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2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry).

https://arctichealth.org/en/permalink/ahliterature89935
Source
J Am Coll Cardiol. 2009 Feb 24;53(8):658-64
Publication Type
Article
Date
Feb-24-2009
Author
Kaltoft Anne
Jensen Lisette Okkels
Maeng Michael
Tilsted Hans Henrik
Thayssen Per
Bøttcher Morten
Lassen Jens Flensted
Krusell Lars Romer
Rasmussen Klaus
Hansen Knud Nørregaard
Pedersen Lars
Johnsen Søren Paaske
Sørensen Henrik Toft
Thuesen Leif
Author Affiliation
Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark. annekaltoft@stofanet.dk
Source
J Am Coll Cardiol. 2009 Feb 24;53(8):658-64
Date
Feb-24-2009
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Disease - mortality - therapy
Drug-Eluting Stents - adverse effects
Female
Humans
Immunosuppressive Agents
Male
Middle Aged
Myocardial Infarction - etiology
Paclitaxel
Sirolimus
Stents - adverse effects
Thrombosis - etiology
Abstract
OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. CONCLUSIONS: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.
Notes
Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
PubMed ID
19232897 View in PubMed
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Clinical reinfarction according to infarct location and reperfusion modality in patients with ST elevation myocardial infarction. A DANAMI-2 long-term follow-up substudy.

https://arctichealth.org/en/permalink/ahliterature91286
Source
Cardiology. 2009;113(1):72-80
Publication Type
Article
Date
2009
Author
Busk Martin
Kristensen Steen D
Rasmussen Klaus
Kelbaek Henning
Thayssen Per
Madsen Jan K
Abildgaard Ulrik
Krusell Lars R
Mortensen Leif S
Thuesen Leif
Andersen Henning R
Nielsen Torsten T
Author Affiliation
Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
Source
Cardiology. 2009;113(1):72-80
Date
2009
Language
English
Publication Type
Article
Keywords
Aged
Denmark - epidemiology
Female
Follow-Up Studies
Humans
Male
Middle Aged
Multicenter Studies as Topic
Myocardial Infarction - etiology - mortality - pathology
Myocardial Reperfusion - methods
Myocardium - pathology
Randomized Controlled Trials as Topic
Recurrence
Abstract
OBJECTIVES: To evaluate clinical reinfarction during a 3-year follow-up after randomization to primary angioplasty versus fibrinolysis in anterior and non-anterior ST elevation myocardial infarction (STEMI). METHODS: Clinical reinfarction was prospectively assessed by an endpoint committee blinded to the study treatment. RESULTS: At 30 days, primary angioplasty compared with fibrinolysis reduced the reinfarction rate both in anterior STEMI patients (n = 823; 2.5 vs. 5.6%, p = 0.02) and in non-anterior STEMI patients (n = 743; 0.8 vs. 7.4%, p or =2 [HR = 1.42 (1.01-2.00)]. The additional late reinfarctions after angioplasty for anterior STEMI were located within the angioplasty-treated target segment. Anterior STEMI patients had smaller mean target vessel diameter, which was associated with reinfarction. CONCLUSIONS: Clinical reinfarction is an independent predictor of death. The early superiority of primary angioplasty over fibrinolysis on reinfarction rate after anterior STEMI diminished during long-term follow-up.
PubMed ID
19005253 View in PubMed
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Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial.

https://arctichealth.org/en/permalink/ahliterature85106
Source
JAMA. 2008 Jan 30;299(4):409-16
Publication Type
Article
Date
Jan-30-2008
Author
Galløe Anders M
Thuesen Leif
Kelbaek Henning
Thayssen Per
Rasmussen Klaus
Hansen Peter R
Bligaard Niels
Saunamäki Kari
Junker Anders
Aarøe Jens
Abildgaard Ulrik
Ravkilde Jan
Engstrøm Thomas
Jensen Jan S
Andersen Henning R
Bøtker Hans E
Galatius Søren
Kristensen Steen D
Madsen Jan K
Krusell Lars R
Abildstrøm Steen Z
Stephansen Ghita B
Lassen Jens F
Author Affiliation
Department of Cardiology, Gentofte University Hospital, Hellerup, Copenhagen, Denmark. anders@galloe.dk
Source
JAMA. 2008 Jan 30;299(4):409-16
Date
Jan-30-2008
Language
English
Publication Type
Article
Abstract
CONTEXT: Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients. OBJECTIVE: To compare the first 2 commercially available drug-eluting stents-sirolimus-eluting and paclitaxel-eluting-for prevention of symptom-driven clinical end points, using a study design reflecting everyday clinical practice. DESIGN, SETTING, AND PATIENTS: Randomized, blinded trial conducted August 2004 to January 2006 at 5 university hospitals in Denmark. Patients were 2098 men and women (mean [SD] age, 63.6 [10.8] years) treated with percutaneous coronary intervention (PCI) and randomized to receive either sirolimus-eluting (n = 1065) or paclitaxel-eluting (n = 1033) stents. Indications for PCI included ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina pectoris, and stable angina. MAIN OUTCOME MEASURES: The primary end point was a composite clinical end point of major adverse cardiac events, defined as either cardiac death, acute myocardial infarction, target lesion revascularization, or target vessel revascularization. Secondary end points included individual components of the composite end point, all-cause mortality, and stent thrombosis. RESULTS: The sirolimus- and the paclitaxel-eluting stent groups did not differ significantly in major adverse cardiac events (98 [9.3%] vs 114 [11.2%]; hazard ratio, 0.83 [95% confidence interval, 0.63-1.08]; P = .16) or in any of the secondary end points. The stent thrombosis rates were 27 (2.5%) and 30 (2.9%) (hazard ratio, 0.87 [95% confidence interval, 0.52-1.46]; P = .60), respectively. CONCLUSION: In this practical randomized trial, there were no significant differences in clinical outcomes between patients receiving sirolimus- and paclitaxel-eluting stents. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00388934.
PubMed ID
18230778 View in PubMed
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Comparison of stent thrombosis, myocardial infarction, and mortality following drug-eluting versus bare-metal stent coronary intervention in patients with diabetes mellitus.

