PIHRATE Trial. Polish-Italian-Hungarian Randomized ThrombEctomy Trial. Dariusz Dudek MD, PhD. On behalf PIHRATE investigators

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1 Polish-Italian-Hungarian Randomized ThrombEctomy Trial PIHRATE Trial On behalf PIHRATE investigators Dariusz Dudek MD, PhD Institute of Cardiology, Krakow, Poland

2 Impact of distal embolization Distal embolization occurs in 15% patients after PCI Henriques et al. EHJ 2002;23:1112-7

3 Aim: Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction. Study design: Multicenter, prospective, non-blinded, randomized. Primary endpoint: ST resolution >70% 60 minutes after PCI.

4 Secondary endpoints Thrombectomy system efficacy: passing trough lesion with thrombus reduction followed by direct stenting ctfc: corrected TIMI frame count MBG 3: myocardial blush grade STR>70% immediately after PCI Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside Major adverse cardiac events (MACE): cardiac death, remi, repci/cabg CMR: measurement of left ventricular end-diastolic volume and end-systolic volume, ejection fraction, infarct size

5 Study design STEMI <6hr ST elevation >3 mm in one lead TIMI 0 or 1 TIMI. ctfc. MBG RANDOMIZATION Grup I THROMBECTOMY Grup II PREDILATATION TIMI 0 or 1 POBA STENTING TIMI. ctfc. MBG TIMI 2 or 3 DIRECT STENTING TIMI. ctfc. MBG TIMI. ctfc. MBG STENT IMPLANTATION TIMI. ctfc. MBG ST SEGMENT RESOLUTION 60 MINUTES AFTER PCI CK/CK-MB LEAK: every 6 hours for 24 hours CMR in the subgroup of patients EDV. ESV. mass and ejection fraction. delayed-contrast-enhancement 6 months follow up MACE: 30 day and 6 month follow up

6 Sample size calculation For primary endpoint assuming that patients from thrombectomy group will achieve >70% ST segment resolution 60 minutes after PCI in 65% and patient from control group achieve in 40%. For 80% test power and statistical significance level 0.05 to demonstrate such difference 70 patients in every group is needed. Due to some ECG which will not fulfill analysis criteria and to strength findings study groups will be enlarged to 100 patients per group.

7 PI: Dariusz Dudek Zabrze Silesian Center of Cardiology Gasior 33 Krakow University Hospital Mielecki 31 Rome Institute of Cardiology Burzotta 22 Nowy Sacz Cardiology Department Legutko 22 Warszawa Institute of Cardiology Witkowski 20 Genua Hospital Villascasi Rubartelli 17 Krakow John Paul II Hospital Zmudka 14 Przemysl Community Hospital Wisniewski 14 Katowice Silesian School of Medicine Ochala 13 Pecs Heart Institute Horvath 10

8 Study organization Study Coordination Angiographic CoreLaboratory ECG CoreLaboratory Krakow Cardiovacular Research Institute, Krakow, Poland. Krakow Cardiovacular Research Institute, Krakow, Poland. Silesian Center of Cardiology, Zabrze, Poland. NCT

9 Baseline characteristic Thrombectomy Predilatation p n Age 61 ± ± Male 79 % 81 % 0.7 CAD history 13 % 4 % 0.04 Previous infarction 2 % 0 % 0.17 Hypertension 58 % 54% 0.56 Smoking 63 % 63 % 0.9 Diabetes 12 % 10 % 0.5 Hyperlipidemia 42% 50 % 0.33 Family hist of CAD 33 % 26 % 0.28 Killip 1 Killip 2 Killip 3 Killip 4 83 % 15 % 2 % 0% 91 % 8 % 1 % 0% BP systolic 132 ± ± BP diastolic 81 ± ± HR 78 ± ±

