Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Background: Single-cohort studies suggest that second-generation stents (SGS; “mesh stents”) may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a “mesh stent” class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.
Competing Interests: Kenneth Rosenfield reports receiving fees for serving on advisory boards from Abbott Vascular, Cardinal Health, Surmodics, Inari Medical, Volcano/Philips, and Proteon; receiving fees and stock options for serving on advisory boards from Cruzar Systems, Valcare, and Eximo; receiving stock options for serving on advisory boards from Capture Vascular, Shockwave, Micell, Endospan, and Silk Road Vascular; receiving stock options for serving on the advisory boards of and the holding of equity positions in Contego, Access Vascular, and MD Insider; holding stock/stock options in Embolitech, Janacare, Primacea, and PQ Bypass; receipt of a future payout from a previous equity position in Vortex; and receiving grant support paid to his institution from Abbott Vascular, Atrium/Maquet, and Lutonix/Bard. David Christopher Metzger is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial. Adnan H. Siddiqui has consulted for Amnis Therapeutics Ltd, Cerebrotech Medical, Systems Inc, CereVasc LLC, Claret Medical Inc, Codman, Corindus Inc, GuidePoint Global Consulting, Medtronic (Formerly Covidien), MicroVention, Neuravi, Penumbra, Pulsar Vascular, Rapid Medical, Rebound Therapeutics Corporation, Silk Road Medical, Stryker, The Stroke Project Inc, Three Rivers Medical Inc, W.L. Gore & Associates, and is a Board Member of Intersocietal Accreditation Commission. He has been Principal Investigator and/or served on Steering Committees for: Codman & Shurtleff, LARGE Trial, Covidien (Now Medtronic), SWIFT PRIME and SWIFT DIRECT Trials; MicroVention, FRED Trial, CONFIDENCE Study, MUSC, POSITIVE Trial; Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial. AHS has financial interests in BuffaloTechnology Partners Inc, Cardinal, International Medical Distribution Partners, Medina Medical Systems, Neuro Technology Investors, StimMed, and Valor Medical. Piotr Pieniazek has proctored and/or consulted for Terumo, Boston Scientific and Balton. Joachim Schofer has been Co-Principal Investigator in the CARENET Trial. Andrej Schmidt has consulted for Abbott Vascular, BD, Cook and Medtronic. Piotr Musialek has proctored and/or consulted for Abbott Vascular, InspireMD, and Medtronic. PM is Co- Principal Investigator in the CGUARDIANS FDA-IDE Trial and has been Co-Principal Investigator in the CARENET Trial; he is Principal Investigator in a series of Investigator-Initiated studies including PARADIGM/PARADIGM-Extend (NCT04271033), FLOW-GUARD (NCT04461717), OPTIMA (NCT04234854), TOP-GUARD (NCT0454738), C-HEAL (NCT04434456), SIM-GUARD (NCT04973579) and SAFEGUARD-STROKE (NCT05195658). PM is the Polish Cardiac Society Board Representative for Stroke and Vascular Interventions and serves on the European Society of Cardiology (ESC) Stroke Council Scientific Documents Task Force and on ESC Research and Grants Committee. Other author declare no conflict of interest.