https://arctichealth.org/en/permalink/ahliterature85978
Source
Am J Cardiol. 2008 Jul 15;102(2):165-72
Publication Type
Article
Date
Jul-15-2008
Author
Maeng Michael
Jensen Lisette O
Kaltoft Anne
Hansen Hans H T
Bøttcher Morten
Lassen Jens F
Thayssen Per
Krusell Lars R
Rasmussen Klaus
Pedersen Lars
Sørensen Henrik T
Johnsen Søren P
Thuesen Leif
Author Affiliation
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Aarhus, Denmark.
Source
Am J Cardiol. 2008 Jul 15;102(2):165-72
Date
Jul-15-2008
Language
English
Publication Type
Article
Abstract
The aim of this study was to examine outcomes subsequent to implantation of drug-eluting stents (DESs) and bare-metal stents (BMSs) in patients with diabetes. From January 2002 to June 2005, data from all percutaneous coronary interventions performed in Western Denmark were prospectively recorded. A total of 1,423 consecutive diabetic patients treated with stent implantation (2,094 lesions) were followed up for 15 months. Of these, 871 patients (1,180 lesions) were treated with a BMS, and 552 patients (914 lesions) were treated with a DES. Dual antiplatelet therapy was recommended for 12 months in both treatment groups. Data for death and myocardial infarction (MI) were ascertained from national health care databases. Use of DESs was not associated with increased risk of definite stent thrombosis (adjusted relative risk [RR] 0.76, 95% confidence interval [CI] 0.10 to 3.26) or MI (adjusted RR 0.90, 95% CI 0.53 to 1.52). In the DES group compared with the BMS group, adjusted RRs of target-lesion revascularization (adjusted RR 0.48, 95% CI 0.33 to 0.71), total mortality (adjusted RR 0.66, 95% CI 0.44 to 0.99), and cardiac mortality (adjusted RR 0.53, 95% CI 0.31 to 0.90) decreased by 52%, 34%, and 47%, respectively. In conclusion, use of DESs reduced target-lesion revascularization in diabetic patients receiving routine clinical care. This result was obtained without increased risk of death, stent thrombosis, or MI.
PubMed ID
18602515 View in PubMed
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Target lesion revascularisation in patients treated with a sirolimus-eluting or paclitaxel-eluting stent.

https://arctichealth.org/en/permalink/ahliterature79290
Source
Heart. 2007 Jun;93(6):694-7
Publication Type
Article
Date
Jun-2007
Author
Maeng Michael
Okkels Jensen Lisette
Rasmussen Klaus
Flensted Lassen Jens
Romer Krusell Lars
Thayssen Per
Thuesen Leif
Author Affiliation
Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, Aarhus, Denmark. michael.maeng@ki.au.dk
Source
Heart. 2007 Jun;93(6):694-7
Date
Jun-2007
Language
English
Publication Type
Article
Keywords
Analysis of Variance
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis - epidemiology - therapy
Coronary Stenosis - therapy
Denmark
Drug Delivery Systems
Equipment Design
Humans
Logistic Models
Paclitaxel - administration & dosage
Registries
Risk factors
Sirolimus - administration & dosage
Stents
Treatment Outcome
Abstract
OBJECTIVE: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario. DESIGN: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms. SETTING: Western Denmark Heart Registry. PATIENTS: 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent. INTERVENTIONS: Percutaneous coronary intervention. MAIN OUTCOME MEASURES: TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure. RESULTS: TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1.05 to 1.95). Implantation of >1 stent per lesion (OR 1.62, 95% CI 1.13 to 2.33) and reference diameter
PubMed ID
17194711 View in PubMed
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