Safety and efficacy of immediate heparin reversal with protamine after complex percutaneous coronary intervention

Abstract

Background Compared to simple percutaneous coronary intervention (PCI), complex PCI is associated with higher bleeding and thrombotic risk. No previous study has evaluated the use of protamine after PCI with contemporary technologies. This study aimed to evaluate the safety and efficacy of manual compression with and without protamine after transfemoral complex PCI. Methods We retrospectively analyzed 160 patients (protamine group, n = 92; non-protamine group, n = 68) who underwent complex PCI via the femoral artery. The primary outcome was a composite of in-hospital death, myocardial infarction, stent thrombosis, stroke/systemic embolism, bleeding requiring blood transfusion, and vascular access complications. Results The primary outcome was significantly lower in the protamine group than in the non-protamine group (4.3% vs. 17.6%; p = 0.006). This was driven mainly by the lower incidences of hematoma in the protamine group (3.3% vs. 13.2%, p = 0.020). Furthermore, the protamine group had a significantly shorter hospital stay than the non-protamine group (4.8 ± 3.7 days vs. 8.4 ± 8.3 days, p = 0.001). While > 90% of the patients had acute coronary syndrome, there were no incidences of myocardial infarction or stent thrombosis in either group. Conclusions Among patients who underwent complex PCI via transfemoral access, immediate protamine administration was associated with a significantly lower rate of vascular access complications, especially hematoma, and shorter hospital stay than no protamine administration.

Utilization and outcomes of protamine after percutaneous left atrial appendage occlusion

“…The effect of Protamine could be, in theory larger as the Protamine arm likely included infarction. 8,9,19,24,25 Additionally, the composite outcome of any major adverse events, including death, ischemic or hemorrhagic stroke, TIA, major bleeding, vascular complications, and pericardial tamponade did not demonstrate a significant difference between the anticoagulation reversal and control groups further reinforcing the safety of protamine administration during LAAO procedures (5.9% vs. 6%, p = 0.7).…”

“…This combination of anticoagulation reversal plays a critical role in cardiovascular procedures by providing early sheath removal and ambulation and reducing major postoperative bleeding and transfusion rates 16–19 . Multiple studies have demonstrated that major bleeding events are independent predictors of mortality after transcatheter cardiac procedures, including LAAO 20–23 .…”

“…Even though reversal of the anticoagulation effect of heparin may generate concerns about a prothrombotic state, in our study, the use of protamine was not associated with an increased number of thrombotic events; the prevalence of ischemic stroke or transient ischemic attack (TIA) was 0.12%, with 21 (0.1%) cases reported in patients who received protamine, and 31 (0.2%) cases in the control group ( p = 0.1). Contrary to the lack of data for LAAO, the safety, and efficacy of protamine administration has been studied in interventional cardiac procedures like percutaneous coronary interventions (PCI) and transcatheter aortic valve replacement (TAVR), demonstrating a similar decrease in life‐threatening bleeding without increasing the risk of thromboembolic complications including ischemic stroke, and myocardial infarction 8,9,19,24,25 . Additionally, the composite outcome of any major adverse events, including death, ischemic or hemorrhagic stroke, TIA, major bleeding, vascular complications, and pericardial tamponade did not demonstrate a significant difference between the anticoagulation reversal and control groups further reinforcing the safety of protamine administration during LAAO procedures (5.9% vs. 6%, p = 0.7).…”

“…This large variation reflects the differences in practice This combination of anticoagulation reversal plays a critical role in cardiovascular procedures by providing early sheath removal and ambulation and reducing major postoperative bleeding and transfusion rates. [16][17][18][19] Multiple studies have demonstrated that major bleeding events are independent predictors of mortality after transcatheter cardiac procedures, including LAAO. [20][21][22][23] In our cohort, reversal of heparin with protamine in patients undergoing LAAO was associated with a reduction in major bleeding events compared with the control group (2.4% vs. 2.8%, p = 0.03).…”

The contemporary role of protamine in the cardiac catheterization laboratory

“…Larger observational studies have suggested safety of protamine use after CTO PCI 25 as well as after PCI for acute coronary syndrome, 22,29 although selection bias is a limitation of these nonrandomized comparisons. In a contemporary cohort undergoing single‐vessel PCI for stable CAD, protamine use was not associated with stent thrombosis or ischemia‐driven revascularization during a median follow‐up of 1.5 years 28 …”