Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.
Department of Medical Biometry, Informatics, and Epidemiology, University Hospital Bonn, Bonn, Germany.
JACC Cardiovasc Interv. 2020 Jun 22;13(12):1471-1480. doi: 10.1016/j.jcin.2020.03.041.
The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.
Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.
This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.
The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.
本研究旨在评估经导管主动脉瓣置换术（TAVR）后使用鱼精蛋白逆转肝素是否可减少出血并发症并影响患者结局。
TAVR 术后发生大出血并发症与发病率和死亡率增加相关。
这项研究纳入了 873 例接受 TAVR 的患者，其中 677 例接受鱼精蛋白逆转肝素。标准入路管理包括使用预闭装置、手动压迫以及经皮腔内血管成形术或必要时植入带膜支架。本研究符合良好临床实践指南，并获得了当地伦理委员会的批准。所有患者均获得书面知情同意。
主要终点（30 天全因死亡率和危及生命的大出血及主要出血复合终点）在鱼精蛋白组（3.2%）低于对照组（8.7%）（p=0.003）。这主要归因于鱼精蛋白组危及生命的大出血和主要出血发生率更低（0.1%比 2.6%[p<0.001]和 1.0%比 4.1%[p=0.008]）。此外，鱼精蛋白组的住院时间明显更短（11.1±5.8 天比 12.7±7.8 天；p=0.05）。在总队列中，1.9%的患者发生卒中，0.2%的患者发生心肌梗死，两组间无显著差异（p>0.05）。多变量分析显示，仅鱼精蛋白组（比值比：0.24；95%置信区间：0.10 至 0.58；p=0.001）和急性肾损伤（比值比：5.82；95%置信区间：2.02 至 16.77；p=0.001）与主要终点独立相关。
与未行肝素逆转的患者相比，鱼精蛋白组的危及生命的大出血并发症发生率显著降低。使用鱼精蛋白并未增加卒中或心肌梗死的发生。
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