Impact of diabetes on 1-year clinical outcome in patients undergoing revascularization with the BioFreedom stents or the Orsiro stents from the SORT OUT IX trial.
DES-stent
DM-diabetes mellitus
PCI-percutaneous coronary intervention
drug eluting
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
03
08
2021
accepted:
25
12
2021
pubmed:
20
1
2022
medline:
22
4
2022
entrez:
19
1
2022
Statut:
ppublish
Résumé
This sub-study of the SORT OUT IX trial sought to compare clinical outcomes between patients with diabetes randomized to implantation of either the polymer-free biolimus A9-coated BioFreedom stent (BF-BES) or the ultra-thin strut, biodegradable polymer sirolimus-eluting Orsiro stent (O-SES). Patients with diabetes have an increased risk of target lesion failure (TLF) after percutaneous coronary intervention (PCI). The impact of different stent types in patients with diabetes is still discussed. A total of 607 of the 3151 patients (19.3%) enrolled in the SORT OUT IX study had diabetes. Randomization was stratified by patients with/without diabetes; 304 received BF-BES and 303 O-SES. The primary endpoint was TLF, which was a composite of cardiac death, myocardial infarction (not related to other than the index lesion) and target lesion revascularization (TLR) within 1 year. After 1 year, patients with diabetes had higher TLF (7.2% vs. 3.7%, incidence rate ratio [IRR]: 1.65; 95% confidence interval [CI]: 1.08-2.50), than patients without diabetes. TLF did not differ significantly between BF-BES and O-SES in patients with diabetes (8.2% vs. 6.3%, IRR: 1.17; 95% CI: 0.63-2.20). In patients with diabetes, cardiac death occurred in 2.3% of BF-BES and in 3.6% of O-SES (IRR: 0.58; 95% CI: 0.23-1.45) and TLR occurred in 5.3% and 2.3% of BF-BES and O-SES, respectively (IRR: 2.12; 95% CI: 0.81-5.56). Definite stent thrombosis rates of 1.3% were found in both stent types. Patients with diabetes had higher 1-year TLF rate after PCI compared to patients without diabetes, whereas TLF did not differ significantly between the two stent types BF-BES and O-SES in patients with diabetes.
Substances chimiques
Polymers
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1095-1103Informations de copyright
© 2022 Wiley Periodicals LLC.
Références
Abizaid A, Kornowski R, Mintz Gs, et al. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. JACC. 1998;32:584-589.
Van Belle E, Périé M, Braune D, et al. Effects of coronary stenting on vessel patency and long-term clinical outcome after percutaneous coronary revascularization in diabetic patients. JACC. 2002;40:410-417.
Schofer J, Schlüter M, Rau T, Hammer F, Haag N, Mathey DG. Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study. JACC. 2000;35:1554-1559.
Elezi S, Kastrati A, Pache J, et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. JACC. 1998;32:1866-1873.
Jensen LO, Maeng M, Raungaard B, et al. Randomized comparison of the polymer-free biolimus-coated biofreedom stent with the ultrathin strut biodegradable polymer sirolimus-eluting orsiro stent in an all-comers population treated with percutaneous coronary intervention: The SORT OUT IX. Trial Circ. 2020;141:2052-2063.
Mulukutla SR, Vlachos HA, Marroquin OC, et al. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National Heart, Lung, and Blood Institute Dynamic Registry. JACC Cardiovasc Interv. 2008;1:139-147.
Sabaté M, Jiménez-Quevedo P, Angiolillo DJ, et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES). trial. Circ. 2005;112:2175-2183.
Maeng M, Jensen LO, Galloe AM, et al. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial. Am J Cardiol. 2009;103:345-349.
Jiménez-Quevedo P, Sabaté M, Angiolillo DJ, et al. Vascular effects of sirolimus-eluting versus bare-metal stents in diabetic patients: three-dimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial. JACC. 2006;47:2172-2179.
