Outcomes after @entity715 aspiration for XXXX : 1-year follow-up of the prospective randomised TOTAL trial.

@entity1 @entity712 @entity64 @entity583 @entity1347 @entity715 @entity1455 @entity65
BACKGROUND: Two large trials have reported contradictory results at 1 year after @entity715 aspiration in @entity583 ( @entity583 ). In a 1-year follow-up of the largest randomised trial of @entity715 aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice. METHODS: The trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in @entity1 with @entity583 (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10   732 @entity1 with @entity583 . Eligible adult @entity1 (aged >= 18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. @entity1 and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of @entity65 , @entity583 , @entity1455 , or @entity712 . However, the results showed improvements in the surrogate outcomes of @entity1347 , but whether or not this finding would translate into a longer term benefit remained unclear. In this longer-term follow-up of the TOTAL study, we report the results on the primary outcome ( @entity65 , @entity583 , @entity1455 , or @entity712 ) and secondary outcomes at 1 year. Analyses of the primary outcome were by modified intention to treat and only included @entity1 who underwent index PCI. This trial is registered with ClinicalTrials.gov, number NCT01149044. FINDINGS: Between Aug 5, 2010, and July 25, 2014, 10   732 eligible @entity1 were enrolled and randomly assigned to thrombectomy followed by PCI (n=5372) or to PCI alone (n=5360). After exclusions of @entity1 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 comprised 10   064 @entity1 (5035 thrombectomy and 5029 PCI alone). The primary outcome at 1 year occurred in 395 (8%) of 5035 @entity1 in the thrombectomy group compared with 394 (8%) of 5029 in the PCI alone group (hazard ratio [HR] 1  00 [95% CI 0  87-1  15], p=0  99). @entity65 within 1 year occurred in 179 (4%) of the thrombectomy group and in 192 (4%) of 5029 in the PCI alone group (HR 0  93 [95% CI 0  76-1  14], p=0  48). The key safety outcome, @entity64 within 1 year, occurred in 60 @entity1 (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). INTERPRETATION: Routine @entity715 aspiration during PCI for @entity583 did not reduce longer-term clinical outcomes and might be associated with an increase in @entity64 . As a result, @entity715 aspiration can no longer be recommended as a routine strategy in @entity583 . FUNDING: Canadian Institutes of Health Research, Canadian Network and Centre for Trials Internationally, and Medtronic Inc.
