Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: Results from the FIRE trial - 17/08/11

Doi : 10.1016/j.ahj.2005.09.018

Amir Halkin, MD ^a, A. Zaki Masud, MD ^c, Campbell Rogers, MD ^d, James Hermiller, MD ^e, Robert Feldman, MD ^f, Patrick Hall, MD ^g, Robert H. Haber, MD ^h, Patrick A. Cambier, MD ⁱ, Ron P. Caputo, MD ^j, Mark Turco, MD ^k, Richard Kovach, MD ^l, Bruce Brodie, MD ^m, Howard C. Herrmann, MD ⁿ, Richard E. Kuntz, MD ^d, Jeffrey J. Popma, MD ^d, Steve Ramee, MD ^o, David A. Cox, MD ^p, Roxana Mehran, MD ^a,^b, Gregg W. Stone, MD ^a,^b,^⁎
^a Cardiovascular Research Foundation, New York, NY
^b Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, NY
^c Cardiac Interventional Unit, Buffalo General Hospital, Buffalo, NY
^d Cardiac Catheterization Laboratory, Brigham and Women's Hospital, Boston, MA
^e Cardiac Catheterization Laboratories, St. Vincent's Hospital, Indianapolis, IN
^f Ocala Heart Institute, Munroe Regional Medical Center, Ocala, FL
^g Providence Heart Institute, Providence Hospital, Columbia, SC
^h Sanger Clinic, Carolinas HealthCare, Charlotte, NC
ⁱ Division of Cardiology, Morton Plant Hospital, Clearwater, CA
^j Cardiovascular Laboratory, St. Joseph's Hospital, Syracuse, NY
^k Cardiovascular Institute, Washington Adventist Hospital, Takoma Park, MD
^l New Jersey heart Institute, Our Lady of Lourdes Medical Center, Camden, NJ
^m Moses Cone Heart and Vascular Center, Moses Cone Memorial Hospital, Greensboro, NC
ⁿ Interventional Cardiology and Cardiac Catheterization Laboratories, University of Pennsylvania Medical Center, Philadelphia, PA
^o Ochsner Heart and Vascular Institute, Ochsner Clinic, New Orleans, LA
^p Cardiac Catheterization Laboratory, Mid Carolina Cardiology, Charlotte, NC

^⁎Reprint requests: Gregg W. Stone, MD, The Cardiovascular Research Foundation, Columbia University Medical Center, 55 E 59th St, 6th Floor, New York, NY 10022.

Résumé

Background

The filter-based FilterWire EX (Boston Scientific, Natick, MA) embolic protection system and the GuardWire (Medtronic, Santa Rosa, CA) balloon occlusion and aspiration device have been previously shown to reduce periprocedural complication rates of percutaneous coronary intervention for saphenous vein graft (SVG) disease and are considered the standard of care in this setting. The late clinical course after treatment with these devices has not been reported.

Methods

In the FIRE trial, 651 patients undergoing SVG intervention were randomized to either the FilterWire EX or GuardWire. Six-month rates of the primary end point (composite major adverse cardiac events [MACE]) and its components (death, myocardial infarction [MI], or target vessel revascularization) were studied.

Results

MACE at 30 days occurred in 9.9% of patients randomized to the FilterWire EX compared with 11.6% with the GuardWire, P = .53. By 6 months, MACE had increased to 19.3% and 21.9% in FilterWire EX and GuardWire groups, respectively, (relative risk 0.88, 95% CI 0.65-1.19; P = .44). All-cause 6-month mortality in the entire population was 3.5% (3.0% with FilterWire EX vs 4.1% with GuardWire, P = .53, with all deaths occurring after hospital discharge). MI occurred in 12.0% of patients at 6 months (12.1% vs 11.9% with the FilterWire EX and GuardWire, respectively, P = .99), and target vessel revascularization was required in 9.1% (8.2% vs 10.0%, respectively, P = .42).

Conclusions

SVG intervention with the FilterWire EX and GuardWire distal protection devices resulted in similar outcomes at 6 months, although the clinical course after hospital discharge was not benign, with significant rates of death, MI, and repeat intervention.

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Plan

Methods

Patient population and protocol

End points, definitions, and statistical analysis

Results

Patient features and procedural outcomes

Six-month outcomes

Determinants of MACE after distal protection device–supported PCI

Discussion

Clinical course following SVG intervention with or without distal protection

Correlates of late events and implications of procedure-related myonecrosis in distal protection device–supported SVG PCI

Study limitations

Conclusions and clinical implications

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Vol 151 - N° 4

P. 915.e1-915.e7 - avril 2006 Retour au numéro

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Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: Results from the FIRE trial - 17/08/11

Résumé

Background

Methods

Results

Conclusions

Plan

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