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Rationale for TOTAL trial: randomized trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI undergoing primary PCI Sanjit Jolly MD MSc, FRCP(C) Assistant Professor, Interventional Cardiologist McMaster University Hamilton, Canada
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Disclosures Received Grant Support from Medtronic
Received Speakers honoria from GlaxoSmithKline, Sanofi-Aventis,Astra Zeneca, Boehringer Ingelheim
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Epicardial flow is important
However, 94% of patients achieve TIMI 3 flow after PPCI Stone GW, et al. JACC 2002;39:591-7.
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Microvascular dysfunction in patients with normal epicardial flow
29% of patients with TIMI 3 flow have reduced microvascular perfusion (Myocardial blush grade <3) after PPCI Stone GW, et al. JACC 2002;39:591-7.
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Review of three largest trials of Thrombectomy
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AIMI Trial: Mechanical Thrombectomy increased infarct size and mortality
P=0.03 Ali, A, et al. JACC.2006;48:
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TAPAS trial : Benefit for Surrogate outcome
Single center trial of Thrombectomy (Export) vs. PCI alone during PPCI (N=1071) Benefit for primary outcome of myocardial blush grade 0 or 1 (poor microvascular flow) P<0.001 Svilaas T, et al. N Engl J Med. 2008;358:
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Unexpected Reduction in Mortality at 1 year
Trend at 30 days became significant at 1 year Experts cautioned that a large confirmatory trial is needed (small trials with unexpected large effect sizes, need to be replicated)
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JET STENT: No difference in Infarct Size, mortality with mechanical thrombectomy
P=0.40 P=ns Migliorini, A, et al. JACC. 2010;56:1298.
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How do we explain conflicting results?
Different thrombectomy devices have different clinical effects More likely: Small trials with few events unreliable A large scale definitive trial is needed
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Stroke: Risk of Harm Trend toward increased risk of stroke with devices 1.9% vs. 0.3% RR 3.43 (95% CI ), p=0.085 Emphasizes the need for a definitive multicenter trial Bavry et al. Eur Heart J ;
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Paradigm Does removal of thrombus during PPCI improve clinical outcomes? Unanswered question: We have the opportunity to answer
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Thrombectomy use only 4% of PPCI in USA
Data from ACC NDR registry of 217,355 primary PCI procedures
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International STEMI survey
27 item online survey (Survey MonkeyTM) Distributed to various investigator networks in North America, Europe and Asia and members of Canadian Association of Interventional Cardiology Received 477 responses (response rate 29%) Russo J, et al. Circulation AHA abstract
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Routine Use of Aspiration thrombectomy during PPCI
Only 36% use aspiration thrombectomy routinely with no significant variation by region
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Have you ever experienced a complications related to Aspiration Thrombectomy?
1 in 5 interventionalists have experienced a serious complication related to thrombectomy
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Existing evidence supports universal AT use
Need for a large RCT Existing evidence supports universal AT use 21% agree A large, definitive AT trial is needed 85% percent of respondents would randomize patient s 89% agree
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Summary Thrombectomy is not used routinely by majority of operators during PPCI TAPAS trial was promising but far from definitive Large multicenter randomized trial needed to determine benefits of routine thrombectomy on clinical outcomes
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TOTAL Trial N=4000 Primary outcome: CV death, recurrent MI, cardiogenic shock and new or worsening NYHA Class IV HF at 180 days Contact Supported by Canadian Network and Center for Trials internationally and Medtronic
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TOTAL trial Potential to be a landmark trial in STEMI
Validate concept that thrombus removal improves clinical outcomes Lead to other breakthroughs in STEMI care If interested in partcipating contact
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