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Coronary Artery Disease: HELP
Articles by Anne Kjer Kaltoft
Based on 29 articles published since 2010
(Why 29 articles?)
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Between 2010 and 2020, Anne Kaltoft wrote the following 29 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Clinical Trial Influence of Coronary Calcification on the Diagnostic Performance of CT Angiography Derived FFR in Coronary Artery Disease: A Substudy of the NXT Trial. 2015

Nørgaard, Bjarne L / Gaur, Sara / Leipsic, Jonathon / Ito, Hiroshi / Miyoshi, Toru / Park, Seung-Jung / Zvaigzne, Ligita / Tzemos, Nikolaos / Jensen, Jesper M / Hansson, Nicolaj / Ko, Brian / Bezerra, Hiram / Christiansen, Evald H / Kaltoft, Anne / Lassen, Jens F / Bøtker, Hans Erik / Achenbach, Stephan. ·Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. Electronic address: bnorgaard@dadlnet.dk. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. · Department of Radiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. · Department of Cardiology, Okayama University Hospital, Okayama, Japan. · Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · Diagnostic Institute of Radiology, Paul Stradins Clinical University Hospital, Riga, Latvia. · Department of Radiology, Golden Jubilee Hospital, Glasgow, Scotland. · MonashHeart, Monash Medical Center and Monash University, Victoria, Australia. · Department of Cardiology, Harrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio. · Department of Cardiology, Erlangen University Hospital, Erlangen, Germany. ·JACC Cardiovasc Imaging · Pubmed #26298072.

ABSTRACT: OBJECTIVES: The goal of this study was to examine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) (FFRCT) in relation to coronary calcification severity. BACKGROUND: FFRCT has shown promising results in identifying lesion-specific ischemia. The extent to which the severity of coronary calcification affects the diagnostic performance of FFRCT is not known. METHODS: Coronary calcification was assessed by using the Agatston score (AS) in 214 patients suspected of having coronary artery disease who underwent coronary CTA, FFRCT, and FFR (FFR examination was performed in 333 vessels). The diagnostic performance of FFRCT (≤0.80) in identifying vessel-specific ischemia (FFR ≤0.80) was investigated across AS quartiles (Q1 to Q4) and for discrimination of ischemia in patients and vessels with a low-mid AS (Q1 to Q3) versus a high AS (Q4). Coronary CTA stenosis was defined as lumen reduction >50%. RESULTS: Mean ± SD per-patient and per-vessel AS were 302 ± 468 (range 0 to 3,599) and 95 ± 172 (range 0 to 1,703), respectively. There was no statistical difference in diagnostic accuracy, sensitivity, or specificity of FFRCT across AS quartiles. Discrimination of ischemia by FFRCT was high in patients with a high AS (416 to 3,599) and a low-mid AS (0 to 415), with no difference in area under the receiver-operating characteristic curve (AUC) (0.86 [95% confidence interval (CI): 0.76 to 0.96] vs. 0.92 [95% CI: 0.88 to 0.96]) (p = 0.45). Similarly, discrimination of ischemia by FFRCT was high in vessels with a high AS (121 to 1,703) and a low-mid AS (0 to 120) (AUC: 0.91 [95% CI: 0.85 to 0.97] vs. 0.95 [95% CI: 0.91 to 0.98]; p = 0.65). Diagnostic accuracy and specificity of FFRCT were significantly higher than for stenosis assessment in each AS quartile at the per-patient (p < 0.001) and per-vessel (p < 0.05) level with similar sensitivity. In vessels with a high AS, FFRCT exhibited improved discrimination of ischemia compared with coronary CTA alone (AUC: 0.91 vs. 0.71; p = 0.004), whereas on a per-patient level, the difference did not reach statistical significance (AUC: 0.86 vs. 0.72; p = 0.09). CONCLUSIONS: FFRCT provided high and superior diagnostic performance compared with coronary CTA interpretation alone in patients and vessels with a high AS.

2 Clinical Trial Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). 2014

Nørgaard, Bjarne L / Leipsic, Jonathon / Gaur, Sara / Seneviratne, Sujith / Ko, Brian S / Ito, Hiroshi / Jensen, Jesper M / Mauri, Laura / De Bruyne, Bernard / Bezerra, Hiram / Osawa, Kazuhiro / Marwan, Mohamed / Naber, Christoph / Erglis, Andrejs / Park, Seung-Jung / Christiansen, Evald H / Kaltoft, Anne / Lassen, Jens F / Bøtker, Hans Erik / Achenbach, Stephan / Anonymous4730783. ·Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. Electronic address: bnorgaard@dadlnet.dk. · Department of Radiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. · MonashHeart, Monash Medical Center and Monash University, Victoria, Australia. · Department of Cardiology, Okayama University Hospital, Okayama, Japan. · Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium. · Department of Cardiology, Harrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio. · Department of Cardiology, Erlangen University Hospital, Erlangen, Germany. · Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany. · Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. · Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. ·J Am Coll Cardiol · Pubmed #24486266.

