ACI London Thrombectomy in STEMI. is the evidence clear? Brad Higginson International marketing manager

Transcription

1 ACI London 2010 Thrombectomy in STEMI is the evidence clear? Brad Higginson International marketing manager

2 Options for Management of Thrombotic Lesions Pharmacologic Therapies Embolic Protection Devices Filters Balloon Occlusion Mechanical Thrombectomy Devices Rheolytic thrombectomy (AngioJet) Aspiration Thrombectomy Devices Dr. Bruce Brodie LeBauer Heart, North Carolina

3 AngioJet history Over ½ million treated WW Cumulative Catheters Sold 500,000 6,53815,238 31,19656, ,610 89, , , , , , ,745 FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY 2010

4 AngioJet technology review

5 CFD analysis mechanical vs aspiration

6 OCT aspiration vs mechanical thrombectomy

7 Practice guidelines and devices

8 Is a Class 1, Level A guideline attainable? Challenging the Class one distinction? TAPAS Bias between treatment arms AiMI AngioJet in Myocardial Infarction Mortality endpoint TIMI 3 flow baseline imbalance between treatment arms

9 TAPAS New England Journal of Medicine (NEJM)

10 TAPAS NEJM Conclusion Thrombus aspiration is applicable in a large majority of patients with myocardial infarction with ST-segment elevation, and it results in better reperfusion and clinical outcomes than conventional PCI, irrespective of clinical and angiographic characteristics at baseline.

11 TAPAS NEJM, respective caveats Small thrombus burden 49% 44% Thrombectomy was primary procedure 90% Predilation was primary procedure 00% 96%

12 New England Journal of Medicine Dr. Vetrovec editorial

13 NEJM technique editorial Dr. Vetrovec summarized Some operators believe that direct stenting without multiple balloon inflations reduces the risk of distal emboli. The majority of patients in the conventional-pci group had balloon angioplasty followed by stenting, which might have increased the relative incidence of embolization in the conventional-pci group.

14 AiMI not our best effort

15 30 Day MACE 10 Angiojet Control n=240 n= P= % P= % % 0% 0% 1.7% 0.8% 2.1% 0.4% 1.7% Death Q wave MI Stroke TLR Total

16 AngioJet for STEMI Cindy L. Grines, M.D. William Beaumont Hospital Royal Oak, Michigan

17 AiMI Control Arm Mortality is Far Lower than in the Meta-Analysis PCI Arm There is extremely low, p=0.0007, chance that a new PCI trial would observe mortality of 0.8% or less AiMI PCI Arm is an outlier, extreme observation, or in the tail, as compared to the body of PCI evidence (N=124 Study Arms)

18 Is a Class 1, Level A guideline attainable? Better science TAPAS 2 JETSTENT Thrombus caveats Large vs Small Fresh vs Organized Platelet rich versus Fibrin rich

19 Thrombus burden re-defined

20 Thrombus burden Harvard style

21 When to use DES in AMI Georgios Sianos, MD, PhD, FESC Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands

22 DES IRA Stent Thrombosis Independent predictor HR 95% CI P value Stent Thrombosis Presentation bifurcational stenting <0.001 Rheolytic Thrombectomy Large Thrombus burden <0.001

23 Large thrombus burden impact (LTB) eorgios Sianos, MD, PhD, FESC

24 JetStent JACC, 2010 LTB predictive!

25 LTB and JetStent study JACC 2010 Pts with STEMI admitted within 12 hours from symptom onset Lysis Stroke < 30 days Surgery < 6 weeks Pre-stented IRA After angiography and IRA wiring: thrombus grade 3 to 5 Randomization 1:1 N = 500 Rheolytic Thrombectomy + DS Direct Stenting (DS) Journal of the American College of Cardiology, Volume 56, Issue 16, 12 October 2010, Pages Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, Renato Valenti, Guido Parodi, Franz- Josef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators

26 Predictors of ST-Segment Resolution and 1-Year MACE 30 min ST Reduction 50% OR 95%CI p value Randomization to RT Anterior AMI <.001 Final TIMI 3 flow year MACE HR 95%CI p value Randomization to RT Age (yrs) Bleeding Journal of the American College of Cardiology, Volume 56, Issue 16, 12 October 2010, Pages Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, Renato Valenti, Guido Parodi, Franz- Josef Neumann, Antonio Colombo, David Antoniucci and JETSTENT Trial Investigators

27 TCT 2010 symposium - publication Classify Thrombus Grade Balloon Predilation Discouraged Dual Thrombectomy Recommendation

28 STEMI protocol recommendation Aspiration AngioJet