Dataset Information

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

ABSTRACT:

Background

Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients.

Objectives

The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a "real-world" clinical setting.

Methods

Among 24,516 patients enrolled in a multicenter, prospective registry, 7,823 patients with DM were treated with 4 contemporary DES: 2,877 with a cobalt chromium everolimus-eluting stent (EES), 789 with a biodegradable polymer biolimus-eluting stent, 2,286 with a platinum chromium-EES, and 1,871 with a Resolute zotarolimus-eluting stent. The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization).

Results

The median follow-up duration was 2.9 years. Observed 3-year rates of TVF were not significantly different according to different DES types. On multigroup propensity-score analysis, the adjusted HRs for TVF were similar in between-group comparisons: biodegradable polymer biolimus-eluting stent (HR: 0.94; 95% CI: 0.76-1.16; P = 0.57), platinum chromium-EES (HR: 0.94; 95% CI: 0.81-1.09; P = 0.41), and Resolute zotarolimus-eluting stent (HR: 1.01; 95% CI: 0.86-1.18; P = 0.93) compared with the cobalt chromium-EES (reference). This trend was maintained in patients with non-insulin- and insulin-treated DM.

Conclusions

In this multicenter clinical-practice PCI registry, no significant between-group differences were found for a 3-year risk of TVF in patients with DM undergoing PCI with various types of contemporary DES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

SUBMITTER: Yang Y

PROVIDER: S-EPMC9627859 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

Yang Yujin Y Hyun Junho J Lee Junghoon J Kim Ju Hyeon JH Lee Jeong Bok JB Kang Do-Yoon DY Lee Pil Hyung PH Ahn Jung-Min JM Park Duk-Woo DW Park Seung-Jung SJ

JACC. Asia 20210921 2

<h4>Background</h4>Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients.<h4>Objectives</h4>The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a "real-world" clinical setting.<h4>Methods</h4>Among 24,516 ...[more]

PMID: 36338165

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Project description:BackgroundLimited data are available on the relative performances of diverse contemporary drug-eluting stents (DES) in patients undergoing complex high-risk indicated procedures (CHIP).ObjectivesThe purpose of this study was to evaluate the comparative effectiveness of contemporary second-generation DES for CHIP patients in "real-world" settings.MethodsOf 28,843 patients enrolled in the IRIS-DES registry, a total of 6,645 patients with CHIP characteristics who received 5 different types of contemporary DES were finally included: 3,752 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 1,258 with Resolute zotarolimus-eluting stents (Re-ZES), 864 with platinum-chromium EES (PtCr-EES), 437 with ultrathin strut biodegradable-polymer sirolimus-eluting stents (UT-SES), and 334 with bioresorbable polymer SES (BP-SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 12 months.ResultsAt 12 months, the rate of target-vessel failure was highest in the CoCr-EES (7.1%) group; intermediate in the Re-ZES (5.0%), PtCr-EES (4.6%), and BP-SES (4.2%) groups; and lowest in the UT-SES (3.8%) group (overall long-rank P = 0.001). In multiple-treatment propensity-score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were significantly lower in the Re-ZES (HR: 0.71; 95% confidence interval [CI]: 0.52-0.97), the UT-SES (HR: 0.52; 95% CI: 0.29-0.95), and BP-SES (HR: 0.33; 95% CI: 0.16-0.70) groups than in the CoCr-EES group (referent).ConclusionsIn this contemporary PCI registry, we observed the differential risks of target-vessel failure according to various types of contemporary DES in patients with CHIP characteristics. However, owing to inherent selection bias, the results should be considered hypothesis-generating, highlighting the need for further randomized trials. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Project description:Background The choice of optimal drug-eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long-term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES) in patients with DM. Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin-strut BP-SES or thin-strut DP-EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (risk ratio, 1.23; 95% CI, 0.87-1.73 [P=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (risk ratio, 0.98; 95% CI, 0.77-1.26 [P=0.90; P for interaction=0.31]). Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES. There was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin-strut BP-SES or thin-strut DP-EES. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104.

