What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Acute coronary syndrome (n=106058). Intervention: Bivalirudin vs. Heparin. Primary outcome: Net adverse clinical events (NACE) (RR 0.82, 95% CI 0.69-0.97, p=0.02).

What does this research mean for the field?

Bivalirudin use during percutaneous coronary intervention reduces the risk of net adverse clinical events by 18% and lowers all-cause death compared to heparin in patients with acute coronary syndrome. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

November 15, 2023Open Access

Bivalirudin versus heparin in contemporary percutaneous coronary interventions for patients with acute coronary syndrome: a systematic review and meta-analysis

JZJunyan ZhangSichuan University ZCZhongxiu ChenSichuan University DWDuolao WangHeart Failure & Transplant

Key Result

Bivalirudin use during percutaneous coronary intervention reduced the risk of net adverse clinical events by 18% compared to heparin in patients with acute coronary syndrome.

Study Design

Type

Meta-Analysis (n=106,058)

Multicenter

Yes

Structured PICO

Does bivalirudin reduce MACE and NACE in patients with ACS undergoing contemporary PCI compared to heparin?

Population

Patients with acute coronary syndrome (ACS) undergoing contemporary percutaneous coronary intervention (PCI). Meta-analysis of 8 studies (4 RCTs, 4 cohort studies).

Intervention

Bivalirudin during PCI (with or without extended post-procedure infusion)

Comparator

Heparin during PCI

Outcome

Incidences of major adverse cardiac events (MACE) and net adverse clinical events (NACE)composite

In contemporary PCI for ACS, bivalirudin reduces the risk of net adverse clinical events and all-cause death primarily by reducing major bleeding, without increasing MACE compared to heparin.

Main Result

Effect estimate: RR 0.82 (95% CI 0.69-0.97)

p-value: p=0.02

Limitations

Included both RCTs and cohort studies, enhancing heterogeneity
Definitions for MACE and NACE were not consistent across studies
Proportions of GPI, novel P2Y12 inhibitors, and radial access differed among studies
BRIGHT-4 study was not included as it was not published before the search completion date

Abstract

BACKGROUND: Bivalirudin is associated with fewer major bleeding events than heparin in patients undergoing percutaneous coronary intervention (PCI), but confounding effects of concomitant glycoprotein IIb/IIIa inhibitors, routine femoral artery access, and less potent effects of clopidogrel limits meaningful comparisons. The present study is a systematic review and meta-analysis to compare bivalirudin to heparin in contemporary practice. METHODS: The Cochrane Library, PubMed, EMBASE, and Ovid MEDLINE databases were searched for relevant studies, including comparisons between bivalirudin and heparin in the current medical era from inception to December 23, 2021. Studies reporting incidences of major adverse cardiac events (MACE) and net adverse clinical events (NACE) in patients undergoing PCI and meeting the inclusion criteria were retained. Data extraction was performed by three independent reviewers. RESULTS: The meta-analysis included 8 studies. Compared to heparin, bivalirudin during PCI was associated with a lower NACE risk, lower all-cause death, and similar MACE risk, with a pooled risk ratio of 0.82 (95% confidence interval CI 0.69-0.97, p = 0.02), 0.83 (95% CI 0.74-0.94, p = 0.002), and 0.93 (95% CI 0.78-1.10, p = 0.38), respectively. Moreover, the reduction in NACE was mainly attributed to reduced bleeding (22% reduction in the risk of major bleeding, 95% CI 0.63-0.97, p = 0.03). CONCLUSIONS: These findings suggest that bivalirudin use during PCI reduced the risk of NACE and all-cause death but did not reduce the risk of MACE compared with heparin use in PCI. More studies specifically designed for anticoagulation strategies and a personalized anticoagulation regimen to comprehensively balance bleeding and ischemia risks are required.

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