Presentation on theme: "on behalf of the TOTAL Investigators"— Presentation transcript:
1 on behalf of the TOTAL Investigators Angiographic Sub-study of the TOTAL trial: a randomized trial of manual thrombectomy during PCI for STEMICB Overgaard, V Sharma, T Hameed, D Sharma, J Chiha, W Chan, F Fuchs, S Kassam, R Leung, D Horak, H Romppanen, M El Omar, S Chowdhary, G Stankovic, S Kedev, M Rokoss, T Sheth, , V Džavík, SS Jollyon behalf of the TOTAL Investigators
2 Disclosures TOTAL trial was funded by: Canadian Institutes of Health ResearchCanadian Network and Centre for Trials Internationally (CANNeCTIN)Medtronic Inc.
3 BackgroundMyocardial blush grade has been shown to predict mortality after primary percutaneous coronary intervention (PPCI)1Small trials have shown improvement in myocardial blush grade with manual thrombectomy2Van 't Hof AW et al Circulation 1998; 97(23):Svilaas T et al NEJM 2008; 358 (96):Svilaas T et al. N Engl J Med 2008;358:
4 BackgroundThe TOTAL trial is an international, prospective randomized (multicenter) trial of manual thrombus aspiration (using the Export® catheter, Medtronic CardioVascular, Santa Rosa, CA) in STEMI patients versus PPCI aloneTOTAL demonstrated no benefit to routine aspiration in patients undergoing PPCI for STEMI
5 Study Questions Does manual thrombectomy compared to PCI Alone impact: Myocardial blush grade 0/1Final TIMI flowDistal embolization and other Angiographic complicationsAre these angiographic outcomes associated with mortality?
6 The TOTAL Trial Study Design STEMI* with Primary PCI ≤12 hours of symptom onsetSample size of 10,700 for 80% power to detect a 20% Relative Risk Reduction1:1 Randomization between strategiesRoutine Upfront Manual Thrombectomyfollowed by PCIPCI Alone(only bailout thrombectomy)Primary Outcome: CV death, MI, cardiogenic shock and class IV heart failure ≤180 daysSafety Outcome: Stroke ≤30 daysBailout Thrombectomy allowed if PCI alone strategy fails:Persistent TIMI 0 or 1 flow with large thrombus after balloon pre-dilatationPersistent large thrombus after stent deployment at target lesion
7 MethodsThe sub-study randomly selected 1610 patients from the TOTAL cohort (80% power to detect 25% RR reduction MBG 0 or 1 for manual thrombectomy)Angiographic parameters were blinded to treatment assignment at the angiographic core lab (Peter Munk Cardiac Centre, Toronto, Canada)
11 Myocardial Blush Grade and Mortality HR 2.84(95%CI )P=0.01
12 Distal Embolization and Mortality HR 3.63(95%CI )P=0.01
13 Independent Predictors of Mortality 0.250.501.002.004.008.00Thrombectomy vs PCIAge per 10 yearsSymptom Onset to device per 30 minutesMBG 0/1 vs 2/3Killip classSBPHeart RateWeight <67 kgDistal embolizationHR(95%CI)0.46 ( )1.35 ( )1.01 ( )2.23 ( )2.73 ( )0.98 (0.97-1)1.03 ( )3.26 ( )3.00 ( )
14 ConclusionsRoutine thrombectomy did not result in an improvement in final myocardial blush or TIMI Flow following PPCI for STEMIRoutine thrombectomy reduced angiographic distal embolizationDistal embolization was independently associated with mortality in multivariable analysis while myocardial blush was not