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
-
Published:2021-06-22
Issue:10
Volume:110
Page:1586-1598
-
ISSN:1861-0684
-
Container-title:Clinical Research in Cardiology
-
language:en
-
Short-container-title:Clin Res Cardiol
Author:
Koch Tobias, Lenz Tobias, Joner Michael, Xhepa Erion, Koppara Tobias, Wiebe Jens, Coughlan J. J., Aytekin Alp, Ibrahim Tareq, Kessler Thorsten, Cassese Salvatore, Laugwitz Karl-Ludwig, Schunkert Heribert, Kastrati Adnan, Kufner SebastianORCID, Mehilli Julinda, Hausleiter Jörg, Kastrati Adnan, Byrne Robert A., Ibrahim Tareq, Laugwitz Karl-Ludwig, Schunkert Heribert, Kufner Sebastian,
Abstract
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).
Funder
Bayerische Forschungsstiftung FP7 Health Deutsches Herzzentrum München
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,General Medicine
Reference29 articles.
1. Arnold SV, Bhatt DL, Barsness GW, Beatty AL, Deedwania PC, Inzucchi SE et al (2020) Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association. Circulation 141:1–28 2. Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V et al (2019) ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2019:3035–3087 3. Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U et al (2018) 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 46(4):517–592 4. Yahagi K, Kolodgie FD, Lutter C, Mori H, Romero ME, Finn AV et al (2017) Pathology of human coronary and carotid artery atherosclerosis and vascular calcification in diabetes mellitus. Arterioscler Thromb Vasc Biol 37(2):191–204 5. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E et al (2006) Pathology of drug-eluting stents in humans. Delayed healing and late thrombotic risk. J Am Coll Cardiol. 48(1):193–202
Cited by
7 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|