Randomized Comparison of Everolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery Disease in Patients With Diabetes Mellitus (ESSENCE-DIABETES)

Kim, Won‐Jang; Lee, Seung-Whan; Park, Seong-Wook; Kim, Young‐Hak; Yun, Sung‐Cheol; Lee, Jong‐Young; Park, Duk‐Woo; Kang, Soo–Jin; Lee, Cheol Whan; Lee, Jae‐Hwan; Choi, Si Wan; Seong, In‐Whan; Lee, Bong Ki; Lee, Nae–Hee; Cho, Yoon Haeng; Shin, Won-Yong; Lee, Seung-Jin; Lee, Se-Whan; Hyon, Min-Su; Bang, Duk-Won; Park, Woo Jung; Kim, Hyun‐Sook; Chae, Jei Keon; Lee, Keun; Park, Hoon Ki; Park, Chang-Bum; Lee, Sang-Gon; Kim, Minkyu; Park, Kyoung-Ha; Choi, Young–Jin; Cheong, Sang-Sig; Yang, Tae–Hyun; Jang, Jae‐Sik; Her, Sung Ho; Park, Seung‐Jung

doi:10.1161/circulationaha.110.015453

Cited by 112 publications

(78 citation statements)

References 31 publications

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“…SES was available in diameters of 2.50, 2.75, 3.00, and 3.50 mm, and in lengths of 8,13,18,23, and 28 mm for stents with a diameter of 2.50 mm, 18 mm, and 23 mm for stents with a diameter of 2.75 mm, and 8, 13, 18, 28, and 33 mm for stents with diameters of 3.00 mm, and 3.50 mm. Use of stents other than the assigned study stent was not allowed unless the delivery of the assigned stent was unsuccessful, in which case crossover to any commercially available coronary stents including the comparator study stent was permitted.…”

Section: Study Proceduresmentioning

confidence: 99%

“…Third, although the noninferiority margin of 0.195 mm in the angiographic substudy was defined according to that used in the SPIRIT III trial, it seems disproportionate to the actual sizes of in-segment late loss in the current study. If we choose the noninferiority margin of 0.15 mm used in the Randomized Comparison of EverolimusEluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery Disease in Patients with Diabetes Mellitus (ESSENCE-DIABETES) trial, 13 noninferiority of EES could still be declared in the current study (P noninferiority ϭ0.002). If we choose the noninferiority margin of 0.1 mm used in the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) and Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III) trials, 9,14 noninferiority of EES was not met in the current study (P noninferiority ϭ0.1).…”

Section: Study Limitationsmentioning

confidence: 99%

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Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

et al. 2012

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on behalf of the RESET InvestigatorsBackground-Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results-Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P noninferiority Ͻ0.0001, and P superiority ϭ0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, Pϭ0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06Ϯ0.37 mm versus 0.02Ϯ0.46 mm, P noninferiority Ͻ0.0001, and P superiority ϭ0.24) at 278Ϯ63 days after index stent implantation. Conclusions-One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.

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Section: Study Proceduresmentioning

confidence: 99%

Section: Study Limitationsmentioning

confidence: 99%

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

et al. 2012

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“…25,26 Similarly, studies of EES versus SES in diabetic patients found that EES are associated with lower rates of restenosis than SES. 27 In comparison, a pooled analysis of randomised studies found no difference in efficacy or safety of EES versus PES among diabetic patients, suggesting that EES may not have significant benefit compared to PES. 28 Based on conflicting data with outcomes of different DES types among patients with diabetes, the recently reported Taxus …”

Section: Stent Type and Outcomes Among Patients With Diabetesmentioning

confidence: 98%

Determining the Most Appropriate Mode of Coronary Artery Revascularisation in Patients With Diabetes

Armstrong

Waldo

2016

Interventional Cardiology Review

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CoronaryPatients with diabetes mellitus (DM) have an increased prevalence of coronary artery disease (CAD) and are more likely to require coronary revascularisation than patients without DM. 1 Similar to the general population, CAD remains the most frequent cause of death among patients with DM. 2 As the prevalence of DM continues to rise worldwide, the appropriate management and method of revascularisation for diabetic patients will become an increasingly important clinical decision point. In this review, we discuss current data regarding the indications and optimal method of coronary revascularisation among patients with DM. Decision to Perform RevascularisationAs with the general population, patients with DM and CAD may present with asymptomatic ischaemia, stable angina or acute coronary syndromes. The clinical presentation and severity of symptoms significantly influences the decision to perform coronary artery revascularisation, as well as the relative timing of such a procedure.Although patients with DM have a higher prevalence of CAD, the majority of patients are asymptomatic before presenting with a myocardial infarction or other cardiovascular event. 3 Numerous studies have therefore investigated the use of routine screening for CAD among diabetic patients that do not have overt symptoms. The Detection of Ischaemia in Asymptomatic Diabetics (DIAD) study investigated routine screening for coronary ischaemia using myocardial perfusion imaging among asymptomatic diabetic patients. 4 During a mean follow-up of 4.8 years, the overall cardiac event rate was only 2.9 % with an event rate of 2.7 % in the screened group and 3.0 % in the unscreened group. The overall rate of revascularisation was also low at 5.5 % in the screened group and 7.8 % in the unscreened group. Similarly, the Screening For Together these two large randomised trials do not support a strategy of routine testing for CAD among asymptomatic diabetic patients.Among diabetic patients with symptomatic stable CAD, the decision to pursue revascularisation with either a percutaneous or surgical approach was studied in the Bypass Angioplasty Revascularisation Investigation in Type 2 Diabetes (BARI 2D) study. 6 In that trial diabetic patients with stable CAD were randomised to either optimal medical therapy with immediate percutaneous or surgical revascularisation at the discretion of the investigator or optimal medical therapy alone.At 5 years there was no difference in overall mortality between the two groups, although the rate of subsequent revascularisation in the medical therapy group was 38 % at 5 years. These results suggest that immediate revascularisation is not necessary among patients with DM and stable CAD in the absence of severe anginal symptoms, while recognising that a significant percentage of patients will eventually require revascularisation due to worsening of their symptoms. AbstractObstructive coronary artery disease is a common cause of morbidity and mortality among patients with diabetes mellitus (DM). Previous research has d...

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“…Everolimus-eluting stents have shown so far very favorable results in the SPIRIT clinical trial program as well as in other independent studies [18][19][20], with outstanding reductions in neointimal hyperplasia and ensuing risks of binary restenosis, target lesion revascularization, target vessel revascularization, and major adverse cardiac events. Such inhibitory effects on smooth muscle cells appear associated with a very favorable impact on endothelial function and strut coverage, at least in light of the risk of stent thrombosis associated with these devices.…”

Section: Second-generation Drug-eluting Stentsmentioning

confidence: 99%

Drug-Eluting Stents in Interventional Cardiology

Biondi‐Zoccai¹

2012

Transl Med

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Randomized Comparison of Everolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery Disease in Patients With Diabetes Mellitus (ESSENCE-DIABETES)

Cited by 112 publications

References 31 publications

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents

Determining the Most Appropriate Mode of Coronary Artery Revascularisation in Patients With Diabetes

Drug-Eluting Stents in Interventional Cardiology

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