Division of Cardiology, Department of Medicine, RJH Department of Veterans Affairs Medical Center, Medical University of South Carolina, SC, USA.
Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114.
During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study.
From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups.
During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.
在 2019 年冠状病毒病（COVID-19）大流行期间，心力衰竭（HF）事件发生率发生了重要变化，已有大量报道，但很少有数据涉及这些变化的潜在原因；在 GUIDE-HF 研究中检查了几种可能性。
2018 年 3 月 15 日至 2019 年 12 月 20 日，患者被随机分配至血流动力学指导管理（治疗）组或对照组，进行 12 个月的治疗，主要终点为全因死亡率加 HF 事件。在 COVID-19 之前，治疗组的主要终点发生率为 0.553 比 0.682 事件/患者年，治疗组[风险比（HR）0.81，P=0.049]。COVID-19 期间治疗差异不再明显（HR 1.11，P=0.526），对照组下降 21%（0.536 事件/患者年），治疗组无变化（0.597 事件/患者年）。检查了可能在 COVID-19 期间改变主要终点发生率的反映提供者、疾病和患者相关因素的数据。治疗组和对照组在 COVID-19 之前和期间的接触频率相似。在 COVID-19 期间，治疗组的每月药物变化率下降了 19.2%，而对照组仅下降了 10.7%，两组之间无差异（P=0.362）。COVID-19 发病率在两组之间无差异。治疗组肺动脉压面积下降-98mmHg·天，对照组下降-100mmHg·天（P=0.867）。两组患者在 COVID-19 期间均遵守研究方案。
在 COVID-19 期间，对照组的主要事件发生率下降，治疗组的发生率保持较低水平，导致 COVID-19 之前存在的组间差异消失。这些结果不是由于提供者或疾病相关因素的变化所致；尽管药物变化较少，但肺动脉压下降，表明患者相关因素在这些结果中发挥了重要作用。临床试验.gov：NCT03387813。
