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The Saphenous vein graft Angioplasty Free of Emboli Randomized trial - SAFER
Description:
SAFER was designed to compare 30-day clinical outcome after saphenous vein graft stenting plus GuardWire distal protection vs that performed over a conventional guide-wire (control arm).
Hypothesis:
The 30-day primary end point rate would be reduced in the embolic protection arm compared with the control arm
Study Design
Study Design:
Patients Enrolled: 801
Mean Follow Up: 30 days
Mean Patient Age: not reported
Female: 17
Mean Ejection Fraction: Baseline ejection fraction was 47.6% in the GuardWire arm and 47.0% in the control arm.
Patient Populations:
History of angina. Signs of myocardial ischemia resulting from a target lesion >50% diameter stenosis (angiographic visual assessment) located in the mid-portion of a saphenous vein graft, with a reference diameter between 3-6 mm. In the first 142 patients, the lesion could not occupy more than one third of the graft length. In subsequent patients, there was no upper limit on lesion length.
Exclusions:
Recent myocardial infarction with baseline elevation of cardiac enzymes. Significantly impaired left ventricular function (ejection fraction <25%). Baseline creatinine >2.5 mg/dL, unless on long-term hemodialysis. Planned use of an atherectomy device.
Primary Endpoints:
MACE rate at 30 days (death, myocardial infarction, emergent bypass surgery, or target vessel revascularization)
Secondary Endpoints:
Acute thrombosis Post-procedure flow Vessel injury (distal dissection or perforation)
Drug/Procedures Used:
Randomized to a 0.014-inch PercuSurge GuardWire balloon occlusion device or a conventional 0.014-inch angioplasty guidewire.
Concomitant Medications:
Pre-stent: aspirin 325 mg During procedure: IV heparin with ACT >250 seconds; GP IIb/IIIa receptor blocker could be used at the discretion of the operator Post-stent therapy: aspirin 325 mg/d; clopidogrel 300 mg oral load, followed by 75 mg/d for 2-4 weeks
Principal Findings:
Major adverse cardiac events (MACE) at 30 days was 9.6% in the embolic protection device arm and 16.5% in the control group (p=0.004), a 42% relative reduction. The reduction was driven primarily by myocardial infarction (8.6% vs 14.7%, p=0.008) and "no-reflow" (3% vs 9%, p=0.02). In the subset of patients receiving GP IIb/IIIa receptor blockers (61%), similar clinical benefit was seen in MACE (10.7% of protection device patients vs 19.4% of control patients (p=0.008). Technical success was achieved in 90.1% of GuardWire cases. Rates of TIMI grade 3 flow were higher for the GuardWire arm (98%) compared with the control arm (95%, p=0.04).
Interpretation:
Use of the GuardWire distal protection device during stenting of stenotic saphenous venous grafts was associated with a highly significant, 42% reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. The benefit of the distal protection device was evident both with and without the use of concomittant GP IIb/IIIa receptor blockers. The SAFER study demonstrates the importance of prevention of distal embolization during catheter-based intervention in saphenous vein grafts. The potential benefit in other territories, such as native coronary, carotid, and renal arteries, has yet to be fully explored.
References:
Baim DS, Wahr D, George B, et al.; Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) Trial Investigators. Circulation 2002;105:1285-90.
Keywords: Myocardial Infarction, Renal Artery, Embolic Protection Devices, Balloon Occlusion, Saphenous Vein, Coronary Disease, Angioplasty, Platelet Membrane Glycoprotein IIb, Stents, Platelet Glycoprotein GPIIb-IIIa Complex
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