Stents In Diabetic Patients Research Articles

Neointimal Response to Second Generation Drug-eluting Stents in Diabetic Patients with De Novo Coronary Lesions; Intravascular Ultrasound Study

Neointimal Response to Second Generation Drug-eluting Stents in Diabetic Patients with De Novo Coronary Lesions; Intravascular Ultrasound Study

‘FREEDOM’ trial: Have the interventional cardiologists lost their freedom?

‘FREEDOM’ trial: Have the interventional cardiologists lost their freedom?

Clinical outcomes after bare‐metal stenting in diabetic patients with lesions carrying a low risk of restenosis

To evaluate the clinical results of diabetic patients undergoing percutaneous coronary intervention (PCI) for coronary artery lesions carrying a low risk of restenosis treated with a bare-metal stent (BMS). There is a discrepancy between current international guidelines on the use of BMS in diabetics with low risk of restenosis coronary artery lesions. Registry data from diabetic patients who underwent non-urgent PCI in a high-volume tertiary referral hospital in the Netherlands was used. The main outcomes were target lesion revascularization (TLR) and the composite of cardiac death, myocardial infarction, and target vessel revascularization at 1-year of follow-up. A total of 1,951 patients were included, of which 1,596 non-diabetics (non-DM), 231 non-insulin requiring diabetics (NIRDM), and 124 insulin requiring diabetics (IRDM).TLR rates in non-DM versus NIRDM were similar (6.3% vs. 5.6%; P = 0.68), whereas TLR in IRDM was higher (6.3% vs. 11.3%; P = 0.03). The composite of cardiovascular clinical outcomes was not significantly different in non-DM versus NIRDM (9.5% vs. 13.4%; P = 0.07), though in IRDM the incidence was higher (9.5% vs. 17.7%; P < 0.01). No differences were observed in TLR or composite clinical endpoint at 1-year between non-DM and NIRDM after BMS placement in coronary artery lesions carrying a low risk of restenosis. The presence of IRDM was associated with higher TLR rates when treated with BMS. These results imply that BMS placement may be considered in patients with NIRDM but further work is required to define treatment strategies and, more importantly, improve the outcomes in diabetics.

TCT-340 Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Everolimus-Eluting Stents in Diabetic Patients - A Prospective Non-Randomized Single Center Long Term Comparison

TCT-340 Efficacy and Safety of Biodegradable Polymer Biolimus-Eluting Stents versus Durable Polymer Everolimus-Eluting Stents in Diabetic Patients - A Prospective Non-Randomized Single Center Long Term Comparison

The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry

The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.

Desempenho do stent farmacológico firebird™ em diabéticos portadores de doença coronária multiarterial

BACKGROUND: Preliminary data have shown the Firebird™ and the Cypher® stents have similar safety and efficacy profiles. However, to date, no study has evaluated the percutaneous coronary intervention (PCI) with the Firebird™ stent in diabetic patients. METHODS: The performance of the Firebird™ stent in diabetic patients with multivessel coronary artery disease (CAD) (n = 100) was compared to that of the Cypher® stent, using historical data from the ARTS-II study (n = 159). We compared the major adverse cardiovascular events (MACE) at one year. RESULTS: Most of the patients in the Firebird™ group were male (65%), with mean age of 63.3 ± 10.4 years and 5% were receiving insulin. Stable coronary syndromes were prevalent (60%), 45% had three-vessel CAD and ventricular function was preserved (56.6 ± 13.7%). In patients with three-vessel CAD, 135 lesions were treated with > 3 stents in 78% of the cases and 2 stents in the remaining ones. In patients with two-vessel CAD, 110 lesions were treated with > 2 stents in 80% of the cases and 1 stent in the remaining ones. The incidence of MACE at one year of the Firebird™ stent was 21%, death was observed in 3% of the patients, myocardial infarction in 2% and a new revascularization procedure in 18%, predominantly at the expense of a new PCI in 14% of the cases. Comparison with the Cypher® group did not show differences for any of the evaluated endpoints. CONCLUSIONS: In our study, the use of the Firebird™ stent showed similar results to those of patients in the ARTS-II study, which makes it attractive for use in the complex scenario of diabetic patients with multivessel CAD.

Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: A German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients

Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients. A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years. Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years. The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS.

Comparing outcomes after off-pump coronary artery bypass versus drug-eluting stent in diabetic patients

Off-pump coronary artery bypass surgery and sirolimus-eluting stent placement have been widely used for the treatment of coronary artery disease. The goal of this study was to compare long-term outcomes after off-pump coronary artery bypass surgery or sirolimus-eluting stent placement in diabetic patients with multivessel disease. This observational study enrolled 350 off-pump coronary artery bypass patients and 143 sirolimus-eluting stent patients receiving care at our institution between 2000 and 2007. All patients had diabetes and multivessel disease including proximal left anterior descending or left main coronary artery. The choice of revascularization (percutaneous coronary intervention versus coronary artery bypass surgery) was left to the physician's discretion rather than randomization. Cox proportional-hazard analyses, adjusting baseline risk factors and propensity score, which predicted the probability of receiving off-pump coronary artery bypass, were conducted to evaluate outcomes, including all-cause mortality, cardiac death, target vessel revascularization, and major adverse cardiac and cerebrovascular events. During the follow-up (2.6±1.6 years) period, there was no difference between off-pump coronary artery bypass and sirolimus-eluting stent placement in all-cause mortality or cardiac death. However, the incidences of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events were markedly lower in the patients undergoing off-pump coronary artery bypass than in those receiving sirolimus-eluting stent placement. Off-pump coronary artery bypass is superior to sirolimus-eluting stent placement in terms of acute coronary syndrome, target vessel revascularization, and major adverse cardiac and cerebrovascular events in diabetic patients with multivessel coronary artery disease.

Performance of the Firebird™ Drug-eluting Stent in Diabetic Patients with Multivessel Coronary Artery Disease

Preliminary data have shown the Firebird™ and the Cypher® stents have similar safety and efficacy profiles. However, to date, no study has evaluated the percutaneous coronary intervention (PCI) with the Firebird™ stent in diabetic patients. The performance of the Firebird™ stent in diabetic patients with multivessel coronary artery disease (CAD) (n = 100) was compared to that of the Cypher® stent, using historical data from the ARTS-II study (n = 159). We compared the major adverse cardiovascular events (MACE) at one year. Most of the patients in the Firebird™ group were male (65%), with mean age of 63.3 ± 10.4 years and 5% were receiving insulin. Stable coronary syndromes were prevalent (60%), 45% had three-vessel CAD and ventricular function was preserved (56.6 ± 13.7%). In patients with three-vessel CAD, 135 lesions were treated with ≥ 3 stents in 78% of the cases and 2 stents in the remaining ones. In patients with two-vessel CAD, 110 lesions were treated with ≥ 2 stents in 80% of the cases and 1 stent in the remaining ones. The incidence of MACE at one year of the Firebird™ stent was 21%, death was observed in 3% of the patients, myocardial infarction in 2% and a new revascularization procedure in 18%, predominantly at the expense of a new PCI in 14% of the cases. Comparison with the Cypher® group did not show differences for any of the evaluated endpoints. In our study, the use of the Firebird™ stent showed similar results to those of patients in the ARTS-II study, which makes it attractive for use in the complex scenario of diabetic patients with multivessel CAD. Desempenho do Stent Farmacológico Firebird™ em Diabéticos Portadores de Doença Coronária Multiarterial Dados preliminares têm demonstrado que o perfil de segurança e eficácia do stent Firebird™ é semelhante ao do stent Cypher®. No entanto, até o presente momento, nenhum estudo avaliou a intervenção coronária percutânea (ICP) com o Firebird™ em diabéticos. Comparamos, em diabéticos portadores de doença arterial coronária (DAC) multiarterial, o desempenho do Firebird™ (n = 100) ao do Cypher®, utilizando os dados históricos do estudo ARTS-II (n = 159). Foram comparados os eventos cardiovasculares adversos maiores (ECAM) em um ano. A maioria dos pacientes do grupo Firebird™ era do sexo masculino (65%), com média de idade de 63,3 ± 10,4 anos e 5% estavam em uso de insulina. Predominaram os quadros clínicos estáveis (60%), 45% eram portadores de DAC triarterial e a função ventricular era preservada (56,6 ± 13,7%). Nos pacientes com DAC triarterial, foram tratadas 135 lesões, com 3 ou mais stents em 78% dos casos e 2 stents nos demais. Nos pacientes com DAC biarterial, foram tratadas 110 lesões com 2 ou mais stents em 80% dos casos e 1 stent nos demais. A incidência de ECAM em um ano do Firebird™ foi de 21%, óbito ocorreu em 3% dos pacientes, infarto do miocárdio em 2%, e novo procedimento de revascularização miocárdica em 18%, predominantemente à custa de nova ICP em 14% dos casos. A comparação com o grupo Cypher® não mostrou diferenças para nenhum dos desfechos avaliados. Em nosso estudo, o uso do stent Firebird™ apresentou resultados similares aos dos pacientes do estudo ARTS-II, o que o torna atrativo para ser utilizado no complexo cenário de pacientes diabéticos portadores de DAC multiarterial.

