Atlantic Cardiovascular Patient Outcomes Research Team Trial - C-PORT

Description:

The C-PORT trial was a prospective randomized trial designed to study whether a strategy of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) results in improved clinical outcomes in hospitals without on-site cardiac surgery compared to a strategy of fibrinolytic therapy.

Hypothesis:

In hospitals without on-site cardiac surgery trained to perform primary PCI, primary PCI as a therapy for AMI would produce superior six-month clinical outcomes compared to a strategy of fibrinolytic therapy.

Study Design

Study Design:

Patients Enrolled: 451
Mean Follow Up: 6 months
Mean Patient Age: Median of 64
Female: 30%

Patient Populations:

Eligible for fibrinolytic therapy; age ≥18; symptoms at least 30 minutes and less than 12 hours; ECG criteria: 1 mm ST-segment elevation in at least two contiguous leads, at least 1 mm ST-segment depression in V1 and V2 consistent with true posterior wall injury, or new left bundle branch block

Exclusions:

Patients taking metformin with renal insufficiency, idiosyncratic reactions to aspirin or contrast dye, or not eligible for fibrinolytic therapy

Primary Endpoints:

Composite at six months of death, recurrent MI, and stroke

Secondary Endpoints:

Incidence of blood transfusions, nonprotocol catheterization and PCI, CABG surgery, and hospital length of stay

Drug/Procedures Used:

All sites received specialized and individualized training through a formal program lasting approximately three months to develop primary PCI capability at each institution.

Primary PCI: Aspirin, IIb/IIa inhibitors encouraged, and stents encouraged for residual stenosis >20% or other suboptimal results. No PCI performed if there was resolution of both symptoms and initial TIMI 3 flow on angiography.

Fibrinolytic therapy: Aspirin, accelerated tissue plasminogen activator (15 mg bolus, infusion of 0.75 mg/kg for 30 minutes followed by 0.5 mg/kg for 60 minutes), and heparin

Principal Findings:

A total of 451 patients were enrolled in the study at 11 centers before it was terminated, due to a lack of funding. The study groups were well-balanced. 9.7% of patients assigned to fibrinolytic therapy (22/226) did not receive the assigned therapy, and 5.8% of patients assigned to primary PCI (13/225) did not undergo catheterization. In an additional 43 patients in the PCI arm (19%), catheterization was completed, but PCI was not performed. The median door-to-therapy time was 46 minutes in the fibrinolytic therapy arm and 101.5 minutes in the primary PCI arm.

In an intention-to-treat analysis, the incidence of the composite endpoint of death, recurrent MI, and stroke was lower at discharge, six weeks, and six months (for six months, 19.9% fibrinolytic arm vs. 12.4% PCI arm, p=0.03). The differences appeared to be largely driven by an early (within 10 days) reduction in recurrent MI and, to some extent, stroke. No patient in the primary PCI group was sent for emergency coronary artery bypass graft (CABG) for a catheterization-related or PCI-related complication, and hospital length of stay was shorter in the PCI arm (4.5 days vs. 6 days, p=0.02).

Interpretation:

Among patients with AMI treated in hospitals without on-site cardiac surgery trained extensively to undertake primary PCI, primary PCI was associated with improved outcomes compared to fibrinolytic therapy, largely through reducing early recurrent MI and stroke. Although the trial was terminated due to a lack of funding and enrollment reached approximately one-fifth of the projected sample size, the results are in line with other studies comparing PCI with fibrinolytic therapy in AMI.

The paucity of PCI-related complications at these sites that did not have surgical backup is additionally reassuring. Whether primary PCI in this setting is superior to a strategy of fibrinolytic therapy with early catheterization and PCI was not addressed in this study, and is an open question.

References:

Aversano T, Aversano LT, Passamani E, et al. Thrombolytic therapy vs primary percutaneous coronary intervention for myocardial infarction in patients presenting to hospitals without on-site cardiac surgery: a randomized controlled trial. JAMA 2002;287:1943-51.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, EP Basic Science, Aortic Surgery, Cardiac Surgery and Arrhythmias, Lipid Metabolism

Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Heparin, Constriction, Pathologic, Fibrinolytic Agents, Electrocardiography, Stents, Percutaneous Coronary Intervention, Length of Stay, Intention to Treat Analysis, Catheterization, Bundle-Branch Block, Coronary Artery Bypass, Tissue Plasminogen Activator, Cardiac Surgical Procedures


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