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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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The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).

https://arctichealth.org/en/permalink/ahliterature181039
Source
J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5
Publication Type
Article
Date
Mar-17-2004
Author
Erick Schampaert
Eric A Cohen
Michael Schlüter
François Reeves
Mouhieddin Traboulsi
Lawrence M Title
Richard E Kuntz
Jeffrey J Popma
Author Affiliation
Hôpital du Sacré-Coeur de Montréal, 5400 Bl. Gouin O., Montréal, Québec, Canada H4J 1C5. erick.schaempaert.hsc@ssss.gouv.qc.ca
Source
J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5
Date
Mar-17-2004
Language
English
Publication Type
Article
Keywords
Angioplasty, Balloon, Coronary - methods
Canada
Coronary Angiography
Coronary Artery Disease - mortality - pathology - radiography - therapy
Coronary Vessels - pathology
Double-Blind Method
Drug Delivery Systems
Female
Humans
Immunosuppressive Agents - administration & dosage
Male
Middle Aged
Sirolimus - administration & dosage
Stents
Survival Analysis
Treatment Outcome
Abstract
We assessed the safety and effectiveness of the sirolimus-eluting stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent (BMS).
The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk.
The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days.
A total of 100 patients were enrolled at eight Canadian sites. The in-stent MLD at eight months was 2.46 +/- 0.37 mm in the SES compared with 1.49 +/- 0.75 mm in the BMS (a 65% increase, p
Notes
Comment In: J Am Coll Cardiol. 2004 Mar 17;43(6):1116-715028376
PubMed ID
15028375 View in PubMed
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Choice of stent and outcomes after treatment of drug-eluting stent restenosis in highly complex lesions.

https://arctichealth.org/en/permalink/ahliterature125152
Source
Catheter Cardiovasc Interv. 2013 Jan 1;81(1):E16-22
Publication Type
Article
Date
Jan-1-2013
Author
Xavier Freixa
Ali S Almasood
Sohail Q Khan
Karen Mackie
Mark Osten
Douglas Ing
Christopher B Overgaard
Eric M Horlick
Peter H Seidelin
Vladimír Džavík
Author Affiliation
Peter Munk Cardiac Centre, University Health Network, Interventional Cardiology Program, Division of Cardiology, Toronto, Ontario, Canada.
Source
Catheter Cardiovasc Interv. 2013 Jan 1;81(1):E16-22
Date
Jan-1-2013
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary - adverse effects - instrumentation
Confidence Intervals
Coronary Angiography - methods
Coronary Restenosis - mortality - radiography - therapy
Coronary Stenosis - mortality - radiography - therapy
Drug-Eluting Stents - utilization
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Multivariate Analysis
Odds Ratio
Ontario
Paclitaxel - administration & dosage
Patient Selection
Prosthesis Failure
Registries
Retreatment
Retrospective Studies
Risk assessment
Severity of Illness Index
Sirolimus - administration & dosage
Survival Analysis
Treatment Outcome
Abstract
Our aim was to compare the outcomes of a same versus different drug-eluting stent (DES) implantation strategy for the treatment of DES instent restenosis (ISR).
The absence of clear data renders the treatment of DES ISR one of the most challenging situations in interventional cardiology.
We identified all cases of DES ISR treated with a second DES between January 2004 and January 2009. The lesions were divided into those treated with the same DES as the initial one that restenosed and those treated with a different DES. The main end-point was repeat target lesion revascularization (TLR).
We included 116 patients with a total of 132 lesions. The patient population was highly complex: 55.5% with diabetes, 56% with type-C lesions, 15.9% with lesions previously stented with BMS and 18.2% with fluoroscopic evidence of stent fracture. A same and different stent strategy was conducted in 41 lesions (31%) and 91 lesions (69%), respectively. Overall TLR was 31.1% and occurred in 46.3% of patients treated with the same stent and 24.4% of those with a different stent (P = 0.012). Multivariable analysis found same stent strategy (OR 2.84, 95%CI 1.23-6.57;P = 0.014) and occurrence of stent fracture (OR 4.03, 95%CI 1.33-12.01;P = 0.012) to be the only independent predictors of TLR after a median follow-up of 20.4 [12.1-30.2] months.
In highly complex lesions, DES implantation for DES ISR is linked to a high need of future revascularization. An association between implanting a DES type other than the original and lower rate of TLR is suggested.
PubMed ID
22511403 View in PubMed
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Clinical and angiographic follow-up after coronary drug-eluting and bare metal stent implantation. Do drug-eluting stents hold the promise?