Performance of the Firebird™ Drug-eluting Stent in Diabetic Patients with Multivessel Coronary Artery Disease

Performance of the Firebird™ Drug-eluting Stent in Diabetic Patients with Multivessel Coronary Artery Disease

A meta-analysis of specifically designed randomized trials of sirolimus-eluting versus paclitaxel-eluting stents in diabetic patients with coronary artery disease

There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients. Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates. No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P = .01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P = .83) and stent thrombosis (HR 1.00 [0.31-3.30], P = .67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P = .79). In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

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

Background— Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. Methods and Results— This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23±0.27 versus 0.37±0.52 mm; difference, −0.13 mm; 95% confidence interval, −0.25 to −0.02; upper 1-sided 95% confidence interval, −0.04; P &lt;0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P =0.029) and in-segment restenosis (0.9% versus 6.5%; P =0.035). However, in-stent late loss (0.11±0.26 versus 0.20±0.49 mm; P =0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P =0.317), death (1.3% versus 3.3%; P =0.448), and myocardial infarction (0% versus 1.3%; P =0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P =0.218), were also not statistically different between the 2 groups. Conclusions— Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00997763.

Is Diabetes the Achilles' Heel of Limus-Eluting Stents?

Patients with diabetes have a 2- to 4-fold increase in the risk of coronary artery disease.1 They have accelerated and more diffuse coronary artery disease2 with increased need for revascularization therapy.3 In addition, patients with diabetes have worse outcomes after surgical or catheter-based revascularization procedures.4 Diabetes promotes endothelial dysfunction and platelet deposition, which enhance the propensity to thrombosis.5 Hyperglycemia is associated with overexpression of several growth factors, and advanced glycosylation promotes inflammatory cell recruitment and smooth muscle cell proliferation.5 Indeed, an excess risk of coronary thrombosis and restenosis has characterized the outcomes of diabetic patients treated with balloon angioplasty or bare-metal stents (BMS).2,6 Although drug-eluting stents (DES) provide better chances than BMS for diabetic patients who need coronary revascularization,7 diabetes remains an important risk factor for coronary events even in the DES era. Moreover, findings about an attenuation of the mammalian target of rapamycin (mTOR) signaling pathway in patients with type 2 diabetes8 have generated concerns about a possible specific limitation of limus-eluting stents in diabetic patients that has not been fully dispelled by existing clinical evidence. Articles see p 886 and p 893 Diabetic patients are in bad need of the best available DES, and 2 studies published in the current issue of Circulation considerably serve our efforts in defining optimal DES strategy in these patients. In the study of Stone et al,9 the investigators pooled together the individual patient data from 4 randomized trials—the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) II, SPIRIT III, SPIRIT IV trials, and the Second-Generation Everolimus-Eluting and Paclitaxel-Eluting Stents in Real-Life Practice (COMPARE) trial—that compared everolimus-eluting stents (EES) with paclitaxel-eluting stents (PES) in patients …

