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 +