Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial

Jiménez‐Quevedo, Pilar; Sabaté, Manel; Angiolillo, Dominick J.; Alfonso, Fernándo; Hernández-Antolín, Rosa Ana; Sanmartín, Marcelo; Gómez-Hospital, J.A.; Bañuelos, Camino; Escaned, Javier; Moreno, Raúl; Fernández, Cristina; Fernández‐Avilés, Francisco; Macaya, Carlos

doi:10.1093/eurheartj/ehm197

Cited by 71 publications

(36 citation statements)

References 31 publications

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“…8,15,16 Smaller randomized trials evaluating DES specifically in diabetic patients have been designed mainly to detect restenosis prevention and not powered to compare long-term important clinical end points or designed to follow up patients beyond 1 year. 6,7,17 A recent network meta-analysis of 35 randomized trials showed no difference in rates of death or MI in diabetic patients who received DES versus BMS. 16 Although our primary goal was simply to evaluate whether DES was associated with increased rates of MI and mortality in long-term follow-up, we observed small absolute differences in mortality and MI favoring drug-eluting stenting.…”

Section: Discussionmentioning

confidence: 99%

Drug-Eluting or Bare-Metal Stenting in Patients With Diabetes Mellitus

et al. 2008

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Background-Patients with diabetes mellitus (DM) are at high risk for restenosis, myocardial infarction, and cardiac mortality after coronary stenting, and the long-term safety of drug-eluting stents (DES) relative to bare-metal stents (BMS) in DM is uncertain. We report on a large consecutive series of patients with DM followed up for 3 years after DES and BMS from a regional contemporary US practice with mandatory reporting. Methods and Results-All adults with DM undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at all acute care nonfederal hospitals in Massachusetts were identified from a mandatory state database. According to index admission stent type, patients were classified as DES treated if all stents were drug eluting and as BMS treated if all stents were bare metal; patients treated with both types of stents were excluded from the primary analysis. Mortality rates were obtained from vital statistics records, and myocardial infarction and revascularization rates were obtained from the state database with complete 3 years of follow-up on the entire cohort. Risk-adjusted mortality, myocardial infarction, and revascularization differences (DESϪBMS) were estimated with propensity-score matching based on clinical, procedural, hospital, and insurance information collected at the index admission. DM was present in 5051 patients (29% of the population) treated with DES or BMS during the study. Patients with DM were more likely to receive DES than BMS (66.1% versus 33.9%; PϽ0.001). The unadjusted cumulative incidence of mortality at 3 years was 14.4% in DES versus 22.2% in BMS (PϽ0.001). Based on propensity-score analysis of 1:1 matched DES versus BMS patients (1476 DES:1476 BMS), the risk-adjusted mortality, MI, and target vessel revascularization rates at 3 years were 17.5% versus 20.7% (risk difference, Ϫ3.2%; 95% confidence interval, Ϫ6.0 to Ϫ0.4; Pϭ0.02), 13.8% versus 16.9% (Ϫ3.0%; 95% confidence interval, Ϫ5.6 to 0.5; Pϭ0.02), and 18.4% versus 23.7% (Ϫ5.4%; confidence interval, Ϫ8.3 to Ϫ2.4; PϽ0.001), respectively. Conclusions-In a real-world diabetic patient population with mandatory reporting and follow-up, DES were associated with reduced mortality, myocardial infarction, and revascularization rates at long-term follow-up compared with BMS. Key Words: angioplasty Ⅲ diabetes mellitus Ⅲ myocardial infarction Ⅲ revascularization Ⅲ stents P atients with diabetes mellitus (DM) have a higher prevalence of ischemic heart disease than the general population. In the United States, approximately one third of percutaneous coronary intervention (PCI) procedures are performed on patients with DM, 1 a proportion that is increasing. PCI has several unique limitations in the diabetic patient population: increased propensity for restenosis, increased extent of coronary artery disease, and a higher risk of subsequent cardiac death and myocardial infarction (MI) compared with the general population. 2,3 Clinical Perspective p 2285Drug-eluting stents (DES) have been...

