Safety of heparin reversal with protamin and immediate sheath removal after coronary angioplasty

Lohne, F.; Kløw, Nils‐Einar; Stavnes, Sindre; Brekke, Magne; Hoffmann, Pavel; Stensæth, Knut Haakon; Søvik, Edmund; Pettersen, Morten

doi:10.1080/02841850410003743

Cited by 7 publications

(13 citation statements)

References 14 publications

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“…Randomized trials in both elective and acute patients have shown that postprocedural protamine administration is safe and associated with a significant reduction in bleeding complications 25,26 . A significant safety concern would be the risk of stent thrombosis.…”

Section: Discussionmentioning

confidence: 99%

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Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR)

et al. 2021

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Background: Coronary angiography (CAG) and percutaneous coronary intervention (PCI) are performed via the femoral or radial arteries. In patients examined via transfemoral access, closure devices facilitate hemostasis, but it is unknown whether it is safe to mobilize these patients immediately and how acceptable this may be in terms of patient comfort. Objective: The aims of this study were to investigate bleeding complications in patients mobilized immediately after transfemoral CAG or PCI compared with patients on bed rest (BR) for 2 hours after the procedure and, furthermore, to investigate patient comfort in relation to mobilization and BR. Methods: SAMOVAR was a noninferiority trial with patients randomized to immediate mobilization (IM) or 2 hours of BR after transfemoral CAG or PCI and use of the AngioSeal as a closure device and reversal of heparin effect. The primary end point was development of hematoma greater than 5 cm, pseudoaneurysm, or bleeding requiring blood transfusion. Secondary end points were oozing from the puncture site, small hematoma, and patient comfort. Results: Of 2027 patients (IM, 1010; BR, 1017), 40% underwent PCI. The primary outcome was recorded in 0.7% patients randomized to IM versus 0.5% in BR (P = .58). There was no difference in the incidence of small hematoma, whereas persistent oozing was seen slightly more often after IM compared with BR (12% vs 9%, P = .04). Patients mobilized immediately reported less back pain and micturition problems (P < .001). Conclusions: In patients who had CAG and PCI performed through transfemoral access, reversal of anticoagulation and use of closure devices allowed IM with low rates of complications and improved patient comfort.

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Section: Discussionmentioning

confidence: 99%

“…Previous randomized trials have shown that protamine sulfate administration after PCI is safe and associated with a significant reduction in bleeding complications in both elective and acute patients without an increased risk of stent thrombosis. [24][25][26]…”

mentioning

confidence: 99%

Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR)

et al. 2021

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“…Other two trials were excluded because of absence of any control group [6,13]. One randomized trials was excluded because of unavailability of complete data [14] whereas another randomized trial was excluded because of the comparison with bivalirudin [10] (Fig. 1).…”

Section: Eligible Studiesmentioning

confidence: 99%

“…Of the 45 potentially relevant articles, 10 trials [5][6][7][8][9][10][11][12][13][14] were initially screened (4 randomized [5,10,11,14] and 6 non randomized trials [6-9, 12, 13]. One non randomized trial [7] was excluded due to extreme difference in the proportion of patients and due to the fact that many patients received protamine due to coronary rupture.…”

Section: Eligible Studiesmentioning

confidence: 99%

Safety and benefits of protamine administration to revert anticoagulation soon after coronary angioplasty. A meta-analysis

Luca

Parodi

Antoniucci

2010

J Thromb Thrombolysis

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Recent studies suggests that bleeding complications are associated with worse clinical outcome and survival among patients undergoing coronary angioplasty. Thus, in the last years increasing interests have been focused on strategies to prevent bleeding complications. The administration of protamine after coronary stenting for early sheath removal seems very attractive to minimize local and systemic bleeding complications. Thus, the aim of the current study is to perform a meta-analysis of randomized and non-randomized trials evaluating the benefits and safety of protamine administration after coronary angioplasty. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL) from January 1990 to December 2009. The following key words were used: coronary angioplasty, primary angioplasty, coronary stenting, protamine, heparin neutralization, bleeding complications. Primary endpoints were death and major bleeding complications, respectively. Secondary endpoint was myocardial infarction. A total of 5 trials, 2 randomized and 3 non randomized were included in the meta-analysis, involving 6,762 patients (4,913 or 72.6% in the protamine group and 1,949 or 27.4% in the standard group). Protamine administration was not associated with difference in short-term mortality (2.8% vs. 2.7%, OR [95% CI] = 0.97 [0.69-1.37], P = 0.88, p(het) = 1.0), but with a significant reduction in major bleeding complications (2.4% vs. 4.1%, OR [95% CI] = 0.51 [0.37-0.69], P < 0.0001, p(het) = 0.53, NNT = 58.8). No difference was observed myocardial infarction (0.9% vs. 0.8%, OR [95% CI] = 1.14 [0.63-2.07], P = 0.66, p(het) = 0.89). This meta-analysis shows that protamine administration after percutaneous coronary intervention seems to be safe and associated with a significant reduction in major bleeding complications. Pending the results of larger randomized trials, its use may be considered after coronary angioplasty.

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“…Before the widespread use of radial access for percutaneous coronary intervention (PCI), as well as the availability of contemporary vascular closure devices, there was interest in routine use of protamine to facilitate femoral access hemostasis and early mobilization. [2][3][4] Contemporary use of protamine to address bleeding in the setting of high-risk PCI with temporary mechanical circulatory support (MCS) device placement is not well characterized. There have been several recent small studies assessing the role of protamine for access hemostasis after structural interventions, suggesting that protamine is safe and may reduce the risk of posttranscatheter aortic valve replacement (TAVR) bleeding.…”

Section: Introductionmentioning

confidence: 99%

The contemporary role of protamine in the cardiac catheterization laboratory

Danek

Kearney

Chung

et al. 2023

Cathet Cardio Intervent

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Access to the arterial circulation and full anticoagulation carries a risk of serious bleeding during and after percutaneous coronary intervention. Important sources of bleeding include the arterial access site and coronary artery perforation. Prompt and effective management of hemorrhagic complications is an essential interventional skill. Protamine sulfate is well-known as a heparin reversal agent. Despite this, there is heterogeneity in the use of protamine during interventional procedures. While protamine is generally well-tolerated, it is associated with a risk of hypersensitivity reaction, including anaphylaxis, among others. The purpose of this review is to summarize the existing evidence about and experience with the use of protamine sulfate in the setting of percutaneous coronary and structural interventional procedures.

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Safety of heparin reversal with protamin and immediate sheath removal after coronary angioplasty

Abstract: Protamin reversal improved patient comfort and reduced immobilization time. The cardiac safety concern observed requires the antiplatelet agent clopidogrel to be given before the procedure.

Cited by 7 publications

References 14 publications

Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR)

Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR)

Safety and benefits of protamine administration to revert anticoagulation soon after coronary angioplasty. A meta-analysis

The contemporary role of protamine in the cardiac catheterization laboratory

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