PCI Outcomes Differ in Clinical Trials vs Reality

Surgeon reaching for tools

When performing percutaneous coronary interventions (PCIs)- nonsurgical procedures that open blocked blood vessels to the heart- stents can be inserted into a blood vessel via an artery in the groin or wrist.

Clinical trials have shown that PCIs utilizing wrist access may result in fewer complications, which can shorten the length of the post-procedure hospital stay. As wrist access procedures cost less than groin access, wrist access PCIs have largely been encouraged. In a study in the Journal of the American Statistical Association, assistant professor in the Department of Population Health at NYU School of Medicine Samrachana Adhikari, PhD, associate professor of health care policy (biostatistics) Sherri Rose, PhD, and S. James Adelstein Professor of Health Care Policy (Biostatistics) Sharon-Lise T. Normand, PhD point out that the experience of actual patients can vary from what is shown in clinical trials.

Using data from a state-mandated clinical registry, the study team employed a hierarchical Bayesian likelihood-based instrumental variable analysis under a latent index modeling framework to examine the outcomes of each PCI procedure, as well as the difference in effectiveness between male and female patients.

The study team found that as in clinical trials, patients who received wrist access PCIs had reduced post-procedure hospitalization times compared to those who underwent groin access PCIs. The wrist access patients had lower amounts of major bleeding and in-hospital complications. While clinical trials have shown that wrist access PCIs are more effective in female patients, the study found a reduction in complications for more male patients than female after the procedure.