Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent

Silber, Sigmund; Serruys, Patrick W.; Leon, Martin B.; Meredith, Ian T.; Windecker, Stephan; Neumann, Franz‐Josef; Belardi, Jorge; Widimský, Petr; Massaro, Joseph M.; Novack, Victor; Yeung, Alan C.; Saïto, Shigeru; Mauri, Laura

doi:10.1016/j.jcin.2012.11.006

Cited by 81 publications

(62 citation statements)

References 41 publications

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“…In a pooled analysis of 878 diabetics enrolled in the global RESOLUTE program this performance goal was met with a 12-month rate of 7.8%. In the overall diabetic group, including complex patients, the composite of cardiac death, target-vessel MI and TLR was 11.7% for insulin-dependent diabetics and 6.1% for non-insulin-dependent [30]. With a 11.41% composite of cardiac death, MI and TLR, and no additional TVR, the event rate of diabetics in ENERGY hence met the performance goal for low-risk diabetics in RESOLUTE.…”

Section: Subgroup Analysismentioning

confidence: 90%

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

Erbel

Eggebrecht

Roguin

et al. 2014

Cardiovascular Revascularization Medicine

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The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt-chromium thin strut bare metal stent with a passive coating showed very good results up to 24months. (ClinicalTrials.gov:NCT01056120) SUMMARY FOR ANNOTATED TABLE OF CONTENTS: The ENERGY international registry evaluated the safety and benefits of a cobalt-chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤2.75mm and acute coronary syndrome.

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Section: Subgroup Analysismentioning

confidence: 90%

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

Erbel

Eggebrecht

Roguin

et al. 2014

Cardiovascular Revascularization Medicine

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“…Comparing our outcome data with the E-Five Registry that enrolled all-comer PCI patients treated with the Endeavor stent [8], we can indirectly extend the SORT OUT III trial data in a real-world population, given that the overall MACE rate in the E-Five registry was consistently higher than that observed in our population (overall mortality 4.0% vs. 2.5% and TLR rate 5.3% vs. 2.8%; Table III, Supporting Information Appendix). Recently, the Resolute zotarolimus-eluting stent (Medtronic) received the FDA labeling for DM patients on the basis of a prespecified performance goal (target vessel failure < 14.5%) at 12 months in diabetics [42]. Interestingly, the prespecified target vessel failure end point (including cardiac death, vessel-related MI, and ischemia driven revascularization) was reported in 7.8% of the 878 diabetic patients [42].…”

Section: Discussionmentioning

confidence: 99%

“…Recently, the Resolute zotarolimus-eluting stent (Medtronic) received the FDA labeling for DM patients on the basis of a prespecified performance goal (target vessel failure < 14.5%) at 12 months in diabetics [42]. Interestingly, the prespecified target vessel failure end point (including cardiac death, vessel-related MI, and ischemia driven revascularization) was reported in 7.8% of the 878 diabetic patients [42]. In our study, a similar outcome of cardiac death, TLR, and MI occurred in 322 (7.0%) of the 4,577 DM patients.…”

Section: Discussionmentioning

confidence: 99%

One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

Bartorelli

Assenza

Abizaid

et al. 2015

Cathet Cardio Intervent

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BackgroundDiabetes mellitus has worse outcome after percutaneous coronary intervention.AimWe assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus‐eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry.MethodsFrom May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee.ResultsComplete follow‐up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin‐treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co‐morbidities, and triple‐vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 ± 0.46 vs. 2.93 ± 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow‐up, without significant difference among subgroups.ConclusionsIn the e‐SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co‐morbidities and complex coronary lesions. Although 1‐year follow‐up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. © 2015 Wiley Periodicals, Inc.

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“…23 Other studies have suggested similar clinical outcomes between R-ZES and everolimus eluting stents (EES) in real-world clinical settings. 24 EES are associated with reduced rates of restenosis and target lesion revascularisation relative to first-generation DES.…”

Section: Stent Type and Outcomes Among Patients With Diabetesmentioning

confidence: 92%

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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Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent

Cited by 81 publications

References 41 publications

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

One‐year clinical outcomes after sirolimus‐eluting coronary stent implantation in diabetics enrolled in the worldwide e‐SELECT registry

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

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