ABSTRACT: OBJECTIVES: The goal of this study was to determine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from standard acquired coronary computed tomography angiography (CTA) datasets (FFR(CT)) for the diagnosis of myocardial ischemia in patients with suspected stable coronary artery disease (CAD). BACKGROUND: FFR measured during invasive coronary angiography (ICA) is the gold standard for lesion-specific coronary revascularization decisions in patients with stable CAD. The potential for FFR(CT) to noninvasively identify ischemia in patients with suspected CAD has not been sufficiently investigated. METHODS: This prospective multicenter trial included 254 patients scheduled to undergo clinically indicated ICA for suspected CAD. Coronary CTA was performed before ICA. Evaluation of stenosis (>50% lumen reduction) in coronary CTA was performed by local investigators and in ICA by an independent core laboratory. FFR(CT) was calculated and interpreted in a blinded fashion by an independent core laboratory. Results were compared with invasively measured FFR, with ischemia defined as FFR(CT) or FFR ≤0.80. RESULTS: The area under the receiver-operating characteristic curve for FFR(CT) was 0.90 (95% confidence interval [CI]: 0.87 to 0.94) versus 0.81 (95% CI: 0.76 to 0.87) for coronary CTA (p = 0.0008). Per-patient sensitivity and specificity (95% CI) to identify myocardial ischemia were 86% (95% CI: 77% to 92%) and 79% (95% CI: 72% to 84%) for FFR(CT) versus 94% (86 to 97) and 34% (95% CI: 27% to 41%) for coronary CTA, and 64% (95% CI: 53% to 74%) and 83% (95% CI: 77% to 88%) for ICA, respectively. In patients (n = 235) with intermediate stenosis (95% CI: 30% to 70%), the diagnostic accuracy of FFR(CT) remained high. CONCLUSIONS: FFR(CT) provides high diagnostic accuracy and discrimination for the diagnosis of hemodynamically significant CAD with invasive FFR as the reference standard. When compared with anatomic testing by using coronary CTA, FFR(CT) led to a marked increase in specificity. (HeartFlowNXT-HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography [HFNXT]; NCT01757678).

3 Clinical Trial Comparison of outcomes in patients with versus without diabetes mellitus after revascularization with everolimus- and sirolimus-eluting stents (from the SORT OUT IV trial). 2012

Jensen, Lisette Okkels / Thayssen, Per / Junker, Anders / Maeng, Michael / Tilsted, Hans-Henrik / Kaltoft, Anne / Hansen, Knud Nørregaard / Christiansen, Evald Høj / Kristensen, Steen Dalby / Ravkilde, Jan / Madsen, Morten / Sørensen, Henrik Toft / Thuesen, Leif / Lassen, Jens Flensted. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk ·Am J Cardiol · Pubmed #22959714.

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.

4 Article Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). 2018

Westra, Jelmer / Tu, Shengxian / Winther, Simon / Nissen, Louise / Vestergaard, Mai-Britt / Andersen, Birgitte Krogsgaard / Holck, Emil Nielsen / Fox Maule, Camilla / Johansen, Jane Kirk / Andreasen, Lene Nyhus / Simonsen, Jo Krogsgaard / Zhang, Yimin / Kristensen, Steen Dalby / Maeng, Michael / Kaltoft, Anne / Terkelsen, Christian Juhl / Krusell, Lars Romer / Jakobsen, Lars / Reiber, Johan H C / Lassen, Jens Flensted / Bøttcher, Morten / Bøtker, Hans Erik / Christiansen, Evald Høj / Holm, Niels Ramsing. ·From the Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.W., S.W., M.-B.V., B.K.A., E.N.H., C.F.M., L.N.A., J.K.S., S.D.K., M.M., A.K., C.J.T., L.R.K., L.J., J.F.L., H.E.B., E.H.C., N.R.H.) · Med-X Research Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T., Y.Z.) · Department of Cardiology, Hospitalsenheden Vest, Regionshospitalet Herning, Denmark (L.N., M.B.) · Department of Cardiology, Hospitalsenheden Midt, Regionshospitalet Silkeborg, Denmark (J.K.J.) · and Department of Radiology, Leiden University Medical Center, The Netherlands (J.H.C.R.). ·Circ Cardiovasc Imaging · Pubmed #29555835.

