Lessons Learned and Insights Gained in the Design, Analysis, and Outcomes of the COMPANION Trial

Bristow, Michael R.; Saxon, Leslie A.; Feldman, Arthur M.; Mei, Chaoqun; Anderson, Susan; DeMets, David L.

doi:10.1016/j.jchf.2016.02.019

Cited by 14 publications

(12 citation statements)

References 46 publications

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“…However, the efficacy of ICD therapy remained statistically significant even if COMPANION was excluded—that is, even after removing all CRT-D patients. Recently, a comparison of the effect of CRT-D with CRT-P (on top of medical therapy) from the COMPANION trial was published18 : the HR for all-cause death was 0.84 (95% CI 0.65 to 1.09); for cardiovascular death it was 0.73 (95% CI 0.55 to 0.98); and for sudden death it was 0.37 (95% CI 0.21 to 0.65). It is instructive to compare these findings with the DANISH trial, where the background use of CRT-P was frequent.…”

Section: Resultsmentioning

confidence: 99%

Non-ischaemic cardiomyopathy, sudden death and implantable defibrillators: a review and meta-analysis

Beggs

Jhund

Jackson

et al. 2017

Heart

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Non-ischaemic cardiomyopathy, sudden death and implantable defibrillators: a review and metaanalysis. Heart, (doi:10.1136/heartjnl-2016-310850) This is the author's final accepted version.There may be differences between this version and the published version. You are advised to consult the publisher's version if you wish to cite from it.http://eprints.gla.ac.uk/145793/ Methods A systematic search for studies that examined the effect of ICDs on outcomes in NICM was performed. Our analysis compared patients randomised to an ICD with those randomised to no ICD, and examined the endpoint of overall mortality.Results Six primary prevention trials and two secondary prevention trials were identified that met the pre-specified search criteria. Using a fixed-effects model, analysis of primary prevention trials revealed a reduction in overall mortality with ICD therapy (RR 0.76, 95% CI 0.65-0.91).Conclusions Although our updated meta-analysis demonstrates a survival benefit of ICD therapy, the effect is substantively weakened by the inclusion of DANISH -which is both the largest and most recent of the analysed trials -indicating that the residual pooled benefit of ICDs may reflect the risk of sudden death in older trials which included patients treated sub-optimally by contemporary standards. As such, these data must be interpreted cautiously. The results of DANISH emphasise that there is no 'one size fits all' indication for primary prevention ICDs in NICM patients, and clinicians must consider age and comorbidity on an individual basis when determining whether a defibrillator is appropriate. 5 KEY QUESTIONSWhat is already known about this subject?Evidence for a mortality benefit with implantable cardiac defibrillators in patients with nonischaemic cardiomyopathy has always been less robust than for patients with ischaemic cardiomyopathy, depending on a meta-analysis of trials which, individually, did not show a statistically significant benefit. The results of the recent DANISH trial suggested that ICDs may not reduce overall mortality in the modern era. What does this study add?Our meta-analysis and critical review provides an update in this field. Although a mortality benefit of defibrillators in NICM patients is still apparent in our pooled analysis, careful interpretation of these data suggest that the neutral result of DANISH may more accurately reflect the utility -or relative lack therein -of ICDs in the modern era. In part, this is because contemporary heart failure therapy reduces both sudden cardiac death and death from worsening heart failure, thus making an additional beneficial effect of defibrillator therapy on overall mortality harder to demonstrate. Closer analysis of DANISH suggests that younger patients with little co-morbidity may still benefit from an ICD, at least in the medium-term when their functional limitation is not severe.

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Section: Resultsmentioning

confidence: 99%

Non-ischaemic cardiomyopathy, sudden death and implantable defibrillators: a review and meta-analysis

Beggs

Jhund

Jackson

et al. 2017

Heart

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“…We can speculate that this is mainly due to healthcare organization, reimbursement, and budget restrictions [ 17 – 19 ]. However, this is in compliance with the new cohort studies and meta-analysis on sudden cardiac death (SCD) in HF population, which stress the importance of pharmacological therapy and CRT-P in SCD prevention [ 20 – 22 ]. Even stricter adherence to guidelines is notable when the patient selection is closely studied: majority have nonischemic aetiology of HF, 80% complete LBBB, two-third QRS >150 ms, and less than 25% were > 75 years old.…”

