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. 2023 Jul 27;120(7):e20230303. [Article in Portuguese] doi: 10.36660/abc.20230303

Table 7.2. – Results of clinical studies with cardiac resynchronization therapy according to gender.

Study N of patients Inclusion criterion Randomization HR of events (95%; P value)
COMPANION2
  • Men: 1025 (67%)

  • Women: 495 (33%)

  • LVEF ≤ 35%

  • NYHA III-IV

  • QRS ≥ 120ms

ODT vs ODT + CRT-D HR for death: men: 0.63 (0.4-0.9) women: 0.58 (0.25-1.13)
CARE-HF3
  • Men: 597 (73%)

  • Women: 216 (27%)

  • LVEF ≤ 35%

  • NYHA III-IV

  • QRS ≥ 130ms

  • LVEDV ≥ 300ms

ODT vs ODT + CRT HR for death or cardiac hospitalization: men: 0.62 (0.49-0.79) women: 0.64 (0.42-0.97)
MADIT CRT4
  • Men: 1367 (75%)

  • Women: 453 (25%)

  • LVEF ≤ 30%

  • NYHA II-III

  • QRS ≥ 120ms

ICD vs CRT-D HR for HF or death: men: 0.76 (0.59-0.97) women: 0.37 (0.22-0.61)
RAFT5
  • Men: 1490 (83%)

  • Women: 308 (17%)

  • LVEF ≤ 30%

  • NYHA II-III

  • QRS ≥ 130ms

ICD vs CRT-D HR for death or HF hospitalization: men: 0.82 (0.7-0.95) women: 0.52 (0.35-0.85)
REVERSE6
  • Men: 479 (78.5%)

  • Women: 131 (21.5%)

  • LVEF < 40%

  • NYHA I-II

  • QRS > 120ms

CRT-on vs CRT-off HR composite clinical outcome: men: 0.69 (0.43-1.11) women: 0.75 (0.26-2.19)
MIRACLE7
  • Men: 216 (67%)

  • Women: 107 (33%)

  • LVEF < 35%

  • NYHA III-IV

  • QRS > 130ms

CRT-on vs CRT-off NYHA. quality of life. exercise capacity; women, but not men, with CRT experienced longer times for first HF hospitalization or death (p = 0.157)

CRT: cardiac resynchronization therapy; CRT-D: cardiac resynchronization therapy with defibrillator; HF; heart failure; HR: hazard ratio; ICD: implantable cardioverter defibrillator; LVEDV: left ventricular end-diastolic volume; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association;ODT: optimized drug therapy; vs: versus.