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