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Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial

BMJ open, 2021-10, Vol.11 (10), p.e049017-e049017 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2021 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2021-049017 ;PMID: 34706949

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  • Title:
    Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial
  • Author: Howell, Stacey ; Stivland, Timothy M ; Stein, Kenneth ; Ellenbogen, Kenneth ; Tereshchenko, Larisa G
  • Subjects: adult cardiology ; Autoimmune diseases ; Body mass index ; Cardiomyopathy ; Cardiovascular Medicine ; Chronic obstructive pulmonary disease ; Diabetes ; Gender differences ; Heart failure ; Heart rate ; Hospitalization ; Hypertension ; Ischemia ; Kidney diseases ; Laboratories ; Mens health ; pacing & electrophysiology ; Population ; Probability ; Regression analysis ; Sensitivity analysis ; Sleep apnea ; Statistical analysis ; statistics & research methods ; Ultrasonic imaging ; Women ; Womens health
  • Is Part Of: BMJ open, 2021-10, Vol.11 (10), p.e049017-e049017
  • Description: ObjectivesThere is a controversy about whether both sexes’ response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.DesignSecondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.SettingThe SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.ParticipantsThe SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m2) were included.InterventionsImplanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed.OutcomeA composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.ResultsThe primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.ConclusionsBoth sexes’ response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes.Trial registration numberClinicalTrials.gov Identifier; NCT00677014.
  • Publisher: London: British Medical Journal Publishing Group
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2021-049017
    PMID: 34706949
  • Source: ProQuest One Psychology
    BMJ Open Access Journals
    GFMER Free Medical Journals
    PubMed Central
    ROAD: Directory of Open Access Scholarly Resources
    ProQuest Central
    DOAJ Directory of Open Access Journals
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