Abstract:
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Propensity score method is widely used in the medical device trial design utilizing historical controls as the least burden approach when abundant historical data are available. In this real world data application, the propensity score quintile approach is utilized to assess the balance of the pre-specified baseline parameters in a stent trial to evaluate the Dual Anti-Platelet Therapy (DAPT) duration effect on clinical outcomes. The trial design will be presented and adjusted baseline variables will be compared between the test and historical control groups, specifically, the subject demographics, clinical history, risk factor, and pre-procedure lesion characteristics will be assessed before and after the propensity score adjustment without assessing the outcome data.
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