Project description:BackgroundToday, diabetes mellitus (DM) has become a worldwide concern. DM is a major risk factor for the development of cardiovascular diseases (CVD). Eligible patients with CVD are treated invasively by percutaneous coronary intervention (PCI) whereby a stent is implanted inside the coronary vessel with the particular lesion to allow sufficient blood flow. Newer scientific research have shown that even though associated with a lower rate of re-stenosis, first-generation drug eluting stents (DES) were associated with a higher rate of late stent thrombosis. Recently, newer stents, namely biodegradable polymer DES (BP-DES) have been developed to overcome the safety issues of earlier generation DES. In this analysis we aimed to systematically compare the long term (≥ 12 months) adverse cardiovascular outcomes observed in DM versus non-DM patients who were implanted with BP-DES.MethodsCochrane central, MEDLINE (Subset PubMed), EMBASE, Web of Science, http://www.Clinicaltrialsgov and Google scholar were searched for relevant publications involving BP-DES in patients with DM versus non-DM and their associated adverse cardiovascular outcomes. The mean follow-up time period ranged from 12 to 120 months. Data analysis was carried out with the latest version of the RevMan software (version 5.4). Based on the Mantel-Haenszel test, risk ratios (RR) with 95% confidence intervals (CI) were calculated and used to represent the results following analysis.ResultsSeven (7) studies with a total number of 10,246 participants were included in this analysis. Stents which were implanted during PCI were BP-DES. Participants were enrolled from the year 2006 to 2013. Our current results showed that in patients who were implanted with BP-DES, the risks of major adverse cardiac events (RR: 1.30, 95% CI: 1.18-1.43; P = 0.00001), myocardial infarction (RR: 1.48, 95% CI: 1.14-1.93; P = 0.003), all-cause mortality (RR: 1.70, 95% CI: 1.29-2.23; P = 0.0002), cardiac death (RR: 1.93, 95% CI: 1.28-2.93; P = 0.002), target vessel revascularization (RR: 1.35, 95% CI: 1.03-1.77; P = 0.03), target lesion revascularization (RR: 1.28, 95% CI: 1.07-1.54; P = 0.007) and target lesion failure (RR: 1.79, 95% CI: 1.52-2.12; P = 0.00001) were significantly higher in the DM group. Definite and probable stent thrombosis (RR: 1.80, 95% CI: 1.28-2.55; P = 0.0009) were also significantly higher in the DM group.ConclusionsDiabetes mellitus was an independent risk factor associated with long term adverse cardiovascular outcomes following PCI with BP-DES.

Project description:BackgroundDrug-eluting stents have been seen as an attractive alternative to bare-metal stents for percutaneous coronary interventions (PCIs) because of the decreased need for revascularization. However, comparative clinical trials have shown no difference in patient outcomes, and drug-eluting stents are considerably more expensive than their bare-metal counterparts. We conducted a systematic review of all published comparative cost-effectiveness analyses to identify the factors contributing to the heterogeneity of their conclusions.MethodsWe retrieved all articles published between Jan. 1, 2000, and July 31, 2006, in which the cost-effectiveness, from a third-party payer perspective, of drug-eluting stents was compared with that of bare-metal stents for PCI in unrestricted patient populations. Electronic databases, Web sites from health technology assessment groups and references of identified articles were searched. Our outcome variable was whether the study's conclusions favoured widespread use of drug-eluting stents, as assessed by 4 independent reviewers. Study characteristics such as quality, funding source, country and year of publication were extracted. Two-by-2 tables and Fisher's exact test were used to study the association between covariates and the outcome variable. A classification and regression tree (CART) model was used for multivariate analysis.ResultsWe identified 19 cost-effectiveness analyses. Ten were in favour of widespread use of drug-eluting stents, and 9 favoured more restrained use. Only 1 of 9 high-quality studies supported widespread use, as compared with 9 of 10 lower quality studies (p < 0.001). All of the 7 sponsored studies argued in favour of widespread use, as compared with 3 of the 12 studies without sponsorship (p = 0.003). Studies from the United States were more likely than those from other countries to endorse unlimited use (p = 0.032). A CART model with 2 covariates--study quality and sponsorship--provided the best fit (error rate 10.5%).InterpretationConclusions drawn by cost-effectiveness analyses of drug-eluting stents for PCI are associated with the study's quality, funding source and country of origin. Vigilance regarding these study characteristics is required when interpreting findings from cost-effectiveness analyses.

Dataset Information

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

Background

Objectives

Methods

Results

Conclusions

Publications

Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus.

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