Page 83 - BH-3-1

Brain & Heart Bovine pericardial patching in CEA

3.4. Non-inferior evaluation and transcarotid artery revascularization. So far, CEA
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remains the “gold-standard treatment” for patients with
As shown in Table 3, the non-inferiority of the BP patch,
compared with the polyurethane patch, was established carotid artery stenosis who are candidates for intervention
to prevent future cerebrovascular events.
Furthermore,
17,18
for CEA with patch closure in the per-protocol (55/60 vs. CEA with patch closure ensures a safer arteriotomy
54/60, p = 0.013, OR = 0.017, 95% CI [−0.087, 0.120]) and closure, leading to a lower rate of bleeding and hematoma.
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full analysis set (54/57 vs. 54/56, p = 0.016, OR = −0.017, Moreover, it may significantly prevent perioperative
95% CI [−0.093, 0.059]). arterial occlusion (odds ratio [OR] = 0.18, 95% CI = 0.08
4. Discussion – 0.41, p < 0.0001; 7 randomized controlled trials),
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restenosis, and recurrent stroke. However, regarding the
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This current multicenter, randomized controlled trial, with type of patch, an international, multispecialty, expert-based
restenosis as the primary outcome, successfully established Delphi consensus document indicates that it depends on
the non-inferiority of BP patch for carotid artery stenosis personal preference. The advantages of the BP patch,
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treatment compared to polyurethane patch. We found no including its compliance with the biological tissue for easy
significant difference in patient morbidity or mortality surgical handling and reduced intraoperative bleeding,
between the BP patch and polyurethane patch treatment. non-thrombogenic inner surface that was beneficial
Our analysis of the restenosis rate revealed that the for endothelialization, and high resistance to infection,
outcomes were comparable between the two groups. have been demonstrated by Neuhauser and Oldenburg.
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The incidence of carotid artery stenosis in individuals Alternatives to BP patch include autologous veins, Dacron,
aged 30 – 79 years worldwide is 1 – 8% in men and 1 – 2% and PTFE. However, previous studies have highlighted the
in women. With increasing age, the incidence rate shows disadvantages of these patches. For the vein patch, an extra
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a clear upward trend. Moreover, 15 – 20% of ischemic surgical incision is required for getting the saphenous vein
stroke or TIA are caused mainly (>50%) by carotid artery with the potential for the patch to undergo aneurysmal
stenosis. 15,16 There are currently four treatment options: dilatation and rupture. The Dacron patch is associated with
optical medical management, carotid artery stenting, CEA, a higher risk of carotid thrombosis. For the PTFE patch, the

Table 2. Restenosis, morbidity, and mortality rates in the two patient groups perioperatively, at the 6‑ and 12‑month follow‑ups
Occlusion, morbidity, and Perioperative period 6‑month follow‑up 12‑month follow‑up
mortality BP patch Polyurethane p‑value BP patch Polyurethane p‑value BP patch Polyurethane p‑value
group patch group group patch group group patch group
(n=60) (n=60) (n=58) (n=56) (n=57) (n=55)
Death or significant disability 3 1 0.619 0 1 0.491 0 1 0.491
Death 1 0 >0.999 0 0 — 0 1 0.491
Disabling stroke: 1 1 >0.999 0 1 0.491 0 0 —
ischemic/embolic
Disabling stroke: ICH 1 0 >0.999 0 0 — 0 0 —
Non-disabling stroke 1 1 >0.999 0 0 — 0 0 —
TIA 1 1 >0.999 0 0 — 0 0 —
Re-exploration hematoma 0 1 >0.999
Cardiac event 0 0 — 0 1 0.491 0 0 —
Surgical site infection 0 0 —
Restenosis or re-occlusion 0 0 — 1 0 >0.999 2 1 >0.999
Abbreviations: BP: Bovine pericardial; ICH: Intracerebral hemorrhagic stroke; TIA: Temporary ischemic attack.
Table 3. Non‑inferiority evaluation of effective rate of restenosis of carotid artery 1 year or more after operation

Date set BP patch group Polyurethane patch group p‑value 95% CI
FAS 55/60 54/60 0.013 0.017 (−0.087, 0.120)
PPS 54/57 54/56 0.016 −0.017 (−0.093, 0.059)
Note: Non-inferiority margin δ = −10%.
Abbreviations: BP: Bovine pericardial; CI: Confidence interval; FAS: Full analysis set; PPS: Per-protocol set.

Volume 3 Issue 1 (2025) 5 doi: 10.36922/bh.4568