Cardiology · 2025
Efficacy and Safety of Protamine Use following Transcatheter Aortic Valve Implantation for Minimizing Post-Procedural Bleeding Risk: A Systematic Review and Meta-Analysis.
СтатьяСистематический обзорНазвание и аннотация: Перевод пока не подготовлен
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Kara Arwi Omar, Beshr Mohammed S, Abdelaziz Ali M, Alzubi Alhasan S, Alansari Arowa Hassan Abdulrahman, Arhaym Esraa, Aburawi Dania Mukhtar, El Awami Mostafa, Farag Abdelrahman, Almezghwi Heyam, Abdulsalam Anas Atiyah, Shahin Hatim Nasruldin, Elhadi Muhammed, Mamas Mamas
Аннотация
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) may be complicated by postoperative bleeding due to heparin use. Heparin antagonists, such as protamine, have shown potential in reducing bleeding risks. This meta-analysis assesses the efficacy and safety of protamine in reducing bleeding complications after TAVI.
METHODS: A systematic search was conducted up to March 2025. Inclusion criteria encompassed studies reporting the use of protamine post-TAVI with a control group. Primary outcomes included major bleeding events as the efficacy endpoint, 30-day mortality, and ischemic events (stroke and transient ischemic attack, or TIA) as safety endpoints. Secondary outcomes included life-threatening bleeding events and the need for blood transfusion. A random-effects model was used to calculate odds ratios (ORs).
RESULTS: Four studies involving 1,569 patients were included. As compared to the control group, protamine was not associated with a statistically significant difference in major bleeding events (OR = 0.59, 95% CI = 0.26-1.34, p = 0.21), life-threatening bleeding events (OR = 0.3, 95% CI = 0.06-1.62, p = 0.16), need for blood transfusions (OR = 0.75, 95% CI = 0.46-1.24, p = 0.27), 30-day mortality (OR = 1.07, 95% CI = 0.54-2.11, p = 0.85), or rate of stroke and TIA (OR = 0.86, 95% CI = 0.05-13.58, p = 0.91).
CONCLUSION: Protamine use after TAVI appeared to be safe with no increase in 30-day mortality or stroke and TIA rates, but there was no observed statistically significant benefit in the reduction of major or life-threatening bleeding events and the need for blood transfusions. These findings are based on a limited number of studies, and larger randomized controlled trials are warranted to confirm them.
METHODS: A systematic search was conducted up to March 2025. Inclusion criteria encompassed studies reporting the use of protamine post-TAVI with a control group. Primary outcomes included major bleeding events as the efficacy endpoint, 30-day mortality, and ischemic events (stroke and transient ischemic attack, or TIA) as safety endpoints. Secondary outcomes included life-threatening bleeding events and the need for blood transfusion. A random-effects model was used to calculate odds ratios (ORs).
RESULTS: Four studies involving 1,569 patients were included. As compared to the control group, protamine was not associated with a statistically significant difference in major bleeding events (OR = 0.59, 95% CI = 0.26-1.34, p = 0.21), life-threatening bleeding events (OR = 0.3, 95% CI = 0.06-1.62, p = 0.16), need for blood transfusions (OR = 0.75, 95% CI = 0.46-1.24, p = 0.27), 30-day mortality (OR = 1.07, 95% CI = 0.54-2.11, p = 0.85), or rate of stroke and TIA (OR = 0.86, 95% CI = 0.05-13.58, p = 0.91).
CONCLUSION: Protamine use after TAVI appeared to be safe with no increase in 30-day mortality or stroke and TIA rates, but there was no observed statistically significant benefit in the reduction of major or life-threatening bleeding events and the need for blood transfusions. These findings are based on a limited number of studies, and larger randomized controlled trials are warranted to confirm them.