TY - JOUR
T1 - Carotid artery revascularization using second generation stents versus surgery
T2 - a meta-analysis of clinical outcomes
AU - Mazurek, Adam
AU - Malinowski, Krzysztof
AU - Sirignano, Pasqualino
AU - Kolvenbach, Ralf
AU - Capoccia, Laura
AU - DE Donato, Gianmarco
AU - VAN Herzeele, Isabelle
AU - Siddiqui, Adnan H
AU - Castrucci, Tomaso
AU - Tekieli, Lukasz
AU - Stefanini, Matteo
AU - Wissgott, Christian
AU - Rosenfield, Kenneth
AU - Metzger, D Christopher
AU - Snyder, Kenneth
AU - Karpenko, Andrey
AU - Kuczmik, Waclaw
AU - Stabile, Eugenio
AU - Knapik, Magdalena
AU - Casana, Renato
AU - Pieniazek, Piotr
AU - Podlasek, Anna
AU - Taurino, Maurizio
AU - Schofer, Joachim
AU - Cremonesi, Alberto
AU - Sievert, Horst
AU - Schmidt, Andrej
AU - Grunwald, Iris Q
AU - Speziale, Francesco
AU - Setacci, Carlo
AU - Musialek, Piotr
N1 - Publisher Copyright:
© 2024 EDIZIONI MINERVA MEDICA.
PY - 2024/2/22
Y1 - 2024/2/22
N2 - INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation (‘mesh’) carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/ COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/ Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/ Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).
AB - INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation (‘mesh’) carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/ COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/ Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/ Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).
KW - Humans
KW - Carotid Arteries
KW - Constriction, Pathologic
KW - Endarterectomy, Carotid/adverse effects
KW - Stents
KW - Stroke/etiology
KW - Vascular Surgical Procedures
KW - Randomized Controlled Trials as Topic
KW - Myocardial infarction
KW - Stroke
KW - Carotid endarterectomy
KW - Mortality
KW - Carotid arteries
U2 - 10.23736/S0021-9509.24.12933-3
DO - 10.23736/S0021-9509.24.12933-3
M3 - Review article
C2 - 38385840
SN - 0021-9509
VL - 64
SP - 570
EP - 582
JO - The Journal of Cardiovascular Surgery
JF - The Journal of Cardiovascular Surgery
IS - 6
ER -