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. METHODS AND 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.
RCT Entities:
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. METHODS AND 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.
Authors: K D Dawkins; T Gershlick; M de Belder; A Chauhan; G Venn; P Schofield; D Smith; J Watkins; H H Gray Journal: Heart Date: 2005-12 Impact factor: 5.994
Authors: René J van der Schaaf; Marije M Vis; Krischan D Sjauw; Karel T Koch; Jan Baan; Jan G P Tijssen; Robbert J de Winter; Jan J Piek; José P S Henriques Journal: Heart Date: 2007-03 Impact factor: 5.994
Authors: R Zahn; E Roth; T Ischinger; B Mark; M Hochadel; U Zeymer; K Haerten; K E Hauptmann; E-R von Leitner; A Schramm; W Kasper; J Senges Journal: Z Kardiol Date: 2005-03