Comparison of a vascular closure device versus the radial approach to reduce access site complications in non‐ST‐segment elevation acute coronary syndrome patients: The angio‐seal versus the radial approach in acute coronary syndrome trial

Andrade, Pedro Beraldo de; Mattos, Luiz Alberto; Rinaldi, Fábio Salerno; Bienert, Igor C.; Barbosa, Robson Alves; Labrunie, André; Tebet, Marden André; Esteves, Vinícius; Abizaid, Alexandre; Sousa, Amanda

doi:10.1002/ccd.26689

Cited by 19 publications

(27 citation statements)

References 23 publications

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“…Of those, 28 articles were excluded because either no RAO/UAO rates were reported or they were reviews/editorials or meta‐analyses not reporting original data on RAO/UAO rates, whereas 5 studies were excluded because they were duplicate reports (Figure ). Finally, 112 original articles assessing RAO and/or UAO were deemed eligible for our meta‐analysis, of which 99 cohorts from 92 studies publishing RAO…”

Section: Resultsmentioning

confidence: 99%

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTE ry Occlusion M eta‐Analys IS ) Systematic Review and Meta‐Analysis

Hahalis

Aznaouridis

Tsigkas

et al. 2017

JAHA

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BackgroundIncidence of radial artery occclusions (RAO) and ulnar artery occclusions (UAO) in coronary procedures, factors predisposing to forearm arteries occlusion, and the benefit of anticoaggulation vary significantly in existing literature. We sought to determine the incidence of RAO/UAO and the impact of anticoagulation intensity.Methods and ResultsMeta‐analysis of 112 studies assessing RAO and/or UAO (N=46 631) were included. Overall, there was no difference between crude RAO and UAO rates (5.2%; 95% confidence interval [CI], 4.4–6.0 versus 4.0%; 95% CI, 2.8–5.8; P=0.171). The early occlusion rate (in‐hospital or within 7 days after procedure) was higher than the late occlusion rate. The detection rate of occlusion was higher with vascular ultrasonography compared with clinical evaluation only. Low‐dose heparin was associated with a significantly higher RAO rate compared with high‐dose heparin (7.2%; 95% CI, 5.5–9.4 versus 4.3%; 95% CI, 3.5–5.3; Q=8.81; P=0.003). Early occlusions in low‐dose heparin cohorts mounted at 8.0% (95% CI, 6.1–10.6). The RAO rate was higher after diagnostic angiographies compared with coronary interventions, presumably attributed to the higher intensity of anticoagulation in the latter group. Hemostatic techniques (patent versus nonpatent hemostasis), geography (US versus non‐US cohorts) and sheath size did not impact on vessel patency.ConclusionsRAO and UAO occur with similar frequency and in the order of 7% to 8% when evaluated early by vascular ultrasonography following coronary procedures. More‐intensive anticoagulation is protective. Late recanalization occurs in a substantial minority of patients.

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Section: Resultsmentioning

confidence: 99%

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTE ry Occlusion M eta‐Analys IS ) Systematic Review and Meta‐Analysis

Hahalis

Aznaouridis

Tsigkas

et al. 2017

JAHA

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“…Recent studies have shown that both radial and femoral approaches were safe after percutaneous coronary intervention but a radial approach had less vascular complications 2,16. On the other hand, a femoral approach with vascular closure device (Angioseal) was noninferior to a radial approach in reducing postcardiac procedure complications 17. However, studies have shown that patients with uninterrupted warfarin undergoing radial approach had less vascular complications 18,19…”

Section: Discussionmentioning

confidence: 99%

Predictors of common femoral artery access site complications in patients on oral anticoagulants and undergoing a coronary procedure

