Efficacy and safety of a biodegradable polymer Cobalt‐Chromium sirolimus‐eluting stent (EXCEL2) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials

Wang, Geng; Wang, Heyang; Xu, Bo; Yang, Yuejin; Yang, Zhiming; Li, Hui; Zhang, Zheng; Wang, Haichang; Yang, Lixia; Han, Yaling

doi:10.1002/ccd.26887

Cited by 6 publications

(7 citation statements)

References 18 publications

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“…Similarly, in the FLEX registry Lemos et al reported 2.2% major adverse cardiac events at 6-month follow-up with Supraflex SES 17. Furthermore, the CREDIT-III trails on the Excel 2 biodegradable polymer–coated, thin-struts (88 µm) DES reported 5% target-lesion failure and 0.1% TLR at 6 months 35. All these observations are comparable with the findings of the present registry (Table 6).…”

Section: Discussionsupporting

confidence: 89%

<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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Section: Discussionsupporting

confidence: 89%

<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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“…The rate of cardiac death in the HELIOS registry was higher than that in previous studies except for the P-SEARCH registry [23–30] . Further analyses showed that the cardiac death rates in patients diagnosed with stable angina, unstable angina, NSTEMI, and STEMI were 1.2%, 0.9%, 3.7%, and 4.3%, respectively, indicating that the relatively higher incidence of cardiac death could be partly due to the high proportion of patients with AMI in our study.…”

Section: Discussioncontrasting

confidence: 68%

“…After the procurement, ten DES brands are currently sharing 80% of the market, and the HELIOS stent is among them. In Supplementary Table 1, http://links.lww.com/CM9/B271, we enumerated the pivotal studies of the centrally purchased stents and currently most commonly used stents worldwide [23–31] . In this table, data from the largest real-world study are presented; otherwise, the results of the latest randomized controlled trial are included.…”

Section: Discussionmentioning

confidence: 99%

A novel biodegradable polymer-coated sirolimus-eluting stent: the 1-year results of the HELIOS registry

Zheng

Liu

Zhang

et al. 2023

Chinese Medical Journal

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Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan–Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54–3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov, NCT03916432

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“…Optical coherence tomography analysis showed rapid endothelialization after EXCROSSAL implantation in the CREDIT I trial, and 93.51% of struts were covered at the 4‐month follow‐up . We have reported the 1‐year clinical follow‐up of CREDIT II and CREDIT III trial, in which lesions are more complex than CREDIT I, here we demonstrate on the 3‐year clinical follow‐up of the EXCROSSAL stent.…”

Section: Introductionmentioning

confidence: 54%

“…In the subgroup analysis, the number of PCI target lesions, RVD, and multi‐vessel diseases had a significant impact on the prognosis, suggesting that these factors should be the focus in a future study. Additionally, lesion length had a significant effect on the incidence of TLF at 1‐year follow‐up data; however, not in the 3‐year follow‐up, which requires further clarification. Furthermore, sirolimus coating was regarded as inferior for patients with diabetes mellitus; however, no diabetic effects were found in our subgroup analysis.…”

Section: Discussionmentioning

confidence: 88%

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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Efficacy and safety of a biodegradable polymer Cobalt‐Chromium sirolimus‐eluting stent (EXCEL2) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials

Abstract: EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc.

Cited by 6 publications

References 18 publications

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

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

A novel biodegradable polymer-coated sirolimus-eluting stent: the 1-year results of the HELIOS registry

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

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