接受Impella支持的高危经皮冠状动脉介入治疗的二尖瓣反流患者的临床结局
Clinical outcomes among patients with mitral valve regurgitation undergoing Impella-supported high-risk PCI.
作者信息
Abu-Much Arsalan, Grines Cindy L, Chen Shmuel, Batchelor Wayne B, Zhao Duzhi, Falah Batla, Maini Aneel S, Redfors Björn, Bellumkonda Lavanya, Bharadwaj Aditya S, Moses Jeffrey W, Truesdell Alexander G, Zhang Yiran, Zhou Zhipeng, Baron Suzanne J, Lansky Alexandra J, Basir Mir B, O'Neill William W, Cohen David J
机构信息
Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.
Department of Cardiology, Northside Hospital Cardiovascular Institute, Atlanta, GA, USA.
出版信息
Int J Cardiol. 2024 Dec 15;417:132555. doi: 10.1016/j.ijcard.2024.132555. Epub 2024 Sep 11.
BACKGROUND
Mitral valve regurgitation (MR) is associated with worse outcomes in patients undergoing percutaneous coronary intervention (PCI). We sought to evaluate outcomes of Impella-supported high-risk PCI (HRPCI) patients according to MR severity.
METHODS
Patients from the PROTECT III study undergoing Impella-supported HRPCI were stratified into 4 groups according to MR severity: No or trace MR, mild MR, moderate MR, and severe MR. Immediate PCI-related complications, major adverse cardiovascular and cerebrovascular events (MACCE: all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days and death at 1-year were assessed.
RESULTS
From March 2017 to March 2020, 631 patients who underwent Impella-supported HRPCI in the PROTECT III study had evaluable MR severity at baseline. Patients with severe MR had lower body mass indices, lower left ventricular ejection fractions (LVEFs), and were more frequently diagnosed with heart failure. The incidence of immediate PCI-related complications was similar between groups. Unadjusted 90-day MACCE and 1-year mortality rates were numerically higher in patients with severe MR compared to the other study groups yet without reaching statistical significance. In multivariable analyses, there was no significant association between the presence of severe MR for 90-day MACCE or 1-year mortality compared with other degrees of MR (adj. HR = 1.71, 95% CI [0.73, 3.98], p = 0.21; adj. HR = 1.79, 95% CI [0.86, 3.74], p = 0.12, respectively).
CONCLUSIONS
Impella-supported HRPCI patients with moderate or severe MR exhibited a higher prevalence of heart failure, lower LVEF, and longer hospital stays. Patients with severe MR showed numerically higher unadjusted rates of 90-day MACCE and 1-year mortality compared to other groups, however these differences did not reach statistical significance even after adjustment for potential confounders.
CLINICAL TRIAL INFORMATION
Trial Name: The Global cVAD Study (cVAD) ClinicalTrial.govIdentifier:NCT04136392 URL: https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.
背景
二尖瓣反流（MR）与接受经皮冠状动脉介入治疗（PCI）的患者预后较差相关。我们试图根据MR严重程度评估接受Impella支持的高危PCI（HRPCI）患者的预后。
方法
将PROTECT III研究中接受Impella支持的HRPCI患者根据MR严重程度分为4组：无或微量MR、轻度MR、中度MR和重度MR。评估即刻PCI相关并发症、90天时的主要不良心血管和脑血管事件（MACCE：全因死亡、心肌梗死、中风/短暂性脑缺血发作和再次血运重建）以及1年时的死亡率。
结果
2017年3月至2020年3月，PROTECT III研究中631例接受Impella支持的HRPCI患者在基线时有可评估的MR严重程度。重度MR患者的体重指数较低、左心室射血分数（LVEF）较低，且更常被诊断为心力衰竭。各组间即刻PCI相关并发症发生率相似。与其他研究组相比，重度MR患者未经调整的90天MACCE和1年死亡率在数值上更高，但未达到统计学意义。在多变量分析中，与其他程度的MR相比，重度MR与90天MACCE或1年死亡率之间无显著关联（调整后HR = 1.71，95%CI[0.73, 3.98]，p = 0.21；调整后HR = 1.79，95%CI[0.86, 3.74]，p = 0.12）。
结论
接受Impella支持的HRPCI且患有中度或重度MR的患者心力衰竭患病率更高、LVEF更低且住院时间更长。与其他组相比，重度MR患者未经调整的90天MACCE和1年死亡率在数值上更高，然而即使在对潜在混杂因素进行调整后，这些差异仍未达到统计学意义。
临床试验信息
试验名称：全球cVAD研究（cVAD） ClinicalTrial.gov标识符：NCT04136392 网址：https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2
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