Dataset Information

Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.

ABSTRACT: New-generation drug-eluting stents (DESs) represent the standard of care for patients undergoing percutaneous coronary intervention (PCI). Recent iterations in DES technology have led to the development of newer stent platforms with a further reduction in strut thickness. This new DES class, known as ultrathin struts DESs, has struts thinner than 70 µm. The evidence base for these devices consists of observational data, large-scale meta-analyses, and randomized trials with long-term follow-up, which have been conducted to investigate the difference between ultrathin struts DESs and conventional new-generation DESs in a variety of clinical settings and lesion subsets. Ultrathin struts DESs may further improve the efficacy and safety profile of PCI by reducing the risk of target-lesion and target-vessel failures in comparison to new-generation DESs. In this article, we reviewed device characteristics and clinical data of the Orsiro (Biotronik, Bülach, Switzerland), Coroflex ISAR (B. Braun Melsungen, Germany), BioMime (Meril Life Sciences Pvt. Ltd., Gujarat, India), MiStent (MiCell Technologies, USA), and Supraflex (Sahajanand Medical Technologies, Surat, India) sirolimus-eluting stents.

SUBMITTER: Leone A

PROVIDER: S-EPMC9503315 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.

Leone Attilio A Simonetti Fiorenzo F Avvedimento Marisa M Angellotti Domenico D Immobile Molaro Maddalena M Franzone Anna A Esposito Giovanni G Piccolo Raffaele R

Journal of personalized medicine 20220825 9

New-generation drug-eluting stents (DESs) represent the standard of care for patients undergoing percutaneous coronary intervention (PCI). Recent iterations in DES technology have led to the development of newer stent platforms with a further reduction in strut thickness. This new DES class, known as ultrathin struts DESs, has struts thinner than 70 µm. The evidence base for these devices consists of observational data, large-scale meta-analyses, and randomized trials with long-term follow-up, w ...[more]

PMID: 36143162

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Project description:BackgroundDrug-eluting stents have been seen as an attractive alternative to bare-metal stents for percutaneous coronary interventions (PCIs) because of the decreased need for revascularization. However, comparative clinical trials have shown no difference in patient outcomes, and drug-eluting stents are considerably more expensive than their bare-metal counterparts. We conducted a systematic review of all published comparative cost-effectiveness analyses to identify the factors contributing to the heterogeneity of their conclusions.MethodsWe retrieved all articles published between Jan. 1, 2000, and July 31, 2006, in which the cost-effectiveness, from a third-party payer perspective, of drug-eluting stents was compared with that of bare-metal stents for PCI in unrestricted patient populations. Electronic databases, Web sites from health technology assessment groups and references of identified articles were searched. Our outcome variable was whether the study's conclusions favoured widespread use of drug-eluting stents, as assessed by 4 independent reviewers. Study characteristics such as quality, funding source, country and year of publication were extracted. Two-by-2 tables and Fisher's exact test were used to study the association between covariates and the outcome variable. A classification and regression tree (CART) model was used for multivariate analysis.ResultsWe identified 19 cost-effectiveness analyses. Ten were in favour of widespread use of drug-eluting stents, and 9 favoured more restrained use. Only 1 of 9 high-quality studies supported widespread use, as compared with 9 of 10 lower quality studies (p < 0.001). All of the 7 sponsored studies argued in favour of widespread use, as compared with 3 of the 12 studies without sponsorship (p = 0.003). Studies from the United States were more likely than those from other countries to endorse unlimited use (p = 0.032). A CART model with 2 covariates--study quality and sponsorship--provided the best fit (error rate 10.5%).InterpretationConclusions drawn by cost-effectiveness analyses of drug-eluting stents for PCI are associated with the study's quality, funding source and country of origin. Vigilance regarding these study characteristics is required when interpreting findings from cost-effectiveness analyses.

Project description:ObjectiveTo compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.DesignMixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials.Data sources and study selectionPubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.OutcomesLong term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.ResultsFrom 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.ConclusionsBiodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven.

Dataset Information

Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.

Publications

Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.

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