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 RR3. Protamine Sulfate Use Does Not Lower Hemorrhagic Complications in Lower Extremity Bypass (LEB)

​James T. McPhee, Karen J. Ho, Joseph Lopez, Robert Glynn, Michael Belkin, Matthew T. Menard
Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA.

OBJECTIVES: Protamine Sulfate (PS) use in LEB is highly variable. We sought to evaluate whether our selective use of PS was associated with hemorrhagic or thrombotic complications following LEB.

METHODS: All LEB in our institutional registry for occlusive disease from 1/05-7/11 were included. 519 LEB underwent 1:1 propensity score matching to create similar PS and no-PS cohorts. The primary endpoint was a composite of hemorrhagic complications (hematoma, re-op for bleeding, transfusion). 30-day graft patency was a secondary endpoint.

RESULTS: 358 matched bypasses were analyzed: 179 received PS and 179 did not. The propensity matched groups were similar across all assessed variables (Table). By univariate analysis, the PS and no-PS groups had similar rates of postop hematoma (5.6% vs. 3.3%, p=0.44), re-exploration for bleeding (1.7% vs. 1.1%, p=0.84), transfusion (20.1% vs. 18.4%, p=0.79), and composite "any-bleeding complication" (24.6% vs. 20.7%,p=0.45). Each group had a similar 30-day primary patency rate of 96%. By multivariable analysis, PS use did not reduce hemorrhagic complications (OR 0.8; 95% CI 0.48-1.3; p=0.35) and was not associated with loss of primary patency (HR 0.72; 95% CI 0.49-1.05; p=0.1).

CONCLUSIONS: This propensity matched analysis demonstrates that while selective use of PS was not protective against hemorrhagic complications, it appears safe for use even in grafts at higher risk of thrombosis.

AUTHOR DISCLOSURES: M. Belkin, Nothing to disclose; R. Glynn, Nothing to disclose; K. J. Ho, Nothing to disclose; J. Lopez, Nothing to disclose; J. T. McPhee, Nothing to disclose; M. T. Menard, Nothing to disclose.

 

Table: Baseline Characteristics

Unmatched Cohort
Propensity Matched Cohort
No protamine (%) N=227 (43.7)
Protamine N=292 (56.3)
p-value
No Protamine (%) N=179 (50)
Protamine (%) N=179 (50)
p
Mean age [StdDev]
68.5 [11.4]
69.4 [11.9]
0.29
69.1 [11.2]
69.0 [12.4]
0.74
White Race
171 (75.3)
240 (82.2)
0.06
140 (78.2)
144 (80.4)
0.7
Diabetes Mellitus
129 (56.8)
140 (47.9)
0.05
95 (53.1)
92 (51.4)
0.83
Critical Limb Ischemia Indication
183 (80.6)
230 (78.8)
0.66
141 (78.8)
137 (76.5)
0.7
Preoperative Coumadin
40 (17.6)
72 (24.7)
0.07
38 (21.2)
40 (22.3)
0.9
InfraPopliteal Target Vessel
131 (57.7)
133 (45.5)
0.006
93 (51.9)
93 (51.9)
>0.99
Any completion study
191 (84.1)
209 (71.6)
0.0007
149 (83.2)
147 (82.1)
0.89
\"Good\" runoff (2-3 vessel)
86 (37.9)
140 (47.9)
0.03
75 (41.9)
76 (42.5)
>0.99
Prosthetic Conduit
46 (20.3)
96 (32.9)
0.001
43 (24.0)
42 (23.5)
>0.99

Posted April 2012

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