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2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial.

https://arctichealth.org/en/permalink/ahliterature120892
Source
J Am Coll Cardiol. 2012 Sep 25;60(13):1140-7
Publication Type
Article
Date
Sep-25-2012
Author
Lisette Okkels Jensen
Per Thayssen
Evald Høj Christiansen
Hans Henrik Tilsted
Michael Maeng
Knud Nørregaard Hansen
Anne Kaltoft
Henrik Steen Hansen
Hans Erik Bøtker
Lars Romer Krusell
Jan Ravkilde
Morten Madsen
Leif Thuesen
Jens Flensted Lassen
Author Affiliation
Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk
Source
J Am Coll Cardiol. 2012 Sep 25;60(13):1140-7
Date
Sep-25-2012
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary
Coronary Artery Disease - mortality - therapy
Death
Denmark
Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Immunosuppressive Agents - therapeutic use
Male
Middle Aged
Myocardial Infarction - etiology
Myocardial Revascularization - statistics & numerical data
Single-Blind Method
Sirolimus - adverse effects - analogs & derivatives - therapeutic use
Thrombosis - etiology
Treatment Outcome
Abstract
There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).
In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.
The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.
At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).
At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
PubMed ID
22958957 View in PubMed
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A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial).

https://arctichealth.org/en/permalink/ahliterature275976
Source
Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1161-7
Publication Type
Article
Date
Dec-1-2015
Author
Michael Maeng
Arvydas Baranauskas
Evald Høj Christiansen
Anne Kaltoft
Niels Ramsing Holm
Lars Romer Krusell
Jan Ravkilde
Hans-Henrik Tilsted
Per Thayssen
Lisette Okkels Jensen
Source
Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1161-7
Date
Dec-1-2015
Language
English
Publication Type
Article
Keywords
Aged
Cardiovascular Agents - administration & dosage
Coronary Angiography
Coronary Artery Disease - mortality - radiography - therapy
Coronary Restenosis - mortality - radiography
Coronary Stenosis - mortality - radiography - therapy
Coronary Thrombosis - mortality - radiography
Denmark
Diabetic Angiopathies - mortality - radiography - therapy
Drug-Eluting Stents
Everolimus - administration & dosage
Female
Humans
Male
Middle Aged
Myocardial Infarction - mortality - radiography
Percutaneous Coronary Intervention - adverse effects - instrumentation - mortality
Predictive value of tests
Prospective Studies
Prosthesis Design
Risk factors
Sirolimus - administration & dosage
Time Factors
Treatment Outcome
Abstract
We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
We randomized 213 patients with diabetes and coronary artery disease to EES (n?=?108) or SES (n?=?105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
At 10-month angiographic follow-up, in-stent late lumen loss was 0.20?±?0.53 mm and 0.11?±?0.49 mm (P?=?0.28), and angiographic restenosis rate was 3.8% and 5.2% (P?=?0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P?=?0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P?=?0.28).
EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
PubMed ID
25640050 View in PubMed
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Comparison of outcomes in patients with versus without diabetes mellitus after revascularization with everolimus- and sirolimus-eluting stents (from the SORT OUT IV trial).

https://arctichealth.org/en/permalink/ahliterature120882
Source
Am J Cardiol. 2012 Dec 1;110(11):1585-91
Publication Type
Article
Date
Dec-1-2012
Author
Lisette Okkels Jensen
Per Thayssen
Anders Junker
Michael Maeng
Hans-Henrik Tilsted
Anne Kaltoft
Knud Nørregaard Hansen
Evald Høj Christiansen
Steen Dalby Kristensen
Jan Ravkilde
Morten Madsen
Henrik Toft Sørensen
Leif Thuesen
Jens Flensted Lassen
Author Affiliation
Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk
Source
Am J Cardiol. 2012 Dec 1;110(11):1585-91
Date
Dec-1-2012
Language
English
Publication Type
Article
Keywords
Angioplasty, Balloon, Coronary - methods
Coronary Artery Disease - complications - mortality - surgery
Denmark - epidemiology
Diabetes Mellitus - mortality
Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Immunosuppressive Agents - pharmacology
Male
Middle Aged
Retrospective Studies
Sirolimus - analogs & derivatives - pharmacology
Survival Rate - trends
Treatment Outcome
Abstract
Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.
Notes
Comment In: Expert Rev Cardiovasc Ther. 2013 Feb;11(2):151-423405836
PubMed ID
22959714 View in PubMed
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Comparison of outcomes of patients = 80 years of age having percutaneous coronary intervention according to presentation (stable vs unstable angina pectoris/non-ST-segment elevation myocardial infarction vs ST-segment elevation myocardial infarction).

