Sep 18 2014
The Spectranetics Corporation today announced that Eric Dippel, MD, at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, presented findings from the EXCITE ISR clinical trial proving Spectranetics' laser atherectomy devices, used with PTA (also known as balloon angioplasty), are clinically superior to PTA alone in both safety and efficacy, triggering a new standard in cardiovascular care.
Eric Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, presented the EXCITE ISR data as part of TCT's Late-Breaking Clinical Trials. TCT is the only platform for first-time presentations of primary endpoint or important secondary endpoint results of prospective, randomized clinical trials with significant impacts in medical treatment. Critical data findings include:
- 93.5% procedural success rate using Turbo-Tandem with PTA (also known as balloon angioplasty) vs. 82.7% with PTA alone (p = 0.01).
- Primary safety endpoint, MAE rates at 30 days 5.8% vs. 20.5% with PTA alone (p < 0.001).
- Primary efficacy endpoint, 73.5% freedom from target lesion revascularization (TLR) at 6 months vs. 51.8% with PTA alone (p < 0.005).
- Excimer laser atherectomy with adjunctive PTA was associated with a 52% reduction in TLR (Hazard Ratio 0.48; 95% CI 0.31 – 0.74).
- Dissection rate of 7.7% vs. 17.2% with PTA alone (p = 0.03).
- Bailout stenting 4.1% vs. 11.1% with PTA alone (p = 0.05).
- There was no procedurally related stent damage observed in either cohort.
Notably, the study's average lesion length was approximately 20 cm as compared to various stent IDE studies with average lesion lengths of 4 to 6 cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating many types of ISR lesions, including the most complex cases.
The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (arteries above the knee) In-Stent Restenosis (EXCITE ISR) is the first large multi-center, prospective randomized trial ever conducted for the treatment of FemPop ISR. In July, Spectranetics received a U.S. Food and Drug Administration (FDA) 510(k) indication of its peripheral atherectomy products, Turbo-Tandem™ and Turbo-Elite™, to treat ISR. Other products are not indicated or contraindicated to treat ISR, uniquely positioning Spectranetics to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.
"Over 200 million people worldwide are afflicted with Peripheral Artery Disease" said Scott Drake, President and CEO of Spectranetics. "This year alone, as many as 400,000 patients around the world will receive stent implants to restore the flow of blood due to complications of the disease. An estimated 30% to 40% of those with stents will develop restenosis. These numbers – as well as patient demand – will continue to grow. The EXCITE trial produced the data that proved safety and efficacy of laser atherectomy to respond to this growing demand."
Once ISR develops, there is a 65% chance of recurrence after treatment with PTA. Each year, up to 250,000 people suffer from ISR globally.
Lead EXCITE ISR investigator Eric Dippel, MD, states, "When it comes to patient care, physicians demand proven results that exhibit superior outcomes, with safety and efficacy as a priority. With 73.5% freedom from TLR at six months versus 51.8% with PTA alone, the data tells the story. The EXCITE results demonstrate that Spectranetics has set a new standard of care for ISR."
Implanting stents to open obstructed blood vessels is an important treatment for patients suffering PAD. While stents deliver improved overall outcomes compared to Percutaneous Transluminal Angioplasty (PTA) treatment, restenosis (a return of the blockage) is very common, and stent re-obstruction or ISR remains therapeutically challenging.
Source: http://www.spectranetics.com/