Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts.
BACKGROUND
Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions.


RESULTS
Of 801 eligible patients, 406 were randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014-inch angioplasty guidewire (control group). The primary end point-a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days-was observed in 65 patients (16.5%) assigned to the control group and 39 patients (9.6%) assigned to the embolic protection device (P=0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%, P=0.008) and "no-reflow" phenomenon (3% versus 9%, P=0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite end points occurring in 10.7% of protection device patients versus 19.4% of control patients (P=0.008).


CONCLUSIONS
Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.
Baim
Donald S
DS
Division of Cardiovascular Diseases, Brigham and Women's Hospital, Boston, Mass 02115, USA. dbaim@partners.org
Wahr
Dennis
D
George
Barry
B
Leon
Martin B
MB
Greenberg
Joel
J
Cutlip
Donald E
DE
Kaya
Unsal
U
Popma
Jeffrey J
JJ
Ho
Kalon K L
KK
Kuntz
Richard E
RE
D000368:Aged; D015415:Biomarkers / Q000097:blood; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D003710:Demography; D018572:Disease-Free Survival; D004617:Embolism / Q000209:etiology* / Q000517:prevention & control*; D005260:Female; D005374:Filtration / Q000295:instrumentation; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D006801:Humans; D007527:Isoenzymes / Q000097:blood; D008297:Male; D009203:Myocardial Infarction / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D012501:Saphenous Vein / Q000601:surgery / Q000637:transplantation; D015607:Stents; D016896:Treatment Outcome
D015415:Biomarkers; D007527:Isoenzymes; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form