One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Methods
2.1. Inclusion–Exclusion Criteria
2.2. Data Search
2.3. Data Collection
2.4. Critical Appraisal
2.5. Statistical Analysis
2.6. Endpoints–Definitions
3. Results
Characteristics of Included Studies
4. Findings
5. Discussion
6. Limitations
7. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study | Country | Site(s) | Setting | Trial Identifier | Patients (Estimated) | Enrollment Phase | Already Published |
---|---|---|---|---|---|---|---|
PARADIGM-EXTEND [7] | Poland | Multi-center | Academic | NCT04271033 | 550 | Recruiting | 12-month results of up to 500 patients presented * |
C-GUARDIANS [5] | Multiple countries | Multi-center | Company-sponsored | NCT04900844 | 316 | Finished | 30-day results, awaiting 12-month results |
OPTIMA [8] | Multiple countries | Multi-center | Academic | NCT04234854 | 339 | Finished | 30-day results, awaiting 12-month results |
POLGUARD [9] | Poland | Single-center | Academic | - | 203 | Finished | 30-day results, awaiting 12-month results |
Study (First Author, Year, Acronym) | Country | Centers | Timing and Type | Source(s) of Information | All Patients | All Arteries | Patients Available for Follow-Up Studies |
---|---|---|---|---|---|---|---|
Musialek 2015 (CARENET) [10] | Germany, Poland | Multi-center | Prospective (cohort) | Publications, presentations | 30 | 30 | 28 |
Capoccia 2018 (IRON-guard) [11] | Italy | Multi-center | Prospective (cohort) | Publications, presentations, conference abstracts | 200 | 200 | 199 |
Sirignano 2021 (IRONGUARD 2) [12] | Italy | Multi-center | Prospective (cohort) | Publications, presentations, conference abstracts | 733 | 733 | 726 |
Musialek 2022 (PARADIGM-EXTEND) [7] | Poland | Multi-center | Prospective (cohort) | Publications, ClinicalTrials protocol, presentations, conference abstracts | 500 | 533 | 500 |
Karpenko 2023 (SIBERIA) [13] | Russia | Single-center | Prospective (RCT) | Publications, ClinicalTrials protocol, presentations, conference abstracts | 50 | 50 | 50 |
Tigkiropoulos 2023 [14] | Greece | Single-center | Prospective (cohort) | Publications, individual patient data | 113 | 113 | 113 |
Bramucci 2023 [15] | Italy | Single-center | Retrospective (cohort) | Publications, individual patient data | 83 | 83 | 83 |
Study | All Patients | Patients with Follow-Up Available * | Males (%) | Arteries | Symptoms (%) | Age (m ± SD) | HTN (%) | CAD (%) | DM (%) | PAD (%) | Smoking History (%) ** | AF (%) | DLP (%) | EPD (%) | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
All EPD (%) | Proximal EPD (%) | Distal EPD (%) | ||||||||||||||
Musialek 2015 (CARENET) [10] | 30 | 28 (93.3%) | 19 (63.3%) | 30 | 10 (33.3%) | 71.6 ± 7.6 | 25 (83.3%) | 8 (26.7%) | 7 (23.3%) | NR | 4 (13.3%) | NR | 27 (90%) | 30 (100%) | 1 (3.3%) | 29 (96.7%) |
Capoccia 2018 (IRON-guard) [11] | 200 | 199 (0.5%) | 132 (66%) | 200 | 17 (8.5%) | 72.6 ± 7.09 | 174 (87%) | 68 (34%) | 56 (28%) | NR | 124 (62%) | NR | 148 (74%) | 200 (100%) | 18 (9%) | 182 (91%) |
Sirignano 2021 (IRONGUARD 2) [12] | 733 | 726 (99%) | 516 (70.4%) | 733 | 131 (17.9%) | 73.03 ± 7.84 | 622 (84.9%) | 278 (37.9%) | 264 (36%) | NR | 429 (58.5%) | NR | 552 (75.3%) | 731 (99.7%) | 138 (18.9%) | 593 (81.1%) |
