Twelve-Month ILLUMENATE Global Study Results Published for the Stellarex DCB
December 11, 2017—The final 12-month results from the ILLUMENATE Global study were published by Herman Schroë, MD, et al online ahead of print in Catheterization and Cardiovascular Interventions (CCI). In January, the data were presented by Professor Thomas Zeller, MD, at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.
The prospective, multicenter, single-arm study evaluated the safety and performance of the Stellarex drug-coated balloon (DCB; Spectranetics, a Philips company) for treatment of femoropopliteal artery disease.
As summarized in CCI, patients in the ILLUMENATE Global study were treated with the Stellarex DCB for intermittent claudication or ischemic rest pain caused by superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD). The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤ 2.5 or clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months.
The investigators reported that 417 lesions were treated in 371 patients, with mean lesion length of 7.5 ± 5.3 cm; 40.8% of lesions were severely calcified per core laboratory fluoroscopic criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4%, and the freedom from CD-TLR rate was 94.8% at 365 days per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.
The ILLUMENATE Global study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes of the Stellarex DCB, concluded the investigators in CCI.