80 likes | 240 Views
MASTER Trial Inclusion Criteria. Prior MI LVEF ≤ 30% ≥ 18 years of age. MASTER Trial Overview. Enrollment (n=654) Baseline Clinical Data, MTWA Testing, ICD Implant. 35 w/o valid MTWA test 44 w/ other exclusion. Clinical follow-up every 6 months (Minimum F/U 2 years).
E N D
MASTER Trial Inclusion Criteria Prior MI LVEF ≤ 30% ≥ 18 years of age
MASTER Trial Overview Enrollment (n=654) Baseline Clinical Data, MTWA Testing, ICD Implant 35 w/o valid MTWA test 44 w/ other exclusion Clinical follow-up every 6 months (Minimum F/U 2 years) Repeat MTWA testing every 12 months Analysis cohort (n=575)
MTWA Testing Cambridge Heart CH2000 or Heartwave Treadmill exercise recommended method MTWA tests interpreted by Core Lab, blinded to patient characteristics and outcomes Protocol required repeat testing of all MTWA indeterminates (unless medical justification supplied) MTWA positive and indeterminate combined (“non-negative”) for primary outcome analysis
Baseline MTWA Classification 68 293 214
Primary Endpoint Events LTVTE HR = 1.26, CI = 0.76-2.09, p = 0.37
MTWA and Total Mortality Total Mortality HR = 2.04, CI = 1.10-3.78, p = 0.02
Conclusions • In ICD treated patients with prior MI and LVEF ≤ 30%, LTVTE does not differ according to MTWA classification. • However, total mortality is higher in MTWA non-negative patients.
Study Implications • MTWA testing should not be used to withhold device therapy in MADIT-II indicated patients. • The biological explanation(s) for excess mortality in non-negative MTWA patients requires further study.