Comparing PCSK9 Monoclonal Antibody Treatment Strategies Following Myocardial Infarction Using Negative Control Outcomes: A Target Trial Emulation Study.

Challenge

Real-world comparative effectiveness of PCSK9 inhibitor treatment strategies following MI had not been established using rigorous causal methods that account for dynamic treatment decisions and unmeasured confounding.

Solution

Target RWE researchers applied negative control outcomes within a target trial emulation framework to compare PCSK9 monoclonal antibody treatment strategies in post-MI patients, leveraging NCOs to assess confounding control before estimating effectiveness.

Impact

Demonstrating valid real-world comparative effectiveness of PCSK9 inhibitors following MI using NCO gating and target trial emulation provides pharma partners with regulatory-credible evidence for this high-value cardiovascular indication.