ABSTRACT: BACKGROUND: Quantitative flow ratio (QFR) is a novel diagnostic modality for functional testing of coronary artery stenosis without the use of pressure wires and induction of hyperemia. QFR is based on computation of standard invasive coronary angiographic imaging. The purpose of WIFI II (Wire-Free Functional Imaging II) was to evaluate the feasibility and diagnostic performance of QFR in unselected consecutive patients. METHODS AND RESULTS: WIFI II was a predefined substudy to the Dan-NICAD study (Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease), referring 362 consecutive patients with suspected coronary artery disease on coronary computed tomographic angiography for diagnostic invasive coronary angiography. Fractional flow reserve (FFR) was measured in all segments with 30% to 90% diameter stenosis. Blinded observers calculated QFR (Medis Medical Imaging bv, The Netherlands) for comparison with FFR. FFR was measured in 292 lesions from 191 patients. Ten (5%) and 9 patients (5%) were excluded because of FFR and angiographic core laboratory criteria, respectively. QFR was successfully computed in 240 out of 255 lesions (94%) with a mean diameter stenosis of 50±12%. Mean difference between FFR and QFR was 0.01±0.08. QFR correctly classified 83% of the lesions using FFR with cutoff at 0.80 as reference standard. The area under the receiver operating characteristic curve was 0.86 (95% confidence interval, 0.81-0.91) with a sensitivity, specificity, negative predictive value, and positive predictive value of 77%, 86%, 75%, and 87%, respectively. A QFR-FFR hybrid approach based on the present results enables wire-free and adenosine-free procedures in 68% of cases. CONCLUSIONS: Functional lesion evaluation by QFR assessment showed good agreement and diagnostic accuracy compared with FFR. Studies comparing clinical outcome after QFR- and FFR-based diagnostic strategies are required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02264717.

5 Article Myocardial Perfusion Imaging Versus Computed Tomography Angiography-Derived Fractional Flow Reserve Testing in Stable Patients With Intermediate-Range Coronary Lesions: Influence on Downstream Diagnostic Workflows and Invasive Angiography Findings. 2017

Nørgaard, Bjarne L / Gormsen, Lars C / Bøtker, Hans Erik / Parner, Erik / Nielsen, Lene H / Mathiassen, Ole N / Grove, Erik L / Øvrehus, Kristian A / Gaur, Sara / Leipsic, Jonathon / Pedersen, Kamilla / Terkelsen, Christian J / Christiansen, Evald H / Kaltoft, Anne / Mæng, Michael / Kristensen, Steen D / Krusell, Lars R / Lassen, Jens F / Jensen, Jesper M. ·Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark bnorgaard@dadlnet.dk. · Department of Nuclear Medicine, Aarhus University Hospital, Aarhus, Denmark. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Section for Biostatistics, Department of Public Health, Aarhus University, Aarhus, Denmark. · Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark. · Department of Radiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. ·J Am Heart Assoc · Pubmed #28862968.

ABSTRACT: BACKGROUND: Data on the clinical utility of coronary computed tomography angiography-derived fractional flow reserve (FFR METHODS AND RESULTS: This was a single-center observational study of symptomatic patients with suspected coronary artery disease referred to coronary computed tomography angiography between 2013 and 2015. Patients were divided into 3 historical groups based on the adjunctive functional testing approach: myocardial perfusion imaging (n=1332) or FFR CONCLUSIONS: Replacing adjunctive myocardial perfusion imaging with FFR

6 Article Fractional flow reserve derived from coronary computed tomography angiography: diagnostic performance in hypertensive and diabetic patients. 2017

Eftekhari, Ashkan / Min, James / Achenbach, Stephan / Marwan, Mohamed / Budoff, Matthew / Leipsic, Jonathon / Gaur, Sara / Jensen, Jesper Møller / Ko, Brian S / Christiansen, Evald Høj / Kaltoft, Anne / Bøtker, Hans Erik / Jensen, Jens Flensted / Nørgaard, Bjarne Linde. ·Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, 8200 Aarhus, Denmark. · Weill Cornell Medical College, Dalio Institute of Cardiovascular Imagaing, New York-Presbyterian Hospital, New York, NY, USA. · Department of Cardiology, University of Erlangen, Erlangen, Germany. · Department of Medicine, Los Angeles Biomedical Research Center, Torrance, CA, USA. · Division of Cardiology, Department of Radiology, St. Paul's Hospital, Vancouver, BC, Canada. ·Eur Heart J Cardiovasc Imaging · Pubmed #28013282.

ABSTRACT: Aims: Fractional flow reserve (FFR) derived from coronary computed tomography (FFRCT) has high diagnostic performance in stable coronary artery disease (CAD). The diagnostic performance of FFRCT in patients with hypertension (HTN) and diabetes (DM), who are at risk of microvascular impairment, is not known. Methods and results: We analysed the diagnostic performance of FFRCT, in patients (vessels) with DM (n = 16), HTN (n = 186), DM + HTN (n = 58) vs. controls (n = 107) with or with suspected CAD. Patients (vessels) were further divided according to left ventricular mass index (LVMI) tertiles. Reference standard was invasively measured FFR ≤0.80. Per-patient diagnostic accuracy (95% CI) in control patients was 71.7% (61.6-81.8) vs. 79.3 (74.0-85.0) (P = 0.12), 75.0% (47.6-92.7) (P = 0.52), and 75.9% (62.8-86.1) (P = 0.39) in patients with HTN, DM, and HTM + DM, respectively. There was no difference in discrimination of ischaemia by FFRCT between groups. On a per-vessel level, there was no significant difference in diagnostic performance or discrimination of ischaemia by FFRCT between groups. There was a decline in both per-patient and -vessel diagnostic specificity of FFRCT in the upper LVMI tertile when compared with lower tertiles; however, discrimination of ischaemia by FFRCT was unaltered across LVMI tertiles. Conclusion: The diagnostic performance of FFRCT is independent of the presence of HTN and DM. FFRCT is a robust method in a broad stable CAD population, including patients at high risk for microvascular disease.

