Protamine Sulfate Following Carotid Artery Stenting: Does the Patient’s Gender Matter?

Abstract

Protamine sulfate can be administrated to decrease the risk of bleeding after the carotid artery stenting (CAS) procedure. Although a few studies reported data regarding the efficacy and safety of protamine, the existing literature assessing its impact under more personalized patient circumstances is limited. Therefore, in this study, we aimed to identify the potential factors where the patients are more likely to benefit from protamine sulfate after CAS procedures. A retrospective review of Vascular Quality Initiative data between 2016 and 2022 to identify all patients who underwent CAS procedures was performed. The patients were divided into two groups based on the surgical approach: transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR). A multivariate model was conducted to identify the perioperative predictors of bleeding complications in each cohort. In addition, a propensity score matching was performed to compare the rates of thrombotic events between protamine vs no protamine groups in both cohorts. A total of 61,686 patients were identified; 36.6% were female. Approximately 53% of the patients underwent TCAR (protamine: 85.6%; no protamine: 14.4%), whereas TF-CAS was performed in 46.8% (protamine: 18.9%; no protamine: 81.1%). Protamine use was associated with a decreased risk of bleeding complications after TCAR (0.26 [0.2-0.3]; P < .001) but not TF-CAS (1.06 [0.8-1.3]; P = .6164). However, the protamine beneficial impact is more apparent among the female patients regardless of the surgical approach (Table). In addition, no significant increase was noted in the thrombotic complications in both TF-CAS (protamine vs no protamine: death, 7.9% vs 11.5%; myocardial infarction, 0.5% vs 0.9%; stroke/transient ischemic attack, 2.8% vs 2.9%; P > .05 for all, except death P < .001) and TCAR (protamine vs no protamine: death, 7.7% vs 7.3%; myocardial infarction, 0.4% vs 0.3%; stroke/transient ischemic attack, 2.4% vs 2.9%; P > .05 for all) groups. Protamine sulfate appears to be effective in reducing the bleeding complications in patients who undergo TCAR but not TF-CAS, without an increase in the thrombotic complications. However, this beneficial impact is more significant among female patients regardless of the CAS approach.TablePerioperative predictors of bleeding complications after TCAR and TF-CASaCovariatebNo protamineProtamineAdjusted odds ratio (95% CI)P valueAdjusted odds ratio (95% CI)P value(A) TCAR Sex (female)1.45 (1.2-1.9).00501.08 (0.9-1.3).4639 Race (Asian) (Ref: White)4.29 (1.4-13.1).01041.31 (0.6-3.0).5139 Symptomatic CHF1.67 (1.1-2.6).02451.21 (0.8-1.7).3206(B) TF-CAS Sex (female)1.76 (1.4 – 2.2)<.0011.14 (0.8 – 1.7).5277ACEI, Angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; CHF, congestive heart failure; CI, confidence interval; COPD, chronic obstructive pulmonary disease; TCAR, transcarotid artery revascularization; TF-CAS, transfemoral carotid artery stenting.aOnly the perioperative predictors that were statistically significant on the univariate and multivariate analysis are shown in this table.bOther covariates: age ≥65, Hispanic ethnicity, comorbidities (hypertension, diabetes, dialysis status, smoking, and COPD), perioperative medications (aspirin, antiplatelet, statin, β-blockers, ACEIs/ARBs), and type of anesthesia. Open table in a new tab