Thrombus Aspiration before PCI: Routine Mandatory. Professor Clinical Cardiology Academic Medical Center University of Amsterdam

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1 Seoul, 27 April TCT AP 2010 Thrombus Aspiration before PCI: Routine Mandatory Robbert J de Winter MD PhD FESC Professor Clinical Cardiology Academic Medical Center University of Amsterdam AMC Amsterdam Interventional Cardiology

2 Case # 1: male, 43 yrs Hypertension, Smoking, Positive family history No prior cardiac history Morning run 10 miles without complaints Chest pain while cooling down Sweating, nausea, near fainting AMC Amsterdam Interventional Cardiology

3 Thrombectomy in primary PCI Male 43 yrs Acute ischemia Urgent CAG - heparin 75IU/kg - aspirin iv -clopidogrel l - abciximab AMC Amsterdam Interventional Cardiology

4 Thrombectomy in primary PCI Male 43 yrs Acute ischemia Urgent CAG - heparin 75IU/kg - aspirin iv -clopidogrel l - abciximab AMC Amsterdam Interventional Cardiology

5 Thrombectomy in primary PCI Male 43 yrs Acute ischemia Urgent CAG - heparin 75IU/kg - aspirin iv -clopidogrel l - abciximab AMC Amsterdam Interventional Cardiology

6 Result after thrombectomy AMC Amsterdam Interventional Cardiology

7 Thrombectomy in primary PCI Result after 5 days -UFH i.v. - ASA - Clopidogrel AMC Amsterdam Interventional Cardiology

8 Case # 1: male, 43 yrs Anterior AMI Large thrombus burden Thrombectomy effective (no additional stenting) in addition to anti-platelet and anti-thrombotic Rx AMC Amsterdam Interventional Cardiology

9 Rationale of Thrombectomy and Embolic Protection ppci preferred treatment in STEMI 85% - 93% restoration epicardial flow Frequent suboptimal myocardial perfusion Distal embolization Slow flow / no-reflow Microvascular obstruction Occurring in up to 33% of patients Reduction of thrombus burden and distal embolization may improve microvascular perfusion, reduce infarct size and possibly clinical outcome AMC Amsterdam Interventional Cardiology

10 Academic Medical Center Amsterdam Interventional Cardiology KOCH Euro PCR 2009

11 Treatment of STEMI Why has it been so difficult to demonstrate beneficial effects of thrombus aspiration? Academic Medical Center Amsterdam Interventional Cardiology KOCH Euro PCR 2009

12 30-day mortality and stroke rate after reperfusion therapy 12 P< % NS % 9.6% 96% 9.6% 9.9% P= % 63% 6.3% 65% 6.5% P= % % 0.79% % 1.26% 1.19% 139% 1.39% 155% 1.55% Placebo SK SK ASA rt-pa ASA APSAC ASA SK ASA SQ Hep Acc t-pa ASA IV Hep 1.98% Lytic 0.70% PTCA GISSI-1, ISAM GISSI-2, ISIS-2 ISIS-3 n= n= Academic Medical Center Amsterdam Interventional Cardiology GUSTO-1 n= Weaver et al. n=2.600 KOCH Euro PCR 2009

13 Treatment of STEMI A randomized controlled trial demonstrating a significant reduction in mortality of adjuvant treatment in primary PCI in STEMI, with conventional ppci 30-day mortality ~4%, would require > 2000 patients Evidence largely based on meta-analyses Academic Medical Center Amsterdam Interventional Cardiology KOCH Euro PCR 2009

14 Rationale of Thrombectomy and Embolic Protection Smaller studies underpowered for clinical endpoints Surrogate endpoints associated with outcome Measures of incomplete reperfusion Distal embolization TIMI-grade flow post PCI Myocardial Blush Grade MBG ST-recovery Infarct size Myocardial salvage AMC Amsterdam Interventional Cardiology

15 Thrombectomy and Embolic Protection Devices Distal embolic protection devices Proximal embolic protection devices Thrombus aspiration catheters Mechanical Non-manual (vacuum) Manual Academic Medical Center Amsterdam Interventional Cardiology KOCH Euro PCR 2009

