The Utilization of Protamine during Peripheral Vascular Interventions in the VQI.

BACKGROUND: Protamine administration was shown to reduce bleeding after carotid surgery but the role of protamine during peripheral vascular interventions (PVIs) remains unknown. This study evaluates the trend and outcomes of protamine use in the Vascular Quality Initiative (VQI). Our hypothesis is that the use of protamine is associated with decreased bleeding after PVI.

METHODS: Patients undergoing elective PVI in the VQI (2016-2020) for peripheral arterial disease were reviewed and the utilization trend for protamine was described. The characteristics of patients undergoing PVI with and without protamine use were compared. After propensity score matching based on the patient's comorbidities, access site, and procedural characteristics, the perioperative outcomes of both groups were compared using multivariable Poisson regression to estimate adjusted rate ratios (aRRs) and 95% confidence intervals (95% CIs).

RESULTS: The total number of patients was 131,618 and patients who received protamine constituted 29.8% of the sample (N = 38,191). After propensity matching, the total number of patients was 94,582, and patients who received protamine constituted 28.8% of the sample (N = 27,275). Protamine use significantly increased during the study period from 5.2 to 22.9%. Before propensity score matching, patients who received protamine were more likely to be white (79% vs. 76.8, P ≤ 0.001), smokers (80.5% vs. 78.5%, P ≤ 0.001), with medical comorbidities including hypertension (88.9% vs. 88.5%, P = 0.074), congestive heart failure (20.5% vs. 19.8%, P = 0.006), and chronic obstructive pulmonary disease (28.2% vs. 26.5%). They were also more likely to be on perioperative medications such as P2Y12 inhibitors (44.3% vs. 45, P = 0.013%) and statin (77.4% vs. 76.5%, P = 0.001) compared to patients who did not receive protamine. After propensity matching, there were no significant differences between the 2 groups. There was a significant decrease in bleeding during procedures where protamine was administered compared to no protamine (2.0% vs. 2.2%) (aRR, 0.89 [95% CI 0.80, 0.98]). Protamine was more likely to be given in procedures complicated by perforation (0.8% vs. 0.5%) (aRR, 1.48 [95% CI 1.24, 1.76]) and less likely to be given during procedures with distal embolization (0.4% vs. 0.7%) (aRR, 0.59 [95% CI 0.49, 0.73]). However, patients receiving protamine had significantly higher cardiac complications (1.4% vs. 1.1%) (aRR, 1.27 [95% CI 1.12, 1.43]). There was no significant difference in mortality between the 2 groups.

CONCLUSIONS: Protamine use is associated with decreased perioperative bleeding but increased cardiac complications. Protamine should be selectively administered to patients at high risk of bleeding during PVI.