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European Heart Journal Advance Access published online on January 16, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi736
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received March 7, 2005
Revised November 23, 2005
Accepted December 22, 2005

Clinical research

Platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment during saphenous vein graft stenting: differential effects after randomization to occlusion or filter-based embolic protection

Michael Jonas 1, Gregg W. Stone 2, Roxana Mehran 2, James Hermiller 3, Robert Feldman 4, Howard C. Herrmann 5, David A. Cox 6, Richard E. Kuntz 1, Jeffrey J. Popma 1, Campbell Rogers 1 *, and for the FilterWire EX Randomized Evaluation (FIRE) Investigators

1 Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA
2 New York Presbyterian Hospital/Cardiovascular Research Foundation, New York, NY, USA
3 St Vincent Hospital, Indianapolis, IN, USA
4 Evanston Hospital, Evanston, IL, USA
5 Hospital of the University of Pennsylvania, Philadelphia, PA, USA
6 6Mid Carolina Cardiology, Charlotte, NC, USA

* To whom correspondence should be addressed.
Campbell Rogers, E-mail: crogers{at}partners.org


  Abstract

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.

Keywords: Saphenous vein graft; Stent; Glycoprotein IIb/IIIa antagonists; Embolic protection devices.
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