Efficacy and safety of protamine for preventing complications in transcatheter aortic valve replacement: a...

Transcatheter aortic valve replacement (TAVR) is increasingly performed nowadays, bleeding and vascular complications are not uncommon. Current recommendations for the use of protamine in the post-TAVR setting remain uncertain. This study aimed to evaluate the efficacy and safety of protamine in this setting.

A systematic search using four databases, including PubMed, Embase, Web of Science, and Cochrane CENTRAL, was conducted from inception to October 17^th, 2024, without language restrictions. The inclusion criteria were studies that compared the efficacy or safety of protamine vs control in post-TAVR patients.

There were six studies (two randomized and four non-randomized) included in this meta-analysis, involving 3897 participants. We used a random-effects model for this meta-analysis. Protamine was associated with a lower risk of major bleeding compared to the control group, with an odds ratio (OR) of 0.47 (95% CI 0.30 to 0.74, P<0.01). Additionally, protamine was associated with a lower risk of major vascular complications compared to the control, with an OR of 0.45 (95% CI 0.31 to 0.65, P<0.01). Protamine also reduced the risk of minor bleeding and life-threatening bleeding compared to the control. For the safety outcome, the administration of protamine did not increase the risk of stroke and myocardial infarction.

The administration of protamine demonstrated efficacy in reducing bleeding and vascular complications without increasing the risk of thromboembolic complications in the post-TAVR setting.