Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery

Iantorno, Micaela; Lipinski, Michael J.; García‐García, Héctor M.; Forrestal, Brian J.; Rogers, Toby; Gajanana, Deepakraj; Buchanan, Kyle; Torguson, Rebecca; Weintraub, William S.; Waksman, Ron

doi:10.1016/j.amjcard.2018.07.040

Cited by 62 publications

(38 citation statements)

References 28 publications

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“…For example, two BRSs, Magmaris (164 μm magnesium, Biotronik, Germany) [ 8 ] and ART-BRS (170 μm PLA, Arterial Remodeling Technologies, France) were approved by CE, and two BRSs, Neovas (170 μm PLA, Lepu, China) [ 9 ] and Xinsorb (160 μm PLA, Huaan, China) were approved by China National Medical Products Administration [ 10 ]. While permanent thin-strut stents gradually demonstrate noninferiority or superiority to state-of-the-art permanent stents [ [11] , [12] , [13] , [14] ], resulting in more rapid endothelial coverage [ 15 ] and thus decreased stent thrombosis (ST) and myocardial infarction [ 16 ], an increasing number of novel designed thin-strut polymeric and metallic BRSs are emerging and coming into market or clinical trials [ 17 ], including MeRes100 (100 μm PLA, Meril Life Science, India) [ 18 ], DESolve Cx (120 μm PLA, Elixir, USA) and Fantom (125 μm polycarbonate, REVA, USA) with CE Mark in 2016–2019, IBS (73 μm iron, Biotyx, China) [ 19 ], Magnitude (98 μm PLA, Amaranth Medical, USA) and Firesorb (100–125 μm PLA, Microport, China) [ 20 ] in clinical research. The future direction of BRS iteration is of thin struts, reduced vessel wall coverage area and sufficient radial strength [ [21] , [22] , [23] ].…”

Section: Introductionmentioning

confidence: 99%

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Lin

Zhang

et al. 2021

Bioactive Materials

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Detection of in vivo biodegradation is critical for development of next-generation medical devices such as bioresorbable stents or scaffolds (BRSs). In particular, it is urgent to establish a nondestructive approach to examine in vivo degradation of a new-generation coronary stent for interventional treatment based on mammal experiments; otherwise it is not available to semi-quantitatively monitor biodegradation in any clinical trial. Herein, we put forward a semi-quantitative approach to measure degradation of a sirolimus-eluting iron bioresorbable scaffold (IBS) based on optical coherence tomography (OCT) images; this approach was confirmed to be consistent with the present weight-loss measurements, which is, however, a destructive approach. The IBS was fabricated by a metal-polymer composite technique with a polylactide coating on an iron stent. The efficacy as a coronary stent of this new bioresorbable scaffold was compared with that of a permanent metal stent with the name of trade mark Xience, which has been widely used in clinic. The endothelial coverage on IBS was found to be greater than on Xience after implantation in a rabbit model; and our well-designed ultrathin stent exhibited less individual variation. We further examined degradation of the IBSs in both minipig coronary artery and rabbit abdominal aorta models. The present result indicated much faster iron degradation of IBS in the rabbit model than in the porcine model. The semi-quantitative approach to detect biodegradation of IBS and the finding of the species difference might be stimulating for fundamental investigation of biodegradable implants and clinical translation of the next-generation coronary stents.

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Section: Introductionmentioning

confidence: 99%

In vivo degradation and endothelialization of an iron bioresorbable scaffold

Lin

Zhang

et al. 2021

Bioactive Materials

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“…However, various studies have reported that thinner struts provide rapid healing and complete endothelial coverage, which may reduce the risk of thrombus formation 14,18. A recent meta-analysis also confirmed that DESs with thinner struts have significant associations with reduced risk of stent thrombosis and MI compared to thicker-strut DESs 19…”

Section: Discussionmentioning

confidence: 94%

<p>Real-World Use Of Ultrathin-Strut Biodegradable Polymer–Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes</p>

Ajmera¹,

Pothineni²,

Chawla³

et al. 2019

VHRM

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BackgroundAlthough a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer–coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt–chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation.MethodsThis was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up.ResultsThe mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up.ConclusionThe results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.

