Improving outcome of STEMI PCI: Preliminary Results of Crystal AMI trial Rajesh M. Dave, MD Principal investigator on behalf of Crystal AMI Investigators Harrisburg, PA Disclosure Atrium Medical: Consultant, Research support, Training and speaking Honorarium Eli Lilly: Speaker Honorariums Background Distal embolization of atherothrombotic material remains a significant challenge during STEMI PCI Consequences: No Reflow, Poor TIMI and MBG grade, Higher MACE, Late ST if DES placed on thrombus Long term mortality is higher in patients with large degree of distal embolization Aspiration thrombectomy has shown improvement in MBG grades, however, it is not universally effective Hence, new modalities to address thrombus burden are investigated Many studies have demonstrated benefit of IC Abciximab- reduce no reflow, infarct size, Improved TIMI flow and Blush Scores Is the myocardial blush grade scored by the operator during primary percutaneous coronary intervention of prognostic value in patients with ST elevation myocardial infarction in routine clinical practice? N= 2,118 consecutive STEMI patients One Year Mortality in Primary PCI TIMI Flow: Blush Scores: 0 I II III 46.3% 25% 8.4% 6.6% 24.0 9.7 5.8% 4.3% Despite TIMI-3 Flow, Normal Blush in ONLY 45% Myocardial Blush Grade: Mortality in pts. w/TIMI-3 Flow P value: < .001 0 I II III 17% 10 6% 4% Normal epicardial flow does not necessarily correlate with normal Perfusion. Microvascular dysfunction caused by embolization, likely results in impaired myocardial perfusion. Kampinga MA, Nijsten MWN, Gu YL, et al. Circ Cardiovasc Interv. 2010;3:216-223. Meta Analysis of IC Versus IV Abciximab administration of peer reviewed studies (N=2,301) 997 STEMI, 1304 NSTEMI Hansen et al. Journal of Invasive Cardiology Vol 22; 6. June 2010. 278-282. IC Abciximab delivery with ClearWay™ Therapeutic Drug Delivery Balloon: Concept ClearWay™ Drug Delivery Balloon: Allows super-selective IC delivery of Abciximab in higher concentration versus IV Superiority to Guide catheter Abciximab delivery: Prevents loss of drug in aorta, no wire exchange needed Higher residence time of drug allows expression of disaggregating and anti- inflammatory properties of Abciximab 1 Hypothesis: Delivery of IC Abciximab with ClearWay™ leads to better ST resolution, higher MBG, Improved TIMI flow and smaller Infarct size than IV Abciximab during STEMI PCI CRYSTAL AMI: Pilot proof of concept trial, not powered to show statistical differences 1. Prati et al., COCTAIL Study, JACC, 2010. CRYSTAL AMI: Study Design Single center, prospectively randomized STEMI within 6 hours, Heparin, 600mg Clopidogrel (n=50) R 1:1 IV Abciximab ClearWay™ IC Abciximab PCI as per standard of care, Evaluate MBG, TIMI flow, ST Resolution, LV Function at Discharge 30 day follow up, Echo, Resting Sestamibi Demographics Treatment arm N=48 IC =25 IV=23 Male/Female M=23, F=2 M=18, F=5 Age 62 + 25 65 + 23 HTN 14 14 Angina 5 2 CHF 1 0 Prior PCI 6 2 CABG 3 1 DM 8 6 Lipids 14 9 Smoking C=9, F=2 C=6, F=0 Manual/Mechanical Extraction catheter use (discretion of operator) (n = 25) (n = 23) TIMI Flow Comparison in first 48 patients 1 5 3 96% TIMI Flow 3 82% 2 1 3 24 19 2 1 0 16 17 4 1 IC TIMI Pre IC TIMI Post (n = 25) IV TIMI Pre IV TIMI Post (n = 23) Primary Endpoint: TIMI Myocardial Blush Grade (MBG) >2 scores comparison in first 48 patients 92% of IC versus 86% of IV patients MBG 0 1 92% 7 3 18 1 2 2 86% 12 2 1 17 0 18 8 5 1 3 1 IC Blush Pre (n = 25) IC Blush Post IV Blush Pre IV Blush Post (n = 23) MBG 3 and ST Resolution Rates comparison 21 80% 18 18 70% 72% 12 52% IC Abciximab IV Abciximab (n = 25) (n = 23) MBG 3 ST Resolution In Tapas, MBG 3 was only achieved in 45% of patients in extraction arm (identical to IV Abciximab group), but was directly linked to 5 times increase in mortality. IC Abciximab Administration through ClearWay™ has resulted in 72% of patients leaving the lab with a blush score of 3. Clinical Outcomes IC IV Readmissions 0 2 Death 0 1 50yomale with Anterior STEMI ClearWay 1.5X20 Abciximab bolus Flow restored after ClearWay Xience V Stent Reinsertion of ClearWay for Localized Nipride administration Conclusions IC Abciximab super-selective delivery is safe and effective delivered via ClearWay™ drug delivery balloon, and produced higher MBG scores (more achieved MBG 3 75% vs 45% ) and trend towards higher STSegment resolution (80% vs 70% ns) • This study supports the findings of previous study such as TAPAS, where MBG of 3 was achieved in only 45% of patients receiving aspiration catheter and IV Abciximab. • An equal number of patients received manual thrombus aspiration in each study arm (65%) suggesting a synergistic effect with IC Abciximab super- selective delivery with ClearWay™