Key result
Patients excluded from DAVIT II had an 18-month mortality of 25.6%, while non-consenters had similar mortality to placebo patients (15.0% vs 13.85%; adjusted HR 1.09; P=0.60).
Cohort (n=3,077)
Patients excluded from the DAVIT II trial had a substantially higher 18-month mortality rate (25.6%) than trial placebo recipients (13.85%), primarily driven by heart failure and other severe comorbidities, whereas non-consenters had mortality similar to the placebo group.
Excluded patients show high mortality from comorbidities; leaves open whether verapamil benefits extend beyond lower-risk trial participants.
The 18 month mortality rate in 2180 patients excluded from the Danish Verapamil Infarction Trail II (DAVIT II) was 25.6%. In non-consenters (n = 368) this was 15.0% compared with 13.85 in 897 placebo-treated patients (hazard ratio 1.09 [P = 0.60] when adjusting for sex and age). The increased mortality rate in excluded patients is attributed to heart failure (45.8%) and other severe diseases (38.9%).
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Jan Kyst Madsen (1993) conducted a cohort in Myocardial infarction (n=3,077). Trial exclusion / non-consent to DAVIT II vs. Placebo-treated trial participants was evaluated on 18-month mortality (HR 1.09, p=0.60). Patients excluded from DAVIT II had an 18-month mortality of 25.6%, while non-consenters had similar mortality to placebo patients (15.0% vs 13.85%; adjusted HR 1.09; P=0.60).
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