Comorbidities and clinical response to cardiac resynchronization therapy: Patient-level meta-analysis from eight clinical trials

IF 16.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Marat Fudim, Frederik Dalgaard, Daniel J. Friedman, William T. Abraham, John G.F. Cleland, Anne B. Curtis, Michael R. Gold, Valentina Kutyifa, Cecilia Linde, Fatima Ali-Ahmed, Anthony Tang, Antonio Olivas-Martinez, Lurdes Y.T. Inoue, Sana M. Al-Khatib, Gillian D. Sanders
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引用次数: 0

Abstract

Aims

Patients with heart failure usually have several other medical conditions that might alter the effects of interventions. We investigated whether the burden of comorbidity modified the clinical response to cardiac resynchronization therapy (CRT).

Methods and results

Original patient-level data from eight randomized trials exploring the effects of CRT versus no CRT were pooled (BLOCK-HF, MIRACLE, MIRACLE-ICD, MIRACLE-ICD II, RAFT, COMPANION, MADIT-CRT and REVERSE). A prior history of the following comorbidities was considered: episodic or persistent atrial fibrillation (n = 920), coronary artery disease (n = 3732), diabetes (n = 2171), and hypertension (n = 3353). Patients were classified into three groups based on the number of comorbidities: 0, 1–2, or ≥3. The outcomes of interest were time to all-cause mortality and time to the composite outcome of heart failure hospitalization (HFH) or all-cause mortality. Outcomes were evaluated within each comorbidity group using a Bayesian hierarchical Weibull survival regression model. Of 6324 patients, 970 (15%) had no comorbidities, 4052 (64%) had 1–2 and 1302 (21%) had ≥3 comorbidities. The adjusted hazard ratio (aHR) for CRT versus no CRT for all-cause mortality in the overall cohort was 0.79 (95% credible interval [CI] 0.68–0.93) (p = 0.010); for no comorbidities the aHR was 0.54 (95% CI 0.34–0.86), for 1–2 comorbidities was 0.81 (95% CI 0.67–0.97) and for ≥3 comorbidities was 0.83 (95% CI 0.64–1.07) (no significant interaction between CRT and comorbidity burden: p = 0.13). For the endpoint of HFH or all-cause mortality, the aHR for the overall cohort was 0.74 (95% CI 0.65–0.84) (p = 0.001), for no comorbidities was 0.69 (95% CI 0.50–0.94), for 1–2 comorbidities was 0.77 (95% CI 0.66–0.90) and for ≥3 comorbidities was 0.68 (95% CI 0.55–0.82) (no significant interaction between CRT and comorbidity burden: p = 0.081).

Conclusion

In a meta-analysis of patient-level data from eight major trials, the totality of evidence suggests that CRT reduces HFH and/or all-cause mortality even when several comorbid diseases are present.

Clinical Trial Registration: NCT00271154, NCT00251251, NCT00267098, NCT00180271.

心脏再同步治疗的合并症和临床反应:来自八项临床试验的患者水平荟萃分析。
目的:心力衰竭患者通常有其他几种可能改变干预效果的疾病。我们研究了合并症的负担是否改变了对心脏再同步治疗(CRT)的临床反应。方法和结果:汇集了8项随机试验的原始患者水平数据,这些试验探讨了CRT与非CRT的效果(BLOCK-HF、MIRACLE、MIRACLE-ICD、MIRACLE-ICD II、RAFT、COMPANION、MADIT-CRT和REVERSE)。既往有以下合并症病史:发作性或持续性心房颤动(n = 920)、冠状动脉疾病(n = 3732)、糖尿病(n = 2171)和高血压(n = 3353)。根据合并症的数量将患者分为三组:0、1-2或≥3。感兴趣的结果是全因死亡率的时间和心力衰竭住院(HFH)或全因死亡率综合结果的时间。使用贝叶斯层次威布尔生存回归模型对每个共病组的结果进行评估。6324名患者中,970名(15%)无合并症,4052名(64%)有1-2名,1302名(21%)有≥3名合并症。在整个队列中,CRT与非CRT对全因死亡率的校正危险比(aHR)为0.79(95%可信区间[CI]0.68-0.93)(p = 0.010);对于无合并症,aHR为0.54(95%CI 0.34-0.86),对于1-2个合并症为0.81(95%CI 0.67-0.97),对于≥3个合并症,a HR为0.83(95%CI 0.64-1.07)(CRT和合并症负担之间没有显著的相互作用:p = 0.13)。对于HFH或全因死亡率的终点,整个队列的aHR为0.74(95%CI 0.65-0.84)(p = 0.001),无合并症为0.69(95%CI 0.50-0.94),1-2合并症为0.77(95%CI 0.66-0.90),≥3合并症为0.62(95%CI 0.55-0.82)(CRT与合并症负担之间无显著交互作用:p = 0.081)。结论:在对八项主要试验的患者水平数据进行的荟萃分析中,所有证据表明,即使存在几种共病,CRT也能降低HFH和/或全因死亡率。临床试验注册:NCT00271154、NCT00251251、NCT00267098、NCT00180271。
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来源期刊
European Journal of Heart Failure
European Journal of Heart Failure 医学-心血管系统
CiteScore
27.30
自引率
11.50%
发文量
365
审稿时长
1 months
期刊介绍: European Journal of Heart Failure is an international journal dedicated to advancing knowledge in the field of heart failure management. The journal publishes reviews and editorials aimed at improving understanding, prevention, investigation, and treatment of heart failure. It covers various disciplines such as molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, clinical sciences, social sciences, and population sciences. The journal welcomes submissions of manuscripts on basic, clinical, and population sciences, as well as original contributions on nursing, care of the elderly, primary care, health economics, and other related specialist fields. It is published monthly and has a readership that includes cardiologists, emergency room physicians, intensivists, internists, general physicians, cardiac nurses, diabetologists, epidemiologists, basic scientists focusing on cardiovascular research, and those working in rehabilitation. The journal is abstracted and indexed in various databases such as Academic Search, Embase, MEDLINE/PubMed, and Science Citation Index.
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