Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial.
Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial.
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充血性心力衰竭和肺动脉导管插入术有效性的评估研究：ESCAPE 试验。
DOI：
10.1001/jama.294.13.1625
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发表时间：
2005
期刊：
影响因子：
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通讯作者：
ESCAPEInvestigatorsandESCAPEStudyCoordinators
中科院分区：
文献类型：
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作者：
Binanay,Cynthia;Califf,RobertM;Hasselblad,Vic;O'Connor,ChristopherM;Shah,MonicaR;Sopko,George;Stevenson,LynneW;Francis,GaryS;Leier,CarlV;Miller,LeslieW;ESCAPEInvestigatorsandESCAPEStudyCoordinators
摘要背景肺动脉导管（PAC）已被用于指导多种情况下的治疗，但最近的研究提出了担心，PAC可能会导致住院患者的死亡率增加。目的确定PAC是否安全，并改善严重症状性和复发性心力衰竭住院患者的临床结局。充血性心力衰竭和肺动脉导管插入术有效性的评价研究（ESCAPE）是一项随机对照试验，从2000年1月18日至2003年11月17日在26个地点进行，共有433名患者参加。患者被分配接受临床评估指导的治疗和PAC或单独的临床评估。两组的目标均为缓解临床充血，额外的PAC目标为肺毛细血管楔压15 mm Hg和右心房压8 mm Hg。药物未详细说明，但明确不鼓励使用正性肌力药。主要结果测量：主要终点是前6个月出院后的存活天数，次要终点是运动、生活质量、生化和超声心动图的变化。结果疾病严重程度由以下数值反映：平均左心室射血分数，19%;收缩压，106 mm Hg;钠水平，137 mEq/L;尿素氮，35 mg/dL（12.40 mmol/L）;肌酐，1.5 mg/dL（132.6 μmol/L）。两组的治疗均导致症状、颈静脉压和水肿显著减轻。PAC的使用并没有显著影响最初6个月内的主要终点生存天数和出院天数（133天vs 135天;风险比[HR]，1.00 [95%置信区间{CI}，0.82-1.21]; P=. 99），死亡率（43例患者[10%] vs 38例患者[9%];比值比[OR]，1.26 [95%CI，0.78-2.03]; P=. 35），或住院天数（8.7 vs 8.3; HR，1.04 [95%CI，0.86-1.27]; P=. 67）。PAC组患者的院内不良事件更常见（47例[21.9%] vs 25例[11.5%]; P=. 04）。无与PAC使用相关的死亡，住院加30天死亡率无差异（10 [4.7%] vs 11 [5.0%]; OR，0.97 [95%CI，0.38-2.22]; P=. 97）。两组的运动和生活质量终点均有所改善，PAC的改善趋势更大，在随机分组后的所有时间点，时间权衡都达到了显著性。结论：在心力衰竭住院期间，减少容量超负荷的治疗可显著改善充盈压升高的体征和症状，无论是否使用PAC。在仔细的临床评估中增加PAC会增加预期的不良事件，但不会影响总死亡率和住院率。未来的试验应测试非侵入性评估与特定的治疗策略，可用于更好地定制治疗的生存时间和生存质量的患者所重视的。
Abstract Context Pulmonary artery catheters (PACs) have been used to guide therapy in multiple settings, but recent studies have raised concerns that PACs may lead to increased mortality in hospitalized patients. Objective To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. Design, Setting, and Participants The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) was a randomized controlled trial of 433 patients at 26 sites conducted from January 18, 2000, to November 17, 2003. Patients were assigned to receive therapy guided by clinical assessment and a PAC or clinical assessment alone. The target in both groups was resolution of clinical congestion, with additional PAC targets of a pulmonary capillary wedge pressure of 15 mm Hg and a right atrial pressure of 8 mm Hg. Medications were not specified, but inotrope use was explicitly discouraged. Main Outcome Measures The primary end point was days alive out of the hospital during the first 6 months, with secondary end points of exercise, quality of life, biochemical, and echocardiographic changes. Results Severity of illness was reflected by the following values: average left ventricular ejection fraction, 19%; systolic blood pressure, 106 mm Hg; sodium level, 137 mEq/L; urea nitrogen, 35 mg/dL (12.40 mmol/L); and creatinine, 1.5 mg/dL (132.6 μmol/L). Therapy in both groups led to substantial reduction in symptoms, jugular venous pressure, and edema. Use of the PAC did not significantly affect the primary end point of days alive and out of the hospital during the first 6 months (133 days vs 135 days; hazard ratio [HR], 1.00 [95% confidence interval {CI}, 0.82-1.21]; P=. 99), mortality (43 patients [10%] vs 38 patients [9%]; odds ratio [OR], 1.26 [95% CI, 0.78-2.03]; P=. 35), or the number of days hospitalized (8.7 vs 8.3; HR, 1.04 [95% CI, 0.86-1.27]; P=. 67). In-hospital adverse events were more common among patients in the PAC group (47 [21.9%] vs 25 [11.5%]; P=. 04). There were no deaths related to PAC use, and no difference for in-hospital plus 30-day mortality (10 [4.7%] vs 11 [5.0%]; OR, 0.97 [95% CI, 0.38-2.22]; P=. 97). Exercise and quality of life end points improved in both groups with a trend toward greater improvement with the PAC, which reached significance for the time trade-off at all time points after randomization. Conclusions Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures with or without the PAC. Addition of the PAC to careful clinical assessment increased anticipated adverse events, but did not affect overall mortality and hospitalization. Future trials should test noninvasive assessments with specific treatment strategies that could be used to better tailor therapy for both survival time and survival quality as valued by patients.