7 Article FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent STEMI. 2017

Gaur, Sara / Taylor, Charles A / Jensen, Jesper M / Bøtker, Hans Erik / Christiansen, Evald H / Kaltoft, Anne K / Holm, Niels R / Leipsic, Jonathon / Zarins, Christopher K / Achenbach, Stephan / Khem, Sophie / Wilk, Alan / Bezerra, Hiram G / Lassen, Jens F / Nørgaard, Bjarne L. ·Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: saga@clin.au.dk. · HeartFlow, Inc., Redwood City, California; Department of Bioengineering, Stanford University, Stanford, California. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Radiology and Division of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada. · HeartFlow, Inc., Redwood City, California; Department of Surgery, Stanford University, Stanford, California. · Department of Cardiology, University of Erlangen, Erlangen, Germany. · HeartFlow, Inc., Redwood City, California. · Cardiovascular Imaging Core Laboratory, Harrington Heart and Vascular Institute, Case Medical Center, Cleveland, Ohio. ·JACC Cardiovasc Imaging · Pubmed #27743953.

ABSTRACT: OBJECTIVES: This study sought to determine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) (FFR BACKGROUND: In patients with stable angina, FFR METHODS: Coronary CTA with calculation of FFR RESULTS: The study evaluated 124 nonculprit vessels from 60 patients. Accuracy, sensitivity, and specificity of FFR CONCLUSIONS: The diagnostic performance of FFR

8 Article Clinical Use of Coronary CTA-Derived FFR for Decision-Making in Stable CAD. 2017

Nørgaard, Bjarne L / Hjort, Jakob / Gaur, Sara / Hansson, Nicolaj / Bøtker, Hans Erik / Leipsic, Jonathon / Mathiassen, Ole N / Grove, Erik L / Pedersen, Kamilla / Christiansen, Evald H / Kaltoft, Anne / Gormsen, Lars C / Mæng, Michael / Terkelsen, Christian J / Kristensen, Steen D / Krusell, Lars R / Jensen, Jesper M. ·Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. Electronic address: bnorgaard@dadlnet.dk. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark. · Department of Radiology, St. Paul's Hospital, University of British Columbia, British Columbia, Canada. · Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark; Faculty of Health, Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark. · Department of Nuclear Medicine, Aarhus University Hospital Skejby, Aarhus, Denmark. ·JACC Cardiovasc Imaging · Pubmed #27085447.

ABSTRACT: OBJECTIVES: The goal of this study was to assess the real-world clinical utility of fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFR BACKGROUND: FFR METHODS: We reviewed the complete diagnostic work-up of nonemergent patients referred for coronary computed tomography angiography over a 12-month period at Aarhus University Hospital, Denmark, including all patients with new-onset chest pain with no known CAD and with intermediate-range coronary lesions (lumen reduction, 30% to 70%) referred for FFR RESULTS: Among 1,248 patients referred for computed tomography angiography, 189 patients (mean age 59 years; 59% male) were referred for FFR CONCLUSIONS: FFR

9 Article 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 Trial. 2016

Jensen, Lisette Okkels / Thayssen, Per / Maeng, Michael / Ravkilde, Jan / Krusell, Lars Romer / Raungaard, Bent / Junker, Anders / Terkelsen, Christian Juhl / Veien, Karsten Tange / Villadsen, Anton Boel / Kaltoft, Anne / Tilsted, Hans-Henrik / Hansen, Knud Nørregaard / Aaroe, Jens / Kristensen, Steen Dalby / Hansen, Henrik Steen / Jensen, Svend Eggert / Madsen, Morten / Bøtker, Hans Erik / Berencsi, Klára / Lassen, Jens Flensted / Christiansen, Evald Høj. ·From the Department of Cardiology, Odense University Hospital, Denmark (L.O.J., P.T., A.J., K.T.V., K.N.H., H.S.H.) · Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (M. Maeng, L.R.K., C.J.T., A.K., S.D.K., H.E.B., J.F.L., E.H.C.) · Department of Cardiology, Aalborg University Hospital, Denmark (J.R., B.R., A.B.V., H.-H.T., J.A., S.E.J.) · and Department of Clinical Epidemiology, Aarhus University, Denmark (M. Madsen, K.B.). ·Circ Cardiovasc Interv · Pubmed #27412869.

ABSTRACT: BACKGROUND: Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05). CONCLUSIONS: The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.