16 Thrombectomy, but not distal protection, reduce no-reflow as compared to standard PCI Endpoint: ST-resolution

17 Burzotta et al. Eur Heart J 2009;30:

18 Burzotta et al. Eur Heart J 2009;30:

19 Burzotta et al. Eur Heart J 2009;30:

20 Meta-analysis MBG 0-1 Tamhane et al. BMC Cardiovasc Disord 2010;10:10 AMC Amsterdam Interventional Cardiology

21 Meta-analysis TIMI-3 flow Tamhane et al. BMC Cardiovasc Disord 2010;10:10 AMC Amsterdam Interventional Cardiology

22 Meta-analysis Mortality Tamhane et al. BMC Cardiovasc Disord 2010;10:10 AMC Amsterdam Interventional Cardiology

23 mary PCI uring prim ombus as spiration d Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) Thr F. Zijlstra, MD PhD Thoraxcenter University Medical Center Groningen, The Netherlands University Medical Center Groningen FZ

24 uring prim mary PCI Thr ombus as spiration d 535 were assigned to thrombus aspiration i 33 did not undergo PCI 502 underwent primary PCI 295 underwent TA followed by direct stenting 153 underwent TA with additional balloon dilation 54 had crossover to conventional PCI 1071 STEMI patients randomized 536 were assigned to conventional PCI 33 did not undergo PCI 503 underwent primary PCI 485 underwent balloon dilation followed by stenting 12 underwent conventional PCI with additional TA 6 had crossover to TA 530 complete follow-up at 1 year 530 complete follow-up at 1 year University Medical Center Groningen FZ

25 uring prim mary PCI Thr ombus as spiration d Primary endpoint: Myocardial blush grade Patie ents (%) / P < Thrombus aspiration Conventional PCI University Medical Center Groningen Svilaas T et al. NEJM 2008;358:557 - FZ

26 uring prim mary PCI Thr ombus as spiration d Patie ents (%) ST-segment elevation resolution P < < 30% % > 70% Thrombus aspiration Conventional PCI University Medical Center Groningen Svilaas T et al. NEJM 2008; FZ

27 uring prim mary PCI Thr ombus as spiration d Morta ality (% %) 10 Mortality at 1 year 12 Conventional PCI Thrombus-Aspiration Log-Rank p = University Medical Center Groningen Time (days) *Unpublished results

28 Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing with Direct Stenting Alone in Patients with Acute Myocardial Infarction: the JETSTENT trial David Antoniucci on behalf of the JETSTENT Investigators

29 Study Design Pts with STEMI admitted within 12 hours from symptom onset Lysis Stroke < 30 days Surgery < 6 weeks Pre-stented t IRA After angiography and IRA wiring: thrombus grade 3 to 5 Randomization 1:1 N = 500 Direct Stenting (DS) Rheolytic Thrombectomy +DS

30 Technique for AngioJet Use and DS Single pass anterograde technique (activate AngioJet proximal to thrombus) Angiographic g check after first AngioJet pass. Temporary pacemaker strongly discouraged. Balloon pre-dilation strongly discouraged. DS had to be attempted in all cases in both arms. Routine Abciximab in both arms.

31 Surrogate Endpoints RT DS p value n=246 n=240 STR 50% at 30 min 211 (85.8) 189 (78.8).043 n=217 n=208 Infarct Size (%) 11.8 [ ] 12.7 [ ].398 n=252 n=241 Final TIMI 3 flow 203 (80.6) 207 (85.9).113 n=228 n=216 ctfc 20 [ ] 20 [ ].357 n=215 n=211 Blush grade (8) 11 (5) 2 43 (20) 33 (16) (72) 167 (79)

32 6-Month Outcome RT DS

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34 upgrade of the recommendation for PCI in unprotected left main disease from a class III to a class IIb indication. the use of aspiration thrombectomy in primary PCI. IIa, LOE B CCI on line; 18 november 2009

35 Thrombus Aspiration in the SCAAR registry Frobert et al. Int J Cardiol 2010;145:572-3 AMC Amsterdam Interventional Cardiology

36 Thrombus Aspiration in the SCAAR registry N = N = 4212 Frobert et al. Int J Cardiol 2010;145:572-3 AMC Amsterdam Interventional Cardiology

37 Thrombus Aspiration Trials in Progress AMC Amsterdam Interventional Cardiology

38 Thrombectomy and Embolic Protection Devices Distal embolic protection devices? Proximal embolic protection devices?? Thrombectomy catheters Mechanical Non-manual (vacuum)?? Manual?!! Academic Medical Center Amsterdam Interventional Cardiology KOCH Euro PCR 2009

39 Paris, 28 mei, EuroPCR 2010 Should we perform Thrombus Aspiration in all STEMI Patients undergoing primary PCI? YES AMC Amsterdam Interventional Cardiology

40 Thank You AMC Amsterdam Interventional Cardiology

41 AMC Amsterdam Interventional Cardiology

42 AMC Amsterdam Interventional Cardiology