AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction - AiMI

Description:

AiMI was a multicenter, prospective randomized two-arm trial comparing AngioJet thrombectomy followed by definitive treatment (angioplasty, stent, and eptifibatide), versus immediate definitive treatment only, in patients undergoing intervention for acute myocardial infarction (MI).

Hypothesis:

Rheolytic thrombectomy with the Possis AngioJet catheter prior to definitive therapy for acute MI would reduce infarct size compared with immediate definitive therapy.

Study Design

Study Design:

Patients Enrolled: 480
Mean Follow Up: 30 days
Mean Patient Age: Mean age 60 years
Female: 25

Patient Populations:

Transmural anterior MI or large inferior MI (ST elevation in at least 2 leads of II, II, or aVF with reciprocal anterior changes), with definitive treatment being initiated within 12 hours of symptom onset.

Treated vessels were native coronary arteries ≥2 mm in diameter. The trial was designed to include all patients who met clinical and ECG entrance criteria; angiographic evidence of thrombus was not required for patient enrollment.

Exclusions:

Prior left ventricular (LV) dysfunction (LV ejection fraction <35%), prior coronary artery bypass grafting, cardiogenic shock, contraindication to treatment with glycoprotein IIb/IIIa inhibitor (eptifibatide), major surgery within the preceding 6 weeks, stroke within 30 days, any history of hemorrhagic stroke, severe uncontrolled hypertension

Primary Endpoints:

Final infarct size at 14-28 days, as measured by Tc-99m sestamibi SPECT imaging

Secondary Endpoints:

ST-segment resolution, post-procedure TIMI flow, corrected TIMI frame count, TIMI myocardial blush grade, MACE (death, new Q-wave MI, stroke, target lesion revascularization), ejection fraction, and procedural complications

Drug/Procedures Used:

Patients were randomized to rheolytic thrombectomy using the Possis AngioJet XMI thrombectomy device (n = 240) or primary percutaneous coronary intervention (PCI) control (n = 240).

Concomitant Medications:

Eptifibatide (95%)

Principal Findings:

As measured by nuclear scan, the 197 intent-to-treat patients in the AngioJet arm had a larger final infarct size than the 205 patients in the control arm (12.5% ± 12.1 vs. 9.8% ± 10.9; p = 0.03). Mortality rates at 30 days were higher in those undergoing thrombectomy (4.6% [n = 11] vs. 0.8% [n = 2]; p = 0.01). The rate of major adverse cardiac events (MACE) was higher in patients undergoing thrombectomy (6.7% vs. 1.7%; p = 0.01).

The rates of TIMI 3 flow after completion of the procedure were lower in those randomized to thrombectomy (92% thrombectomy vs. 97% control, p < 0.02). For all of the remaining secondary endpoints, there were no statistically significant differences between the two treatment arms.

Interpretation:

Among patients with ST elevation MI, infarct size and mortality rates significantly increased among patients treated with rheolytic thrombectomy compared with the primary PCI control arm. These results do not support the routine use of rheolytic thrombectomy in ST segment elevation MI.

References:

Ali A, Cox D, Dib N, et al. Rheolytic thrombectomy with percutaneous coronary intervention for infarct size reduction in acute myocardial infarction: 30-day results from a multicenter randomized study. J Am Coll Cardiol 2006;48:244–52.

Ali A. A Prospective, Randomized, Controlled Trial of Thrombectomy With the AngioJet in Acute Myocardial Infarction (AiMI). Paper presented at Transcatheter Therapeutics 2004, September 27, Washington, DC.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Myocardial Infarction, Thrombosis, Thrombectomy, Coronary Disease, Electrocardiography, Coronary Vessels, Angioplasty, Stents, Percutaneous Coronary Intervention


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