Three-year data from the XIENCE V® INDIA study: Safety and efficacy of XIENCE V® in 1000 real world Indian patients

Seth, Ashok; Patel, Tejas; Stuteville, Marrianne; Kumar, Ravindra; Mullasari, Ajit; Kaul, Upendra; Mathew, Rony; Kumar, Ajay; Shen, Ying; Sudhir, Krishnankutty

doi:10.1016/j.ihj.2014.03.007

Cited by 15 publications

(12 citation statements)

References 19 publications

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“…tries and from randomized trials evaluating CoCr-EES. 11, [16][17][18][19] These results further confirmed the long-term safety of CoCr-EES. Furthermore, the long-term efficacy of EES was also confirmed in the present study.…”

Section: Discussionsupporting

confidence: 64%

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan

Aoki

Kozuma

Awata

et al. 2016

Circ J

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906AOKI J et al. Circulation JournalOfficial Journal of the Japanese Circulation Society http://www. j-circ.or.jp EES), have not been fully evaluated in routine clinical practice in Japan. Therefore, we evaluated 3-year clinical outcomes after EES implantations in a real-world setting at 47 Japanese sites using the EES Japan PMS database. Methods Subjects and Follow-upCoCr-EES PMS Japan is a prospective multicenter registry enrolling 2,000 patients who received CoCr-EES. The study was designed to evaluate the safety and efficacy of the CoCr-EES in routine clinical practice shortly after the launch of ate stent thrombosis and late in-stent restenosis are the 2 major limitations of first-generation drug-eluting stents (DES). 1,2 Second-generation DES are associated with significantly lower in-stent restenosis rate and lower rate of late stent thrombosis as compared with first-generation DES. 3-6 Therefore, second-generation DES are used currently as the first-line coronary stents in routine clinical practice. Clinical outcomes of first-generation DES, such as sirolimusand paclitaxel-eluting stents, in earlier Japanese post-marketing surveillance studies (PMS) have been published previously, 7-9 but long-term clinical outcomes for second-generation DES, such as cobalt-chromium everolimus-eluting stents (CoCr-

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Section: Discussionsupporting

confidence: 64%

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan

Aoki

Kozuma

Awata

et al. 2016

Circ J

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“…The encouraging safety and efficacy outcomes with everolimus-eluting coronary stents (Xience V; Abbott Vascular, USA) are also established in a study of 1,000 Indian patients with coronary artery disease. The study reported that 3.1% had composite endpoint of cardiac death and any myocardial infarction, while 0.51% patients had definite/probable stent thrombosis through a 3-year follow up [28]. Likewise, we believe that the encouraging outcomes in the present study of novel Tetrilimus coronary stents could be due to the use of everolimus as antiproliferative drug and other characteristic features including cobalt-chromium stent platform, ultra-thin strut thickness, and biodegradable polymers.…”

Section: Discussionsupporting

confidence: 53%

“…The scanning electron microscopy images of sterile crimped stents and expanded stents shows a smooth and uniform coating surface, without any coating anomalies and defects such as webbing,bridging, and strut-to-strut contact, even after expansion of the stent(Figure 2). During the study period, Tetrilimus everolimus-eluting coronary stent was made available in lengths of8,12,16,20,24,28, 32, 36, 40, 44, 48 mm and diameters of 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 mm.…”

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confidence: 99%

Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes

Kasturi¹,

Polasa²,

Singh³

et al. 2016

WJCD

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Introduction: Tetrilimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) is a recently-introduced biodegradable-polymer coated everolimus-eluting cobaltchromium coronary stent system with an ultra-thin strut thickness. We aimed to evaluate the clinical outcomes with Tetrilimus coronary stents in "real-world" patients with coronary artery disease. Methods: In this retrospective, single-arm, openlabel, multi-center registry, all consecutive patients who received Tetrilimus stents between July-2015 and April-2016 at two tertiary-care centers in India were analyzed. Primary endpoint was 30-day incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, and target vessel revascularization. The Academic Research Consortium (ARC)-defined stent thrombosis was assessed as additional safety endpoint. Results: During the study period, 280 Tetrilimus stents (1.4 ± 0.5 stent/patient) were implanted to treat 252 coronary lesions (1.1 ± 0.3 stent/lesion) in 208 patients (age: 57.5 ± 11.9 years). Of study population, 65.9% were males, 46.6% were hypertensives, 25% were diabetics, 36.5% were alcoholics, 29.3% were smokers, 13.9% were tobacco chewers, 5.3% had previous revascularization, and 45.2% displayed multi-vessel disease. Of treated lesions, 67.5% were complex and 18.7% had total occlusion. Average length and diameter of implanted stents were 25.5 ± 8.8 mm and 2.9 ± 0.3 mm respectively. Subsequently, 30-day MACE were reported in 2 (0.96%) patients; both cases owing to in-hospital cardiac deaths. Events of stent thrombosis or noncardiac death were not reported in any patient. Conclusion: Low MACE rates and absence of stent thrombosis at early 30-day follow-up indicates that Tetrilimus everolimus

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“…Stent restenosis and thrombosis are less frequent with the new‐generation DES but are still considered major complications . Each stent is associated with specific biomechanical characteristics that may be related to definite benefits and/or complications .…”

Section: Introductionmentioning

confidence: 99%

Standardized bench test evaluation of coronary stents: Biomechanical characteristics

Bonin

Guérin

Olive

et al. 2018

Cathet Cardio Intervent

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Objectives: The purpose of the study was to develop a standardized and global bench test protocol to evaluate the biomechanical characteristics of the most currently used drug-eluting coronary stents.Background: The use of coronary stents has contributed to the reduction of cardiovascular mortality but can be associated with specific complications. Improving the biomechanical matching between the stents and the coronary anatomy may reduce these complications. Methods:We assessed five commercially available drug-eluting stents: the Absorb, Orsiro, Resolute Onyx, Synergy, and Xience Alpine stents. Following stent deployment at nominal pressure in ambient air, radial elastic recoil and foreshortening were measured. Flexibility (crimped and deployed stents) and longitudinal and radial resistances were evaluated using a mechanical tester.Results: Biomechanical characteristics were significantly different for all tested devices (ANOVA, P < 0.01). The Synergy, Orsiro, and Xience Alpine stents presented the lowest elastic recoil. The Synergy and Resolute Onyx stents were the most flexible devices. The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances.Conclusions: Drug-eluting coronary stents used in current clinical practice have very different biomechanical characteristics, which should be taken into consideration to select the most appropriate device for each clinical situation. K E Y W O R D Sbench test, biomechanical performance, scoronary stents

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Three-year data from the XIENCE V® INDIA study: Safety and efficacy of XIENCE V® in 1000 real world Indian patients

Abstract: Despite the high risk population of coronary artery disease, the use of XIENCE V in 'real world' Indian patients was associated with very low clinical event rates upto three years of follow up.

Cited by 15 publications

References 19 publications

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan

Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes

Standardized bench test evaluation of coronary stents: Biomechanical characteristics

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