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England;Univ Liverpool, Liverpool, Merseyside, England,University of Liverpool,Liverpool Heart and Chest Hospital

Shahzad, Adeel (författare): Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England,Liverpool Heart and Chest Hospital

Steg, Philippe Gabriel (författare): Hop Bichat Claude Bernard, Paris, France;Royal Brompton Hosp, Imperial Coll, London, England,Royal Brompton Hospital,Hopital Bichat-Claude-Bernard AP-HP

Goldstein, Patrick (författare): Lille Univ Hosp, Lille, France,Lille University Hospital

Frigoli, Enrico (författare): Univ Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland,University of Bern,Bern University Hospital

Mehran, Roxana (författare): 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

Valgimigli, Marco (författare): Univ Bern, Bern Univ Hosp, Dept Cardiol, Bern, Switzerland,University of Bern,Bern University Hospital

Stone, Gregg W. (författare): 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,Icahn School of Medicine at Mount Sinai,Cardiovascular Research Foundation, New York

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2019-12-09
2020
Engelska.
Ingår i: Thrombosis and Haemostasis. - : Georg Thieme Verlag KG. - 0340-6245 .- 2567-689X. ; 120:2, s. 348-361

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Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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..

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Nyckelord

bivalirudin
heparin
pooled analysis
percutaneous coronary intervention
acute myocardial infarction

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kardiologi

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