Two-Year Results Presented for Spectranetics' Stellarex in the Direct DCB Cohort of ILLUMENATE FIH Trial

November 2, 2015—Prakash Krishnan, MD, presented 2-year data from the ILLUMENATE first-in-human study, which was designed to assess the safety and effectiveness of the Stellarex drug-coated balloon (DCB, Spectranetics Corporation) to inhibit restenosis in the femoropopliteal artery in the treatment of peripheral artery disease. The data were revealed during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

The background of the trial is that the necessity or additional benefit of predilation of a target lesion with an uncoated angioplasty catheter before use of a DCB is unknown. Most studies assessing the effectiveness of DCBs for the treatment of peripheral artery disease have required predilatation of the target lesion with an uncoated angioplasty balloon before use of the DCB. 

As summarized at VIVA, the study was composed of two sequentially enrolled cohorts. Lesions in the first 50 patients were treated with traditional predilatation with an uncoated angioplasty balloon before inflation of the Stellarex DCB. The subsequent 30 patients were enrolled into the direct cohort. Within the direct cohort, the mean age was 65.7 years, and 53.6% of patients presented with diabetes. The mean lesion length was 6.4 cm; 48.6% were calcified and 5.4% were occluded. Postdilatation was needed more frequently in the direct cohort (35.1% vs 12.1%; P = .01), as was the use of stents (8.1% vs 5.2%; P = .67). 

Dr. Krishnan reported that late lumen loss at 6 months was .03 mm, demonstrating a good drug effect of Stellarex in the absence of predilatation. Functional outcome improvements, such as walking distance, were similar between groups and sustained through 2 years. Per Kaplan-Meier analysis, primary patency at 1 year (day 365) and 2 years (day 730) was 86.2% and 78.2%, respectively. Rates of freedom from clinically driven target lesion revascularization were 85.4% and 81.7%, respectively. These rates were not statistically different as compared to the predilatation cohort.

These data suggest that Stellarex is effective without predilatation in noncomplex disease. Furthermore, the outcomes are in alignment with the durable outcomes observed in the predilatation cohort, concluded Dr. Krishnan at VIVA.