Meeting News Coverage

TOTAL follow-up results reject manual thrombectomy as STEMI treatment strategy

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 Jolly, MD, MSc

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

References:

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.

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 Jolly, MD, MSc

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

References:

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.

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