Atrium's ClearWay RX Study Presented
July 15, 2009—Atrium Medical Corporation (Hudson, NH) announced that Francesco Prati, MD, presented interim results from the COCTAIL study on the performance of the company's ClearWay RX local therapeutic infusion catheter at the C3/Capital Cardiovascular Conference held June 14 through 17 in Baltimore, Maryland, and at the EuroPCR 2009 meeting held May 17 through 22 in Barcelona, Spain. ClearWay RX is indicated for localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.
Atrium stated that the COCTAIL study is a multicenter, randomized, and controlled clinical trial. COCTAIL compared local coronary administration of abciximab (ReoPro, Eli Lilly and Company, Indianapolis, IN) through a guide catheter, with local coronary administration of abciximab using the ClearWay RX. The primary objective is to verify whether intracoronary (IC) ClearWay infusion of abciximab is capable of reducing thrombus burden by optical coherence tomography (OCT) as compared to traditional IC guide catheter infusion. The secondary objective is to address whether the administration of abciximab by IC ClearWay RX, as compared to IC guide catheter delivery, can improve macro- and microcirculation postintervention by measuring corrected TIMI frame count (cTFC) and myocardial blush grade.
The current interim results are for the first 48 patients. The study will enroll a total of 50 patients. Of the first 48 patients, 39 had evaluable OCT scans, 19 in the ClearWay RX group and 20 in the guide catheter group. The interim results demonstrated that super-selective intracoronary infusion of abciximab through the ClearWay RX catheter significantly reduced thrombus burden as measured by OCT, whereas local guide catheter infusion did not.
According to the company, the primary endpoint demonstrated that ClearWay RX significantly reduced the thrombus score by more than 35% (P = .0015), whereas local guide catheter infusion only reduced the thrombus burden by 3.7% (P = NS). There was a statistically significant improvement in the cTFC in the ClearWay RX infusion group compared to the guide catheter infusion group. The ClearWay RX infusion group had an average cTFC of 15.75 versus 20.75 for the guide catheter infusion group (P < .05). The ClearWay RX infusion group had more patients reach a myocardial blush grade of 3, whereas the overall myocardial blush grade showed a trend toward improvement in the ClearWay RX group that was not statistically significant. Additionally, the interim results after intervention showed that the ClearWay RX group had a diameter stenosis of 5.9% versus 11.9% for the guide catheter group (P = .015).
The company advised that these findings and this treatment strategy will be further tested in a large, multicenter, randomized, controlled trial known as INFUSE AMI with Principal Investigator Gregg Stone, MD, and Coprincipal Investigator C. Michael Gibson, MD.