Third-Party Evaluation Confirms Safety Profile of Philips' Stellarex 0.035-Inch, Low-Dose, Paclitaxel-Based DCB

October 1, 2019—Royal Philips announced results from third-party analyses of patient-level data from worldwide clinical trials of the company’s paclitaxel-based Stellarex .035-inch, low-dose, drug-coated balloon (DCB). The analyses were performed by Syntactx, a United States–based contract research organization. William A. Gray, MD, et al published the findings in Circulation (2019;140:1145–1155).

The company stated that the primary analysis examined the 3-year patient-level data from the ILLUMENATE pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT), which together included a total of 589 patients. Of these patients, 419 were treated with the Stellarex DCB to restore and maintain blood flow to above-the-knee (ATK) arteries and 170 patients were treated with an uncoated percutaneous transluminal angioplasty (PTA) balloon, the current standard of care.

Only 2.3% of patients in the pivotal study and 3.7% of patients in the EU RCT study were lost to follow-up within the respective 3-year follow-up windows. The additional analysis comprised the two Stellarex DCB RCTs in addition to the four Stellarex DCB single-arm studies in the meta-analysis, including 2,495 patients with peripheral artery disease, of which 2,325 were treated with Stellarex DCB to restore and maintain blood flow to ATK arteries.

According to the company, the primary safety analysis demonstrated that there is no difference in mortality between patients treated with Stellarex DCB and uncoated PTA through 3 years. It also identified no device-related deaths and no correlation of Stellarex DCB to late all-cause mortality. These findings were confirmed and reinforced by the additional analysis.

Sean Lyden, MD, Coprimary Investigator for the ILLUMENATE pivotal trial and senior author of the safety manuscript, commented in Royal Philips’s announcement, “This manuscript further substantiates the results presented earlier this year at the 2019 Leipzig Interventional Course in Leipzig, Germany. The systematic analysis included a robust statistical method to ensure we could pool the individual patient data from the trials in order to enhance the accuracy of the results.”

Dr. Gray, added, “After a careful, detailed, and appropriately directed analysis of the controlled data available from the Stellarex suite of studies, we have a robust assessment of the patient-level outcomes related to the Stellarex drug-coated balloon. We are confident in the finding of no difference in mortality rates between patients treated with Stellarex and those treated with PTA.”

Philips advised that as the study sponsor, the company was involved in study design and data collection but was not involved in the analysis or interpretation of data. Dr. Lyden and Dr. Gray have consulting relationships with Philips but have not received financial compensation from Philips in connection with their role in this analysis.

The company also noted that the results of this study, combined with the 3-year efficacy data presented by S. Jay Mathews, MD, at the New Cardiovascular Horizons 20th annual conference held May 29–31, 2019, in New Orleans, Louisiana, confirm the safety and performance of the Stellarex low-dose DCB.