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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 ; McAndrew, Thomas ; Crowley, Aaron ; Chen, Shmuel ; Mehdipoor, Ghazaleh ; Redfors, Björn ; Liu, Yangbo ; Zhang, Zixuan ; Liu, Mengdan and Zhang, Yiran , et al. (2020) In Thrombosis and Haemostasis 120(2). p.348-362
Abstract

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,... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Thrombosis and Haemostasis
volume
120
issue
2
pages
15 pages
publisher
Schattauer GmbH
external identifiers
  • scopus:85078870503
  • pmid:31820428
ISSN
0340-6245
DOI
10.1055/s-0039-1700872
language
English
LU publication?
yes
id
6bf267f4-4d5f-45b8-94f8-5dbcb9e788c9
date added to LUP
2020-02-11 14:58:50
date last changed
2024-04-17 03:59:52
@article{6bf267f4-4d5f-45b8-94f8-5dbcb9e788c9,
  abstract     = {{<p>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.</p>}},
  author       = {{Bikdeli, Behnood and McAndrew, Thomas and Crowley, Aaron and Chen, Shmuel and Mehdipoor, Ghazaleh and Redfors, Björn and Liu, Yangbo and Zhang, Zixuan and Liu, Mengdan and Zhang, Yiran and Francese, Dominic P. and Erlinge, David and James, Stefan K. and Han, Yaling and Li, Yi and Kastrati, Adnan and Schüpke, Stefanie and Stables, Rod H. and Shahzad, Adeel and Steg, Philippe Gabriel and Goldstein, Patrick and Frigoli, Enrico and Mehran, Roxana and Valgimigli, Marco and Stone, Gregg W.}},
  issn         = {{0340-6245}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{348--362}},
  publisher    = {{Schattauer GmbH}},
  series       = {{Thrombosis and Haemostasis}},
  title        = {{Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction : Rationale and Methodology}},
  url          = {{http://dx.doi.org/10.1055/s-0039-1700872}},
  doi          = {{10.1055/s-0039-1700872}},
  volume       = {{120}},
  year         = {{2020}},
}