To round off late-breaking clinical trial coverage from TCT 2014, here's one last trial with exciting results (no pun intended). The EXCITE-ISR trial compared treatment options for femoropopliteal (fem-pop) in-stent restenosis (ISR). The treatment options: the use of the excimer laser atherectomy (ELA) with percutaneous transluminal angioplasty (PTA) versus PTA alone. Now, this is another trial, like RIBS IV, that appears very intuitive that ELA with PTA will, of course, provide the better results. But as we saw with the RIBS IV trial results, science can surprise us sometimes. Were we surprised for a second time at TCT. Not with these trial results.
Results from the EXCITE-ISR trial demonstrated that ELA with PTA is indeed more effective that PTA alone for treating ISR for the fem-pop indication. Primary efficacy data demonstrated that over 20% more patients in the ELA with PTA study arm experienced freedom from clinically driven target vessel revascularization after 6 months compared to the PTA only study arm. More impressive was the primary safety endpoint data almost 95% of patients treated with ELA and PTA experienced freedom from a major adverse event at 30 days versus less than 30% of patients treated with PTA alone. Furthermore, patient enrollment in the trial was reduced due to the early statistical significance of data.
What do these trial results mean for patients, Atherectomy devices became the first FDA-approved device for ISR treatment in July 2014. The use of two atherectomy devices in addition to a PTA balloon for ISR treatment in 80% of patients will mean significantly higher costs and increased time spent on the procedure. However, with favorable reimbursement for atherectomy procedures in the United States, it is likely that doctors will gradually start supplementing ISR procedures with atherectomy in patients who seem at greater risk for recurring ISR.