Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial

Lansky, Alexandra J.; Wijns, William; Xu, Bo; Kelbæk, Henning; Royen, Niels van; Zheng, Ming; Morel, Marie‐Angèle; Knaapen, Paul; Slagboom, Ton; Johnson, Tom; Vlachojannis, Georgios J.; Arkenbout, Karin; Holmvang, Lene; Janssens, Luc; Ochała, Andrzej; Brugaletta, Salvatore; Naber, Christoph; Anderson, Richard; Rittger, Harald; Berti, Sérgio; Barbato, Emanuele; Tóth, Gábor G.; Maillard, Luc; Valina, Christian; Buszman, Paweł; Thiele, Holger; Schächinger, Volker; Baumbach, Andreas

doi:10.1016/s0140-6736(18)31649-0

Cited by 46 publications

(36 citation statements)

References 26 publications

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“…Comparing the TLF rate of 6.1% and the PoCE rate of 7.7% in the 1‐year follow‐up, we deduced that the majority of TLF and PoCE occur in the first year, especially within the first month after procedure, which may be related to gradual endothelialization. Among the components of the TLF, TVMI contributed the highest proportion (71.0%), similar to results from other related studies . The diameter of the reference vessel, number of PCI targets, and presence multi‐vessel disease were confirmed to have a significant impact on TLF events, while length of target lesion and diabetes did not.…”

Section: Discussionsupporting

confidence: 87%

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Wang

Tao

et al. 2020

Cathet Cardio Intervent

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Objectives To analyze the 3‐year outcomes of the biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. Background Though approved by CFDA, the long‐term safety and efficacy of EXCROSSAL is still unknown. Methods CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single‐arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3‐year follow‐up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3‐year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically indicated target lesion revascularization (CI‐TLR). The patient‐oriented composite endpoint (PoCE) (all‐cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. Results A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3‐year follow‐up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi‐lesion PCI, and multi‐vessel disease. Conclusions The 3‐year follow‐up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug‐eluting stent.

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Section: Discussionsupporting

confidence: 87%

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Wang

Tao

et al. 2020

Cathet Cardio Intervent

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“…Nevertheless, in-stent restenosis (ISR) is still a major concern resulting from a cascade of molecular and cellular events associated with stenting, such as thrombus, inflammation, leukocyte accumulation, and hyperproliferation of smooth muscle cells (SMCs) [4]. Over the past two decades, numerous approaches (e.g., new drugs [5], polymer coatings [6], endothelial progenitor cell (EPC) capture [7], gene [8], and biomolecule modification [9,10]) have emerged to ameliorate clinical outcomes. Nonetheless, substantial progress is limited such as the inability of using these strategies to facilitate the formation of a robust, competently functioning new endothelial layer.…”

Section: Introductionmentioning

confidence: 99%

Endothelium-Mimicking Multifunctional Coating Modified Cardiovascular Stents via a Stepwise Metal-Catechol-(Amine) Surface Engineering Strategy

et al. 2020

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Stenting is currently the major therapeutic treatment for cardiovascular diseases. However, the nonbiogenic metal stents are inclined to trigger a cascade of cellular and molecular events including inflammatory response, thrombogenic reactions, smooth muscle cell hyperproliferation accompanied by the delayed arterial healing, and poor reendothelialization, thus leading to restenosis along with late stent thrombosis. To address prevalence critical problems, we present an endothelium-mimicking coating capable of rapid regeneration of a competently functioning new endothelial layer on stents through a stepwise metal (copper)-catechol-(amine) (MCA) surface chemistry strategy, leading to combinatorial endothelium-like functions with glutathione peroxidase-like catalytic activity and surface heparinization. Apart from the stable nitric oxide (NO) generating rate at the physiological level (2.2×10−10 mol/cm2/min lasting for 60 days), this proposed strategy could also generate abundant amine groups for allowing a high heparin conjugation efficacy up to ∼1 μg/cm2, which is considerably higher than most of the conventional heparinized surfaces. The resultant coating could create an ideal microenvironment for bringing in enhanced anti-thrombogenicity, anti-inflammation, anti-proliferation of smooth muscle cells, re-endothelialization by regulating relevant gene expressions, hence preventing restenosis in vivo. We envision that the stepwise MCA coating strategy would facilitate the surface endothelium-mimicking engineering of vascular stents and be therefore helpful in the clinic to reduce complications associated with stenosis.

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“…Although the in‐stent late lumen loss was comparable between the two groups, patients enrolled in the TARGET I trial had low‐risk profiles with strict angiographic and clinical selection criteria, thus target vessel failure (TLF) at 1‐year follow‐up was only 2.2% in both groups 8 . The subsequent TARGET All Comers study evaluated outcomes in an expanded risk population with minimal exclusion criteria and no restrictions on PCI procedures 9 . At 1 year the primary endpoint of TLF in this RCT was 6.1% with Firehawk versus 5.9% with XIENCE ( p for noninferiority .004).…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent

Saito

Baumbach

Wijns

et al. 2019

Cathet Cardio Intervent

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Background The Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel biodegradable polymer sirolimus‐eluting coronary stent has been evaluated in the randomized TARGET I trial in which low‐risk patients were enrolled with strict eligibility criteria. Recently, the TARGET All Comers study has shown similar results of the Firehawk compared to the XIENCE stent (Abbott Vascular, Santa Clara). However, clinical outcomes in high‐risk patients are unclear. Methods The TARGET All Comer study was a randomized trial that assigned patients to either Firehawk or XIENCE implantation. This TARGET AC subanalysis sought to evaluate the 2 year clinical outcomes of patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET I trial were classified as “low‐risk,” while their counterparts were classified as “high‐risk.” The primary endpoint was target lesion failure. Results A total of 1,585 patients were included, of which 1,334 (84%) were classified as high‐risk. At 2 years, the high‐risk group had a significantly higher rate of TLF than the low‐risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02). The Firehawk and XIENCE had no significant differences in TLF among both low‐risk (3.1% vs. 4.2%, p = .66) and high‐risk (9.9% vs. 9.1%, p = .57) patients. Conclusions High‐risk patients had worse clinical outcomes at 2 years in the TARGET All Comer study. Outcomes with the Firehawk were similar to the XIENCE stent among both low‐risk and high‐risk patients at 2 years.

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Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial

Cited by 46 publications

References 26 publications

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials

Endothelium-Mimicking Multifunctional Coating Modified Cardiovascular Stents via a Stepwise Metal-Catechol-(Amine) Surface Engineering Strategy

Clinical outcomes of complex lesions treated with an abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent and durable polymer everolimus‐eluting stent

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