Page 81 - BH-3-1

Brain & Heart Bovine pericardial patching in CEA

age, sex, smoking status, drinking status, and comorbidities statistically significant. A 95% confidence interval (CI) was
such as hypertension, hyperlipidemia, diabetes mellitus, also calculated.
coronary artery disease, and history of stroke. The surgeon
introduced the study to the patients prior to obtaining 3. Results
their informed consent for participating in this study. A total of 120 patients were included in the study, with
2.2. Surgical procedures 60 patients in each group (Figure 1). The average age of
patients was around 65 years old. The majority of patients
The patients received a single oral antiplatelet therapy enrolled were male, accounting for 85% of the subjects
(aspirin 100 mg or clopidogrel 75 mg) before surgery recruited. Three-quarters of patients had experienced
and dual antiplatelet therapy (100 mg aspirin and 75 mg an ischemic event in the past 6 months. There was no
clopidogrel) after surgery. Routine monitoring was significant difference in the variables between the BP patch
carried out using transcranial Doppler during surgery. group and the polyurethane patch group (Table 1; p > 0.05).
If ischemia was detected, shunting was performed to Similarly, the risk factors were comparable between the
maintain adequate brain perfusion. Systemic heparin two groups (Table 1; p > 0.05).
was administered during surgery. Before the first skin
incision, the randomized results were communicated to 3.1. Perioperative outcome
the nurse and surgeon using a study controller. Normal One death occurred in the BP patch group (Table 2). The
internal carotid artery was measured using calipers distal patient experienced a sudden disturbance of consciousness
to the lesion. 6-0 polyprolene sutures (Prolene; Ethicon, 5 days after surgery, and computed tomography (CT)
Somerville, NJ, USA) were used to suture the BP and revealed intracranial hemorrhage. The patient subsequently
polyurethane patches. Post-operative duplex ultrasound succumbed to brain herniation. The BP patch group
scanning was performed in all patients on post-operative recorded three stroke cases and one TIA incident, whereas
day 2, and all patients were continued on a dual antiplatelet two strokes and one TIA occurred in the polyurethane
regimen at home. patch group.

2.3. Outcome assessment Table 2 lists the other perioperative complications;
one patient underwent re-exploration hematoma in the
Patients were followed up perioperatively and at 6 and polyurethane patch group. There were no significant
12 months postoperatively. Duplex ultrasonography or CTA differences between the two groups for any event (p > 0.6).
was used to establish post-operative vessel patency. The The overall death and significant disability rates of the
primary outcome was freedom from post-CEA restenosis patients were 3.3% (4/120) in all participants.
(≥50%) measured using color duplex ultrasonography
or CTA at 1 year after surgery. The secondary outcomes 3.2. Six-month outcomes
included the occurrences of post-operative cranial nerve Six patients were lost to follow-up because they refused to
injury, myocardial infarction, ischemic stroke, heart continue participating in the trial or had died (Table 2).
failure, TIA, hemorrhagic stroke, surgical site infection, The outcomes of the two groups were comparable
and/or re-exploration hematoma and patch dilatation. (p > 0.4). The combined all-cause mortality and disability
2.4. Statistical analysis rates were 0.87% (1/114). An instance of disabling stroke
occurred in the polyurethane patch group. This patient
Based on a previous study, the incidence rate of resolution received medical treatment, which led to symptomatic
of post-CEA restenosis following the utilization of improvement. Patients in the polyurethane patch group
polyurethane patches was approximately 97%. The underwent coronary intervention for myocardial ischemia.
13
patients were randomized to receive the two types of A case of carotid restenosis was recorded in the BP patch
patches in a 1:1 ratio. The non-inferiority boundary was group; however, the patient was asymptomatic and
set at 0.1. Assuming a power of 80%, a two-sided α level of achieved good recovery.
0.025, the target sample size for each group was 48 patients.
Taking into account the additional 10% dropout rate, 3.3. Twelve-month outcomes
the final target sample size was 120 patients (60 in each Eight patients were lost to follow-up due to refusal to
treatment group). participate or death. There were no significant differences
Non-continuous variables were compared using the in any outcome measures between the two groups (p > 0.4;
chi-squared or Fisher’s exact tests, as appropriate. Student’s Table 2). The combined all-cause mortality and disability
t-test or Wilcoxon rank-sum test was used to compare rates at 12 months were 0.89% (1/112). Additional deaths
continuous variables, and a p < 0.05 was considered were recorded in the polyurethane patch group. No new

Volume 3 Issue 1 (2025) 3 doi: 10.36922/bh.4568