scholarly journals Ten‐Year Clinical Outcomes of Biodegradable Versus Durable Polymer New‐Generation Drug‐Eluting Stent in Patients With Coronary Artery Disease With and Without Diabetes Mellitus

2021 ◽  
Author(s):  
Tobias Lenz ◽  
Tobias Koch ◽  
Michael Joner ◽  
Erion Xhepa ◽  
Jens Wiebe ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Outcome ◽  
Major Adverse Cardiac Event ◽  
Cardiac Event ◽  
Adverse Cardiac Event ◽  
Drug Eluting Stents ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
Event Rates ◽  
New Generation

Background Extended long‐term follow‐up data of new‐generation drug‐eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10‐year clinical outcome of new‐generation biodegradable polymer‐based sirolimus‐eluting stents (Yukon Choice PC) versus permanent polymer‐based everolimus‐eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug‐eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus ( P <0.001; hazard ratio [HR], 1.41; 95% CI, 1.22–1.63). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with ( P =0.91; HR, 1.01; 95% CI, 0.79–1.30) nor without diabetes mellitus ( P =0.50; HR, 0.94; 95% CI, 0.79–1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34–2.60; P =0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new‐generation drug‐eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://clinicaltrials.gov . Unique Identifier: NCT00598676.

scholarly journals Drug-eluting stents with biodegradable polymer for the treatment of patients with diabetes mellitus: clinical outcome at 2 years in a large population of patients

2015 ◽  
pp. 153 ◽  
Author(s):  
Marcus Wiemer ◽  
Gian Battista Danzi ◽  
Nick West ◽  
Vassilios Voudris ◽  
Stefan Hoffmann ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Outcome ◽  
Biodegradable Polymer ◽  
Large Population ◽  
Drug Eluting Stents ◽  
Patients With Diabetes ◽  
Drug Eluting

scholarly journals TCT-191 Long-term Outcomes Of The New Generation Drug-Eluting Stents In Patients With Diabetes Mellitus And Single Vessel Disease

2013 ◽  
Vol 62 (18) ◽  
pp. B62
Author(s):  
Chrysoula Patsa ◽  
Konstantinos Toutouzas ◽  
Eleftherios Tsiamis ◽  
Anastasios Spanos ◽  
Tolis Hlias ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Drug Eluting Stents ◽  
Long Term Outcomes ◽  
Vessel Disease ◽  
Single Vessel ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
New Generation ◽  
Single Vessel Disease

scholarly journals Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus

2021 ◽  
Author(s):  
Tobias Koch ◽  
Tobias Lenz ◽  
Michael Joner ◽  
Erion Xhepa ◽  
Tobias Koppara ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Cardiac Events ◽  
Kaplan Meier ◽  
Durable Polymer ◽  
Adverse Cardiac Events ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
Artery Disease ◽  
Event Rates ◽  
New Generation

Abstract Background Very long-term outcomes according to diabetic status of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) are scant. Both, the durable polymer zotarolimus-eluting stent (DP-ZES), the first DES to gain FDA-approval for specific use in patients with diabetes mellitus, and the polymer-free sirolimus- and probucol-eluting stent (PF-SES), with a unique design that enables effective drug release without the need of a polymer offer the potential to enhance clinical long-term outcomes especially in patients with diabetes mellitus. Methods We investigate 10-year clinical outcomes of the prespecified subgroups of patients with and without diabetes mellitus, randomly assigned to treatment with PF-SES versus DP-ZES in the ISAR-TEST 5 trial. The primary endpoint of interest was major adverse cardiac events (MACE), defined as the composite of all-cause death, any myocardial infarction or any revascularization. Further endpoints of interest were cardiac death, myocardial infarction related to the target vessel and target lesion revascularization as well as the individual components of the primary composite endpoint and the incidence of definite or probable stent thrombosis at 10 years. Results This analysis includes a total of 3002 patients randomly assigned to PF-SES (n = 2002) or DP-ZES (n = 1000). Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66). At 10 years 53.5% of patients with diabetes mellitus and 68.5% of patients without diabetes mellitus were alive. Regarding major adverse cardiac events, PF-SES as compared to DP-ZES showed comparable event rates in patients with diabetes mellitus (74.8% vs. 79.6%; hazard ratio 0.86; 95% CI 0.73–1.02; P = 0.08) and in patients without diabetes (PF-SES 62.5% vs. DP-ZES 62.2%; hazard ratio 0.99; 95% CI 0.88–1.11; P = 0.88). Conclusion At 10 years, both new-generation DES show comparable clinical outcome irrespective of diabetic status or polymer strategy. Event rates after PCI in patients with diabetes mellitus are considerable higher than in patients without diabetes mellitus and continue to accrue over time. Trial registration ClinicalTrials.gov, NCT00598533, Registered 10 January 2008, https://clinicaltrials.gov/ct2/show/NCT00598533?term=NCT00598533 Graphic abstract Kaplan-Meier estimates of endpoints of interest for patients with vs. without diabetes mellitus treated with PF-SES vs. DP-ZES. Bar graphs: Kaplan-Meier estimates as percentages. PF-SES: polymer-free sirolimus-eluting stent; DP-ZES: durable polymer zotarolimus-eluting stent; DM: diabetes mellitus. Comparison of event rates of individual endpoints in patients with and without diabetes mellitus treated with PF-SES vs. DP-ZES all without statistically significant differences. Comparison of event rates of individual endpoints in overall patients with vs. without diabetes mellitus significantly different (P ≤ 0.01 for all comparisons).

102 Clinical outcome in patients treated with Nobori, a new generation drug eluting stents in a real life setting: Abstract 102 Table 1

Heart ◽  
2010 ◽  
Vol 96 (Suppl 1) ◽  
pp. A60-A60
Author(s):  
F Fath-Ordoubadi ◽  
N West ◽  
S Talwar ◽  
F Witherow ◽  
D Hildick-Smith ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Real Life ◽  
Drug Eluting Stents ◽  
Real Life Setting ◽  
Drug Eluting ◽  
New Generation

Angiographic and 3D intravascular ultrasound assessment of overlapping bare metal stent and three different formulations of drug-eluting stents in patients with diabetes mellitus

2007 ◽  
Vol 24 (2) ◽  
pp. 125-132 ◽  
Author(s):  
Ren Kawaguchi ◽  
Manel Sabate ◽  
Dominick J. Angiolillo ◽  
Pilar Jimenez-Quevedo ◽  
Nobuaki Suzuki ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Intravascular Ultrasound ◽  
Bare Metal Stent ◽  
Drug Eluting Stents ◽  
Bare Metal ◽  
Metal Stent ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
Ultrasound Assessment

scholarly journals Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Eline H. Ploumen ◽  
Tineke H. Pinxterhuis ◽  
Paolo Zocca ◽  
Ariel Roguin ◽  
Rutger L. Anthonio ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Major Bleeding ◽  
Cardiac Death ◽  
Drug Eluting Stents ◽  
High Risk Population ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Patients With Diabetes ◽  
Drug Eluting ◽  
New Generation

Abstract Background Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia. Methods For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38–2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85–2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49–5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29–2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03–2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23–2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant. Conclusions Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors. Trial registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

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

JACC: Asia ◽  
2021 ◽  
Vol 1 (2) ◽  
pp. 173-184
Author(s):  
Yujin Yang ◽  
Junho Hyun ◽  
Junghoon Lee ◽  
Ju Hyeon Kim ◽  
Jeong Bok Lee ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Drug Eluting Stents ◽  
Patients With Diabetes ◽  
Drug Eluting
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