Stratified treatment of myocardial infarction with non-obstructive coronary arteries: the PROMISE trial.

The DSMB recommended to stop the trial enrolment on the basis of: (i) clear benefit in the primary endpoint in the ‘stratified treatment’ arm (observed difference in SAQSS between groups was highly significant [ t = 7.25, P < .0001], with the corresponding Z -score [6.42] exceeding the O’Brien–Fleming boundary [Z = 2.74], confirming the robustness of the result and a low risk of false-positive conclusion due to interim testing); (ii) a numerically higher rate of MACE in the ‘standard of care’ arm; (iii)

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Angina-free patients at 12 months were 64 (71.1%) in the overall population, with a borderline significance for a higher number of patients angina-free in the stratified treatment group compared with the standard of care group of [36 (80.0%) vs 28 (62.2%), P = .06, respectively].

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