SAN FRANCISCO — One-year follow-up data from the TOTAL trial presented at the annual TCT Scientific Symposium showed routine thrombus aspiration during PCI for STEMI did not decrease long-term clinical outcomes and could increase stroke risk.
“A strategy of routine manual thrombectomy compared to a strategy of PCI alone with only bailout thrombectomy did not reduce the composite of [CV] death or current MI, cardiogenic shock and class IV [HF] at 1 year,” Sanjit S. Jolly, MD, MSc, of McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada, said in a presentation. “Routine thrombectomy was associated with a significant increase of stroke.”
Sanjit S. Jolly
Results from this largest trial of routine manual thrombectomy in STEMI were presented in context of the TAPAS trial data, showing a reduction in mortality during 1 year that was not apparent at 30 days, and TASTE trial results, showing no reduction at either point, Jolly said.
Early results from the TOTAL trial — demonstrating benefit for surrogate outcomes of ST-segment resolution and distal embolization, but no reduction in CV death, recurrent MI, cardiogenic shock and class IV HF within 180 days and increased risk for stroke — left the question of whether the outcomes would translate into long-term benefit.
The long-term study population involved 10,064 patients (thrombectomy, n = 5,035; PCI alone with only bailout thrombectomy, n = 5,029).
Crossover from the thrombectomy arm to PCI alone occurred in 4.5% of patients. Bailout thrombectomy in the initial PCI alone group occurred in 7% of patients.
At 1 year, the incidence of primary outcomes was 8% in the thrombectomy group and the PCI-alone group (HR = 1; 95% CI, 0.87-1.15), and CV death occurred in 4% of both groups (HR = 0.93; 95% CI, 0.76-1.14). Stroke was more frequent with thrombectomy (1.2%) than with PCI alone (0.7%; HR = 1.66; 95% CI, 1.1-2.51).
“Based on these results, manual thrombectomy can no longer be recommended as a routine strategy during primary PCI for STEMI,” Jolly said. – by Allegra Tiver
Jolly SS, et al. TOTAL: A prospective randomized trial of thrombus aspiration in patients with ST-segment elevation myocardial infarction — one-year outcomes. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Jolly SS, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)00448-1.
Disclosure: Jolly reports receiving institutional grants from Medtronic.