Is Heparin Reversal with Protamine after Carotid Endarterectomy Dangerous?

Dellagrammaticas, D.; Lewis, Steff; Gough, Michael

doi:10.1016/j.ejvs.2008.01.021

Cited by 42 publications

(33 citation statements)

References 8 publications

(10 reference statements)

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“…13-15 Other literature, including a report from the General Anaesthetic vs Local Anaesthetic for Carotid Surgery (GALA) Trial, has shown conflicting evidence, with reduction in hematoma when using protamine but no differences in reoperation rates. 16-17 …”

Section: Discussionmentioning

confidence: 99%

Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England

Patel

Beaulieu

Homa

et al. 2013

Journal of Vascular Surgery

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Objective The goal of this study was to evaluate whether protamine usage after carotid endarterectomy (CEA) increased within the Vascular Study Group of New England (VSGNE) in response to studies indicating that protamine reduces bleeding complications associated with CEA without increasing the risk of stroke. Methods We reviewed 10,059 CEAs, excluding concomitant coronary bypass, performed within the VSGNE from January 2003 to July 2012. Protamine use and reoperation for bleeding were evaluated monthly using statistical process control. Twelve centers and 77 surgeons entering the VSGNE between 2003 and 2008 were classified as original participants, and 14 centers and 60 surgeons joining after May 2009 were considered new. Protamine use for surgeons was categorized as rare (<10%), selective (10%-80%), or routine (>80%). Outcome measures were in-hospital reoperation for bleeding, postoperative myocardial infarction (POMI), and stroke or death. Results Two significant increases occurred in protamine use for all VSGNE centers over time. From 2003 to 2007, the protamine rate remained stable at 43%. In 2008, protamine usage increased to 52% (P< .01), coincident with new centers joining the VSGNE. Protamine usage then increased to 62% in 2010 (P< .01), shortly after the presentations of the data showing a benefit of protamine. This effect was due to 10 surgeons in the original VSGNE centers who increased their usage of protamine: six surgeons from rare use to selective use and four surgeons to routine use. Reoperation for bleeding was reduced by 0.84% (relative risk reduction, 57.2%) in patients who received protamine (0.6% vs 1.44%; P< .001). There were no differences in POMI (1.1% vs 1.09%) or stroke or death (1.1% vs 1.03%) between protamine treated and untreated patients, respectively. Reoperation for bleeding was decreased for surgeons who used protamine routinely (0.5%; P< .001) compared with selective (1.4%) and rare users (1.5%) of protamine. There were no differences in POMI (0.9%, 1.2%, 1.1%; P = .720) and stroke or death rates (1.0%, 1.2%, 1.0%; P = .656) for rare, selective, and routine users of protamine. Conclusions Protamine use increased over time by VSGNE surgeons, most significantly after the presentations of VSGNE-derived data showing the benefit of protamine, and was associated with a decrease in reoperation for bleeding. Improvements in processes of care and outcomes can be achieved in regional quality groups by sharing safety and efficacy data.

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Section: Discussionmentioning

confidence: 99%

Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England

Patel

Beaulieu

Homa

et al. 2013

Journal of Vascular Surgery

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“…Risk factors for an adverse reaction are sensitivity to fish (as may occur in traditional fishermen who are often exposed to fish proteins when cutting themselves), a history of vasectomy (which may demolish the blood-testis barrier with consequent formation of anti-semen antibodies) and a history of receiving protamine sulphate containing insulin. Initial reports that the use of protamine sulphate could lead to an increased risk of rebound thrombosis, in particular ischemic stroke [12,13] are not confirmed in a recent randomized controlled study [14].…”

Section: Heparin and Low Molecular Weight (Lmw) Heparinmentioning

confidence: 99%

Emergency reversal of antithrombotic treatment

Levi

2008

Intern Emerg Med

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The most important adverse effect of antithrombotic treatment is the occurrence of bleeding. In case of serious or even life-threatening bleeding in a patient who uses anticoagulant agents or when a patient on anticoagulants needs to undergo an urgent invasive procedure, anticoagulant treatment can be reversed by various specific strategies. Heparin and heparin derivatives can be counteracted by protamine sulphate, whereas the anticoagulant effect of vitamin K antagonists may be neutralized by administration of vitamin K or prothrombin complex concentrates. The anti-hemostatic effect of aspirin and other anti-platelet strategies can be corrected by the administration of platelet concentrate or desmopressin, if needed. Recently, a new generation of anticoagulants with a greater specificity towards activated coagulation factors has been introduced and most of these agents are presently being evaluated in clinical studies. The new generation anticoagulants include specific inhibitors of factor IIa, factor Xa (including pentasaccharides) and agents that interfere with tissue factor activity. A limitation of this new class of anticoagulants may be the lack of an appropriate strategy to reverse the effect if a bleeding event occurs, although in some cases the administration of recombinant factor VIIa may be an option.

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“…Early studies noted a higher risk of stroke with postoperative protamine reversal, [4][5][6] but subsequent larger studies found no increased risk of stroke with protamine in patients with carotid endarterectomy. [7][8][9][10] Several of these studies reported a benefit to protamine use via reduced risk of bleeding complications. 6,[9][10][11] Protamine use after percutaneous coronary interventions has also been studied extensively.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][10] Several of these studies reported a benefit to protamine use via reduced risk of bleeding complications. 6,[9][10][11] Protamine use after percutaneous coronary interventions has also been studied extensively. Protamine administration did not predispose to stent thrombosis, 12 myocardial infarction, 13 or coronary restenosis 14 but was found to be associated with reduction in major femoral access site bleeding complications.…”

Section: Discussionmentioning

confidence: 99%

Protamine Does Not Increase Risk of Stroke in Patients With Elective Carotid Stenting

McDonald

Kallmes

Lanzino

et al. 2013

Stroke

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Background and Purpose-Reversal of anticoagulation with protamine might predispose to a higher risk of stroke in patients with carotid stenting. We evaluated a national, multihospital patient database to examine the risk of stroke in patients with carotid stenting receiving protamine compared with those who did not. Methods-The Premier Perspective database was used to identify patients who were electively hospitalized for carotid stenting from 2006 through 2011. The incidence of in-hospital mortality and morbidity was compared between patients who did and did not receive protamine after propensity score adjustment via 1:1 matching to reduce selection bias. Results-Of 6664 patients with carotid stenting treated at 193 hospitals, 556 (8%) received protamine on the day of the procedure. After matching by propensity score, patients who received protamine had a similar likelihood of stroke or transient ischemic attack (P=0.77), in-hospital mortality (P=0.12), discharge to long-term care (P=0.15), and access site complications (P=0.90) as compared with patients who did not receive protamine. Conclusions-Protamine administration is not associated with additional risk of adverse events after carotid stenting.

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Is Heparin Reversal with Protamine after Carotid Endarterectomy Dangerous?

Cited by 42 publications

References 8 publications

Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England

Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England

Emergency reversal of antithrombotic treatment

Protamine Does Not Increase Risk of Stroke in Patients With Elective Carotid Stenting

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