Methods

Study design: RCT
Method of randomisation: block
Concealment of allocation: unblinded

Participants

Country: USA

No: 151

Ages: 70 ± 6.6, 74 ± 11, 73 ± 8.8 for PG, PS and femoral cut down (cut‐down femoral artery access) groups respectively

Sex: 136 male, 15 female

Inclusion criteria:

• presenting with AAA with maximal diameter ≥ 5 cm or rapidly expanding

• over the age of 18

• informed consent form understood and signed, and agreement to all follow‐up visits

• suitable ipsilateral common femoral artery for percutaneous access with preclose technique ‐ with criteria for this specified

• anatomical eligibility for Endologix System (EVAR stent)

• life expectancy > 1 yr (judged by investigator)

• serum creatinine level ≤ 1.7 mg/dL

• no planned major intervention or surgery within 30 days after study procedure

• not morbidly obese (BMI < 40 kg/m²)

Exclusion criteria:

• prior groin incision, haematoma or significant scarring at ipsilateral arterial access site, clip based vascular closure device placement ever, collagen‐based vascular closure device placement in either arterial access site within prior 90 days, femoral artery needle puncture in either arterial access site within prior 30 days

• localised groin infection, traumatic vascular injury, femoral artery aneurysm, arteriovenous fistula, pseudoaneurysm

• allergy to any device component, coagulopathy or uncontrolled bleeding disorder, active systemic infection, connective tissue disease, prior renal transplant

• cerebrovascular event or myocardial infarction within 3 months of enrolment

Interventions

All aneurysms were repaired using the Endologix 21F profile based sheath system (Endologix, Inc, Irvine, California).
Open femoral exposure, n = 50. In these participants a small oblique incision was made, with direct exposure and control of the femoral artery. Access site closure was achieved with direct artery repair and layered wound closure
Perclose ProGlide, n = 50. In these participants a 8F Perclose ProGlide (PG) device (Abbott Vascular, Inc, Redwood City, California) was used in the pre‐close technique for closure of the access site
Prostar XL, n = 51. In these participants a 10F Prostar (PS) XL device (Abbott Vascular, Inc, Redwood City, California) was used in the pre‐close technique for closure of the access site.
Postdeployment graft position/aneurysm exclusion was confirmed angiographically in all cases.

Outcomes

Primary endpoint: 'treatment success'; a composite endpoint comprising procedural technical success and absence of major adverse events or vascular complications at 30 days.
Secondary endpoints: activated clotting time, contrast volume, fluoroscopy time, estimated blood loss, blood transfusion, procedure time, ipsilateral time to haemostasis, time to ambulation, time to normal diet, ICU length of stay, medication for groin pain and time to hospital discharge.
Subgroup analysis: major ipsilateral access‐related complications (vascular injury, lower extremity ischaemia, bleeding/transfusion, nerve injury) of PS and PG versus femoral exposure at 30 days.

Notes

It should be noted that one study author served on the Scientific Advisory Board for Endologix, Inc, and three authors are on the Endologix, Inc speaker’s bureau. In addition, the trial was funded by Endologix, Inc, with financial contribution by Abbott Vascular, Inc. and all Abbott Vascular, Inc ipsilateral closure devices provided free of charge. This is unlikely to have influenced the primary outcomes as there was good follow up to 30 days and the protocol was adhered to. However had the results shown inferiority of percutaneous access publication bias may have been introduced.

One further manuscript (Krajcer 2013), presented the 30‐day results of the same trial. The data extracted from Krajcer 2013 was the same as Nelson 2014, and was not considered as a separate data set; data were cross checked to ensure reporting consistency.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation by study site, using two block sizes (3 or 6) with random choice of block size order. Sealed randomisation envelopes were used. 2:1 randomisation (PEVAR:FE) was used, with equal allocation to the two PEVAR groups (PG, PS).

Allocation concealment (selection bias)

Low risk

Sealed randomisation envelopes were used: on screening eligibility confirmation the next sequential randomisation envelope was opened and assignment immediately allocated

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding was not possible due to due nature of surgical interventions

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Unlikely relating to the primary endpoint and subgroup analysis as they are objective in nature

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants reported with no loss to follow‐up at 30 days. There was 9% loss to follow‐up at 6 months. This only affects 1 secondary outcome within the review (long‐term complications). Reasons for loss to follow‐up were given for each group.

Selective reporting (reporting bias)

Low risk

Primary endpoint, secondary outcomes and subgroup analysis clearly defined and reported

Other bias

Low risk

See 'notes' section in table above

Methods

Study design: RCT

Method of randomisation: not reported

Concealment of allocation: unblinded

Participants

Country: Germany

No: 30

Age: 51‐90 years (mean 72.9 ± 9.9 years)

Sex: 29 male, 1 female

Inclusion criteria:

• anyone presenting with an AAA considered, including those with calcification of femoral artery, scars in the groin or obesity

Exclusion criteria:

• people with psychiatric conditions

• those undergoing the implantation of an aorto‐mono‐iliac graft

• people with an aneurysm of the femoral artery

Interventions

Aneurysms were repaired using either the Zenith graft (Cook, Bloomington, Ind), n = 16, or using the Talent endovascular graft (Medtronic, Sunrise, Fla), n = 14

Percutaneous access, n = 15. In these participants a 10F Prostar XL percutaneous vascular surgery device (Perclose, Redwood City, Calif) was used in the pre‐close technique for closure of the access site.

Surgical cut‐down (femoral artery access), n = 15. In these participants a transverse groin incision was made to expose the common femoral artery for direct needle puncture.

All participants received 5000 IU of heparin after sheath insertion. Duplex ultrasound scanning was performed before and after the procedure.

Outcomes

Outcomes: operative success (the successful closure of the femoral artery following insertion of graft); in‐hospital mortality and major complications; wound complications; re‐intervention rate; blood loss; operative time and time to ambulation; total operative cost.

Notes

No conflicts of interest reported. Attempt made to contact authors via e‐mail on 21/12/2015 with no reply received.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method of randomisation not reported

Allocation concealment (selection bias)

Unclear risk

Allocation concealment not reported and no details given

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible due to nature of surgical interventions

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Unlikely given the outcome measures used being objective in nature

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All patients fully reported with no loss to follow‐up due to small numbers and short time scale

Selective reporting (reporting bias)

Unclear risk

Selected outcomes not outlined making the paper more prone to selective reporting, however most major outcomes appear to have been reported

Other bias

Low risk

None identified