https://arctichealth.org/en/permalink/ahliterature131661
Source
Am J Cardiol. 2011 Nov 15;108(10):1395-400
Publication Type
Article
Date
Nov-15-2011
Author
Lisbeth Antonsen
Lisette Okkels Jensen
Per Thayssen
Evald Høj Christiansen
Anders Junker
Hans-Henrik Tilsted
Christian Juhl Terkelsen
Anne Kaltoft
Michael Maeng
Knud Noerregaard Hansen
Jan Ravkilde
Jens Flensted Lassen
Morten Madsen
Henrik Toft Sørensen
Leif Thuesen
Author Affiliation
Department of Cardiology, Odense University Hospital, Odense, Denmark. dr_lissie@hotmail.com
Source
Am J Cardiol. 2011 Nov 15;108(10):1395-400
Date
Nov-15-2011
Language
English
Publication Type
Article
Keywords
Aged, 80 and over
Angina, Stable - mortality - therapy
Angina, Unstable - mortality - therapy
Angioplasty, Balloon, Coronary - statistics & numerical data - trends
Arrhythmias, Cardiac - mortality
Cohort Studies
Comorbidity
Coronary Artery Disease - mortality - therapy
Denmark - epidemiology
Female
Follow-Up Studies
Heart Failure - mortality
Humans
Male
Myocardial Infarction - mortality - therapy
Registries
Regression Analysis
Abstract
Patients = 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients = 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (= 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients = 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time.
PubMed ID
21890087 View in PubMed
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Comparison of zotarolimus-eluting and sirolimus-eluting coronary stents: a study from the Western Denmark Heart Registry.

https://arctichealth.org/en/permalink/ahliterature120203
Source
BMC Cardiovasc Disord. 2012;12:84
Publication Type
Article
Date
2012
Author
Michael Maeng
Lisette Okkels Jensen
Anne Kaltoft
Hans-Henrik Tilsted
Evald Høj Christiansen
Per Thayssen
Morten Madsen
Henrik Toft Sørensen
Jens Flensted Lassen
Leif Thuesen
Author Affiliation
Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark. michael.maeng@ki.au.dk
Source
BMC Cardiovasc Disord. 2012;12:84
Date
2012
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary
Cohort Studies
Denmark - epidemiology
Drug-Eluting Stents - adverse effects
Female
Humans
Male
Middle Aged
Registries
Sirolimus - administration & dosage - analogs & derivatives
Abstract
We evaluated the effectiveness and safety of a zotarolimus-eluting (ZES) versus a sirolimus-eluting (SES) coronary stent in a large cohort of patients treated with one of these stents in Western Denmark.
A total of 6,122 patients treated with ZES (n=2,282) or SES (n=3,840) were followed for up to 27 months. We ascertained clinical outcomes based on national medical databases.
Incidence of target lesion revascularization (no. per 100 person-years) was 5.3 in the ZES group compared to 1.9 in the SES group (adjusted hazard ratio (HR)=2.19, 95% confidence intervals (CI): 1.39-3.47; p=0.001). All-cause mortality was also higher in the ZES group (ZES: 6.3; SES: 3.3; adjusted HR=1.34, 95% CI: 1.05-1.72; p=0.02), while stent thrombosis (ZES: 1.2; SES: 0.5; adjusted HR=1.98, 95% CI: 0.75-5.23; p=0.14) did not differ significantly.
In agreement with previously published randomised data, this observational study indicated that the ZES was associated with an increased risk of death and TLR in a large cohort of consecutive patients.
Notes
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PubMed ID
23031197 View in PubMed
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Influence of diabetes mellitus on clinical outcomes following primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

https://arctichealth.org/en/permalink/ahliterature128975
Source
Am J Cardiol. 2012 Mar 1;109(5):629-35
Publication Type
Article
Date
Mar-1-2012
Author
Lisette Okkels Jensen
Michael Maeng
Per Thayssen
Hans Henrik Tilsted
Christian Juhl Terkelsen
Anne Kaltoft
Jens Flensted Lassen
Knud Nørregaard Hansen
Jan Ravkilde
Evald Høj Christiansen
Morten Madsen
Henrik Toft Sørensen
Leif Thuesen
Author Affiliation
Department of Cardiology, Odense University Hospital, Denmark. okkels@dadlnet.dk
Source
Am J Cardiol. 2012 Mar 1;109(5):629-35
Date
Mar-1-2012
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary - methods
Blood Glucose - metabolism
Denmark - epidemiology
Diabetes Mellitus - blood - epidemiology
Electrocardiography
Female
Follow-Up Studies
Humans
Incidence
Male
Middle Aged
Myocardial Infarction - complications - epidemiology - surgery
Prognosis
Registries
Retrospective Studies
Stents
Survival Rate - trends
Time Factors
Treatment Outcome
Abstract
Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval [CI] 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death.
PubMed ID
22152969 View in PubMed
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Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial.

https://arctichealth.org/en/permalink/ahliterature267746
Source
Am Heart J. 2015 Aug;170(2):210-5
Publication Type
Article
Date
Aug-2015
Author
Lisette Okkels Jensen
Per Thayssen
Michael Maeng
Jan Ravkilde
Henrik Steen Hansen
Svend Eggert Jensen
Hans Erik Bøtker
Klára Berencsi
Jens Flensted Lassen
Evald Høj Christiansen
Source
Am Heart J. 2015 Aug;170(2):210-5
Date
Aug-2015
Language
English
Publication Type
Article
Keywords
Coronary Artery Disease - surgery
Denmark
Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Immunosuppressive Agents - pharmacology
Male
Middle Aged
Percutaneous Coronary Intervention - methods
Prosthesis Design
Retrospective Studies
Single-Blind Method
Sirolimus - analogs & derivatives - pharmacology
Societies, Medical
Treatment Outcome
Abstract
Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population.
The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were =18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and =1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%.
The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event.
PubMed ID
26299216 View in PubMed
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Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV.

