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SIMPLE SVG - SIMPLE SVG
Description:
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.
Study Design
Study Design:
Mean Patient Age: Mean age 70 years
Female: 11
Primary Endpoints:
Major adverse cardiac events (MACE), defined as death, MI or clinically driven target vessel revascularization.
Secondary Endpoints:
Technical success
Drug/Procedures Used:
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.
Principal Findings:
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%.
Interpretation:
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.
References:
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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