BVS Uptake Decreased Following Release of Adverse Events Data
NCDR Study Looks at Real-World Implications of ABSORB II and III Trials
There was a "modest" uptake of bioresorbable vascular scaffolds (BVS) in PCI procedures in the 90 days after the U.S. Food and Drug Administration (FDA) approved the device, followed by a decline when new data reported negative outcomes, according to a study published May 8 in JAMA Cardiology.
Katherine Hsin-Yu Chau, MD, et al., used data from ACC's CathPCI Registry to examine patterns in BVS uptake after FDA approval and changes in uptake following the release of new adverse event data and FDA warnings. The primary outcome was monthly use of BVS among all PCI procedures. Researchers also looked at characteristics of patients who received a BVS and of hospitals that used the device.
Of 682,951 PCI procedures, BVS was used in 4,265 (0.6 percent) procedures after FDA approval. Younger patients, men and those with fewer comorbidities were more likely to receive a BVS. At the hospital level, 337 CathPCI Registry sites (20.5 percent) used BVS implants. The device was more common at hospitals with higher annual PCI volumes and among urban, public or teaching hospitals. Among hospitals that used BVS, the device was used in a median of 1.42 percent of monthly PCI procedures.
Results showed that within 90 days of FDA approval, there was "modest growth" in BVS use to 703 (1.25 percent) of 56,430 PCI procedures. However, BVS use decreased following the release of the ABSORB II trial, which revealed safety concerns. There was a larger decline in BVS use after the release of ABSORB III trial, which included additional safety concerns, and was accompanied by a FDA safety warning.
According to the researchers, the "slow update of BVS after a highly anticipated approval suggests that most physicians and hospitals exercised initial caution in using the device." The results "illustrate an example of an appropriate physician response to adverse data updates and FDA warnings," they conclude.
The study is part of ACC's Research to Practice (R2P) initiative, which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC's NCDR clinical registries.
Keywords: Absorbable Implants, United States Food and Drug Administration, Registries, National Cardiovascular Data Registries, CathPCI Registry, Percutaneous Coronary Intervention
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