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Meta-Analysis
. 2023 Oct 17;148(16):1207-1219.
doi: 10.1161/CIRCULATIONAHA.123.063946. Epub 2023 Sep 25.

Bivalirudin Versus Heparin During PCI in NSTEMI: Individual Patient Data Meta-Analysis of Large Randomized Trials

Behnood Bikdeli  1   2   3 , David Erlinge  4 , Marco Valgimigli  5 , Adnan Kastrati  6   7 , Yaling Han  8 , Philippe Gabriel Steg  9   10 , Rod H Stables  11   12 , Roxana Mehran  13   14 , Stefan K James  15 , Enrico Frigoli  5 , Patrick Goldstein  16 , Yi Li  8 , Adeel Shahzad  11   12 , Stefanie Schüpke  6   7 , Ghazaleh Mehdipoor  17 , Shmuel Chen  18 , Björn Redfors  19 , Aaron Crowley  20 , Zhipeng Zhou  14 , Gregg W Stone  13
Affiliations
Meta-Analysis

Bivalirudin Versus Heparin During PCI in NSTEMI: Individual Patient Data Meta-Analysis of Large Randomized Trials

Behnood Bikdeli et al. Circulation. .

Abstract

Background: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non-ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non-ST-segment-elevation myocardial infarction undergoing PCI.

Methods: We performed an individual patient data meta-analysis of patients with non-ST-segment-elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding.

Results: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86-1.79]; P=0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site-related and non-access site-related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48-0.72; P<0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up.

Conclusions: In patients with non-ST-segment-elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.

Keywords: anticoagulants; hemorrhage; mortality; myocardial infarction; prognosis.

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Conflict of interest statement

Disclosures Dr Bikdeli reports that he is a consulting expert, on behalf of the plaintiff, for litigation related to 2 brand models of inferior vena cava filters and is supported by the Scott Schoen and Nancy Adams IGNITE award from the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital, and a career development award from the American Heart Association and VIVA Physicians (No. 938814). Dr Erlinge has received honoraria for advisory boards from AstraZeneca, Bayer, Chiesi, and Sanofi, and speaker honoraria from Bayer, AZ, Novartis, and Chiesi. Dr Valgimigli reports personal grants and personal fees from Terumo, and personal fees from Astra Zeneca, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CorFlow, Idorsia Pharmaceuticals, Universität Basel Dept Klinische Forschung, Bristol Myers Squib SA, Medscape, Biotronik, and Novartis, outside the submitted work. Dr Steg has received research grants from Amarin, AstraZeneca, Bayer, Sanofi, and Servier and honoraria for clinical trials (steering committee, clinical events committee, Data Safety and Monitoring Board) from Amarin, AstraZeneca, Bayer, Bristol-Myers Squibb, Idorsia, Novartis, PhaseBio, Pfizer, Sanofi, Servier, and The Medicines Company, and for consulting or speaking from Amarin, Amgen, Bristol Myers Squibb, Novo-Nordisk, and Regeneron. Dr Steg is a senior associate editor at Circulation. Dr Mehran reports institutional research payments from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, AtriCure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Element Science, Faraday, Humacyte, Idorsia, Janssen, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, Pi-Cardia, RenalPro, RM Global, Shockwave, Vivasure, and Zoll; reports personal fees from Cine-Med Research, and WebMD; reports equity <1% in Applied Therapeutics, Elixir Medical, Stel, ControlRad (spouse); is in the scientific advisory board for American Medical Association, American College of Cardiology (Board of Trustee member), Society of Cardiovascular Angiography and Intervention (Women in Innovations committee member), is a JAMA associate editor; and is among the faculty at Cardiovascular Research Foundation (no fee). Dr James’s employer has received research grants from Novartis, Amgen, Jansen, Bayer, AstraZeneca, and Infraredex. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s daughter is an employee at IQVIA. Institutional disclosure: Dr Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. The other authors report no conflicts.

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