| Methods |
Monocentric, single surgeon
Randomisation: list of randomly generated binary digits
No sample size calculation
Patient assignment by sequentially numbered, sealed, opaque envelopes
Recruitment period: 5 years
Mean duration of follow up 34 months (range 1.69 months)
No patients were lost to follow up |
| Participants |
310 patients (31% female)
Mean age 70 years (41 to 89 years)
336 CEA
26 bilateral CEA
Asymptomatic = 46%: 45% in eversion group and 48% in control group |
| Interventions |
Two groups.
Control: PTFE patch CEA
Treatment: 169 arteries by eversion CEA and 167 arteries by CEAP (carotid endarterectomy with PTFE patch)
158 patients by eversion and 152 patients by patch |
| Outcomes |
Perioperative mortality
Perioperative stroke
Recurrent carotid stenosis/occlusion
Local complications: neck hematoma, cranial nerve injuries
Perioperative myocardial infarction |
| Notes |
Exclusions: repeated CEA; CEA with combined CABG, or patients with associated supraaortic trunk lesions requiring contemporary surgery
Patients randomised twice = 26 (bilateral procedures) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
