Bivalirudin as compared to unfractionated heparin in patients undergoing percutaneous coronary revascularization: A meta-analysis of 22 randomized trials.

Abstract

Bivalirudin has gained ground against unfractionated heparin (UFH) in percutaneous coronary interventions (PCI), due to a reported better safety profile. However, whether bivalirudin may provide also advantages in clinical outcome beyond the known benefits in major bleedings, is still a debated matter and was, therefore, the aim of present meta-analysis of randomized trials, evaluating efficacy and safety of bivalirudin as compared with UFH in PCI.

METHODS AND STUDY OUTCOMES:

Literature archives (Pubmed, EMBASE, Cochrane) and main scientific sessions were scanned. Primary endpoint was overall mortality. Secondary endpoints were: 1) mortality within 30-days; 2) overall and within 30-days non fatal myocardial infarction; 3) overall and within 30-days stent thrombosis. Safety endpoints were major bleedings (per protocol definition or TIMI classification). A prespecified analysis was conducted according to clinical presentation (Elective, ACS, STEMI).

RESULTS:

A total of 22 randomized clinical were finally included, involving 40156 patients randomized to bivalirudin (52.9%) or to UFH (47.1%). Death occurred in 1100 (2.8%) of patients, with no difference between bivalirudin and UFH (2.7% vs 2.8% OR[95%C]=0.94[0.83,-.06], p=0.32, phet=0.48). The results did not change according to clinical presentation. By meta-regression analysis, the effects on mortality were not related to patients risk profile (r=-0.38(-0.89-0.14), p=0.15) or the reduction in bleeding complications (r=-0.008(-0.86-0.85), p=0.98). A significant increase in short-term stent thrombosis was observed with bivalirudin (OR[95%CI]=1.42 [1.10-1.83], p=0.006). However, Bivalirudin significantly reduced bleedings according to both study protocol definition (OR[95%CI]=0.62[0.56-0.69],p<0.00001; phet=0.0003) or TIMI major criteria (OR[95%CI]=0.65[0.53-0.79],p<0.0001, phet=0.95).

CONCLUSIONS:

In present meta-analysis, among patients undergoing PCI, bivalirudin, as compared with UFH, is associated with a significant reduction in major bleeding complications that, however, does not translate into mortality benefits. Furthermore, bivalirudin is associated with higher rate of 30-days stent thrombosis and recurrent MI among STEMI patients.

• Authors: Monica Verdoia, Alon Schaffer, Lucia Barbieri, Harry Suryapranata, Giuseppe De Luca
• Journal: Thrombosis research (Thromb Res) Vol. 135 Issue 5 Pg. 902-15 (May 2015) ISSN: 1879-2472 [Electronic] United States
• PMID: 25772138 (Publication Type: Comparative Study, Journal Article, Meta-Analysis)
• Copyright: Copyright © 2015 Elsevier Ltd. All rights reserved.

Chemical References

• Anticoagulants
• Hirudins
• Peptide Fragments
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Anticoagulants (therapeutic use)
• Hemorrhage (prevention & control)
• Heparin (therapeutic use)
• Hirudins
• Humans
• Peptide Fragments (therapeutic use)
• Percutaneous Coronary Intervention (adverse effects, methods)
• Randomized Controlled Trials as Topic
• Recombinant Proteins (therapeutic use)
• Thrombosis (drug therapy, epidemiology)