Jensen LO, Maeng M, Thayssen P, et al. Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial. Eur Heart J. 2008;29:2733-2741.
Dibra A, Kastrati A, Mehilli J, et al. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. NEJM. 2005;353:663-670.
Billinger M, Beutler J, Taghetchian KR, et al. Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients. Eur Heart J. 2008;29:718-725.
Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. NEJM. 2002;346:1773-1780.
Räber L, Kelbaek H, Taniwaki M, et al. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circ Cardiovasc Interv. 2014;7:355-364.
Lipinski MJ, Forrestal BJ, Iantorno M, Torguson R, Waksman R. A comparison of the ultrathin Orsiro Hybrid sirolimus-eluting stent with contemporary drug-eluting stents: a meta-analysis of randomized controlled trials. Cardiovasc Revasc Med. 2018;19:5-11.
Kandzari DE, Mauri L, Koolen JJ, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017;390:1843-1852.
Jensen LO, Thayssen P, Maeng M, et al. Randomized comparison of a biodegradable polymer ultrathin strut sirolimus-eluting stent with a biodegradable polymer biolimus-eluting stent in patients treated with percutaneous coronary intervention: The SORT OUT VII. Circ Cardiovasc Interv. 2016;9(7):e003610.
Costa RA, Abizaid A, Mehran R, et al. Polymer-free biolimus A9-coated stents in the treatment of de novo coronary lesions: 4- and 12-month angiographic follow-up and final 5-year clinical outcomes of the prospective, multicenter bioFreedom FIM clinical trial. JACC Cardiovasc Interv. 2016;9:51-64.
Lipiecki J, Brunel P, Morice MC, et al. Biolimus A9 polymer-free coated stents in high bleeding risk patients undergoing complex PCI: evidence from the LEADERS FREE randomised clinical trial. EuroIntervention. 2018;14:418-425.
Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J. 2008;29:1975-1982.
Iglesias JF, Heg D, Roffi M, et al. Five-year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents. J Am Heart Assoc. 2019;8:e013607.
Ellert J, Christiansen EH, Maeng M, et al. Impact of diabetes on clinical outcomes after revascularization with sirolimus-eluting and biolimus-eluting stents with biodegradable polymer from the SORT OUT VII trial. Catheter Cardiovasc Interv. 2019;93:567-573.
Andersen TF, Madsen M, Jorgensen J, Mellemkjoer L, Olsen JH. The Danish National Hospital Register. A valuable source of data for modern health sciences. Dan Med Bul. 1999;46:263-268.
Juel K, Helweg-Larsen K. The Danish registers of causes of death. Dan Med Bul. 1999;46:354-357.
Frank L. Epidemiology. When an entire country is a cohort. Science. 2000;287:2398-2399.
Maeng M, Jensen LO, Kaltoft A, et al. Comparison of stent thrombosis, myocardial infarction, and mortality following drug-eluting versus bare-metal stent coronary intervention in patients with diabetes mellitus. Am J Cardiol. 2008;102:165-172.
Garot P, Morice MC, Tresukosol D, et al. 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents. JACC. 2017;69:162-171.
Sardella G, Stefanini GG, Briguori C, et al. Safety and efficacy of polymer-free biolimus-eluting stents in all-comer patients: the RUDI-FREE study. EuroIntervention. 2018;14:772-779.
Pepe M, Sardella G, Stefanini GG, et al. Impact of insulin-treated and noninsulin-treated diabetes mellitus in all-comer patients undergoing percutaneous coronary interventions with polymer-free biolimus-eluting stent (from the RUDI-FREE Registry). Am J Cardiol. 2019;124:1518-1527.
Waksman R, Shlofmitz E, Windecker S, et al. Efficacy and safety of ultrathin, bioresorbable-polymer sirolimus-eluting stents versus thin, durable-polymer everolimus-eluting stents for coronary revascularization of patients with diabetes mellitus. Am J Cardiol. 2019;124:1020-1026.