10 Article Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. 2016

Jensen, Lisette Okkels / Thayssen, Per / Christiansen, Evald Høj / Maeng, Michael / Ravkilde, Jan / Hansen, Knud Nørregaard / Hansen, Henrik Steen / Krusell, Lars / Kaltoft, Anne / Tilsted, Hans Henrik / Berencsi, Klara / Junker, Anders / Lassen, Jens Flensted / Anonymous5830858. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address: okkels@dadlnet.dk. · Department of Cardiology, Odense University Hospital, Odense, Denmark. · Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. · Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark. ·J Am Coll Cardiol · Pubmed #26892409.

ABSTRACT: BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).

11 Article A "normal" invasive coronary angiogram may not be normal. 2015

Nørgaard, Bjarne L / Hansson, Nicolaj C / Christiansen, Evald H / Kaltoft, Anne / Bøtker, Hans Erik / Lassen, Jens F / Mæng, Michael / Jensen, Jesper M. ·Department of Cardiology, Aarhus University Hospital Skejby, Skejby, Aarhus N, Aarhus DK-8200, Denmark. Electronic address: bnorgaard@dadlnet.dk. · Department of Cardiology, Aarhus University Hospital Skejby, Skejby, Aarhus N, Aarhus DK-8200, Denmark. ·J Cardiovasc Comput Tomogr · Pubmed #26088376.

ABSTRACT: In clinical practice, a normal or near-normal invasive coronary angiogram is considered to be reliable evidence for the absence of hemodynamically significant coronary artery disease. We present 2 patients with near-normal coronary angiograms who had noninvasive evidence of vessel-specific ischemia confirmed by invasive measurement of fractional flow reserve.

12 Article 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). 2015

Maeng, Michael / Baranauskas, Arvydas / Christiansen, Evald Høj / Kaltoft, Anne / Holm, Niels Ramsing / Krusell, Lars Romer / Ravkilde, Jan / Tilsted, Hans-Henrik / Thayssen, Per / Jensen, Lisette Okkels. ·Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Department of Cardiology, Center of Cardiology and Angiology, Vilnius University Hospital, Vilnius, Lithuania. · Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark. · Department of Cardiology, Odense University Hospital, Odense, Denmark. ·Catheter Cardiovasc Interv · Pubmed #25640050.

ABSTRACT: OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes. BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients. METHODS: 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. RESULTS: 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). CONCLUSION: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.

13 Article Co-registration of optical coherence tomography and X-ray angiography in percutaneous coronary intervention. the Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) fusion study. 2015

Hebsgaard, Lasse / Nielsen, Troels Munck / Tu, Shengxian / Krusell, Lars Romer / Maeng, Michael / Veien, Karsten Tange / Raungaard, Bent / Terkelsen, Christian Juhl / Kaltoft, Anne / Reiber, Johan H C / Lassen, Jens Flensted / Christiansen, Evald Høj / Holm, Niels Ramsing. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. · Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address: niels.holm@ki.au.dk. ·Int J Cardiol · Pubmed #25585362.

ABSTRACT: BACKGROUND: Intracoronary imaging provides accurate lesion delineation and precise measurements for sizing and positioning of coronary stents. During percutaneous coronary intervention (PCI), it may be challenging to identify corresponding segments between intracoronary imaging and angiography. Computer based online co-registration may aid the target segment identification. METHODS: The DOCTOR fusion study was a prospective, single arm, observational study including patients admitted for elective PCI. Optical coherence tomography (OCT) was acquired pre-stent implantation for sizing of stents. The operator subsequently indicated on the angiogram the target area as identified by OCT. Computer based co-registration was performed on-line immediately after pre-stent acquisition to assess feasibility. The cumulated numerical difference between operator based, and computer based co-registration was assessed as the "Operator Registration Error". The operator implanted the stent blind to the co-registrated angiogram. The difference between the co-registered stent border positions and the actual stent deployment border positions was the "Geographic Miss Distance". RESULTS: Twenty-two patients were included in the study. Two patients were excluded due to missing pre or post-OCT acquisitions. Online co-registration pre-stenting was successful in all analyzed cases. The mean "Operator Registration Error" was 5.4±3.5mm. The mean "Geographic Miss Distance" was 5.4±2.6mm. Without access to the computer-based co-registration, segments of the target lesion indicated on OCT were left uncovered by stent in 14 patients (70%). CONCLUSION: Computer based online co-registration of OCT and angiography is feasible. Frequent inaccuracies in operator based registration indicate that computer aided co-registration may reduce errors in corresponding OCT findings to the angiogram.

14 Article Long-term outcome of sirolimus-eluting and zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a Danish organization for randomized trials on clinical outcome III substudy). 2015

Olesen, Kevin K W / Tilsted, Hans-Henrik / Jensen, Lisette O / Kaltoft, Anne / Krusell, Lars R / Ravkilde, Jan / Christiansen, Evald H / Madsen, Morten / Thayssen, Per / Sørensen, Henrik T / Lassen, Jens F / Maeng, Michael. ·Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark. · Department of Cardiology, Odense University Hospital, Odense, Denmark. · Department of Clinical Epidemiology, Aalborg University Hospital, Aarhus, Denmark. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk. ·Am J Cardiol · Pubmed #25499925.