Section: Discussionmentioning

confidence: 62%

“…Even stricter adherence to guidelines is notable when the patient selection is closely studied: majority have nonischemic aetiology of HF, 80% complete LBBB, two-third QRS >150 ms, and less than 25% were > 75 years old. All aforementioned are the significant predictors of good CRT response and better long-term clinical outcome [ 1 – 3 , 6 – 8 , 20 – 22 ]. This kind of selection from HF population with a CRT indication is presumably caused by limited budget.…”

Section: Discussionmentioning

confidence: 99%

“…In Croatia, although procedures did not last significantly longer than the European average, most patients had the LV lead positioned laterally, which is the golden standard, but not easily achievable [ 1 – 3 , 24 , 25 ]. Moreover, this could explain the very narrow postprocedural QRS in Croatian patients, significantly narrower in comparison with the European counterparts, which is a predictor of clinical outcome, but could also explain higher incidence of coronary sinus dissection [ 2 , 3 , 22 – 25 ]. Procedures were mostly done in the catheterization laboratory, probably influenced by organizational characteristics of implanting centres.…”

Section: Discussionmentioning

confidence: 99%

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Croatian National Data and Comparison with European Practice: Data from the Cardiac Resynchronization Therapy Survey II Multicenter Registry

Brusich

Zeljković

Pavlović

et al. 2018

Cardiology Research and Practice

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Aims The Cardiac Resynchronization Therapy (CRT) Survey II was conducted between October 2015 and December 2016 and included data from 11088 CRT implantations from 42 countries. The survey's aim was to report on current European CRT practice. The aim of this study was to compare the Croatian national CRT practice with the European data. Methods Five centres from Croatia recruited consecutive patients, in a 15-month period, who underwent CRT implantation, primary or an upgrade. Data were collected prospectively by using online database. Results A total of 115 patients were included in Croatia, which is 33.2% of all CRT implants in Croatia during the study period (total n=346). Median age of the study population was 67 (61–73) years, and 21.2% were women. Primary heart failure (HF) aetiology was nonischemic in 61.1% of patients, and HF with wide QRS was the most common indication for the implantation (73.5%). 80% of patients had complete left bundle branch block, and over two-third had QRS ≥150 ms. Device-related adverse events were recorded in 4.3% of patients. When compared with European countries, Croatian patients were significantly younger (67 vs. 70 years, p=0.012), had similar rate of comorbidities with the exception of higher prevalence of hypertension. Croatian patients significantly more often received CRT-pacemaker when compared with European population (58.3 vs. 29.9%, OR 3.27, 95%CI 2.25–4.74, p < 0.001). Conclusion Our data indicate strict selection of patients among HF population and adherence to guidelines with exception of higher proportion of CRT-pacemaker implantation. This is likely to be influenced by healthcare organization and reimbursement issues in Croatia.

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“…In this context, recent analysis of patients receiving the most optimal medical therapy in COMPANION yields a salient observation [ 43 • ]. Across the entire trial cohort, the reductions in ACM with CRT-D and CRT-P when each was compared to CMT were 36% and 24% respectively (CRT-D vs CMT: HR 0.64, 95%CI 0.48–0.86; CRT-P vs CMT: HR 0.76, 95% CI 0.57–1.01).…”

Section: Who Benefits From a Primary Prevention Defibrillator?mentioning

confidence: 99%

Who Benefits From a Defibrillator—Balancing the Risk of Sudden Versus Non-sudden Death

Beggs

Gardner

McMurray

2018

Curr Heart Fail Rep

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Purpose of ReviewTreatment with a defibrillator can reduce the risk of sudden death by terminating ventricular arrhythmias. The identification of patient groups in whom this function reduces overall mortality is challenging. In this review, we summarise the evidence for who benefits from a defibrillator.Recent FindingsRecent evidence suggests that contemporary pharmacologic and non-defibrillator device therapies are altering the potential risks and benefits of a defibrillator.SummaryWho benefits from a defibrillator is determined by both the risk of sudden death and the competing risk of other, non-sudden causes of death. The balance of these risks is changing, which calls into question whether historic evidence for the use of defibrillators remains robust in the modern era.

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Lessons Learned and Insights Gained in the Design, Analysis, and Outcomes of the COMPANION Trial

Cited by 14 publications

References 46 publications

Non-ischaemic cardiomyopathy, sudden death and implantable defibrillators: a review and meta-analysis

Non-ischaemic cardiomyopathy, sudden death and implantable defibrillators: a review and meta-analysis

Croatian National Data and Comparison with European Practice: Data from the Cardiac Resynchronization Therapy Survey II Multicenter Registry

Who Benefits From a Defibrillator—Balancing the Risk of Sudden Versus Non-sudden Death

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