1. on behalf of the TOTAL Investigators
1 year results of the TOTAL trial: Randomized trial of manual Thrombectomy in STEMI
SS Jolly, JA Cairns, S Yusuf, MJ Rokoss, P Gao, B Meeks, S Kedev, G Stankovic, R Moreno, A Gershlick, S Chowdhary, S Lavi, K Niemelä, I Bernat, WJ Cantor, AN Cheema, PG Steg, RC Welsh, T Sheth, OF Bertrand, A Avezum, R Bhindi, MK Natarajan, D Horak, RCM Leung, S Kassam, SV Rao, M El-Omar, SR Mehta, JL Velianou, S Pancholy, V Džavík
on behalf of the TOTAL Investigators

2. Disclosures TOTAL trial was funded by:
Canadian Institutes of Health Research
Canadian Network and Centre for Trials Internationally (CANNeCTIN)
Medtronic Inc.

3. Rationale for Thrombectomy
Major Limitation of Primary PCI:
Distal Embolization and Reduced Flow
Hypothesis: Aspiration thrombectomy may reduce embolization and
improve clinical outcomes

4. The TOTAL Trial Study Design
STEMI* with Primary PCI ≤12 hours of symptom onset
Sample size of 10,700 for 80% power to detect a 20% Relative Risk Reduction
1:1 Randomization between strategies
Routine Upfront Manual Thrombectomy
followed by PCI
PCI Alone
(only bailout thrombectomy)
Primary Outcome: CV death, MI, cardiogenic shock and class IV heart failure ≤180 days
Safety Outcome: Stroke ≤30 days
Bailout Thrombectomy allowed if PCI alone strategy fails:
Persistent TIMI 0 or 1 flow with large thrombus after balloon pre-dilatation
Persistent large thrombus after stent deployment at target lesion

5. Summary of Primary Results of TOTAL trial
Improvement in Surrogate Outcomes (ST resolution, Distal embolization)
Thrombectomy did not reduce primary outcome at 180 days
Increase in stroke at 30 days
Question:
Would the benefit for surrogate outcomes translate into a long term benefit at 1 year?
Jolly SS, et al. N Engl J Med. 2015;372:

6. Primary Outcome at 1 year
Thrombectomy
(N=5033) (%)
PCI alone
(N=5030) (%) HR
95% CI p
CV death, MI, shock or
class IV heart failure
395 (7.8)
394 (7.8)
1.00
(0.87 – 1.15)
0.99
CV death
179 (3.6)
192 (3.8)
0.93
(0.76 – 1.14)
0.48
Recurrent MI
125 (2.5)
118 (2.3)
1.05
( )
0.68
Cardiogenic Shock
95 (1.9)
105 (2.1)
0.90
(0.68 – 1.19)
0.47
Class IV heart failure
106 (2.1)
96 (1.9)
1.01
(0.83 – 1.45)
0.50

7. Safety Outcomes at 1 year
Thrombectomy
(N=5033) (%)
PCI alone
(N=5030) (%) HR
95% CI p
Stroke at 1 year
60 (1.2)
36 (0.7)
1.66
(1.10 – 2.51)
0.015
Stroke or TIA at 1 year
73 (1.4)
44 (0.9)
1.65
(1.14 – 2.40)
0.008
Landmark Analyses
Stroke 180 days to 1 year
7 (0.1)
10 (0.2)
0.70
(0.27 – 1.83)
0.46

8. Updated Meta-analysis N=20,352 All-Cause Mortality
OR 0.90 (95% CI ) P=0.10

9. Stroke
0.9% thrombectomy vs. 0.6% PCI alone, OR 1.43 (95% CI ) P=0.03

10. Conclusions
Routine thrombectomy compared to PCI alone did not reduce CV death, MI, shock or heart failure at 1 year
Routine thrombectomy was associated with increased rate of stroke
Manual Thrombectomy can no longer be recommended as a routine strategy

11. Available Online at the Lancet