Vein Graft AngioJet Study 2 - VEGAS-2

Feb 04, 2002
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Date Published:
01/01/1998
Date Updated:
02/04/2002
Original Posted Date:
02/04/2002
References

Description:

Safety and efficacy of rheolytic thrombectomy in CAD.

Hypothesis:

Comparison of safety and efficacy of rheolytic thrombectomy and thrombolytic therapy.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 349 patients (352 lesions)

Patient Populations:

Angina or MI >24 hours prior to procedure
Objective evidence of ischemia
Target vessel ≥2.0mm
Discrete, mobile, intraluminal defect or a total occlusion with thrombus confirmed by multi-sidehole infusion catheter

Primary Endpoints:

Acute 30-day success defined as >20% improvement in minimal lumen diameter, a final diameter stenosis of ≤50%, TIMI grade III flow, and freedom from major coronary events.

Secondary Endpoints:

Acute gain, volume of thrombus removal, final minimal lumen diameter, late outcome at 1 year, hospital costs/length of stay, and safety endpoints.

Drug/Procedures Used:

Rheolytic thrombectomy (AngioJet) vs. continuous (> 6 hours) intra-coronary urokinase.

Principal Findings:

This two-armed, multicenter, prospective randomized trial was designed to determine the safety and efficacy of rheolytic thrombectomy in patients with angiographic evidence of thrombus. Patients underwent either standard intra-coronary or graft urokinase (n=169) or thrombectomy using the AngioJet system (n=180). The AngioJet was followed by definitive therapy; adjunctive lytics and abciximab were discouraged with only 12% in this arm receiving abciximab versus 15% of patients in the urokinase cohort.

Baseline demographic, clinical, and angiographic characteristics were similar, with slightly more men randomized to urokinase.

Both treatments were equally effective with respect to the primary endpoint, although procedural success was significantly higher in the AngioJet group (86.3% vs 72.7%). AngioJet patients were more likely to be free of major adverse coronary events (MACE) at 30 days compared to the urokinase group (82.2% vs. 65.7%). In both groups, the vast majority of events occurred in hospital.

Overall, thrombectomy was safer than urokinase with respect to in-hospital MACE, bleeding complications, and vascular complications. Furthermore, mechanical thrombectomy allowed for rapid thrombus removal and stenting during the same catheterization laboratory visit. The resulting decreased length of hospital stay in this group probably reduced costs versus lytic therapy.

Interpretation:

The results of this study establish the safety and efficacy of the AngioJet device vs. intracoronary urokinase. Since AngioJet use allows other interventions (stenting) at the same sitting, the reduction in cath lab usage has significant financial implications.

References:

1. Circulation 1998;98(Suppl I):I-86. Preliminary results

Keywords: Thrombolytic Therapy, Urokinase-Type Plasminogen Activator, Platelet Aggregation Inhibitors, Thrombosis, Thrombectomy, Catheterization, Coronary Disease, Immunoglobulin Fab Fragments


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