A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI

The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an
aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of
cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or
worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing
primary PCI.

Inclusion Criteria:

1. Patients presenting with:

- Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND

- Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in
two contiguous limb leads or 0.2 mV in two contiguous precordial leads

2. Referred for primary PCI

3. Randomized within 12 hours of symptoms onset and prior to diagnostic angiography

4. Informed consent

Exclusion Criteria:

1. Age ≤ 18 years

2. Prior coronary artery bypass surgery (CABG)

3. Life expectancy less than six months due to non-cardiac condition

4. Treatment with fibrinolytic therapy for qualifying index STEMI event