Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials
Meta-analysis published in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (2016)
Abstract
OBJECTIVE: To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality. BACKGROUND: In primary PCI, lower risk of bleeding with bivalirudin (vs. unfractionated heparin [UFH]) is counterbalanced by an increased risk of acute stent thrombosis (ST). Several randomized clinical trials (RCTs) and a recent meta-analysis suggest that acute ST risk may be eliminated without compromising the bleeding benefit, but only if the full dose, not a low dose, of bivalirudin is continued post-PCI. However, it is not known whether this improved risk leads to lower rates of NACEs and mortality. METHODS: Scientific databases and Web sites were searched for RCTs. Trials were included if study patients were undergoing primary PCI for acute ST-segment elevation myocardial infarction and were randomly assigned to bivalirudin or UFH treatment. The bivalirudin arm was divided based on post-PCI bivalirudin dosage: The Biv-Full group received 1.75 mg/kg/h, the Biv-Low group, 0.25 mg/kg/h, and the Biv-No group, none. RESULTS: Six RCTs involving 16,842 patients were found. In pairwise meta-analysis, bivalirudin improved 30-day all-cause mortality by 35% and cardiac mortality by 32%, but did not yield a NACE rate better than that achieved with UFH. Subgroup analysis showed the Biv-Full group had a 46% lower NACE rate and 47% lower all-cause mortality than UFH. These effects were not seen in the other two groups. Network meta-analysis yielded similar results. At treatment ranking, the Biv-Full group yielded the best treatment efficacy. CONCLUSIONS: In primary PCI, full-dose bivalirudin infusion for 3-4 hr after PCI appeared to improve NACE rates compared to UFH. It also seemed to be the most effective strategy for improving cardiac mortality and all-cause mortality. © 2016 Wiley Periodicals, Inc.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
To compare the efficacies of various post-percutaneous coronary intervenetion (PCI) bivalirudin doses on net adverse clinical events (NACEs) and mortality.
Why This Matters for Hirudotherapy
This pairwise and network meta-analysis of six randomized controlled trials (16,842 patients undergoing primary PCI for ST-segment elevation myocardial infarction) compared post-procedural bivalirudin dosing strategies against unfractionated heparin, finding that full-dose post-PCI bivalirudin infusion (1.75 mg/kg/h for 3–4 hours) ranked best in treatment efficacy, with 46% lower net adverse clinical event rates and 47% lower all-cause mortality versus UFH in subgroup analysis. Bivalirudin is a synthetic direct thrombin inhibitor modeled on hirudin, the signature anticoagulant of medicinal leech saliva, making these cardiovascular outcomes directly relevant to the leech secretome and to ASH's interest in hirudin-derived therapeutics. The study illustrates how a leech-saliva-inspired anticoagulant continues to be refined in modern interventional cardiology. An important caveat is that the dose-stratified findings derive from subgroup rather than head-to-head randomized contrasts, and pooled estimates remain vulnerable to between-trial heterogeneity in concomitant antithrombotic regimens.
Citation
Effect of post-primary percutaneous coronary intervention bivalirudin infusion on net adverse clinical events and mortality: A comprehensive pairwise and network meta-analysis of randomized controlled trials
Shah R et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2016
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