https://arctichealth.org/en/permalink/ahliterature81244
Source
J Intern Med. 2006 Aug;260(2):118-24
Publication Type
Article
Date
Aug-2006
Author
Jensen J.
Lagerqvist B.
Aasa M.
Särev T.
Nilsson T.
Tornvall P.
Author Affiliation
Department of Cardiology, Karolinska University Hospital, Solna, Stockholm, Sweden. jens.jensen@karolinska.se
Source
J Intern Med. 2006 Aug;260(2):118-24
Date
Aug-2006
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Angiography
Coronary Restenosis - mortality - prevention & control - radiography
Coronary Stenosis - mortality - radiography - therapy
Delayed-Action Preparations
Disease-Free Survival
Drug Implants
Female
Follow-Up Studies
Humans
Immunosuppressive Agents - administration & dosage
Male
Metals
Middle Aged
Multivariate Analysis
Radiographic Image Interpretation, Computer-Assisted - methods
Registries
Sirolimus - administration & dosage
Stents
Sweden
Abstract
OBJECTIVES: To investigate the influence of drug-eluting stent (DES) implantation on clinical and angiographic restenosis. DESIGN: Registry study of data from the Swedish Coronary Angiography and Angioplasty Registry with a coronary angiographic substudy. SETTING: Multi-centre study. SUBJECTS: During October 2002 to May 2004 a total of 23 590 percutaneous coronary intervention (PCI) procedures were performed at 25 hospitals. After selection, to achieve comparable groups, a total of 5068 patients of whom 4111 had a bare metal stent (BMS) implanted and 957 had a DES implanted, remained. End-point in the registry follow-up was >50% diameter restenosis at clinically driven reangiography within 12 months after index PCI. The primary end-point in the angiographic substudy was late loss in patients' DES at 6-month angiographic follow-up. RESULTS: The rate of clinically driven restenosis, within 12 months, in patients receiving DES was less (3.9%) compared with those who received BMS (7.0%). In multivariate analysis the risk of clinical restenosis was one-third for DES compared with BMS (HR 0.36, 95% CI 0.25-0.52). In the angiographic substudy late loss was 0.07+/-0.53 mm (range -0.88 to 1.62). The amount of late loss was related to the presence of diabetes mellitus or not (0.19+/-0.45 mm vs. -0.12+/-0.58 mm), and lack of postdilatation of the stent or not (0.23+/-0.51 mm vs. -0.09+/-0.50 mm). CONCLUSIONS: The use of DES in the Swedish 'real world' is effective in reducing the clinically driven restenosis rate, when compared with patients with BMS treatment. In the angiographic follow-up the average late loss was as low as observed in recent randomized multi-centre trials.
PubMed ID
16882275 View in PubMed
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Clinical impact of second-generation everolimus-eluting stent compared with first-generation drug-eluting stents in diabetes mellitus patients: insights from a nationwide coronary intervention register.

https://arctichealth.org/en/permalink/ahliterature118728
Source
JACC Cardiovasc Interv. 2012 Nov;5(11):1141-9
Publication Type
Article
Date
Nov-2012
Author
Elvin Kedhi
Marc E Gomes
Bo Lagerqvist
J Gustav Smith
Elmir Omerovic
Stefan James
Jan Harnek
Göran K Olivecrona
Author Affiliation
Department of Cardiology, Maasstad Hospital, Rotterdam, The Netherlands. kedhie@maasstadziekenhuis.nl
Source
JACC Cardiovasc Interv. 2012 Nov;5(11):1141-9
Date
Nov-2012
Language
English
Publication Type
Article
Keywords
Aged
Coronary Artery Disease - surgery
Diabetic Angiopathies - surgery
Drug-Eluting Stents
Female
Humans
Immunosuppressive Agents - administration & dosage
Male
Paclitaxel - administration & dosage
Percutaneous Coronary Intervention
Prosthesis Design
Registries
Retrospective Studies
Sirolimus - administration & dosage - analogs & derivatives
Sweden
Abstract
This study sought to study the second-generation everolimus-eluting stent (EES) as compared with first-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM) patients.
There are limited data available comparing clinical outcomes in this setting with EES and SES, whereas studies comparing EES with PES are not powered for low-frequency endpoints.
All DM patients treated with EES, PES, or SES from January 18, 2007, to July 29, 2011, from the SCAAR (Swedish Coronary Angiography and Angioplasty Registery) were included. The EES was compared with SES or PES for the primary composite endpoint of clinically driven detected restenosis, definite stent thrombosis (ST), and all-cause mortality.
In 4,751 percutaneous coronary intervention-treated DM patients, 8,134 stents were implanted (EES = 3,928, PES = 2,836, SES = 1,370). The EES was associated with significantly lower event rates compared with SES (SES vs. EES hazard ratio [HR]: 1.99; 95% confidence interval (CI): 1.19 to 3.08). The same was observed when compared with PES (PES vs. EES HR: 1.33; 95% CI: 0.93 to 1.91) but did not reach statistical significance. These results were mainly driven by lower incidence of ST (SES vs. EES HR: 2.87; 95% CI: 1.08 to 7.61; PES vs. EES HR: 1.74, 95% CI: 0.82 to 3.71) and mortality (SES vs. EES HR: 2.02; 95% CI: 1.03 to 3.98; PES vs. EES HR: 1.69; 95% CI: 1.06 to 2.72). No significant differences in restenosis rates were observed between EES and SES or PES (SES vs. EES HR: 1.26; 95% CI: 0.77 to 2.08; PES vs. EES HR: 1.05; 95% CI: 0.71 to 1.55).
In all-comer DM patients the use of EES was associated with improved outcomes compared with SES and PES mainly driven by lower rates of ST and mortality. These results suggest better safety rather than efficacy with EES when compared with SES or PES.
PubMed ID
23174638 View in PubMed
Less detail

Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: the Nordic Stent Technique Study 36-month follow-up results.

https://arctichealth.org/en/permalink/ahliterature106024
Source
JACC Cardiovasc Interv. 2013 Nov;6(11):1160-5
Publication Type
Article
Date
Nov-2013
Author
Kari Kervinen
Matti Niemelä
Hannu Romppanen
Andrejs Erglis
Indulis Kumsars
Michael Maeng
Niels R Holm
Jens F Lassen
Pål Gunnes
Sindre Stavnes
Jan S Jensen
Anders Galløe
Inga Narbute
Dace Sondore
Evald H Christiansen
Jan Ravkilde
Terje K Steigen
Jan Mannsverk
Per Thayssen
Knud Nørregaard Hansen
Steffen Helqvist
Saila Vikman
Rune Wiseth
Jens Aarøe
Jari Jokelainen
Leif Thuesen
Author Affiliation
Division of Cardiology, Department of Medicine, Oulu University Hospital, Oulu, Finland. Electronic address: kari.kervinen@ppshp.fi.
Source
JACC Cardiovasc Interv. 2013 Nov;6(11):1160-5
Date
Nov-2013
Language
English
Publication Type
Article
Keywords
Aged
Cardiovascular Agents - administration & dosage
Coronary Angiography
Coronary Artery Disease - diagnosis - mortality - therapy
Coronary Restenosis - etiology
Coronary Thrombosis - etiology
Drug-Eluting Stents
Female
Finland
Humans
Latvia
Male
Middle Aged
Percutaneous Coronary Intervention - adverse effects - instrumentation - methods - mortality
Prosthesis Design
Risk factors
Scandinavia
Sirolimus - administration & dosage
Time Factors
Treatment Outcome
Abstract
The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions.
The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study.
A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint.
Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively.
At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).
PubMed ID
24262616 View in PubMed
Less detail

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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Cyclosporine reduction in the presence of everolimus: 3-month data from a Canadian pilot study of maintenance cardiac allograft recipients.

https://arctichealth.org/en/permalink/ahliterature158868
Source
J Heart Lung Transplant. 2008 Feb;27(2):197-202
Publication Type
Article
Date
Feb-2008
Author
Heather Ross
Peter Pflugfelder
Haissam Haddad
Marcelo Cantarovich
Michael White
Andrew Ignaszewski
Jonathan Howlett
Marc Vaillancourt
Richard Dorent
Jeffrey R Burton
Author Affiliation
Department of Cardiology, Toronto General Hospital, Toronto, Ontario, Canada. heather.ross@uhn.on.ca
Source
J Heart Lung Transplant. 2008 Feb;27(2):197-202
Date
Feb-2008
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Canada
Confidence Intervals
Cyclosporine - administration & dosage
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Female
Graft Rejection - drug therapy - prevention & control
Graft Survival
Heart Transplantation - immunology - methods - mortality
Humans
Immunosuppressive Agents - administration & dosage
Male
Middle Aged
Pilot Projects
Risk assessment
Single-Blind Method
Sirolimus - administration & dosage - analogs & derivatives
Statistics, nonparametric
Survival Analysis
Transplantation Immunology - drug effects
Transplantation, Homologous
Treatment Outcome
Abstract
Concentration-controlled everolimus with concomitant cyclosporine (CsA) dose reduction in renal transplantation permits preservation of kidney function without loss of efficacy. Data are lacking regarding everolimus with reduced-dose CsA in maintenance cardiac transplant patients.
In a multicenter, open-label, single-arm pilot study, concentration-controlled everolimus was initiated in patients receiving CsA microemulsion (Neoral) with/without mycophenolate mofetil (MMF) or azathioprine, and with/without corticosteroids. On the day of everolimus initiation, MMF/azathioprine was discontinued and CsA dose was reduced by 25% with further reductions as required in response to decreasing calculated glomerular filtration rate (cGFR).
Of the 36 patients enrolled (intent-to-treat [ITT]), 27 underwent CsA dose reduction as planned (per protocol [PP]). During Week 1, the CsA dose was reduced by 23.3 +/- 7.3% in the ITT population (p or=3A occurred (2.7%). There was no graft loss or death. Hemoglobin and hematocrit levels decreased significantly, whereas cholesterol and triglyceride levels increased (all p
PubMed ID
18267227 View in PubMed
Less detail

