One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry.
Absorbable Implants
Aged
Cardiovascular Agents
/ administration & dosage
Coronary Artery Disease
/ diagnostic imaging
Coronary Thrombosis
/ etiology
Drug-Eluting Stents
Female
Humans
Italy
Male
Middle Aged
Myocardial Infarction
/ diagnostic imaging
Percutaneous Coronary Intervention
/ adverse effects
Polymers
/ chemistry
Progression-Free Survival
Prosthesis Design
Recurrence
Registries
Retrospective Studies
Risk Factors
Sirolimus
/ administration & dosage
Time Factors
acute myocardial infarction
biodegradable-polymer sirolimus-eluting coronary stent
percutaneous coronary interventions
stent thrombosis
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:
01 12 2019
01 12 2019
Historique:
received:
09
01
2019
revised:
19
03
2019
accepted:
10
04
2019
pubmed:
1
5
2019
medline:
2
9
2020
entrez:
1
5
2019
Statut:
ppublish
Résumé
The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.
Sections du résumé
BACKGROUND
The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI).
METHODS
We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR).
RESULTS
Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF.
CONCLUSIONS
In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.
Substances chimiques
Cardiovascular Agents
0
Polymers
0
Sirolimus
W36ZG6FT64
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
972-979Commentaires et corrections
Type : CommentIn
Type : ErratumIn
Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
Neumann F-J, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2018;40:87-165. https://doi.org/10.1093/eurheartj/ehy394.
van Beusekom HMM, Saia F, Zindler JD, et al. Drug-eluting stents show delayed healing: paclitaxel more pronounced than sirolimus. Eur Heart J. 2007;28(8):974-979. https://doi.org/10.1093/eurheartj/ehm064.
Finn AV, Nakazawa G, Joner M, et al. Vascular responses to drug eluting stents. Arterioscler Thromb Vasc Biol. 2007;27(7):1500-1510. https://doi.org/10.1161/ATVBAHA.107.144220.
Chisari A, Pistritto AM, Piccolo R, La Manna A, Danzi GB. The Ultimaster biodegradable-polymer sirolimus-eluting stent: an updated review of clinical evidence. Int J Mol Sci. 2016;17(9):E1490. https://doi.org/10.3390/ijms17091490.
Jiménez VA, Iñiguez A, Baz JA, et al. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: the CENTURY II high risk ACS substudy. Cardiovasc Revasc Med. 2016;17(6):355-361. https://doi.org/10.1016/j.carrev.2016.04.001.
Godino C, Beneduce A, Ferrante G, et al. One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry). Int J Cardiol. 2018;260:36-41. https://doi.org/10.1016/j.ijcard.2018.02.014.
Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344-2351. https://doi.org/10.1161/CIRCULATIONAHA.106.685313.
Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370(9591):937-948. https://doi.org/10.1016/S0140-6736(07)61444-5.
Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356(10):998-1008. https://doi.org/10.1056/NEJMoa067193.
Chen JP, Hou D, Pendyala L, Goudevenos JA, Kounis NG. Drug-eluting stent thrombosis: the Kounis hypersensitivity-associated acute coronary syndrome revisited. JACC Cardiovasc Interv. 2009;2(7):583-593. https://doi.org/10.1016/J.JCIN.2009.04.017.
Räber L, Kelbaek H, Ostojic M, et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction. JAMA. 2012;308(8):777-787. https://doi.org/10.1001/jama.2012.10065.
Raber 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(3):355-364. https://doi.org/10.1161/CIRCINTERVENTIONS.113.001440.
Valdes-Chavarri M, Kedev S, Neskovic AN, et al. Randomized evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study. EuroIntervention. 2019;14:e1836-e1842. https://doi.org/10.4244/eij-d-17-01087.
Stefanini GG, Kalesan B, Serruys PW, et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011;378(9807):1940-1948. https://doi.org/10.1016/S0140-6736(11)61672-3.
Hou D, Huibregtse B, Dawkins K, et al. Current state of bioabsorbable polymer-coated drug-eluting stents. Curr Cardiol Rev. 2017;13(2):139-154. https://doi.org/10.2174/1573403X12666161222155230.
Natsuaki M, Kozuma K, Morimoto T, et al. Five-year outcome of a randomised trial comparing second-generation drug-eluting stents using either biodegradable polymer or durable polymer: the NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial (NEXT). EuroIntervention. 2018;14(7):815-818. https://doi.org/10.4244/EIJ-D-17-01050.
Planer D, Smits PC, Kereiakes DJ, et al. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes. JACC Cardiovasc Interv. 2011;4(10):1104-1115. https://doi.org/10.1016/j.jcin.2011.06.018.
Buccheri S, Sarno G, Lagerqvist B, et al. Bioabsorbable polymer everolimus-eluting stents in patients with acute myocardial infarction: a report from the Swedish coronary angiography and angioplasty registry. EuroIntervention. 2018;14(5):e562-e569. https://doi.org/10.4244/EIJ-D-18-00392.
Otsuka F, Cheng Q, Yahagi K, et al. Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model. JACC Cardiovasc Interv. 2015;8(9):1248-1260. https://doi.org/10.1016/j.jcin.2015.03.029.
Khan AR, Tripathi A, Farid TA, et al. Stent thrombosis with bioabsorbable polymer drug-eluting stents. Coron Artery Dis. 2017;28(7):564-569. https://doi.org/10.1097/MCA.0000000000000539.