The Saphenous vein graft Angioplasty Free of Emboli Randomized trial - SAFER
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).
The 30-day primary end point rate would be reduced in the embolic protection arm compared with the control arm
Patients Enrolled: 801
Mean Follow Up: 30 days
Mean Patient Age: not reported
Mean Ejection Fraction: Baseline ejection fraction was 47.6% in the GuardWire arm and 47.0% in the control arm.
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.
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.
MACE rate at 30 days (death, myocardial infarction, emergent bypass surgery, or target vessel revascularization)
Acute thrombosis Post-procedure flow Vessel injury (distal dissection or perforation)
Randomized to a 0.014-inch PercuSurge GuardWire balloon occlusion device or a conventional 0.014-inch angioplasty guidewire.
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
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).
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.
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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