Randomized multicenter trial on percutaneous versus open access in endovascular aneurysm repair (PiERO)

Vierhout, B.P.; Pol, Robert A.; Ott, Marc; Pierie, M.E.; Kempenaer, Ties M.G. van Andringa de; Hissink, R.J.; Wikkeling, O.R.; Bottema, Jan T.; Moumni, Mostafa El; Zeebregts, Clark J.

doi:10.1016/j.jvs.2018.07.052

Cited by 31 publications

(41 citation statements)

References 23 publications

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“…The oldest trial was published in 2003 14 and the most recent in 2019. 11 The patient recruitment period spanned from 2002 to 2017. Three RCTs were conducted in Europe (the Netherlands, 11 Austria, 12 and Germany 14 ) and the fourth in the USA.…”

Section: Description Of Studiesmentioning

confidence: 99%

“…11 The patient recruitment period spanned from 2002 to 2017. Three RCTs were conducted in Europe (the Netherlands, 11 Austria, 12 and Germany 14 ) and the fourth in the USA. 13 Two were multicentre studies, 11,13 and two were single centre studies.…”

Section: Description Of Studiesmentioning

confidence: 99%

“…Three RCTs were conducted in Europe (the Netherlands, 11 Austria, 12 and Germany 14 ) and the fourth in the USA. 13 Two were multicentre studies, 11,13 and two were single centre studies. 12,14 Vierhout et al 11 assigned cases to open or percutaneous access of the main device; access on the contralateral side was achieved with the opposite technique.…”

Section: Description Of Studiesmentioning

confidence: 99%

“…13 Two were multicentre studies, 11,13 and two were single centre studies. 12,14 Vierhout et al 11 assigned cases to open or percutaneous access of the main device; access on the contralateral side was achieved with the opposite technique. In the RCT by Uhlmann et al, 12 the assignment to percutaneous access and cutdown was balanced to 25 left sided and 25 right sided percutaneous approaches.…”

Section: Description Of Studiesmentioning

confidence: 99%

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Editor's Choice – Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Antoniou

2021

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDSA meta-analysis was conducted of the most up to date, randomised clinical trial data of percutaneous vs. cutdown endovascular aneurysm repair (EVAR). The risk of bias was assessed with the updated Cochrane methodology, and the evidence was appraised with the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). Percutaneous EVAR was not found to have superior clinical outcomes to cutdown EVAR. The studies were judged to be high risk of bias or have some concerns, and the level of evidence was graded as low or very low for all investigated outcomes. The study highlights the need for high quality evidence on the potential advantages of percutaneous over cutdown EVAR.Objective: To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms. Data sources: MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. Review methods: Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The ManteleHaenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). Results: Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04e0.83]) and the procedure time was significantly shorter (MD e11.53 minutes; 95% CI e15.71e7.34), but hospital length of stay was not different between treatments. Neither the O'BrieneFleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes. Conclusion:The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.

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Section: Description Of Studiesmentioning

confidence: 99%

Section: Description Of Studiesmentioning

confidence: 99%

Section: Description Of Studiesmentioning

confidence: 99%

Section: Description Of Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Editor's Choice – Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Antoniou

2021

European Journal of Vascular and Endovascular Surgery

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“…This study aims to demonstrate the use of percutaneous-only access techniques during these procedures is not inferior to open or combined access methods despite using larger sheaths and devices and may be performed for aortic repair procedures anticipating decreased postoperative pain and shorter recovery with percutaneous access techniques. 9,12…”

Section: Introductionmentioning

confidence: 99%

Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry

Baxter

Hansen

Gable

et al. 2021

Annals of Vascular Surgery

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Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair

Wang

et al. 2023

Cochrane Database of Systematic Reviews

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Randomized multicenter trial on percutaneous versus open access in endovascular aneurysm repair (PiERO)

Cited by 31 publications

References 23 publications

Editor's Choice – Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Editor's Choice – Percutaneous Access Does Not Confer Superior Clinical Outcomes Over Cutdown Access for Endovascular Aneurysm Repair: Meta-Analysis and Trial Sequential Analysis of Randomised Controlled Trials

Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry

Totally percutaneous versus surgical cut-down femoral artery access for elective bifurcated abdominal endovascular aneurysm repair

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