Decreased risk of stent fracture-related restenosis between paclitaxel-eluting stents and sirolimus eluting stents: results of long-term follow-up.

https://arctichealth.org/en/permalink/ahliterature134544
Source
Catheter Cardiovasc Interv. 2012 Mar 1;79(4):559-65
Publication Type
Article
Date
Mar-1-2012
Author
Xavier Freixa
Ali S Almasood
Sohail Q Khan
Rodrigo Wainstein
Azriel Osherov
Karen Mackie
Peter H Seidelin
Vladimír Džavík
Author Affiliation
Peter Munk Cardiac Centre, Interventional Cardiology Program, Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
Source
Catheter Cardiovasc Interv. 2012 Mar 1;79(4):559-65
Date
Mar-1-2012
Language
English
Publication Type
Article
Keywords
Aged
Angioplasty, Balloon, Coronary - adverse effects - instrumentation
Chi-Square Distribution
Coronary Angiography
Coronary Restenosis - etiology - radiography - therapy
Coronary Stenosis - radiography - therapy
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Ontario
Paclitaxel - administration & dosage
Prosthesis Design
Prosthesis Failure
Retrospective Studies
Risk assessment
Risk factors
Sirolimus - administration & dosage
Time Factors
Treatment Outcome
Abstract
To compare the outcomes between paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for the treatment of drug-eluting stent (DES) fracture.
DES fracture is considered as an important predictor of in-stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting.
From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points.
Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024).
This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture-associated DES ISR with PES as compared with SES, and better long-term outcomes, is in need of confirmation by larger prospective registries and randomized trials.
Notes
Comment In: Catheter Cardiovasc Interv. 2012 Mar 1;79(4):56622344989
PubMed ID
21567881 View in PubMed
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Everolimus with reduced calcineurin inhibitor in thoracic transplant recipients with renal dysfunction: a multicenter, randomized trial.

https://arctichealth.org/en/permalink/ahliterature146175
Source
Transplantation. 2010 Apr 15;89(7):864-72
Publication Type
Article
Date
Apr-15-2010
Author
Lars Gullestad
Martin Iversen
Svend-Aage Mortensen
Hans Eiskjaer
Gerdt C Riise
Lena Mared
Oystein Bjørtuft
Björn Ekmehag
Kjell Jansson
Svein Simonsen
Einar Gude
Bengt Rundqvist
Hans E Fagertun
Dag Solbu
Claes-Håkan Bergh
Author Affiliation
Department of Cardiology, Oslo University Hospital, Rikshospitalet, and Faculty of Medicine, University of Oslo, Oslo, Norway.
Source
Transplantation. 2010 Apr 15;89(7):864-72
Date
Apr-15-2010
Language
English
Publication Type
Article
Keywords
Aged
Calcineurin - antagonists & inhibitors
Cyclosporine - administration & dosage - adverse effects
Drug Therapy, Combination
Female
Glomerular Filtration Rate - drug effects
Graft Rejection - etiology - prevention & control
Graft Survival - drug effects
Heart Transplantation
Humans
Immunosuppressive Agents - administration & dosage - adverse effects
Kidney Diseases - complications - physiopathology
Lung Transplantation
Male
Middle Aged
Scandinavia
Sirolimus - administration & dosage - adverse effects - analogs & derivatives
Tacrolimus - administration & dosage - adverse effects
Time Factors
Treatment Outcome
Abstract
The proliferation signal inhibitor everolimus offers the potential to reduce calcineurin inhibitor (CNI) exposure and alleviate CNI-related nephrotoxicity. Randomized trials in maintenance thoracic transplant patients are lacking.
In a 12-month, open-labeled, multicenter study, maintenance thoracic transplant patients (glomerular filtration rate > or =20 mL/min/1.73m and 1 year posttransplant were randomized to continue their current CNI-based immunosuppression or start everolimus with predefined CNI exposure reduction.
Two hundred eighty-two patients were randomized (140 everolimus, 142 controls; 190 heart, 92 lung transplants). From baseline to month 12, mean cyclosporine and tacrolimus trough levels in the everolimus cohort decreased by 57% and 56%, respectively. The primary endpoint, mean change in measured glomerular filtration rate from baseline to month 12, was 4.6 mL/min with everolimus and -0.5 mL/min in controls (P
PubMed ID
20061999 View in PubMed
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