Outcomes with drug-eluting stents in diabetic patients

The relationship between diabetes mellitus and coronary artery disease is well established. The percentage of patients participating in clinical trials of percutaneous coronary intervention who have diabetes is quickly rising. Diabetic patients have a worse prognosis than nondiabetic patients, with generally greater rates of death, myocardial infarction and need for target lesion and vessel revascularization. Stenting has improved the outcome of diabetic patients receiving percutaneous coronary intervention. Compared with bare-metal stents, the use of drug-eluting stents in diabetic patients has resulted in a significant reduction in late lumen loss, binary restenosis, and clinically driven target vessel revascularization. The safety and efficacy of drug-eluting stents in diabetic patients is now well established; they are the preferred option in this subgroup in the absence of contraindications. New stent designs, polymers and drugs are resulting in better outcomes overall, but more research is required ...

Novel Approaches for Preventing or Limiting Events in Diabetic Patients (Naples-Diabetes) Trial

Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c &gt;7% and low-density lipoprotein cholesterol &gt;100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group ( P =0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P =1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P =0.012) and the Taxus group (adjusted P =0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P =0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P =0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P =0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P =0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with Diabetes mellitus: a patient-level meta-analysis of randomized trials

Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking. We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated. There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36-0.63, P<0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18-0.41, P<0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59-1.41, P=0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54-1.09, P=0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15-1.69, P=0.26). Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.

Comparison of Bypass Surgery with Drug-Eluting Stents in Diabetic Patients with Left Main Coronary Stenosis

PurposeSeveral studies have compared the effects of coronary stenting and coronary-artery bypass grafting (CABG) on left main coronary artery (LMCA) disease. However, there are limited data on the long-term outcomes of these two interventions in diabetic patients.Materials and MethodsWe evaluated 56 patients with LMCA stenosis who underwent drug-eluting stent (DES) implantation and 116 patients who underwent CABG in a single hospital in China between January 2004 and December 2006. We compared long-term major adverse cardiac events (death; a "serious outcome" composite of death, myocardial infarction, or stroke; and target-vessel revascularization).ResultsIn-hospital (30-day) mortality was 0% for the DES group and 3.4% for the CABG group (p=0.31). There was no difference between the two groups in terms of risk of death [hazard ratio for stenting group, 0.49; 95% confidence interval (CI), 0.13-1.63; p=0.55] or risk of serious outcome (hazard ratio for DES group, 1.11; 95% CI, 0.39-1.45; p=0.47). The target-vessel revascularization rate was higher in the DES group than in the CABG group (hazard ratio, 3.67; 95% CI, 1.24-11.06; p=0.018).ConclusionIn this cohort of diabetic patients with LMCA stenosis, there was no difference in composite endpoints between patients receiving DESs and those undergoing CABG. However, stenting was associated with higher rates of target-vessel revascularization than CABG. DES implantation in diabetic patients with LMCA disease was found to be at least as safe as CABG.

Outcomes in Diabetic and Nondiabetic Patients Treated With Everolimus- or Paclitaxel-Eluting Stents: Results From the SPIRIT IV Clinical Trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System)

We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial. Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined. In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2:1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]). The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (p(interaction) = 0.02) was observed. In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047).

Comparison of three‐year clinical outcomes between sirolimus‐versus paclitaxel‐eluting stents in diabetic patients: Prospective randomized multicenter trial

Three-year follow-up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus-eluting stent (SES) or paclitaxel-eluting stent (PES) implantation have not been reported. Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES. Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three-year follow-up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25-22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07-29.44, P < 0.001) during the three-year follow-up. The rates of MACEs, TVR, and stent thrombosis during the three-year follow-up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three-year follow-up after either SES or PES implantation.

TCT-114: Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents in Diabetic Patients: A Subgroup Analysis of the Randomized, Clinical Trial

TCT-114: Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents in Diabetic Patients: A Subgroup Analysis of the Randomized, Clinical Trial