SPIDER - SPIDER

Description:

The goal of the trial was to evaluate treatment with the Spider saphenous vein graft (SVG) distal protection device compared with distal protection using either the FilterWire or GuardWire device among patients undergoing percutaneous intervention for de novo SVG lesions.

Hypothesis:

Use of the Spider SVG distal protection device will be noninferior with regard to major adverse cardiac events (MACE) at 30 days compared with distal protection using either the FilterWire or GuardWire device.

Study Design

Study Design:

Patients Enrolled: 732
Mean Follow Up: 30 days
Mean Patient Age: Mean age 69 years
Female: 18

Patient Populations:

Myocardial ischemia, lesion diameter 3.0-6.0 mm, de novo lesion with stenosis ≥50%, TIMI flow grade 1, and ≥40 mm proximal to the distal anastomosis for device placement

Exclusions:

Recent acute MI, left ventricular ejection fraction <25%, SVG <6 months, or renal insufficiency

Primary Endpoints:

MACE at 30 days, defined as death, MI, target vessel revascularization, or urgent coronary artery bypass grafting, evaluated for noninferiority

Drug/Procedures Used:

Patients were randomized to intervention with the Spider SVG distal protection device (n=375) or intervention with distal protection using either the FilterWire or GuardWire device (n=357).

Concomitant Medications:

All patients were treated with aspirin and clopidogrel.

Principal Findings:

Among patients randomized to the control group, the FilterWire was used in 76% of cases. There were 396 vessels treated among the 375 patients in the Spider group and 379 vessels treated among the 357 patients in the control group. Mean SVG age was 11.2 years and 11.7 years, respectively. The graft target location was the right coronary artery in 41% of patients. Visible debris was retrieved in 63.5% and 61.9%, respectively. Device success occurred in 94.0% of the Spider group and 95.9% of the control group, and procedure success occurred in 91.6% and 93.1%.

The primary endpoint of MACE at 30 days met the criteria for noninferiority (9.1% for the Spider group vs. 8.4% for the control group, p=0.012 for noninferiority). There were no differences between groups in components of the MACE composite, including death (0.3% vs. 0.6%), myocardial infarction (MI) (8.5% vs. 7.6%), or target vessel revascularization (1.1% each).

Interpretation:

Among patients undergoing percutaneous intervention for de novo SVG lesions, use of the Spider SVG distal protection device was noninferior with regard to MACE at 30 days compared with distal protection using the FilterWire or GuardWire device.

Distal protection with filter devices requires that the lesion be crossed before the filter can be delivered. The Spider device is a preloaded filter with a dual-ended catheter that allows for both delivery and recovery of the filter. MACE at 30 days was noninferior, and there was no difference in device or procedure success.

References:

Presented by Dr. Simon R. Dixon at TCT 2005, Washington, DC.

Clinical Topics: Atherosclerotic Disease (CAD/PAD)

Keywords: Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Saphenous Vein, Human Rights, Constriction, Pathologic


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