Spectranetics Achieves Statistical Endpoints of EXCITE ISR Adjunct Analysis
February 24, 2014—Spectranetics Corporation (Colorado Springs, CO) announced that the EXCITE ISR trial achieved the statistical endpoints of the adjunct analysis. The trial evaluates laser atherectomy plus percutaneous transluminal angioplasty (PTA) compared with PTA alone for the treatment of in-stent restenosis (ISR) in patients with peripheral artery disease.
Spectranetics advised that it anticipates submitting the 510(k) application to the US Food and Drug Administration (FDA) in the next 45 days. FDA review of a 510(k) application with clinical data takes an average of five months, noted the company.
The EXCITE adjunct analysis was approved by the FDA in May 2013. The analysis allowed for multiple interim data analyses during the randomized trial. Statistical success was achieved based on enrollment of 250 patients at 35 sites across the United States.
Spectranetics stated that the EXCITE ISR trial was designed to enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 treatment to control. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from target lesion revascularization (TLR) through 6 months. The primary safety endpoint is 30-day freedom from major adverse events, including all-cause mortality, major amputation in the target limb, or TLR. The goal of the adjunct analysis plan was to demonstrate statistically significant clinical superiority of laser atherectomy plus PTA compared with PTA alone prior to full enrollment of the EXCITE ISR trial.
Freedom from TLR at 6 months was hypothesized to be 70% in the laser atherectomy-plus-PTA arm and 53% for the PTA-alone arm to prove statistical superiority. This benchmark was exceeded, which demonstrated early success.
In the company’s press release, EXCITE ISR’s Primary Investigator, Eric J. Dippel, MD, commented, “EXCITE is a landmark randomized, controlled trial that represents a major step forward in treating patients with ISR. This is a very large patient population that has suffered from insufficient, unproven treatment for too long.”
The trial’s largest enroller, Satyaprakash Makam, MD, added, “Many ISR patients are in poor health. Stent replacement is not an option, and balloon angioplasty sometimes lasts just weeks. The data from this trial has the power to change clinical practice and improve patient care in this challenging disease state.”