SIMPLE SVG - SIMPLE SVG
The goal of the SIMPLE SVG trial was to evaluate use of the SpideRX filter device, a rapid exchange heparin-coated filter system, among patients undergoing percutaneous coronary intervention of saphenous vein grafts.
Mean Patient Age: Mean age 70 years
Major adverse cardiac events (MACE), defined as death, MI or clinically driven target vessel revascularization.
Patients undergoing percutaneous coronary intervention of saphenous vein grafts were treated with the SpideRX filter device, a rapid exchange heparin-coated filter system. The study was designed as a registry and was conducted in Europe.
Among the patients in the study, 48% had a prior MI and 15% were diabetics. The device was successfully placed in 85% of patients, and among those patients 100% had successful retrievial. Atherogenic or plaque associated debris was present in 86% of filters, with an average volume of 0.0065 cc. TIMI grade 3 flow was present in 95% of patients. No reflow occurred in 6.7% of patients and abrupt closure in 1.6%. There were no perferations.
There were no deaths among the patients. Q-wave MI occurred in 1.3% and non-Q-wave MI in 2.7%. There were also no target vessel revascularizations or strokes. The overall MACE rate was 4%. A procedural related serious adverse event occurred in 1 patient (2%), and the overall SAE rate was 7%.
Among patients undergoing percutaneous coronary intervention of saphenous vein grafts, use of the SpideRX filter device was feasible and safe, with successful placement in 85% of patients, debris retrieved in 86% of filters, and a low MACE rate (4%) in the present registry. The upcoming Spider SVG randomized trial will enroll 1130 patients in the United States. The device is still investigational and not yet approved for use.
Presented by Dr. Waksman at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.
Keywords: Registries, Coronary Artery Disease, Myocardial Infarction, Stroke, Saphenous Vein, Heparin, Diabetes Mellitus, Percutaneous Coronary Intervention
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