The Vein Graft AngioJet Study I Pilot Trial - VeGAS I
The goal of the multicenter VeGAS I Pilot Trial was to evaluate the POSSIS AngioJet catheter as an alternative method to mechanically remove thrombus in patients with ischemic coronary disease and complex anatomy.
The purpose of the multicenter VeGAS I Pilot Trial was to evaluate the POSSIS AngioJet catheter as an alternative method to mechanically remove thrombus in patients with ischemic coronary disease and complex anatomy. Additionally, researchers sought to determine the frequency of early angiographic complications as well as determine the late clinical outcome.
Patients Enrolled: 90
A total of 90 patients were included in the pilot registry. Inclusion criteria were age >18 years with either stable or unstable angina, 1 or 2 vein graft or native vessel lesions with a reference diameter of >2.5 mm and angiographic evidence of thrombus. The patients needed to have stenosis >70% by visual inspection. MIs were classified primarily based on the level of MB isoenzyme of creatine kinase (CK-MB) as follows: Class I infarctions had CK-MB less than 3 times the upper limit of normal with no electrocardiographic (EKG) changes or clinical manifestations of heart failure or clinical instability. Intermediate Class II MIs included those with CK-MB elevations that were more than 3 times normal with EKG changes or between 3 and 8 times normal without EKG changes. Class III MIs were any Q-wave infarction or CK-MB elevations >8 times normal.
A high-risk group overall, the patient population was predominantly older males with unstable angina; the majority had a prior MI, diabetes, and high blood pressure. One-third had acute MI and 7% cardiogenic shock. In the registry, 39 native vessels and 52 vein grafts were treated with 96% of lesions being complex (ACC/AHA class B2 or C).
The 5 French POSSIS AngioJet catheter is 145 cm long and advanced over 0.014 guide wire. A stainless steel hypotube carries high-pressure saline to the distal 3.5 French tip, which ends in a loop containing 6 proximally directed jets. A pressurized high-velocity ceiling stream through the direct orifices in the distal catheter creates a vortex suction; the thrombus is then entrained and evacuated in the artery.
Device success, defined as >20% improvement in minimal lumen diameter (MLD), a final diameter stenosis of <50%, and TIMI 3 flow after AngioJet use, was 41%. In 90% of patients there was an adjunct device used, most commonly stents. Procedural success, which used the same criteria plus TIMI 3 flow after all treatments, was 86.8%; success was slightly higher in patients with acute MI (p=NS). Clinical success, requiring procedural success plus absence of death, cerebrovascular accident, CABG, or acute MI, was 79% overall.
The AngioJet procedure reduced thrombus area from 81.8 mm2 to 21.4 mm2.
At 1-year follow-up, the overall mortality rate was 4.4% (6.7% acute MI vs. 3.3 no acute MI, p = ns). Late cardiac death occurred in 7.8%, slightly higher among the acute MI patients. The incidence of any death or MI within the first year was 17.8% overall (26.7% acute MI vs. 13.3% no acute MI). With respect to comparable trials, the target lesion revascularization rate was relatively low at 13.3%.
The Kaplan-Meier estimate of 1-year survival or event-free survival was surprisingly good considering the high risk population treated: 87% of MI patients versus 69% of patients without an acute MI.
This pilot study demonstrates the effectiveness of the POSSIS AngioJet catheter system in removing thrombus in high-risk patients with a low rate of distal lumenalization and other angiographic complications. To compare the AngioJet system to alternative treatment techniques, the investigators have enrolled approximately 300 patients in the ongoing, randomized VeGAS II trial.
AHA 1997, Clinical Trials, presented by Jeffrey J. Popma, MD, Washington Hospital, Washington, DC
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Hypertension
Keywords: Infarction, Stroke, Kaplan-Meier Estimate, Isoenzymes, Follow-Up Studies, Creatine Kinase, MB Form, Disease-Free Survival, Constriction, Pathologic, Electrocardiography, Stents, Shock, Cardiogenic, Registries, Stainless Steel, Thrombectomy, Thrombosis, Heart Failure, Hypertension, Diabetes Mellitus
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