Randomized Comparison of Distal Protection With a Filter-Based Catheter and a Balloon Occlusion and Aspiration System During Percutaneous Intervention of Diseased Saphenous Vein Aorto-Coronary Bypass Grafts

Abstract

for the FilterWire EX Randomized Evaluation (FIRE) InvestigatorsBackground-The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established. Methods and Results-A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (Pϭ0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, Pϭ0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]ϭϪ1.7% [Ϫ6.4%, 3.1%]; P for superiorityϭ0.53, P for noninferiorityϭ0.0008). Conclusions-Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days. (Circulation. 2003;108:548-553.)

Drug-Eluting Stents Compared with Bare Metal Stents Improve Late Outcome after Saphenous Vein Graft but Not after Large Native Vessel Interventions

“…Thus, treatment of SVG disease currently accounts for about 10% of all percutaneous coronary interventions (PCI) [12]. Since embolization of friable material was a main problem with percutaneous techniques, distal embolic protection [13, 14] and mechanical thrombectomy of large luminal thrombi [15, 16] were beneficial regarding short-term major adverse clinical events (MACE), but long-term outcome after PCI of SVG lesions remains poor, primarily due to the high incidence of restenosis and atherosclerotic disease progression [17, 18]. …”

Scintigraphic evaluation of routine filterwire distal protection in percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: a randomized controlled trial

“…Use of the filterwire resulted in a median 3-minute increase in procedure time (median [IQR]) (16 [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] vs 13 [IQR 8-23], P = .06). After the procedure TIMI III flow was obtained in 94% of patients treated with distal protection compared with 87% who received conventional treatment (P = .03) ( Table 3).…”

“…[10][11][12] Use of a filterwire system has improved PCI results of saphenous vein grafts. 13 Therefore, The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction (DEDICATION) trial was designed to evaluate the potential benefit of routine filterwire treatment in adjunctive to conventional PCI in patients with a STEMI presenting within 12 hours of symptom onset. 14 In the DEDICATION trial we observed a 10% increase in achieved TIMI flow 3 in the filterwire group, but there was no significant benefit with respect to ECG ST-segment resolution, which was the primary endpoint of the study.…”

Interventional treatment of vein graft disease

“…4), providing equivalent results to the GuardWire TM device, while offering the advantage of maintained perfusion to the distal vessel segment during PTCA and stenting [29].…”