AIMS: Although embolic protection devices reduce complications during saphenous vein graft (SVG) stenting, adverse events still occur in approximately 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.
RCT Entities:
AIMS: Although embolic protection devices reduce complications during saphenous vein graft (SVG) stenting, adverse events still occur in approximately 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.
Authors: Rafał Januszek; Zbigniew Siudak; Artur Dziewierz; Tomasz Rakowski; Dariusz Dudek; Stanisław Bartuś Journal: Arch Med Sci Date: 2019-01-30 Impact factor: 3.318