Study Presented at CIRSE Explores Impact of Severe Calcification on Outcomes Following Stellarex DCB

September 27, 2018—Fabrizio Fanelli, MD, EBIR, shared results from a study seeking to determine the impact of severe calcification and 12-month outcomes of femoropopliteal disease treatment using the Stellarex drug-coated balloon (DCB) (Philips) during the late-breaking trials session at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Lisbon, Portugal. Key among the results were similar outcomes when using the device in severely calcified lesions versus those without severe calcium.

Dr. Fanelli is Director of the Vascular and Interventional Radiology Department at Careggi University Hospital in Florence, Italy, and a leading expert in the study of the effects of calcium in peripheral artery disease (PAD) and its treatment. At CIRSE, he detailed the nature of calcification and its demographic prevalence, as well as early findings regarding DCB efficacy in these lesions. Despite the research to date and rise in the use of DCBs, the impact of calcium on their performance is still not fully defined and understood, Dr. Fanelli noted. Additionally, multiple publications studying the effects of calcium in PAD (including his own 2014 paper) each define its severity in different ways, making comparisons and pooling challenging.

Against this backdrop, Dr. Fanelli presented a post hoc pooled analysis of 571 patients from two prospective studies involving the Stellarex DCB—ILLUMENATE Global (full cohort of the single-arm study) and ILLUMENATE Pivotal (DCB arm of the randomized trial). Both studies included independent core lab and clinical event adjudication with prospective definitions of severe calcification.

The pooled 12-month outcomes of the studies showed remarkably similar rates of freedom from the primary safety event, which was defined in this study as a composite of freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven TLR through 12 months postprocedure (93% for nonseverely calcified vs 93% for severely calcified, respectively), 12-month major adverse events (7.3% vs 7.8%), clinically driven target lesion revascularization (TLR) (7% vs 7%), and all TLR (8% vs 8.3%). Primary patency rates by Kaplan-Meier analysis were similar, although higher in nonseverely calcified patients (82.9% vs 80%).

Procedurally, longer predilatation pressures and durations were seen in the severely calcified group (9.5 atm/lesion; 3.9 min/lesion vs 8.8 atm/lesion; 3.4 min/lesion, respectively). The rate of bailout stenting was also similar, but lower in the severely calcified group (12.7%) than the nonseverely calcified group (13.5%).

Dr. Fanelli summarized the results of the analysis as demonstrating similar 12-month outcomes using the Stellarex device in severely and nonseverely calcified lesions. The study also confirms previous understanding regarding the patients in whom severe calcium is most likely to be present: those with diabetes, hypertension, hyperlipidemia, coronary artery disease, and renal insufficiency. Success in treating severe calcification requires "longer and stronger" inflation, which in this study enabled similar rates of bailout stenting between the two cohorts, concluded Dr. Fanelli.