748 patients undergoing percutaneous coronary intervention or elective catheterisation in nine USA centres were assigned in a 2×2 factorial randomisation either off-site prayer by established congregations of various religions or no off-site prayer (double-blinded) and MIT therapy or none (unmasked). The primary endpoint was combined in-hospital major adverse cardiovascular events and 6-month readmission or death. Prespecified secondary endpoints were 6-month major adverse cardiovascular events, 6 month death or readmission, and 6-month mortality.
371 patients were assigned prayer and 377 no prayer; 374 were assigned MIT therapy and 374 no MIT therapy. The factorial distribution was: standard care only, 192; prayer only, 182; MIT therapy only, 185; and both prayer and MIT therapy, 189. No significant difference was found for the primary composite endpoint in any treatment comparison. Mortality at 6 months was lower with MIT therapy than with no MIT therapy (hazard ratio 0·35 (95%CI 0·15–0·82, p=0·016).
Neither masked prayer nor MIT therapy significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.