Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial

BackgroundTwo large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.MethodsThe trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (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. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear...

Design and rationale of the TOTAL trial: A randomizedtrial of routine aspiration ThrOmbecTomy withpercutaneous coronary intervention (PCI) versus PCIALone in patients with ST-elevation myocardialinfarction undergoing primary PCI

Background A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation

myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with

thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical

trials have shown mixed results regarding thrombectomy.

Objective The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during

PPCI compared with percutaneous coronary intervention alone in patients with STEMI.

Design This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes.

Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export

catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is

the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York

Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients.

Summary The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically

Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial

Background Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reducesvascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronaryangiography with possible intervention.Methods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group,multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voiceresponse system to radial or femoral artery access. The primary outcome was a composite of death, myocardialinfarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273. Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries.3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72–1·17; p=0·50). Of the six prespecifi ed subgroups, there was a signifi cant interaction for the primary outcome with benefi t for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28–0·87; p=0·015)...

Design and rationale of the radIal Vs. femorAL access for coronary intervention (RIVAL) trial: A randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes

Background Major bleeding in acute coronary syndromes (ACS) is associated with an increased risk of subsequentmortality and recurrent ischemic events. Observational data and small randomized trials suggest that radial instead of femoralaccess for coronary angiography/intervention results in fewer bleeding complications, with preserved and possibly improvedefficacy. Radial access versus femoral access has yet to be formally evaluated in a randomized trial adequately powered forthe comparison of clinically important outcomes.Objectives The aim of this study is to evaluate the efficacy and safety of radial versus femoral access for coronaryangiography/intervention in patients with ACS managed with an invasive strategy.Design This was a multicenter international randomized trial with blinded assessment of outcomes. 7021 patients withACS (with or without ST elevation) have been randomized to either radial or femoral access for coronary angiography/intervention. The primary outcome is the composite of death, myocardial infarction, stroke, or non–coronary artery bypassgraft-related major bleeding up to day 30. The key secondary outcomes are (1) death, myocardial infarction, or stroke up today 30 and (2) non–coronary artery bypass graft-related major bleeding up to day 30. Percutaneous coronary intervention(PCI) success rates will also be compared between the two access sites.Conclusions The RIVAL trial will help define the optimal access site for coronary angiography/intervention in patientswith ACS.