https://arctichealth.org/en/permalink/ahliterature274377
Source
J Am Coll Cardiol. 2016 Feb 23;67(7):751-62
Publication Type
Article
Date
Feb-23-2016
Author
Lisette Okkels Jensen
Per Thayssen
Evald Høj Christiansen
Michael Maeng
Jan Ravkilde
Knud Nørregaard Hansen
Henrik Steen Hansen
Lars Krusell
Anne Kaltoft
Hans Henrik Tilsted
Klara Berencsi
Anders Junker
Jens Flensted Lassen
Source
J Am Coll Cardiol. 2016 Feb 23;67(7):751-62
Date
Feb-23-2016
Language
English
Publication Type
Article
Keywords
Coronary Artery Disease - surgery
Denmark - epidemiology
Drug-Eluting Stents
Everolimus - pharmacology
Female
Follow-Up Studies
Humans
Immunosuppressive Agents - pharmacology
Incidence
Kaplan-Meier Estimate
Male
Middle Aged
Percutaneous Coronary Intervention - methods
Postoperative Complications - epidemiology
Prosthesis Design
Retrospective Studies
Single-Blind Method
Sirolimus - pharmacology
Survival Rate - trends
Time Factors
Treatment Outcome
Abstract
Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.
This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.
Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.
At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).
At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877).
Notes
Comment In: J Am Coll Cardiol. 2016 Feb 23;67(7):763-526892410
PubMed ID
26892409 View in PubMed
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Scintigraphic evaluation of routine filterwire distal protection in percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature150341
Source
J Nucl Cardiol. 2009 Sep-Oct;16(5):784-91
Publication Type
Article
Author
Anne Kaltoft
Søren Steen Nielsen
Christian Juhl Terkelsen
Morten Bøttcher
Jens Flensted Lassen
Lars Romer Krusell
Steen Dalby Kristensen
Jan Ravkilde
Henning Kelbaek
Hans Erik Bøtker
Evald Høj Christiansen
Michael Rehling
Leif Thuesen
Author Affiliation
Department of Cardiology B, Aarhus University Hospital, Skejby, 8200, Aarhus N, Denmark. annekaltoft@stofanet.dk
Source
J Nucl Cardiol. 2009 Sep-Oct;16(5):784-91
Language
English
Publication Type
Article
Keywords
Angioplasty, Balloon, Coronary - mortality
Combined Modality Therapy - mortality
Denmark - epidemiology
Embolization, Therapeutic - mortality
Female
Humans
Incidence
Male
Middle Aged
Myocardial Infarction - mortality - radionuclide imaging - surgery
Risk Assessment - methods
Risk factors
Survival Analysis
Survival Rate
Abstract
Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) may result in reduced myocardial perfusion, infarct extension and impaired prognosis. In a prospective randomized trial, we assessed the effect of routine filterwire distal protection on scintigraphic estimated infarct size.
The effect of routine filterwire distal protection was evaluated in 344 patients with STEMI
PubMed ID
19521742 View in PubMed
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Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial.

https://arctichealth.org/en/permalink/ahliterature262954
Source
Lancet. 2015 Apr 18;385(9977):1527-35
Publication Type
Article
Date
Apr-18-2015
Author
Bent Raungaard
Lisette Okkels Jensen
Hans-Henrik Tilsted
Evald Høj Christiansen
Michael Maeng
Christian Juhl Terkelsen
Lars Romer Krusell
Anne Kaltoft
Steen Dalby Kristensen
Hans Erik Bøtker
Leif Thuesen
Jens Aarøe
Svend Eggert Jensen
Anton Boel Villadsen
Per Thayssen
Karsten Tange Veien
Knud Nørregaard Hansen
Anders Junker
Morten Madsen
Jan Ravkilde
Jens Flensted Lassen
Source
Lancet. 2015 Apr 18;385(9977):1527-35
Date
Apr-18-2015
Language
English
Publication Type
Article
Keywords
Absorbable Implants
Aged
Coated Materials, Biocompatible
Denmark
Drug-Eluting Stents
Equipment Design
Female
Humans
Immunosuppressive Agents - administration & dosage
Intention to Treat Analysis
Male
Middle Aged
Myocardial Ischemia - etiology - mortality - therapy
Percutaneous Coronary Intervention
Polymers
Sirolimus - administration & dosage - analogs & derivatives
Treatment Outcome
Abstract
New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.
This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.
Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.
The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.
Medtronic Cardiovascular and Biosensors Interventional Technologies.
Notes
Comment In: Lancet. 2015 Apr 18;385(9977):1487-925601787
Erratum In: Lancet. 2015 Apr 18;385(9977):151025933283
PubMed ID
25601789 View in PubMed
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