Heart Centre, The Alfred Hospital, Melbourne, Australia.
Heart+Vascular Center, Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.
JAMA Cardiol. 2024 Oct 1;9(10):901-908. doi: 10.1001/jamacardio.2024.2454.
Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce.
To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI.
DESIGN, SETTING, AND PARTICIPANTS: The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment.
Eligible patients were randomized 1:1 between routine protamine administration and placebo.
The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values.
The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use.
In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo.
anzctr.org.au Identifier: ACTRN12621001261808.
经股动脉经导管主动脉瓣置换术（TAVI）后的血管并发症仍然是与手术相关发病率的一个重要原因。在经股 TAVI 结束时常规使用鱼精蛋白逆转抗凝可以减少并发症，但数据仍然很少。
评估经股 TAVI 后常规使用鱼精蛋白的疗效和安全性。
设计、地点和参与者：ACE-PROTAVI 试验是一项由澳大利亚 3 家医院的多学科心脏团队发起的、双盲、安慰剂对照的随机临床试验，随访期为 1 年。所有经多学科心脏团队接受经股 TAVI 的患者均有资格入组。
符合条件的患者按 1:1 随机分为常规鱼精蛋白组和安慰剂组。
主要复合结局为止血成功率和止血时间（TTH），以分类变量呈现，采用 χ2 检验进行比较；以连续变量表示，均值（SD）或中位数（IQR），取决于分布情况。主要次要结局为 30 天后全因死亡、主要和次要出血并发症以及主要和次要血管并发症的复合发生率，以比值比（OR）及其 95%置信区间（CI）和 P 值表示。
研究人群包括 410 例患者：鱼精蛋白组 199 例，安慰剂组 211 例。鱼精蛋白组患者的中位（IQR）年龄为 82（77-85）岁，199 例患者中有 68 例（34.2%）为女性。安慰剂组患者的中位（IQR）年龄为 80（75-85）岁，211 例患者中有 89 例（42.2%）为女性。接受鱼精蛋白 upfront 治疗的患者止血成功率更高（192 例患者中的 188 例[97.9%]），高于安慰剂组的 203 例患者中的 186 例（91.6%）；绝对风险差异为 6.3%；95%CI 为 2.0%-10.6%；P = .006）；此外，接受鱼精蛋白 upfront 治疗的患者 TTH 中位数更短（181 [120-420] 秒 vs 279 [122-600] 秒；P = .002）。鱼精蛋白组的复合结局风险降低（192 例患者中的 10 例[5.2%]），安慰剂组为 203 例患者中的 26 例（12.8%）；OR 为 0.37；95%CI 为 0.1-0.8；P = .01）。这种差异主要是由小血管并发症发生率的差异引起的。与鱼精蛋白使用相关的不良事件没有发生。
在 ACE-PROTAVI 随机临床试验中，常规使用鱼精蛋白可提高止血成功率并缩短 TTH。与安慰剂组相比，接受常规鱼精蛋白治疗的患者在止血成功率、TTH、小血管并发症发生率、手术时间和术后住院时间方面均有获益。
anzctr.org.au 标识符：ACTRN12621001261808。
