Data captured in NCDR registries may be similar in quality, depth and granularity when compared to data captured through clinical trials, according to research published June 21 in JACC: Cardiovascular Interventions that compared data from the DAPT study to ACC's CathPCI Registry data.

Neel M. Butala, MD, et al., linked a group of DAPT study patients to the CathPCI Registry and compared data elements for the same patients. All patients receiving PCI with drug-eluting stents randomized in the DAPT study who could be linked to the CathPCI Registry were included. Baseline patient and procedural characteristics were compared using data collected by two methods: reports submitted by DAPT study investigators and site-reported data submitted to the CathPCI Registry.

Out of 8,864 DAPT study patients, 5,743 (65%) were successfully matched to data in the CathPCI Registry. There was strong agreement with many data elements, including demographics and procedural characteristics. For some prior history and risk factors, there was more modest agreement and agreement was poor for clinical presentation. According to the researchers, most notably, angina was more likely to be classified as unstable in the CathPCI Registry vs. the DAPT Study.

The results suggest that CathPCI Registry data could be used to support future clinical trials, decreasing the burden of data collection on sites participating in both trials and the registry. However, variables that could be considered more subjective, such as clinical presentation, would likely need to be defined more precisely. Future trials leveraging the CathPCI Registry would also need to ensure that the key data elements are suitable to answer key trial questions.

"Being able to leverage existing registries to provide data for clinical trials has the potential to greatly enhance the efficiency and lower the costs of conducting these important studies," adds Robert W. Yeh, MD, MSc, FACC, senior study author. "Whether these findings generalize to other types of data in the CathPCI Registry or other clinical registries is unknown and remains a rich area for future inquiry. Overall, however, the data are promising in pointing to an important mechanism to make clinical trials more feasible and less costly, helping to overcome one of the most significant barriers to clinical research."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: National Cardiovascular Data Registries, CathPCI Registry, Drug-Eluting Stents, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention, Research Design, Risk Factors, Data Collection, Demography

< Back to Listings