One-Year Outcomes from the TOTAL Study Reported at TCT 2015 and Published in The Lancet

SAN FRANCISCO – October 13, 2015 – The one-year outcomes of the largest randomized trial of its kind showed no benefit of thrombus aspiration during percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).

One-year findings from TOTAL were reported today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in The Lancet.

TOTAL was a prospective, randomized, investigator-initiated trial of routine manual thrombectomy with PCI versus PCI alone in patients with STEMI within 12 hours of symptom onset. The study enrolled 10,732 eligible patients from 87 hospitals in 20 countries. Using a 1:1 randomization, patients were assigned to thrombectomy followed by PCI (n=5,372) or to PCI alone (n=5,360). After excluding patients who did not undergo PCI in each group (337 in the PCI and thrombectomy group and 331 in the PCI alone group), the final study population was comprised of 10,064 patients (5,035 thrombectomy and 5,029 PCI alone).

The primary outcome (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class IV heart failure) at one year occurred in 395 (8%) of 5,035 patients in the thrombectomy group compared with 394 (8%) of 5,029 in the PCI alone group (hazard ratio [HR] 1.00 [95% CI 0.87–1.15], p=0.99). Cardiovascular death at one year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) in the PCI alone group (HR 0.93 [95% CI 0.76–1.14], p=0.48). Recurrent myocardial infarction, cardiogenic shock, or heart failure at one year were similar between the groups, as were all-cause death, stent thrombosis, definite stent thrombosis, target vessel revascularization, and major bleeding.

The key safety outcome of the study, stroke within one year, occurred in 60 patients (1.2%) in the thrombectomy group compared with 36 (0.7%) in the PCI alone group (HR 1.66 [95% CI 1.10–2.51], p=0.015).

“Routine thrombus aspiration during PCI for STEMI did not reduce cardiovascular death, myocardial infarction, shock, or heart failure after one year compared with PCI alone,” said lead investigator Sanjit S. Jolly, MD, MSc. Dr. Jolly is an interventional cardiologist at Hamilton Health Sciences and an Associate Professor at McMaster University in Hamilton, Canada.

“A strategy of routine thrombus aspiration may be associated with an increased rate of stroke. The TOTAL trial is the largest trial of thrombus aspiration with significantly more power to detect differences in which stroke was a prespecified safety outcome. As a result, thrombus aspiration can no longer be recommended as a routine strategy in STEMI.”

The study was funded by a research grant from the Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc. Dr. Jolly reported institutional grants from Medtronic and speakers fees from Astra Zeneca.

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