David H. Stone1, Brian W. Nolan1, Andres Schanzer2, Philip P. Goodney1, Robert A. Cambria3, Donald S. Likosky1, Daniel B. Walsh1, Jack L. Cronenwett1, for the Vascular Study Group of Northern New England (VSGNNE)
1Dartmouth Hitchcock Medical Center, Lebanon, NH; 2University of Massachusetts Medical School, Worcester, MA; 3Eastern Maine Medical Center, Bangor, ME
OBJECTIVES: Controversy exists about whether protamine given during carotid endarterectomy (CEA) prevents bleeding or increases thrombotic complications such as stroke or myocardial infarction (MI). The purpose of this study was to determine the effect of protamine reversal of heparin anticoagulation on the outcome of CEA.
METHODS: A prospective regional registry in Northern New England of 4,712 patients undergoing CEA by 66 surgeons from 11 centers from 2003-2008, was reviewed. Protamine use varied by surgeon (38% routine use, 44% rare use, 18% variable use). The primary endpoint was postoperative bleeding requiring reoperation. Secondary endpoints included stroke, death and MI. Predictors of endpoints were determined by univariate analysis using Pearson chi-square (Fisher’s exact correction) and multivariate logistic regression.
RESULTS: Among 4712 patients undergoing CEA, 46% received protamine while 54% did not. Patients who did not receive protamine had a 2.6-fold increase in reoperation for bleeding (Table 1). Protamine use did not affect the rate of stroke, death, or MI. By multivariate analysis, protamine reduced bleeding complications after accounting for other potential predictors of bleeding including center variation, surgical technique, and antiplatelet therapy; (OR 0.43, 95% CI 0.18-0.98, p<.05). Consequences of reoperation for bleeding were a 7-fold increase in stroke, a 30-fold increase in death and a 4-fold increase in MI.
CONCLUSIONS: Protamine reduces serious bleeding complications during CEA without increasing the risk of stroke, death, or MI. Thus, protamine is both safe and beneficial during CEA as practiced in this large, prospective registry. In light of substantial complications referable to bleeding, liberal use of protamine during CEA appears warranted.
AUTHOR DISCLOSURES: D.H. Stone, None; B.W. Nolan, None; A. Schanzer, None; P.P. Goodney, None; R.A. Cambria, None; D.S. Likosky, None; D.B. Walsh, None; J.L. Cronenwett, None.
Table 1.