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 (TOTAL)

Population Health Research Institute (PHRI)

Status: Completed

Conditions: ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Treatments: Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01149044

TOTAL Trial

Details and patient eligibility

About

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

Full description

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.

Enrollment: 10,732 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,732 participants in 2 patient groups

Upfront Thrombectomy followed by PCI

Active Comparator group

Description:

Upfront manual aspiration thrombectomy followed by PCI

Treatment:

Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

PCI Alone

Active Comparator group

Description:

PCI without upfront manual aspiration thrombectomy

Treatment:

Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy