Bivalirudin versus heparin during PCI in NSTEMI: individual patient data meta-analysis of large randomized trials
IPD meta-analysis published in Circulation (2023)
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.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
Individual patient-data meta-analysis of large bivalirudin-vs-heparin RCTs in NSTEMI PCI. Bivalirudin associated with reduced major bleeding without ischemic penalty.
Warum dies für die Hirudotherapie relevant ist
Diese Metaanalyse auf Basis individueller Patientendaten aus 5 großen randomisierten Studien (12.155 Patienten mit Nicht-ST-Hebungs-Myokardinfarkt, die sich einer PCI unterzogen) verglich Bivalirudin mit Heparin zur prozeduralen Antikoagulation. Bivalirudin ist ein synthetisches Peptid-Analogon von Hirudin, dem ursprünglich aus dem Speichel des medizinischen Blutegels isolierten direkten Thrombininhibitor, wodurch diese Befunde relevant sind für das Verständnis, wie ein aus dem Blutegelsekretom stammendes Antikoagulans in der modernen Praxis abschneidet. Die Studie ergab keinen signifikanten Unterschied in der 30-Tage-Mortalität oder bei ischämischen Ereignissen, aber Bivalirudin reduzierte schwere Blutungen im Vergleich zu Heparin (3,3 % vs. 5,5 %; adjustierte Odds Ratio 0,59; p < 0,0001). Eine wesentliche Einschränkung besteht darin, dass sich diese Befunde auf ein entwickeltes pharmazeutisches Analogon in der interventionellen Kardiologie beziehen, nicht auf die Blutegeltherapie oder natives Hirudin selbst, und der Blutungsvorteil muss gegen vergleichbare ischämische Ergebnisse abgewogen werden.
Zitation
Bivalirudin versus heparin during PCI in NSTEMI: individual patient data meta-analysis of large randomized trials.
Bikdeli B et al. · Circulation, 2023
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