Musialek 2022 (PARADIGM-EXTEND) [7] *** | 500 | 500 (100%) | 363 (72.6%) | 533 | 299 (59.8%) | 69.96 ± 8.14 | NR | 152 (30.4%) | NR | NR | NR | 68 (13.6%) | NR | 533 (100%) | 259 (48.6%) | 274 (51.4%) |
Karpenko 2023 (SIBERIA) [13] | 50 | 50 (100%) | 38 (76%) | 50 | 16 (32%) | 65 ± 7.5 | 48 (96%) | 39 (78%) | 10 (20%) | 15 (30%) | 17 (34%) | NR | NR | 50 (100%) | 0 (0%) | 50 (100%) |
Tigkiropoulos 2023 [14] **** | 113 | 113 (100%) | 82 (72.6%) | 113 | 54 (47.8%) | 70.14 ± 8.63 | 91 (80.5%) | 44 (38.9%) | 42 (37.2%) | 42 (37.2%) | 66 (58.4%) | 12 (10.6%) | 89 (78.8%) | 6 (5.3%) | 0 (0%) | 6 (100%) |
Bramucci 2023 [15] **** | 83 | 83 (100%) | 65 (78.3%) | 83 | 30 (36.1%) | 73 ± 13 | 77 (92.8%) | 32 (38.6%) | 41 (49.4%) | NR | 64 (77.1%) | 14 (16.9%) | 79 (95.2%) | 81 (97.6%) | 59 (72.8%) | 22 (27.2%) |
Total (%) | 1709 | 1699/1709 (99.4%) | 1215/1709 (71.1%) | 1742 | 557/1709 (32.6%) | 71.63 ± 8.39 | 1037/1209 (85.8%) | 621/1709 (36.3%) | 420/1209 (34.7%) | 57/163 (35%) | 704/1209 (58.2%) | 94/696 (13.5%) | 895/1159 (77.2%) | 1631/1742 (93.6%) | 475/1631 (29.1%) | 1156/1631 (70.9%) |
Study | Clear Inclusion Criteria | Standard, Reliable Measurement | Valid Identification Method | Consecutive Inclusion of Patients | Complete Inclusion of Patients | Clear Report of Participant Demographics | Clear Report of Patient Clinical Information | Clear Report of Outcomes/Follow Up | Clear Report of Presenting Site(s)’/Clinic(s)’ Demographic Information * | Appropriate Statistical Analysis ** | Overall Appraisal |
---|---|---|---|---|---|---|---|---|---|---|---|
Musialek 2015 (CARENET) [10] | Yes | Yes | Yes | Yes | Unsure | Yes | Yes | Yes | Unsure | Not applicable | Include |
Capoccia 2018 (IRON-guard) [11] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Unsure | Yes | Include |
Sirignano 2021 (IRONGUARD 2) [12] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Unsure | Yes | Include |
Musialek 2022 (PARADIGM-EXTEND) [7] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Unsure | Yes | Include |
Karpenko 2023 (SIBERIA) [13] | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Unsure | Yes | Include |
Tigkiropoulos [14] 2023 | Yes | Yes | Yes | Yes | Unsure | Yes | Yes | Yes | Unsure | Not applicable | Include |
Bramucci 2023 [15] | Yes | Yes | Yes | No | Unsure | Yes | Yes | Yes | Unsure | Not applicable | Include |
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© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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Tigkiropoulos, K.; Nikas, S.; Manolis, A.-P.; Sidiropoulou, K.; Stavridis, K.; Karamanos, D.; Lazaridis, I.; Saratzis, N. One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis. Medicina 2024, 60, 286. https://doi.org/10.3390/medicina60020286
Tigkiropoulos K, Nikas S, Manolis A-P, Sidiropoulou K, Stavridis K, Karamanos D, Lazaridis I, Saratzis N. One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis. Medicina. 2024; 60(2):286. https://doi.org/10.3390/medicina60020286
Chicago/Turabian StyleTigkiropoulos, Konstantinos, Spyridon Nikas, Abatzis-Papadopoulos Manolis, Katerina Sidiropoulou, Kyriakos Stavridis, Dimitrios Karamanos, Ioannis Lazaridis, and Nikolaos Saratzis. 2024. "One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis" Medicina 60, no. 2: 286. https://doi.org/10.3390/medicina60020286