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“…In support of these findings, but in a low-risk population, the Ticagrelor Monotherapy After three Months in the Patients Treated With New Generation Sirolimus-eluting Stent for ACS (TICO) study demonstrated that switching to ticagrelor monotherapy after three months of DAPT significantly reduced the frequency of the composite primary endpoint Considering the evidence, it is becoming increasingly apparent that a tailored approach is required for ticagrelortreated patients, particularly those with ACS. While the management of modifiable risk factors and development of thinstrut, biocompatible DES is improving clinical outcomes [8,133], current evidence suggests the need for a dichotomization of treatment whereby those with unmodifiable risk factors for atherothrombotic events, but with a low risk of bleeding, receive long-term DAPT and those with controllable risk factors or a high risk of bleeding receive ticagrelor monotherapy following short-term DAPT [134].…”

Section: Studies Of Ticagrelor In Percutaneous Coronary Interventionmentioning

confidence: 99%

“…While contemporary advances have improved the control of modifiable risk factors, reduced complications associated with percutaneous coronary intervention (PCI) [8], and reduced the risk of recurrent ischaemia post-ACS, there remains a significant degree of residual risk in patients with CAD. Ticagrelor provides several hypothetical and pharmacological advantages over aspirin and other oral P2Y 12 inhibitors that have the potential to optimise patient outcomes in novel antiplatelet strategies by reducing the risk of ischaemia in DAPT or reducing the risk of bleeding as a monotherapy [9,10].…”

Section: Introductionmentioning

confidence: 99%

Ticagrelor: clinical development and future potential

Sanderson¹,

Parker²,

Storey³

2021

Rev. Cardiovasc. Med.

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Platelets participate centrally in atherothrombosis, resulting in vessel occlusion and ischaemia. Consequently, optimisation of antiplatelet regimens has the potential to further reduce the residual burden of morbidity and mortality associated with atherosclerosis. Ticagrelor is a potent oral platelet P2Y12 receptor antagonist that (1) inhibits a central amplification pathway of platelet activation directly as well as via an active metabolite, (2) has a rapid onset and offset of antiplatelet action that remains consistent in the circulation during twice-daily administration and is amenable to reversal, (3) has inverse agonist properties, and (4) demonstrates pleiotropic effects that contribute to anti-thrombotic, anti-inflammatory and vasodilatory properties. These advantageous characteristics of ticagrelor have translated to beneficial clinical outcomes in patients with acute coronary syndromes or ischaemic stroke, during prolonged maintenance therapy in specific high-risk populations, and following percutaneous coronary intervention but not definitively following coronary artery bypass graft surgery or in peripheral artery disease patients. Novel innovative strategies aim to reduce the risk of bleeding during dual antiplatelet therapy via shortening the duration of treatment and replacing the standard-of-care with ticagrelor monotherapy. In cases where aspirin is an essential component in secondary prevention, dose modification when combined with ticagrelor may hypothetically provide desirable clinical outcomes following appropriate clinical assessment as predicted by pharmacological studies. Overall, the future management of acute coronary syndromes could potentially involve the dichotomisation of antithrombotic therapies, whereby only those with high-risk of ischaemia, without a high-risk of bleeding, receive ticagrelor plus very-low-dose aspirin, while ticagrelor monotherapy is administered to the remaining majority.

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Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery

Cited by 62 publications

References 28 publications

In vivo degradation and endothelialization of an iron bioresorbable scaffold

In vivo degradation and endothelialization of an iron bioresorbable scaffold

<p>Real-World Use Of Ultrathin-Strut Biodegradable Polymer–Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes</p>

Ticagrelor: clinical development and future potential

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