Department of Cardiology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.
Department of Nephrology, Tel-Aviv Medical Center Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 weizman st, Tel-Aviv, Israel.
Eur Heart J. 2019 Oct 7;40(38):3169-3178. doi: 10.1093/eurheartj/ehz343.
Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) and is associated with increased risk for short- and long-term mortality. In patients undergoing percutaneous coronary intervention (PCI), forced diuresis with matched hydration has been shown to reduce the incidence of AKI by ∼50%. The aim of the present study was to evaluate whether forced diuresis with matched intravenous hydration reduces AKI in patients undergoing TAVI.
Reducing Acute Kidney Injury (REDUCE-AKI) was a single-centre, prospective, randomized, double-blind sham-controlled clinical trial, designed to examine the effect of an automated matched saline infusion with urine output for the prevention of AKI in patients undergoing TAVI. A total of 136 TAVI patients were randomized, 68 in each group. Mean age was 83.9 ± 5 years and 41.2% were males. There were no differences in baseline characteristics between the two groups. The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408). There was a significant increase in long-term mortality in the active group (27.9% vs. 13. 2% HR 3.744, 95% CI 1.51-9.28; P = 0.004). The study was terminated prematurely by the Data Safety Monitoring Board for futility and a possible signal of harm.
Unlike in PCI, forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI, and might be associated with increased long-term mortality. Future studies should focus on understanding the mechanisms behind these findings.
CLINICALTRIALS.GOV REGISTRATION: NCT01866800, 30 April 2013.
急性肾损伤（AKI）是经导管主动脉瓣植入术（TAVI）后的常见并发症，与短期和长期死亡率增加相关。在接受经皮冠状动脉介入治疗（PCI）的患者中，已证实强制性利尿与匹配的水化可将 AKI 的发生率降低约 50%。本研究旨在评估 TAVI 患者中，强制性利尿与匹配的静脉水化是否可降低 AKI 的发生率。
减少急性肾损伤（REDUCE-AKI）是一项单中心、前瞻性、随机、双盲假对照临床试验，旨在研究自动匹配的生理盐水输注与尿量在预防 TAVI 患者 AKI 中的作用。共纳入 136 例 TAVI 患者，随机分为两组，每组 68 例。平均年龄为 83.9±5 岁，41.2%为男性。两组间的基线特征无差异。两组间 AKI 的发生率无统计学差异（活性组为 25%，假手术组为 19.1%，P=0.408）。活性组的长期死亡率显著增加（27.9%比 13.2%，HR 3.744，95%CI 1.51-9.28；P=0.004）。数据安全监测委员会出于无效性和可能的危害信号提前终止了研究。
与 PCI 不同，TAVI 患者中强制性利尿与匹配的水化并不能预防 AKI，并且可能与长期死亡率增加相关。未来的研究应侧重于理解这些发现背后的机制。
NCT01866800，2013 年 4 月 30 日。
