Treatment with 48-mm everolimus-eluting stents

Tan, Chong Keat; Tin, Zhang; Arshad, Mohd Fadzil; Loh, Jason Kwok Kong; Jafary, Fahim H.; Ho, Hee‐Hwa; Ong, Paul Jau Lueng; Watson, Timothy

doi:10.1007/s00059-017-4670-2

Cited by 13 publications

(11 citation statements)

References 25 publications

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“…There were no additional cardiac deaths or the occurrent of very late ST. Acknowledging the limitations of comparing trials, the event rates in previous studies align with those observed in EVOLVE 48; although the rate of ST appears to be lower in patients treated with 48 mm SYNERGY stent 3,24,25 …”

Section: Discussionsupporting

confidence: 53%

“…Also, procedure and fluoroscopy time were lower with the use of very long stents, and required less contrast volume 3 . A single center study evaluating the performance of 48 mm Xience Expedition durable polymer EES showed favorably low incidence of major adverse cardiac events (3.3%) and ST (1.3%) at 1‐year 24 . Two‐year TLF rate in an observational registry for patients treated with a single long 48 mm Xience Expedition stent was 5.3% and probable ST was 0.9% 25 .…”

Section: Discussionmentioning

confidence: 99%

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Safety and efficacy of Everolimus‐Eluting bioabsorbable Polymer‐Coated stent in patients with long coronary lesions: The EVOLVE 48 study

Karmpaliotis

Stoler

Walsh

et al. 2021

Cathet Cardio Intervent

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Objectives The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. Background Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long‐term data in a broad population of patients undergoing PCI. Methods Patients with lesion length >34‐ ≤44 mm and reference vessel diameter (RVD) ≥2.5‐ ≤ 4.0 mm were enrolled in this prospective, multicenter, single‐arm study. The primary endpoint was 12‐month target lesion failure (TLF; composite of target lesion revascularization [TLR], target‐vessel myocardial infarction [TV‐MI], or cardiac death) compared to a prespecified performance goal (PG). Results A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre‐TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One‐year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV‐MI in two patients treated with SYNERGY 48 mm stent. Between the 1‐2‐year timeframe, TV‐MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. Conclusions PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of Everolimus‐Eluting bioabsorbable Polymer‐Coated stent in patients with long coronary lesions: The EVOLVE 48 study

Karmpaliotis

Stoler

Walsh

et al. 2021

Cathet Cardio Intervent

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“…21,22 The outcomes of the 48 mm-EES were previously reported in two studies based on a single-center experience and concluded good safety and efficacy over 1-year. 23,24 Our findings are | 185 assess the performance of the 48 mm-EES in a wider range of use. This translated into a slightly higher TLF rate at 1 year in our study (5.3% vs.…”

Section: Discussionmentioning

confidence: 77%

Safety and efficacy of 48 mm Xience Xpedition everolimus‐eluting stent for the treatment of long coronary lesions

Gautier

Hovasse

Arroyo

et al. 2022

Cathet Cardio Intervent

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Introduction Long drug‐eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. Aim The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus‐eluting stent (48mm‐EES) for the treatment of long coronary lesions, in an all‐comer population. Methods Patients receiving at least one 48mm‐EES were prospectively included from March 2014 to December 2018. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 1 year. The main secondary endpoint was the patient‐oriented composite endpoint (POCE) defined as a composite of death, stroke, myocardial infarction, and reintervention. Results A total of 268 patients with 276 long coronary lesions, including 94 chronic total occlusions (CTO), were successfully treated using at least one 48mm‐EES. The total stent length per lesion was 66 ± 22 mm. A single 48mm‐EES was suitable to successfully treat the target lesion in 48% of cases (60% for non‐CTO lesions). One‐year follow‐up rate was 96.3%. TLF occurred in 13 patients (5.3%), mainly driven by TLR (4.1%). Two cardiac death occurred (0.7%). POCE occurred in 30 patients (11.6%) mainly driven by repeat revascularization (9.7%). Definite stent thrombosis was observed in two patients (0.7%). No difference was observed in one‐year outcomes between single 48mm‐EES and multiple stents implantation as well as between CTO and non‐CTO lesions. Conclusion The 48mm‐EES is safe and effective to treat long coronary lesions, including CTOs, and provides attractive cost‐effectiveness by limiting multiple stenting.

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“…Percutaneous coronary intervention (PCI) with stent implantation is the most widely used treatment strategy for coronary artery disease (CAD). Moreover, current generation drug-eluting coronary stents (DES) have remarkable features to improve the clinical outcomes of PCI [1]. However, treatment of long diffused lesions is still a challenge for interventional cardiologists, especially in tapered coronary arteries where the vessel diameter discrepancies may warrant using more than one stent for a long lesion.…”

Section: Introductionmentioning

confidence: 99%

“…The strategies adopted for treatment of long diffused lesions in tapered arteries include the use of either multiple stents or a single long stent, both of which are associated with clinical failure due to the potential risk of mechanical mismatch of stent size [1, 4, 5]. Multiple short stents with variable diameters are often implanted (overlapping) to match the size of the long-tapered lesions adequately.…”

Section: Introductionmentioning

confidence: 99%

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions

et al. 2018

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BackgroundWhen coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world’s first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario.MethodsThis was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up.ResultsOut of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient.ConclusionsThe present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

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Treatment with 48-mm everolimus-eluting stents

Abstract: The Xience 48-mm EES device appears to be safe and efficacious with a low clinical event rate at the 12-month follow-up. Where feasible, this would support the use of the ultra-long 48-mm platform in lieu of multiple overlapping shorter devices.

Cited by 13 publications

References 25 publications

Safety and efficacy of Everolimus‐Eluting bioabsorbable Polymer‐Coated stent in patients with long coronary lesions: The EVOLVE 48 study

Safety and efficacy of Everolimus‐Eluting bioabsorbable Polymer‐Coated stent in patients with long coronary lesions: The EVOLVE 48 study

Safety and efficacy of 48 mm Xience Xpedition everolimus‐eluting stent for the treatment of long coronary lesions

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions

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