Data captured in a segment of the National Cardiovascular Data Registry (NCDR) registry suite is similar in quality, depth, and granularity to data captured in clinical trials, research in JACC: cardiovascular interventions compared the data from the Dual Antiplatelet Therapy (DAPT) study with the data from the NCDR CathPCI registry. This is good news for streamlining data collection and supports recent efforts to standardize data items and definitions used in clinical trials and registries.
“We found that the data between these two sources was very similar overall. This suggests that registries may also be useful in assisting basic data collection for many clinical trials, ”said lead study author Robert W. Yeh, MD, MSc, 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. “The ability to use existing registries to provide data for clinical trials has the potential to significantly increase the efficiency of conducting these important studies and reduce costs.”
The researchers linked a group of patients from the DAPT study to the NCDR CathPCI registry and compared data items for the same patients. All patients who received percutaneous coronary intervention (PCI) with drug-eluting stents that were randomized in the DAPT study and linked to the CathPCI registry were included. Baseline patient and procedural characteristics were compared using data collected by two methods: reports submitted by investigators in the DAPT study and site-based data submitted to the CathPCI registry.
Of the 8,864 patients in the DAPT study, 5,743 (65%) were successfully compared with the data in the CathPCI registry. There was a strong match on many elements of the data, including demographics and procedural characteristics. There was a more modest agreement for some history and risk factors, and the agreement was poor for clinical presentation. According to the researchers, angina in particular was classified as more unstable in the CathPCI registry than in the DAPT study.
The results suggest that the data from the CathPCI registry could be used to support future clinical trials, thereby reducing the effort involved in data collection for the sites participating in the trials and the registry. However, variables that could be viewed as more subjective, such as clinical presentation, would likely need to be defined more precisely. Future studies using the CathPCI registry would also need to ensure that the key data elements are appropriate to answer the most important study questions.
“Whether these results generalize to other types of data in the CathPCI registry or other clinical registries is unknown and remains a rich area for future investigation,” said Yeh. “Overall, however, the data are encouraging as they indicate an important mechanism that makes clinical trials more feasible, less expensive, and helps overcome one of the biggest barriers to clinical research.”
The main limitations of the study were the inability to link all patients. In addition, it is unknown how these results would have been for other clinical studies.
Edited by Gary Cramer