摘要
Aims: Although embolic protection devices reduce complications during saphenous vein graft(SVG) stenting, adverse events still occur in ~10%of patients. IIb/IIIa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. Methods and results: In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. IIb/IIIa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for IIb/IIIa inhibitor use(n=345) had higher baseline risk, with increased 30-day major adverse cardiac events(MACE, 13.0 vs. 8.0%, P=0.03). GuardWire assigned patients treated with IIb/IIIa inhibitors had higher 30-day MACE compared with those not treated with IIb/IIIa inhibitors(16.0 vs. 6.3%, P=0.007). In contrast, MACE in high-risk FilterWire patients treated with IIb/IIIa inhibitors were similar to their lower risk, untreated counterparts(9.9 vs. 9.5%, P=0.89). Multivariable analysis detected a borderline significant(P=0.056) interaction for lower MACE between FilterWire and IIb/ IIIa inhibitor use. Adjustment by the propensity to use IIb/IIIa inhibitors resulted in a significant(P=0.023) interaction for lower MACE rates. IIb/IIIa inhibition in conjunction with FilterWire was associated with less abrupt closure, no reflow, or distal embolization. Conclusion: IIb/IIIa antagonists may improve procedural outcome during SVG stenting in high risk patients, utilizing filter-based embolic protection devices.
Aims: Although embolic protection devices reduce complications during saphenous vein graft(SVG) stenting, adverse events still occur in -10% of patients. Ⅱb/Ⅲa antagonists have not been proven effective during SVG intervention. We hypothesized that adjunctive use of these agents might enhance the efficacy of embolic protection devices. Methods and results: In the prospective, multicentre FilterWire EX Randomized Evaluation trial, 651 patients undergoing SVG stenting were randomized to either filter-based FilterWire EX or balloon occlusion/aspiration GuardWire embolic protection devices. Ⅱb/Ⅲa inhibitor use was at the discretion of the investigator, with randomization stratified by intended use. Patients pre-selected for Ⅱb/Ⅲa inhibitor use(n = 345) had higher baseline risk, with increased 30-day major adverse cardiac events (MACE, 13.0 vs. 8.0%, P=0.03) . GuardWire assigned patients treated with Ⅱb/Ⅲa inhibitors had higher 30-day MACE compared with those not treated with Ⅱb/ Ⅲa inhibitors(16.0 vs. 6. 3%, P =0. 007). In contrast, MACE in high-risk FilterWire patients treated with Ⅱb/Ⅲa inhibitors were similar to their lower risk, untreated counterparts(9.9 vs. 9.5%, P =0.89). Multivariable analysis detected a borderline significant(P = 0. 056) interaction for lower MACE between FilterWire and Ⅱb/ Ⅲa inhibitor use. Adjustment by the propensity to use Ⅱb/Ⅲa inhibitors resulted in a significant (P = 0. 023) interaction for lower MACE rates.