ABSTRACT: We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover, during the last 4 years, ZES had fewer MACE, TVR, and stent thrombosis events among nondiabetic patients. In conclusion, SES remains superior to ZES in patients with diabetes throughout the 5-year follow-up, however, among nondiabetic patients, SES demonstrated a highly dynamic performance with favorable initial results followed by a late catch-up that included an overall higher risk of stent thrombosis.

15 Article Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. 2015

Modrau, Ivy S / Nielsen, Per H / Bøtker, Hans E / Christiansen, Evald H / Krusell, Lars R / Kaltoft, Anne K / Mæng, Michael / Terkelsen, Christian J / Kristensen, Steen D / Lassen, Jens F / Thuesen, Leif. ·Department of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Aarhus, Denmark. ·EuroIntervention · Pubmed #24103704.

ABSTRACT: AIMS: To assess the procedural feasibility and early safety of hybrid coronary revascularisation, combining off-pump left internal mammary artery grafting to the left descending coronary artery (LAD) through an inferior J-hemisternotomy (JOPCAB) with percutaneous coronary intervention (PCI) of non-LAD lesions. METHODS AND RESULTS: A total of 100 patients with multivessel coronary artery disease involving LAD were included in this prospective registry. Hybrid revascularisation was performed by JOPCAB, either prior to PCI (89%) or following PCI (11%). In 96% of the cases, the procedure was carried out according to the preoperative strategy and without perioperative (24 hours) major adverse cardiac or cerebral events. At one month, we observed no deaths, one stroke and two procedure-related myocardial infarctions. Five patients underwent reoperation for graft dysfunction, four of whom were identified by angiography without prior signs of ischaemia. Reoperation due to bleeding was necessary in six patients, and nine patients received red blood cell transfusion. CONCLUSIONS: Our prospective registry documented promising procedural feasibility and early safety of coronary hybrid revascularisation combining JOPCAB with PCI. ClinicalTrials.gov identifier: NCT01496664.

16 Article Fractional flow reserve derived from coronary CT angiography: variation of repeated analyses. 2014

Gaur, Sara / Bezerra, Hiram G / Lassen, Jens F / Christiansen, Evald H / Tanaka, Kentaro / Jensen, Jesper M / Oldroyd, Keith G / Leipsic, Jonathon / Achenbach, Stephan / Kaltoft, Anne K / Bøtker, Hans Erik / Nørgaard, Bjarne L. ·Department of Cardiology, Aarhus University Hospital, Brendstrupgaardsvej 100, Skejby, 8200 Aarhus N, Denmark. Electronic address: sargau@rm.dk. · Harrington Heart and Vascular Institute, Case Medical Center, Cleveland, OH, USA. · Department of Cardiology, Aarhus University Hospital, Brendstrupgaardsvej 100, Skejby, 8200 Aarhus N, Denmark. · Department of Cardiology, Golden Jubilee National Hospital, Glasgow, Scotland. · Department of Radiology, St. Paul's Hospital, Vancouver, BC, Canada. · Department of Cardiology, University of Erlangen, Erlangen, Germany. ·J Cardiovasc Comput Tomogr · Pubmed #25151923.

ABSTRACT: BACKGROUND: Fractional flow reserve (FFR) is the standard of reference for assessing the hemodynamic significance of coronary stenoses in patients with stable coronary artery disease. Noninvasive FFR derived from coronary CT angiography (FFRCT) is a promising new noninvasive method for assessing the physiologic significance of epicardial stenoses. The reproducibility of FFRCT has not yet been established. OBJECTIVE: The aim of this study was to evaluate the variation of repeated analyses of FFRCT per se and in the context of the reproducibility of repeated FFR measurements. METHODS: Coronary CT angiography and invasive coronary angiography with repeated FFR measurements were performed in 28 patients (58 vessels) with suspected stable coronary artery disease. Based on the coronary CT angiography data set, FFRCT analyses were performed twice by 2 independent blinded analysts. RESULTS: In 12 of 58 (21%) vessels FFR was ≤ 0.80. The standard deviation for the difference between first and second FFRCT analyses was 0.034 vs 0.033 for FFR repeated measurements (P = .722). Limits of agreement were -0.06 to 0.08 for FFRCT and -0.07 to 0.06 for FFR. The coefficient of variation of FFRCT (CVFFRct) was 3.4% (95% confidence interval [CI], 1.4%-4.6%) vs 2.7% (95% CI, 1.8%-3.3%) for FFR. In vessels with mean FFR ranging between 0.70 and 0.90 (n = 25), the difference between the first and second FFRCT analyses was 0.035 and FFR repeated measurements was 0.043 (P = .357), whereas CVFFRct was 3.3% (95% CI, 1.5%-4.3%) and coefficient of variation for FFR was 3.6% (95% CI, 2.3%-4.6%). CONCLUSIONS: The reproducibility of both repeated FFRCT analyses and repeated FFR measurements is high.

