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An optimal medical therapy for efficient cardiovascular protection in subjects with coronary artery diseases in Japan: Comparisons and analyses by quasi-randomized controlled trials with propensity score matching and inverse probability treatment weighting methods for a Japanese cohort

: Background: Optimal medical therapy (OMT) may play an important role in preventing secondary events in coronary artery diseases (CAD) and peripheral artery diseases (PAD). However, few practical pharmaceutical evidence-based regimens are available for patients with CAD and PAD to prevent secondary cardiovascular events due to practical reasons for performing clinical trials using the OMT regimen. Methods: To elucidate OMT for subjects with prior cardiovascular diseases in Japan, we performed a quasi-randomized clinical trial using statistically sophisticated propensity score matching and subsequent inverse probability treatment weighting methods to test which combination of medicines was most effective as OMT to prevent secondary cardiovascular events. Two hundred and sixty-one subjects who were admitted in our hospital were consecutively enrolled. We constructed the Cox models for the composite of death, myocardial infarction, stroke, ad-mission for heart failure, and target region revascularization. Results: On multivariable inverse probability of treatment-weighted Cox modeling, the best combination was antiplatelet agents, statins, and calcium channel blockers (CCBs) to prevent major adverse cardiac events (MACE) in patients with CAD in Japan, and significant effects were found in the new OMT group for both MACE and cardiovascular death. In contrast, we could not find any significantly effective combinations in patients with PAD. Conclusions: These findings suggested that the multiple medical regimen including antiplatelet agents, statins, and CCBs, which might be prescribed as new OMT, has significant effects for the prevention of secondary events in patients with CAD in Japan.