Key result
Protamine administration during percutaneous coronary intervention significantly reduced the risk of major bleeding (OR 0.489; 95% CI 0.362-0.661; p<0.001) without increasing mortality or thrombosis.
Why the study?
The safety and benefits of administering protamine to reduce bleeding complications during PCI remained unclear.
Does protamine administration reduce bleeding complications in patients undergoing percutaneous coronary intervention?
Meta-Analysis (n=6,936)
Does protamine administration reduce bleeding complications in patients undergoing percutaneous coronary intervention?
Odds Ratio: 0.489 (95% CI 0.362–0.661)
p-value: p=< .001
Protamine administration during PCI significantly reduces major and minor bleeding without increasing the risk of ischemic events or mortality.
May reduce major bleeding during PCI without ischemic harm; supports randomized trials before routine adoption.
BACKGROUND: The safety and the benefits of reducing the risk of bleeding complications via protamine administration during the percutaneous coronary intervention (PCI) remains unclear. This study aimed to systematically assessed the efficacy and safety of using protamine in PCI. METHOD: Potential academic studies were identified from PubMed, Cochrane Library, EMBASE, and Web of Science. The time range we retrieved from was that from the inception of electronic databases to March 31, 2022. Gray studies were identified from the references of included literature reports. Stata version 12.0 statistical software (StataCorp LP) was used to analyze the pooled data. RESULTS: A total of seven studies were involved in our study. The overall participants of the protamine group were 4983, whereas it was 1953 in the nonprotamine group. This meta-analysis indicated that protamine was preferable for PCI as its lower value of major bleeding (odds ratio [OR] = 0.489, 95% confidence interval [CI]: 0.362-0.661, p < .001) and minor bleeding (OR = 0.281, 95% CI: 0.123-0.643, p = .003). Additionally, the protamine did not tend to be related a higher incidence of mortality (p = .143), myocardial infarction (p = .990), and stent thrombosis (p = .698). CONCLUSIONS: Based on available evidence, use of protamine may reduce the risk of bleeding complications without increasing the risk of mortality, myocardial infarction, and stent thrombosis. Given the relevant possible biases in our study, adequately powered and better-designed studies with long-term follow-up are required to reach a firmer conclusion.
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Jiang et al. (2022) conducted a meta-analysis in Percutaneous coronary intervention (PCI) (n=6,936). Protamine vs. Nonprotamine was evaluated on Major bleeding (OR 0.489, 95% CI 0.362-0.661, p=< .001). Protamine administration during percutaneous coronary intervention significantly reduced the risk of major bleeding (OR 0.489; 95% CI 0.362-0.661; p<0.001) without increasing mortality or thrombosis.
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