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Section: Discussionmentioning

confidence: 99%

Drug-Eluting or Bare-Metal Stenting in Patients With Diabetes Mellitus

et al. 2008

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“…20 Several reports focusing on diabetes and SES produced varied results with regard to long-term outcome. 20- 22 The reasons for such discrepancy are thought to be differences in accuracy of optimal stent landing between the studies. In diabetic patients, such a variety of implantation techniques may strongly impact on the resultant late outcomes due to an increased rate of margin re-stenosis.…”

Section: New Considerations and Speculations Related To Ses Re-stenosmentioning

confidence: 99%

Intravascular Ultrasound Criteria for Determination of Optimal Longitudinal Positioning of Sirolimus-Eluting Stents

Morino

Tamiya

Masuda

et al. 2010

Circ J

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Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp dge re-stenosis is a major problem following sirolimus-eluting stent (SES) implantation for the treatment of native coronary artery lesions. 1 To minimize the incidence of these events, longitudinal positioning of SES is considered to be critically important. Due to the current lack of a standard guideline, however, practitioners must decide the landing position by a somewhat arbitrary assessment in the actual clinical setting. The SIRIUS trial that used intravascular ultrasound (IVUS) to investigate lesions reported that the residual plaque burden is associated with edge re-stenosis. 2 Of particular interest, edge re-stenosis was mostly observed in cases of residual plaque area (PA)/volume >50% at the stent margins. According to these observations, we (1) determined unique stepwise IVUS criteria to achieve optimal longitudinal positioning of SES using plaque burden at the peri-stent margins, which might fit a variety of actual lesion subsets (Figure 1), and (2) have put them to practical use continuously. Because long-term clinical and angiographic outcomes are currently available, we verified these new criteria in terms of achievability and their actual impact on margin re-stenosis rates and long-term clinical outcomes. Methods Study PopulationFrom January 2005 to April 2006, 162 consecutive stable angina patients whose native coronary lesions were electively treated with SES were studied at Tokai University School of Medicine. SES were implanted according to the IVUS criteria (Figure 1) of longitudinal stent positioning, which were determined with reference to the previous investigation. 2 A cut-off for plaque burden of <50% in the criteria was determined by either (1) visual assessment with reference to Figure 1 or (2) measurement by manual tracing using a software package installed in the IVUS console during the procedure. The consecutive patients who had completion of poststenting (after final balloon dilation) IVUS pullback were the subjects of the present study. Patients with native coronary

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“…However, studies focusing exclusively on diabetics like ISAR-DIABETES [9], DIABETES [10] and SCORPIUS [11] failed to meet ESC and DGK quality standards and used surrogate parameters like in-stent late lumen loss (LLL) as primary endpoints. Moreover, studies focusing on diabetics were not adequately powered to assess clinical end points like target lesion revascularization (TLR), target vessel revascularization (TVR) or target vessel failure (TVF).…”

Section: Introductionmentioning

confidence: 99%

Outcomes after differential use of drug‐eluting stents in diabetic patients: 1‐Year results from the DES.DE (Drug‐Eluting Stent.DEutschland) registry

Akın

Eckardt

Reinecke

et al. 2010

Cathet Cardio Intervent

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Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial

Abstract: SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.

Cited by 71 publications

References 31 publications

Drug-Eluting or Bare-Metal Stenting in Patients With Diabetes Mellitus

Drug-Eluting or Bare-Metal Stenting in Patients With Diabetes Mellitus

Intravascular Ultrasound Criteria for Determination of Optimal Longitudinal Positioning of Sirolimus-Eluting Stents

Outcomes after differential use of drug‐eluting stents in diabetic patients: 1‐Year results from the DES.DE (Drug‐Eluting Stent.DEutschland) registry

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