The TOTAL trial is a randomized, event-driven study designed to evaluate the efficacy of routine manual aspiration thrombectomy during primary PCI in 10,700 patients with STEMI.
RCT (n=10,700)
Open-label with blinded outcome assessment
randomized
Yes
Does routine upfront manual aspiration thrombectomy during primary PCI reduce the composite of cardiovascular death, recurrent MI, cardiogenic shock, or worsening heart failure in patients with STEMI?
The TOTAL trial is a large-scale randomized trial designed to evaluate the efficacy of routine manual aspiration thrombectomy during primary PCI for STEMI.
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 important outcomes.
Jolly et al. (Sat,) conducted a rct in ST-elevation myocardial infarction (STEMI) (n=10,700). Routine upfront manual aspiration thrombectomy vs. Percutaneous coronary intervention (PCI) alone was evaluated on 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 TOTAL trial is a randomized, event-driven study designed to evaluate the efficacy of routine manual aspiration thrombectomy during primary PCI in 10,700 patients with STEMI.