SHA24/075005

DES are Indicated in All STEMI Patients Pro Tarek Kashour, MBChB, FRCPC, FACC King Khalid University Hospital Riyadh, Saudi Arabia

Meta-Analysis of Stent vs POBA in Primary PCI 25

P<0.001 Stent Stent

22.5% P<0.001

POBA 20

18.7%

15 %

13.3%

9.2% 10

P=0.22 5

3.7%

P=0.13 3.6%

2.9% 2.1%

0

Death

Re-Infarction

1 Stent vs Balloon

TVR

MACE

Zhu et al, Am J Cardiol 2001

Manual Thrombus Aspiration is Indicated in All STEMI Patients Pro Tarek Kashour, MBChB, FRCPC, FACC King Khalid University Hospital Riyadh, Saudi Arabia

Conâ&#x20AC;&#x2122;s primitive weapons

Manual Thrombectomy castle

Short and Long-term Outcomes of 23 RCT of IV Thrombolysis vs PPCI

Keeley et al Lancet 2003

Distal Embolization During PPCI 

It is neither infrequent nor benign



Occurs in 15.2 % of patients



Associated with larger infarct size, lower EF and increased long term mortality  5 year mortality of 44% vs 9%

Henriques et al, Eur Heart J 2002

Distal Embolization and Myocardial Perfusion

Henriques et al, Eur Heart J 2002

Distal Embolization During PPCI No embolization

70

Embolization

57

60

44

50

42

40 30 20

9

10 0

5-yr mortality

LVEF Henriques et al, Eur Heart J 2002

Distal Embolization and No-Reflow Predictors of DE:

Open Bar = DE Closed Bar = NDE

• Cut-off pattern •RCA intervention •Vessel diameter ≥ 3.5

Napodano et al. Eur Heart J 2009

No-Reflow and AMI Outcomes • N = 1406 • Pts with STEMI undergoing PCI • Occurred in 30% of pts • 7-14 day infarct size 15% vs. 8% p<0.001 • 5-year mortality 18.2% vs. 9.5%, p < 0.001

Ndrepepa G, et al.. J Am Coll Cardiol. 2010

No-Reflow and In-Hospital Outcomes: NCDR-CathPCI Registry (291,380 patients)

Harrison et al, Am J Cardiol 2013

What would you use to open this artery?

Distal Embolization During PPCI 54.7

60 50 40 23.4

30

17.1

20 10 0

4.7

Basal

Guide wire

Balloon

Stent

Napodano Met al. Eur Heart J 2009

Routine Thrombus Aspiration in STEMI A“NO BRAINER” 

Prevents distal embolization



Prevents no-reflow



Reduces thrombotic burden



Facilitates visualization of coronary anatomy



Facilitates direct stenting



Can work on its own and save a stent



Cheap and safe



Aspirated material offers opportunity for research

But… Does It Really Work? 

It should remove the thrombus



It should improve blood flow at the epicardial coronary and the myocardial level

YES  Should reduce infarct size 

Should improve mortality

Silva-Orrego et al, JACC 2006

Burzotta et al, JACC 2005

DEAR-MI Trial

(Silva-Orrego aet al JACC 2006)

Thrombus Aspiration during Primary Percutaneous Coronary Intervention TAPAS Trial Tone Svilaas, M.D., Pieter J. Vlaar, M.Sc., Iwan C. van der Horst, M.D., Ph.D., Gilles F.H. Diercks, M.D., Ph.D., Bart J.G.L. de Smet, M.D., Ph.D., Ad F.M. van den Heuvel, M.D., Ph.D., Rutger L. Anthonio, M.D., Ph.D., Gillian A. Jessurun, M.D., Ph.D., EngShiong Tan, M.D., Albert J.H. Suurmeijer, M.D., Ph.D., and Felix Zijlstra, M.D., Ph.D.