10 Angiographic baseline characteristics 50,1% 10,7% Thrombectomy 38,2% IRA LAD Cx RCA p= ,2% Predilatation 12,9% 40,9% 30% 25% Small Thrombus Large Thrombus ~30% ~70% p=0.76 Thrombectomy Predilatation 20% 15% 10% TIMI Thrombus scale after wiring 5% 0%

11 Technical aspects Thrombectomy Predilatation p Stent implantation, % Direct stenting, % 75 5 < Stent diameter, mm 3.3 ± ± Stent length, mm 19.4 ± ± Max pressure, atm 14.8 ± ± Abciximab, %

12 DIVER CE Efficacy Successful thrombectomy & direct stenting 75% no lesion passing 2% no thrombus removal 7% no direct stenting 16%

13 Angiographic results Thrombectomy Predilatation p TIMI 3 baseline 0 % 2 % 0.07 TIMI 3 after thrombectomy/predilatation 54 % 63 % 0.33 TIMI 3 final 88 % 82 % 0.4 Thrombectomy Predilatation p ctfc baseline 99 ± 8 98 ± ctfc after thrombectomy/predilatation 44 ± ± ctfc final 28 ± ±

14 Primary Endpoint STR > 70% (60 minutes after PCI) 60% p= % 40% 30% 50% 41% Thrombectomy Predilatation 20% 10% 0%

15 Primary Endpoint STR > 70% (immediately after PCI) 60% 50% 40% 30% 20% 10% 0% 41% p= % Thrombectomy Predilatation

16 Secondary Endpoints Thrombectomy Predilatation STR 70% (immediately after PCI) 41% 27% MBG 3 76% 59% MBG 3 + TIMI 3 73% 56% 0.02 MBG 3 + STR 70% (immediately after PCI) 35% 12% MBG3 + STR>70% (60 min after PCI) 39% 24% MBG 3 + TIMI 3 +STR 70% (immediately after PCI) MBG 3 + TIMI 3 + STR>70% (60 min after PCI) 35% 12% % 22% 0.07

17 Periprocedural complications Thrombectomy Predilatation p Periprocedural complication 15.7% 22.6% 0.22 Distal embolisation 4.9% 5.4% 0.88 No-Flow / Slow-flow 9.8% 16.1% 0.18 Bail out IIb/IIIa 8% 10.5% 0.54 Adenosine / nitropruside 2.9% 8.6% 0.08

18 Six Month Follow Up 7% p=0.74 p=0.29 p=0.7 6,2% 6% 5% 5,0% 4% 3% 4,0% 3,1% 3,1% Thrombectomy Predilatation 2% 1% 1,0% 0% Death ReMI Death+ReMI

19 Conclusions In patients with STEMI with occluded infarct related artery simple thrombectomy and direct stenting provides better myocardial reperfusion than standard balloon predilatation followed by stent implantation. Aspiration thrombectomy and direct stenting is easy. safe and effective in STEMI patient with early presentation.

20 CAN WE HAVE A FLOW-CHART FOR THROMBUS-ASPIRATION USE? STEMI PT ARRIVES TO CATH LAB TIMI 0-1 GUIDEWIRE CROSSING OF CULPRIT LESION TIMI 2-3 See Flow See Thrombus Burden THROMBECTOMY SMALL THROMBUS-BURDEN LARGE THROMBUS-BURDEN TIMI 2-3 DIRECT STENTING SMALL-MID VESSEL LARGE VESSEL See culprit vessel NoTIMI 2-3 Small Balloon Predilatation THROMBECTOMY CONSIDER DISTAL PROTECTION or/and THROMBECTOMY with fragmentation (Spectranetics. AngioJet)?

21 Authors Dariusz Dudek Waldemar Mielecki Francesco Burzotta Mariusz Gasior Adam Witkowski Andrzej Ochala Paolo Rubartelli Ivan Horvath Roman M. Wojdyla Michal Hawranek Piotr Buchta Jerzy Pregowski Daniel Aradi Jacek Legutko Krzysztof Zmudka