Study Suggests ACC’s NCDR Registry Data Could Support Clinical Trials

June 21, 2021—The American College of Cardiology (ACC) announced the publication of a study showing that data captured in ACC's National Cardiovascular Data Registry (NCDR) suite of cardiovascular data registries are similar in quality, depth, and granularity when compared to data captured through clinical trials. This is good news for streamlining data collection and supports recent efforts to standardize data elements and definitions used in clinical trials and registries, stated ACC.

Data from the DAPT study were compared to data from the NCDR CathPCI registry. The study was published by Neel M. Butala, MD, et al in ACC’s JACC: Cardiovascular Interventions (2021;14:1386-1388).

According to ACC, the investigators linked a group of DAPT study patients to the NCDR CathPCI registry and compared data elements for the same patients. All patients receiving percutaneous coronary intervention 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.

ACC reported that 5,743 (65%) of the 8,864 DAPT study patients were successfully matched to data in the CathPCI registry. There was strong agreement with many data elements, including demographics and procedural characteristics. For some previous history and risk factors, there was more modest agreement. For clinical presentation, agreement was poor. Most notably, the investigators found angina was more likely to be classified as unstable in the CathPCI registry versus the DAPT study.

As noted in the ACC press release, 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. The primary limitations of the study were the inability to link all patients. Additionally, it is not known how these results would have fared for other clinical trials.

The study’s senior investigator is Robert W. Yeh, MD, Director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

“We found an overall high level of similarity in data between these two sources,” commented Dr. Yeh in the ACC announcement. “This suggests that registries may also be suitable to support baseline data collection for many clinical studies. 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.”

Additionally, Dr. Yeh advised, “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.”