N Engl J Med 358(6):557-567 February 7, 2008

Primary Endpoint: Myocardial Blush Grade 60

P < 0.001

50

) % ( st nei t aP

40 30 20

46 0/1 2 3

41

37 32 26 17

10 0

Thrombus aspiration

Conventional PCI Svilaas T et al. NEJM 2008

ST-segment Elevation Resolution P < 0.001

57

60 Patients (%)

< 30% 50 40

30-70%

44

> 70%

38 31

30 20

18 13

10 0

Thrombus aspiration

Conventional PCI

Svilaas T et al. NEJM 2008

TAPAS: 30-day Mortality

One Year Follow Up

All cause mortality: 38% reduction Cardiac death: 46% reduction Cardiac death/MI: 43% reduction Vlaar et al. Lancet 2008.

EXPERIA Trial 

175 patients with STEMI within 9 hrs from symptom onset



TIMI flow ≤ 1



Thrombus score ≥ 3



CMR substudy (75 patients with anterior MI) at 3-5 days and repeated at 90 days



MBG ≥ 2: 88% vs 59%, p< 0.0001



90 minute STR > 70%: 64% vs 39%, p= 0.001



Final infarct size reduction: 17 ± 15 g to 11 ± 8.7g, p= 004 Sardella et al JACC 2009

EXPERIA: 2-year Survival

Sardella et al Am J Cardiol 2010

Infarct Size Reduction 

Ciszewski et al (Cath Cardiovasc Interv 2011):  Randomized trial  137 patients (AMI <12 hours)  TIMI flow ≤ 2 and visible thrombus  LAD and RCA only  Sestamibi SPECT was used to measure myocardial

salvage

3750 patients 1 year- mortality = 7.2 vs. 9.3

Burzotta et al. Eur Heart J. 2009

Kaplanâ&#x20AC;&#x201C;Meier curves for cumulative survival. P = 0.049

NNT to prevent one death = 34

Burzotta et al. Eur Heart J 2009

Kaplanâ&#x20AC;&#x201C;Meier curves for MACE-free survival. P = 0.011.

Burzotta et al. Eur Heart J 2009

Thrombectomy ± IIb/IIIa inhibitors MORTALITY

8%

7.4%

P=0.022

6%

5.0%

4%

3.3%

2%

IIb/IIIa inhib Thrombectomy

-

IIb/IIIa inhib Thrombectomy

+ -

IIb/IIIa inhib Thrombectomy

– +

IIb/IIIa inhib Thrombectomy

+ +

Burzotta et al. Eur Heart J. 2009

If it worksâ&#x20AC;Ś Only in patients with visible thrombus or all?

DEAR-MI Trial

(Silva-Orrego aet al JACC 2006)

â&#x20AC;˘Thrombotic material was present in 70/74 (95%) of aspirates

TAPAS: +ve Aspirate According to TIMI flow and Angiographic Evidence of Thrombus 

Thrombus was retrieved from 74% of patients



In 76% of TIMI 0-1 vs. 69% of TIMI 2-3



In 77% of patients with visible thrombus vs. 67% with no visible thrombus



RCA= 82%, LAD= 69%, LCX= 65%

Svilaas T et al. NEJM 2008

+ Ve Aspirate According to Thrombus Score 

Balevski et al: Am J Cardiol 2011  181 STEMI patients  46 with TS 0-1  135 with TS 2-5  Catheter crossed in 89% of TS 0-1 and 96% of TS 2-5  +ve aspirate in 90% of TS 2-5 and 67% of TS 0-1  Angiographic success was the same

Conclusion ď&#x201A;¤

Manual thrombus aspiration is the only device intervention that has been shown to reduce mortality in AMI in the last 10 years

ď&#x201A;¤

Routine thrombus aspiration in PPCI should be the initial strategy in all cases presenting with STEMI

End of Round 1

Is there a room to improve STEMI outcomes?

??

Baseline Risk and Impact of ReoPro on Outcomes Death or MI at 30 days Placebo 20.0 18.0 16.0 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0

Abciximab 18.3

P=0.02

13.1

P=0.91

4.0 4.0

ISAR REACT 1 Stable patients Kastrati A, NEJM 2004, JAMA 2006

P=0.98

4.6 4.6

ISAR REACT 2 NSTEACS TnT -

ISAR REACT 2 NSTEACS TnT +