Atrium Medical Corporation is proud to announce the release of the interim results of the “COCTAIL Study.” Dr. Francesco Prati of San Giovanni Hospital and the European Imaging Laboratory in Rome, Italy presented the interim results of the COCTAIL Study at the recent C3 cardiology meeting in Baltimore, Maryland and at the EuroPCR 2009 cardiology meeting in Barcelona, Spain. The interim results demonstrated that super selective intracoronary infusion of Abciximab* through the ClearWay™ RX Local Therapeutic Infusion Catheter significantly reduced thrombus burden as measured by OCT (Optical Coherence Tomography) while local guide catheter infusion did not.
The COCTAIL Study is a multi-centered, randomized, controlled clinical trial comparing local coronary administration of Abciximab through a guide catheter compared with local coronary administration of Abciximab using the ClearWay™ RX Local Therapeutic Infusion Catheter. The primary objective is to verify whether intracoronary (IC) ClearWay™ infusion of Abciximab is capable of reducing thrombus burden by 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 micro circulation post intervention by measuring corrected TIMI Frame Count (cTFC) and Myocardial Blush Grade.
The study will enroll a total of 50 patients. The current interim results presented are for the first 48 patients. Thirty-nine had evaluable OCT scans, 19 in the ClearWay™ RX group and 20 in the guide catheter group.
The primary endpoint demonstrated ClearWay™ RX significantly reduced the thrombus score by over 35% (p = 0.0015) while local guide catheter infusion only reduced the thrombus burden by 3.7% (p = ns). There was a statistically significant improvement in the Corrected TIMI Frame Count (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 < 0.05). The ClearWay™ RX infusion group had more patients reach Myocardial Blush Grade of 3, while the overall Myocardial Blush Grade showed a trend toward improvement in the ClearWay™ RX group that was not statistically significant. Another interesting finding from the interim results was the ClearWay™ RX group post intervention had a percentage (%) Diameter Stenosis of 5.9% vs 11.9% for the Guide Catheter group (p = 0.015).
The findings are very exciting and this treatment strategy will be further tested in a large multi-centered, randomized, controlled trial known as INFUSE AMI (Principal Investigator – Gregg Stone, MD, Co-Principal Investigator – C. Michael Gibson, MD).
Disclaimer: ClearWay™ RX is manufactured & distributed by Atrium Medical and is indicated for localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.
*Abciximab (Reopro) is indicated as an adjunct to PCI for the prevention of cardiac ischemic complications: In patients undergoing PCI and in patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours.
Source: Atrium Medical