Comparison Between Thrombolysis and Primary Percutaneous Coronary Intervention (PCI) to Treat ST-Segment Elevation Myocardial Infarction (SWEDES)

Sahlgrenska University Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Procedure: primary PCI; Drug: reteplase 10+10 U

Study type: Interventional

Funder types: Other

Identifiers

NCT00806403

SWEDES 23/09/01

Details and patient eligibility

About

The main objective is to compare a fibrinolytic strategy with an interventional strategy initiated as early as possible, preferably in the pre-hospital phase, with respect to resolution of ST-segment elevation at 120 minutes after inclusion and Thrombolysis In Myocardial Infarction (TIMI) flow grade evaluated at a mandated coronary angiography 5 to 7 days after inclusion.

Full description

Patients in the fibrinolytic group received an intravenous injection of 30 mg enoxaparin followed by subcutaneous injections of 1 mg/kg body weight every 12 hours during hospital stay.

Patients in the invasive group were given an intravenous injection of enoxaparin of (0.75 mg/kg body weight) and abciximab as a intravenous bolus (0.25 mg/kg body weight) followed by a 12 hour infusion (10 microg/minute).

Secondary outcome measures were death, myocardial infarction and stroke alone or as a composite at 30 days.

Data on use of health care resources, loss of production and health-related quality of life were collected during one year. Cost-effectiveness was determined by comparing costs and quality-adjusted survival.

Enrollment: 205 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting within 6 h after onset of chest pain lasting for more than 30 min and with significant ST-segment elevation on ECG.

Exclusion criteria

• BP >180/110
• Known bleeding disorder
• Cardiogenic shock
• CPR>10 min
• Ongoing anticoagulant therapy
• Renal insufficiency
• Weight >120 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

thrombolysis

Active Comparator group

Treatment:

Drug: reteplase 10+10 U

invasive

Active Comparator group

Treatment:

Procedure: primary PCI