MUST-EECP Do Not Provide Firm Evidence of The Clinical Effectiveness of EECP in Refractory Stable Angina or in Heart Failure 體外反搏治療對難治性穩定心絞痛和心臟衰竭患者的成效不明確

Source From 資料來源 : https://www.journalslibrary.nihr.ac.uk/hta/hta13240/#/abstract

MUST-EECP Do Not Provide Firm Evidence of The Clinical Effectiveness of EECP in Refractory Stable Angina or in Heart Failure

OBJECTIVES:

To determine the clinical effectiveness and cost-effectiveness of enhanced external counterpulsation (EECP) compared with usual care and placebo for refractory stable angina and heart failure, and to undertake analyses of the expected value of information to assess the potential value of future research on EECP.

DATA SOURCES:

Major electronic databases were searched between November 2007 and March 2008.

REVIEW METHODS:

A systematic review of the literature was undertaken and a decision model developed to compare EECP treatment with no treatment in adults with chronic stable angina.

RESULTS:

Five studies were included in the review. In the Multicenter Study of Enhanced External Counterpulsation (MUST-EECP), time to greater than or equal to 1-mm ST segment depression (exercise-induced ischaemia) was statistically significantly improved in the EECP group compared with the control group (sham EECP), mean difference (MD) 41 seconds [95% confidence interval (CI) 9.10-73.90]. However, there was no statistically significant difference between the EECP and control groups in the change in exercise duration from baseline to end of treatment, self-reported angina episodes or daily nitroglycerin use, and the clinical significance of the limited benefits was unclear. There was also a lack of data on long-term outcomes. There were more withdrawals due to adverse events in the EECP group than in the control group, as well as a greater proportion of patients with adverse events [relative risk (RR) 2.13, 95% CI 1.35-3.38]. The three non-randomised studies compared EECP with elective percutaneous coronary intervention (PCI) and usual care. There was a high risk of selection bias in all three studies and the results should be treated with considerable caution. The study comparing an EECP registry with a PCI registry reported similar 1-year all-cause mortality in both groups. In the Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, patients with heart failure were randomised to EECP or to usual care (pharmacotherapy only). At 6 months post treatment, the proportion of patients achieving at least a 60-second increase in exercise duration was higher in the EECP group (RR 1.39, 95% CI 0.89-2.16), but the proportion with an improvement in peak VO2 was similar in both groups. The clinical significance of this is unclear. The proportion of patients in the EECP group with an improvement in New York Heart Association classification was higher (RR 2.25, 95% CI 1.25-4.06) at 6 months, as was mean exercise duration, MD 34.6 (95% CI -4.86 to 74.06). There were more withdrawals in the EECP group than in the control group as a result of adverse events (RR 1.05, 95% CI 0.67-1.66). There were limitations in the generalisability of results of the trial and, again, a lack of data on long-term outcomes. The review of cost-effectiveness evidence found only one unpublished study but demonstrated that the long-term maintenance of quality of life benefits of EECP is central to the estimate of its cost-effectiveness. The incremental cost-effectiveness ratio of EECP was 18,643 pounds for each additional quality-adjusted life-year (QALY), with a probability of being cost-effective of 0.44 and 0.70 at cost-effectiveness thresholds of 20,000 pounds and 30,000 pounds per QALY gained respectively. Results were sensitive to the duration of health-related quality of life (HRQoL) benefits from treatment.

CONCLUSIONS:

The results from a single randomised controlled trial (MUST-EECP) do not provide firm evidence of the clinical effectiveness of EECP in refractory stable angina or in heart failure. High-quality studies are required to investigate the benefits of EECP, whether these outweigh the common adverse effects and its long-term cost-effectiveness in terms of quality of life benefits.

「體外反搏治療對難治性穩定心絞痛和心臟衰竭的治療:系統性回顧和經濟分析」

目標

評估體外反搏治療(EECP)相對於常規治療和安慰劑治療在難治性穩定心絞痛和心臟衰竭患者中的臨床有效性和 成本效益 ,並分析預期資訊價值,以評估未來研究EECP的潛在價值。

資料來源

從2007年11月至2008年3月,搜索了主要的電子數據庫。

綜述方法

對文獻進行詳盡綜述,並開發決策模型,比較EECP治療與無治療對患有慢性穩定心絞痛的成人的效果。

結果

評論中包括了五個研究。在體外反搏治療多中心研究(MUST-EECP)中,與對照組(假EECP)相比,EECP組的ST段節段下沉大於或等於1毫米(運動誘發缺血)在統計上顯著改善,平均差異(MD)為41秒。然而,在EECP組和對照組之間,在從基線到治療結束時的運動持續時間變化、自報心絞痛發作或日常硝酸甘油使用方面,並無顯著統計差異,而且有限效益的臨床意義不明確。對於長期結果的數據也不足。EECP組中因不良事件而退出的患者比對照組更多,並且有更高比例的患者出現不良事件[相對風險(RR)。三個非隨機研究將EECP與選擇性經皮冠狀動脈介入治療(PCI – percutaneous coronary intervention)和常規治療進行了比較。這三個研究中都存在選擇偏差的風險,結果應謹慎對待。比較EECP登記表與PCI登記表的研究報告顯示兩組在1年的全因死亡率上相似。在充血性心力衰竭,增強體外反搏治療前瞻評估(PEECH)試驗中,心臟衰竭患者被隨機分為EECP組和常規治療組(僅藥物治療)。治療後6個月,ECCP 組增加至少60秒運動時間的患者較多,但峰值氧耗改善的比例在兩組中相似。這一點的臨床意義不明確。在EECP組中,紐約心臟協會分級改善的患者比例在6個月時較高,運動持續時間平均差異為34.6。由於不良事件,EECP組的退出率高於對照組。試驗結果不能概括,同樣缺乏關於長期結果的數據。對於 成本效益 證據的回顧僅發現一項未發表的研究,但顯示EECP的長期生活質量維持對其 成本效益 的估計至關重要。EECP的增量 成本效益 比為每增加一個品質調整的生命年(QALY)成本為18,643英鎊,對於每QALY增益的 成本效益 閾值,其 成本效益 概率分別為0.44和0.70,閾值分別為20,000英鎊和30,000英鎊。結果對於治療的健康相關生活質量(HRQoL)效益持續時間敏感。

結論

來自單一隨機對照試驗(MUST-EECP)的結果並未提供EECP在難治性穩定心絞痛或心臟衰竭中的臨床有效性的確鑿證據。需要高質量的研究來探討EECP的益處,以及這些益處是否超過常見的不良反應,以及其在生活質量效益方面的長期 成本效益 。

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