RESET: No survival benefit of CRT-defibrillator over CRT-pacemaker in heart failure

In patients with heart failure (HF) and an indication for cardiac resynchronisation therapy (CRT), patients who had a CRT-defibrillator (D) device did not show a survival benefit over patients who had a CRT-pacemaker (P) device. The results of the observational part of the RESET-CRT project further warrant the ongoing randomised part of the RESET-CRT project comparing CRT-D and CRT-P devices in patients with HF.

“Should patients with HF and an indication for CRT receive a defibrillator?” asked Prof. Nikolaos Dagres (Heart Center Leipzig, Germany) [1,2]. Since the risk of sudden cardiac death in this population has decreased in recent years due to improved medication, this issue has come into question [2]. The existing evidence on this topic is conflicting. A post-hoc analysis of the COMPANION trial (NCT00180258) suggested that CRT-D reduced all-cause mortality compared with CRT-P in patients with non-ischaemic cardiomyopathy (NICM) [3]. In contrast, a subgroup analysis of the DANISH trial (NCT00542945) did not display a benefit of CRT-D over CRT-P in patients with NICM [4]. A head-to-head trial comparing these devices was needed.

The RESET-CRT project includes a randomised clinical trial comparing CRT-D and CRT-P in patients with HF and an indication for CRT, and a retrospective observational part, mimicking the randomised trial. Prof. Dagres presented the results of the observational part, in which 847 patients with a CRT-P device and 2,722 patients with a CRT-D device were analysed [1,5]. All-cause mortality was the primary outcome of the study.

Baseline characteristics revealed a mean age difference of approximately 7 years between participants with CRT-P devices (76.7 years) and participants with CRT-D devices (69.9 years). Furthermore, patients with CRT-P devices were less often men (52% vs 65%) and were more likely to have atrial fibrillation (59% vs 41%), reflecting the situation in clinical practice.

After a median follow-up of 2.4 years, the non-adjusted analysis showed a reduced mortality rate in patients with CRT-D devices compared with those with CRT-P devices (24% vs 19%; HR 1.63; P<0.001) (see Figure). However, the age-adjusted analysis demonstrated no survival benefit of CRT-D over CRT-P (HR 1.13; P=0.165). Further adjustment for prognostic factors and comorbidities established that CRT-D did not outperform CRT-P in this population (HR 0.99; P=0.89).

Figure: Difference in all-cause death between CRT-P and CRT-D: unadjusted and adjusted results [1,2]



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reprinted from Hadwiger M, et al. Eur Heart J, Apr 3 2020. DOI: 10.1093/eurheartj/ehac053 under the terms of the Creative Commons CC BY-NC 4.0.

“After adjustment for age and comorbidities, we observed no survival difference between CRT-D and CRT-P, justifying the need for the randomised part of the RESET-CRT trial, which will provide a head-to-head comparison between the 2 devices,” concluded Dr Dagres.

1. Dagres N, et al. Survival of cardiac resynchronization therapy patients with and without defibrillator: Real-world evidence from the observational part of the RESET-CRT project. Late-breaking science 1, EHRA 2022, 3–5 April, Copenhagen, Denmark.
2. Barra S, et al. Eur Heart J. 2020;41:1976‒1986.
3. Doran B, et al. JACC: Heart Failure. 2021;9(6):439‒449.
4. Kober L, et al. N Engl J Med 2016;375:1221‒1230.
5. Hadwiger M, et al. Eur Heart J. Apr 3, 2022. DOI: 10.1093/eurheartj/ehac053.

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Posted on 1 June 202213 June 2022