Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the results of a patient-level meta-analysis that confirms the safety profile of its Stellarex drug-coated balloon (DCB) at four years. Including data from two major randomized controlled trials (RCTs), the results show no difference in mortality between patients treated with the Stellarex DCB and those treated with percutaneous angioplasty (PTA), the current standard of care. The meta-analysis, which represents the highest level of the evidence pyramid, was presented at the virtual 2020 Vascular Interventional Advances conference (VIVA20).
The meta-analysis found that over four years, there was no significant difference in survival among patients treated with the Stellarex DCB (85.7%) compared to those treated with PTA (85.6%). The data includes two Stellarex RCTs: the ILLUMENATE EU RCT and the ILLUMENATE Pivotal RCT, comprised of 589 patients in the U.S. and Europe followed up to four years with a high compliance on vital status data.
“The meta-analysis reinforces previously presented results from the ILLUMENATE RCTs, demonstrating low mortality rates each year through four years, with no difference in rates between the two patient cohorts,” said Sean Lyden, MD, Chairman of the Department of Vascular Surgery, Cleveland Clinic (U.S.), who presented the data. Dr. Lyden is also co-Primary Investigator for the ILLUMENATE Pivotal trial, one of the two RCTs included in the meta-analysis, and a paid consultant to Philips. “This independent, patient-level meta-analysis continues to provide consistent, long-term data for a large group of patients.”
In addition to demonstrating no significant difference in all-cause mortality between patients treated with the Stellarex DCB and those treated with PTA (14.3% vs. 14.4%), the results of the meta-analysis also show no difference in cardiovascular mortality (3.6% vs. 4.0%) and non-cardiovascular mortality (10.8% vs. 10.9%).
