Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
Advanced Heart Disease Section, Heart and Vascular Center, Brigham and Women's Hospital, Boston, MA, USA.
Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.
In the CHAMPION trial, significant reductions in admissions to hospital for heart failure were seen after 6 months of pulmonary artery pressure guided management compared with usual care. We examine the extended efficacy of this strategy over 18 months of randomised follow-up and the clinical effect of open access to pressure information for an additional 13 months in patients formerly in the control group.
The CHAMPION trial was a prospective, parallel, single-blinded, multicentre study that enrolled participants with New York Heart Association (NYHA) Class III heart failure symptoms and a previous admission to hospital. Patients were randomly assigned (1:1) by centre in block sizes of four by a secure validated computerised randomisation system to either the treatment group, in which daily uploaded pulmonary artery pressures were used to guide medical therapy, or to the control group, in which daily uploaded pressures were not made available to investigators. Patients in the control group received all standard medical, device, and disease management strategies available. Patients then remained masked in their randomised study group until the last patient enrolled completed at least 6 months of study follow-up (randomised access period) for an average of 18 months. During the randomised access period, patients in the treatment group were managed with pulmonary artery pressure and patients in the control group had usual care only. At the conclusion of randomised access, investigators had access to pulmonary artery pressure for all patients (open access period) averaging 13 months of follow-up. The primary outcome was the rate of hospital admissions between the treatment group and control group in both the randomised access and open access periods. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00531661.
Between Sept 6, 2007, and Oct 7, 2009, 550 patients were randomly assigned to either the treatment group (n=270) or to the control group (n=280). 347 patients (177 in the former treatment group and 170 in the former control group) completed the randomised access period in August, 2010, and transitioned to the open access period which ended April 30, 2012. Over the randomised access period, rates of admissions to hospital for heart failure were reduced in the treatment group by 33% (hazard ratio [HR] 0·67 [95% CI 0·55-0·80]; p<0·0001) compared with the control group. After pulmonary artery pressure information became available to guide therapy during open access (mean 13 months), rates of admissions to hospital for heart failure in the former control group were reduced by 48% (HR 0·52 [95% CI 0·40-0·69]; p<0·0001) compared with rates of admissions in the control group during randomised access. Eight (1%) device-related or system related complications and seven (1%) procedure-related adverse events were reported.
Management of NYHA Class III heart failure based on home transmission of pulmonary artery pressure with an implanted pressure sensor has significant long-term benefit in lowering hospital admission rates for heart failure.
St Jude Medical Inc.
在 CHAMPION 试验中，与常规治疗相比，在 6 个月的肺动脉压力指导管理后，心力衰竭住院人数显著减少。我们检查了这种策略在随机随访 18 个月的扩展疗效，以及在以前处于对照组的患者中额外 13 个月开放获取压力信息的临床效果。
CHAMPION 试验是一项前瞻性、平行、单盲、多中心研究，招募了具有纽约心脏协会（NYHA）III 级心力衰竭症状和既往住院治疗的患者。患者按中心以 4 人为一组的块大小（1:1）通过安全验证的计算机随机化系统随机分配到治疗组或对照组，治疗组每天上传的肺动脉压力用于指导药物治疗，对照组则不向研究者提供每天上传的压力信息。对照组患者接受所有标准的药物、设备和疾病管理策略。然后，患者在随机分组研究组中保持盲法，直到最后一名入组患者完成至少 6 个月的研究随访（随机进入期），平均随访 18 个月。在随机进入期内，治疗组患者接受肺动脉压力管理，对照组患者仅接受常规护理。在随机进入期结束时，所有患者（开放进入期）的研究者都可以获得肺动脉压力，平均随访 13 个月。主要结局是治疗组和对照组在随机进入期和开放进入期的住院率。分析采用意向治疗。该试验在 ClinicalTrials.gov 注册，编号为 NCT00531661。
2007 年 9 月 6 日至 2009 年 10 月 7 日，550 名患者被随机分配到治疗组（n=270）或对照组（n=280）。347 名患者（前治疗组 177 名，前对照组 170 名）于 2010 年 8 月完成随机进入期，并进入开放进入期，于 2012 年 4 月 30 日结束。在随机进入期内，治疗组心力衰竭住院率降低了 33%（风险比[HR]0.67[95%CI 0.55-0.80]；p<0.0001），而对照组则降低了 33%。在开放进入期（平均 13 个月）可获得肺动脉压力信息以指导治疗后，前对照组心力衰竭住院率降低了 48%（HR 0.52[95%CI 0.40-0.69]；p<0.0001），而对照组在随机进入期的住院率降低了 48%。报告了 8 例（1%）与器械相关或系统相关的并发症和 7 例（1%）与操作相关的不良事件。
基于植入式压力传感器的家庭传输肺动脉压的 NYHA III 级心力衰竭管理在降低心力衰竭住院率方面具有显著的长期益处。
圣犹达医疗公司。