17 Article Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial. 2014

Jensen, Lisette Okkels / Thayssen, Per / Maeng, Michael / Christiansen, Evald Høj / Ravkilde, Jan / Hansen, Knud Nørregaard / Kaltoft, Anne / Tilsted, Hans Henrik / Madsen, Morten / Lassen, Jens Flensted / Anonymous2460802. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address: okkels@dadlnet.dk. · Department of Cardiology, Odense University Hospital, Odense, Denmark. · Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Aalborg, Denmark. · Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. ·JACC Cardiovasc Interv · Pubmed #25086842.

ABSTRACT: OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT 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 SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. METHODS: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). RESULTS: At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70). CONCLUSIONS: At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).

18 Article Pre-hospital evaluation of electrocardiographic grade 3 ischemia predicts infarct progression and final infarct size in ST elevation myocardial infarction patients treated with primary percutaneous coronary intervention. 2014

Ringborn, Michael / Birnbaum, Yochai / Nielsen, Søren Steen / Kaltoft, Anne Kjer / Bøtker, Hans Erik / Pahlm, Olle / Wagner, Galen S / Platonov, Pyotr G / Terkelsen, Christian Juhl. ·Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden; Center for Integrative Electrocardiology at Lund University (CIEL), Lund, Sweden; Thoracic Center, Blekingesjukhuset, Karlskrona, Sweden. Electronic address: michaelringborn@yahoo.com. · Department of Medicine, Section of Cardiology, Baylor College of Medicine, Houston, TX, USA. · Department of Nuclear Medicine, Hospital of South-Western Jutland, Esbjerg, Denmark. · Department of Cardiology, Aarhus University Hospital in Skejby, Denmark. · Center for Integrative Electrocardiology at Lund University (CIEL), Lund, Sweden; Department of Clinical Physiology, Lund University, Lund, Sweden. · Duke University Medical Center, Durham, NC, USA. · Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden; Center for Integrative Electrocardiology at Lund University (CIEL), Lund, Sweden. ·J Electrocardiol · Pubmed #24878030.

ABSTRACT: BACKGROUND: In STEMI, grade-3 ischemia (G3) on admission ECG predicts larger infarct size (IS) than grade-2 (G2). We evaluated whether pre-hospital G3 and its temporal behavior are associated with IS and salvage after pPCI. METHODS: In 401 STEMI patients, pre-hospital and pre-PCI ECGs were classified as G3 or G2. IS was assessed by single-photon emission computed tomography (SPECT) at 30days. In 245 patients, pre-PCI SPECT was available to determine myocardium at risk (MaR). RESULTS: G3 criteria were met by 88, and G2 by 313 patients. G3 was independently associated with IS (p=0.006). With ST resolution (STR) group as a reference, G2->G2, G2->G3 and G3->G3 were associated with larger IS (B=4.4, p=0.004; B=5.4, p=0.01; B=10.2, p<0.001, respectively), whereas G3->G2 was not. Salvage was similar between G3 and G2 on pre-hospital ECG if treated early, however lower for G3 when treated later (>2.5h); 48% (35-78) vs 62% (40-87); p=0.04. CONCLUSION: Development or persistence of G3 is associated with larger IS and less salvage, but decreasing grade G3->G2 was not.

19 Article Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. 2014

Maeng, Michael / Tilsted, Hans Henrik / Jensen, Lisette Okkels / Krusell, Lars Romer / Kaltoft, Anne / Kelbæk, Henning / Villadsen, Anton B / Ravkilde, Jan / Hansen, Knud Nørregaard / Christiansen, Evald Høj / Aarøe, Jens / Jensen, Jan Skov / Kristensen, Steen Dalby / Bøtker, Hans Erik / Thuesen, Leif / Madsen, Morten / Thayssen, Per / Sørensen, Henrik Toft / Lassen, Jens Flensted. ·Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk. · Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark. · Department of Cardiology, Odense University Hospital, Odense, Denmark. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. · Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark. · Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. ·Lancet · Pubmed #24631162.

ABSTRACT: BACKGROUND: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents. METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478. FINDINGS: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period. INTERPRETATION: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation. FUNDING: Cordis and Medtronic.

20 Article Long-term outcome following percutaneous coronary intervention with drug-eluting stents compared with bare-metal stents in saphenous vein graft lesions: from Western Denmark Heart Registry. 2014

Hougaard, Mikkel / Thayssen, Per / Kaltoft, Anne / Tilsted, Hans-Henrik / Maeng, Michael / Lassen, Jens Flensted / Thuesen, Leif / Okkels Jensen, Lisette. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. ·Catheter Cardiovasc Interv · Pubmed #24311384.