Shammas

Jones-Miller

et al. 2017

TCRM

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BackgroundIt is unclear whether patients on oral anticoagulants (OAC) undergoing a procedure using common femoral artery access have higher adverse events when compared to patients who are not anticoagulated at the time of the procedure.MethodsWe retrospectively reviewed data from consecutive patients who underwent a cardiac procedure at a tertiary medical center. Patients were considered (group A) fully or partially anticoagulated if they had an international normalized ratio (INR) ≥1.6 on the day of the procedure or were on warfarin or new OAC within 48 h and 24 h of the procedure, respectively. The nonanticoagulated group (group B) had an INR <1.6 or had stopped their warfarin and new OAC >48 h and >24 h preprocedure, respectively. The index primary end point of the study was defined as the composite end point of major bleeding, vascular complications, or cardiovascular-related death during index hospitalization. The 30-day primary end point was defined as the occurrence of the index primary end point and up to 30 days postprocedure.ResultsA total of 779 patients were included in this study. Of these patients, 27 (3.5%) patients were in group A. The index primary end point was met in 11/779 (1.4%) patients. The 30-day primary composite end point was met in 18/779 (2.3%) patients. There was no difference in the primary end point at index between group A (1/27 [3.7%]) and group B (10/752 [1.3%]; P=0.3155) and no difference in the 30-day primary composite end point between group A (2/27 [7.4%]) and group B (16/752 [2.1%]; P=0.1313). Multivariable analysis showed that a low creatinine clearance (odds ratio [OR] =0.56; P=0.0200) and underweight patients (<60 kg; OR =3.94; P=0.0300) were independent predictors of the 30-day primary composite end point but not oral anticoagulation (P=0.1500).ConclusionPatients on OAC did not have higher 30-day major adverse events than those who were not anticoagulated at index procedure.

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“…The superiority of radial to femoral access for a variety of endpoints is generally accepted, with a high level evidence base . In this issue, Andrade et al attempted to take this comparison further by performing a randomized study that added use of a vascular closure device (VCD), Angio‐Seal, for the femoral access cohort. Though well intentioned, the trial has features that limit high level comparisons.…”

mentioning

confidence: 99%

“…It has been our perspective that femoral versus radial access studies have been handicapped by not following a wide range of what we believe are best practices for femoral access: (1) micropuncture, (2) fluoroscopic guidance with iterative fluoroscopy, (3) ultrasound guidance (either with or as an alternative to fluoro), (4) femoral angiography at the beginning (not the end) of the case, and (5) hemostasis followed by repuncture if the access is suboptimal, or postponing the case if clinically possible. The methods section and the authors’ prior methodology publication do not clarify whether any of these techniques were used. Ultimately, where a higher level evidence base favors VCDs, it may be as much a testimonial to good access as to the benefits of the VCDs being studied.…”

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confidence: 99%

Revisiting Femoral vs. Radial access—do vascular closure devices level the playing field?

Pasala

Turi

2017

Cathet Cardio Intervent

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Previous large randomized multicenter trials have shown superiority of radial to femoral access in reducing major bleeding, vascular complications, and in some cohorts, mortality Vascular closure devices improve time to hemostasis and ambulation, as well as patient comfort, but have not been shown to reduce major complications or mortality consistently in the high level evidence base. The combination of optimal femoral access and closure with a vascular closure device has the potential to narrow the gap between the radial and femoral approaches in high risk patients, but unfortunately this study was too limited to confirm either non-inferiority or equivalence.

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Comparison of a vascular closure device versus the radial approach to reduce access site complications in non‐ST‐segment elevation acute coronary syndrome patients: The angio‐seal versus the radial approach in acute coronary syndrome trial

Abstract: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 2016 Wiley Periodicals, Inc.

Cited by 19 publications

References 23 publications

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTE ry Occlusion M eta‐Analys IS ) Systematic Review and Meta‐Analysis

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTE ry Occlusion M eta‐Analys IS ) Systematic Review and Meta‐Analysis

Predictors of common femoral artery access site complications in patients on oral anticoagulants and undergoing a coronary procedure

Revisiting Femoral vs. Radial access—do vascular closure devices level the playing field?

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