ABSTRACT: OBJECTIVES: We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention (PCI) with drug-eluting stents (DES) or bare-metal stents (BMS). BACKGROUND: The use of DES compared with BMS during PCI has reduced the risk of restenosis in native coronary artery lesions. In saphenous vein grafts (SVG) the outcome after DES compared with BMS is insufficiently described. METHODS: From January 1, 2002 to December 31, 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants. Stent failure was defined as clinically driven target lesion revascularization, graft occlusion without intervention, or stent thrombosis. RESULTS: The study cohort consisted of 529 patients with 755 SVG lesions (348 DES patients with 510 lesions and 181 BMS patients with 245 lesions). Mean age did not differ between patients with DES-treated lesions compared to patients with BMS-treated lesions (67.5 ± 9.1 years vs. 67.6 ± 9.3 years; P = 0.85). The median follow-up time was 3.0 years (25th-75th percentile: 1.4-5.1 years). One-year (n = 27 (8.2%) vs. n = 12 (6.7%), log rank P = 0.60) and 3-year cumulative mortality (n = 31 (18.8%) vs. n = 59 (21.8%), log rank P = 0.64) did not differ significantly between DES- and BMS-treated patients. One-year cumulative stent failure was seen in 39 (6.6%) DES-treated lesions vs. 24 (10.8%) BMS-treated lesions (P = 0.088), and 3-year cumulative stent failure in 48 (15.4%) vs. 34 (18.8%) lesions (P = 0.25), respectively. CONCLUSION: In SVG lesions, DES showed no long-term benefit compared to BMS in rates of all-cause mortality or stent failure.

21 Article Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. 2014

Antonsen, Lisbeth / Maeng, Michael / Thayssen, Per / Christiansen, Evald Høj / Hansen, Knud Nørregaard / Kaltoft, Anne / Hansen, Henrik Steen / Thuesen, Leif / Lassen, Jens Flensted / Jensen, Lisette Okkels. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. ·Catheter Cardiovasc Interv · Pubmed #23996918.

ABSTRACT: OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients. BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH). METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling. CONCLUSION: In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.

22 Article Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. 2013

Christiansen, Evald Høj / Jensen, Lisette Okkels / Thayssen, Per / Tilsted, Hans-Henrik / Krusell, Lars Romer / Hansen, Knud Nørregaard / Kaltoft, Anne / Maeng, Michael / Kristensen, Steen Dalby / Bøtker, Hans Erik / Terkelsen, Christian Juhl / Villadsen, Anton Boel / Ravkilde, Jan / Aarøe, Jens / Madsen, Morten / Thuesen, Leif / Lassen, Jens Flensted / Anonymous1200749. ·Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. evald.christiansen@dadlnet.dk ·Lancet · Pubmed #23374649.

ABSTRACT: BACKGROUND: Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting. METHODS: This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981. FINDINGS: From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03). INTERPRETATION: At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice. FUNDING: Terumo and Cordis (Johnson & Johnson).

23 Article 2-year patient-related versus stent-related outcomes: the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial. 2012

Jensen, Lisette Okkels / Thayssen, Per / Christiansen, Evald Høj / Tilsted, Hans Henrik / Maeng, Michael / Hansen, Knud Nørregaard / Kaltoft, Anne / Hansen, Henrik Steen / Bøtker, Hans Erik / Krusell, Lars Romer / Ravkilde, Jan / Madsen, Morten / Thuesen, Leif / Lassen, Jens Flensted / Anonymous2970736. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk ·J Am Coll Cardiol · Pubmed #22958957.

ABSTRACT: OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

24 Article 3-Year clinical outcomes in the randomized SORT OUT III superiority trial comparing zotarolimus- and sirolimus-eluting coronary stents. 2012

Maeng, Michael / Tilsted, Hans-Henrik / Jensen, Lisette Okkels / Kaltoft, Anne / Kelbæk, Henning / Abildgaard, Ulrik / Villadsen, Anton B / Krusell, Lars Romer / Ravkilde, Jan / Hansen, Knud Nørregaard / Christiansen, Evald Høj / Aarøe, Jens / Jensen, Jan Skov / Kristensen, Steen Dalby / Bøtker, Hans Erik / Madsen, Morten / Thayssen, Per / Sørensen, Henrik Toft / Thuesen, Leif / Lassen, Jens Flensted. ·Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. maeng@ki.au.dk ·JACC Cardiovasc Interv · Pubmed #22917452.

ABSTRACT: OBJECTIVES: This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice. BACKGROUND: The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear. METHODS: The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis. RESULTS: At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005). CONCLUSIONS: Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478).

25 Article Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). 2012

Jensen, Lisette Okkels / Thayssen, Per / Hansen, Henrik Steen / Christiansen, Evald Høj / Tilsted, Hans Henrik / Krusell, Lars Romer / Villadsen, Anton Boel / Junker, Anders / Hansen, Knud Nørregaard / Kaltoft, Anne / Maeng, Michael / Pedersen, Knud Erik / Kristensen, Steen Dalby / Bøtker, Hans Erik / Ravkilde, Jan / Sanchez, Richardo / Aarøe, Jens / Madsen, Morten / Sørensen, Henrik Toft / Thuesen, Leif / Lassen, Jens Flensted / Anonymous3080717. ·Department of Cardiology, Odense University Hospital, Denmark. okkels@dadlnet.dk ·Circulation · Pubmed #22308301.

ABSTRACT: BACKGROUND: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88). CONCLUSION: The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.

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