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Coronary Artery Disease: HELP
Articles by Hans Henrik Tilsted
Based on 25 articles published since 2010
(Why 25 articles?)
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Between 2010 and 2020, Hans H. Tilsted wrote the following 25 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 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.

2 Article Pilot study of the multicentre DISCHARGE Trial: image quality and protocol adherence results of computed tomography and invasive coronary angiography. 2020

De Rubeis, Gianluca / Napp, Adriane E / Schlattmann, Peter / Geleijns, Jacob / Laule, Michael / Dreger, Henryk / Kofoed, Klaus / Sørgaard, Mathias / Engstrøm, Thomas / Tilsted, Hans Henrik / Boi, Alberto / Porcu, Michele / Cossa, Stefano / Rodríguez-Palomares, José F / Xavier Valente, Filipa / Roque, Albert / Feuchtner, Gudrun / Plank, Fabian / Štěchovský, Cyril / Adla, Theodor / Schroeder, Stephen / Zelesny, Thomas / Gutberlet, Matthias / Woinke, Michael / Károlyi, Mihály / Karády, Júlia / Donnelly, Patrick / Ball, Peter / Dodd, Jonathan / Hensey, Mark / Mancone, Massimo / Ceccacci, Andrea / Berzina, Marina / Zvaigzne, Ligita / Sakalyte, Gintare / Basevičius, Algidas / Ilnicka-Suckiel, Małgorzata / Kuśmierz, Donata / Faria, Rita / Gama-Ribeiro, Vasco / Benedek, Imre / Benedek, Teodora / Adjić, Filip / Čanković, Milenko / Berry, Colin / Delles, Christian / Thwaite, Erica / Davis, Gershan / Knuuti, Juhani / Pietilä, Mikko / Kepka, Cezary / Kruk, Mariusz / Vidakovic, Radosav / Neskovic, Aleksandar N / Lecumberri, Iñigo / Diez Gonzales, Ignacio / Ruzsics, Balazs / Fisher, Mike / Dewey, Marc / Francone, Marco / Anonymous2931127. ·Department of Radiology, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy. · Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. · Department of Statistics, Informatics and Data Science, Jena University Hospital, Jena, Germany. · Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. · Department of Cardiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany. · Department of Radiology, Rigshospitalet Region Hovedstaden, Rigshospitalet 9, 2100, Copenhagen, Denmark. · Department of Cardiology, Rigshospitalet Region Hovedstaden, Rigshospitalet 9, 2100, Copenhagen, Denmark. · Department of Cardiology, Azienda Ospedaliera Brotzu, Cagliari, CA, Italy. · Department of Radiology, Azienda Ospedaliera Universitaria di Cagliari, AOU di Cagliari - Polo di Monserrato, 09042, Monserrato, CA, Italy. · Department of Radiology, Azienda Ospedaliera Brotzu, Cagliari, CA, Italy. · Department of Cardiology, Hospital Universitari Vall d´Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig de Vall d'Hebron 119, 08035, Barcelona, Spain. · Department of Radiology, Hospital Universitari Vall d´Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Passeig de Vall d'Hebron 119, 08035, Barcelona, Spain. · Department of Radiology, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. · Department of Cardiology, Medical University Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria. · Department of Cardiology, University Hospital Motol, Vuvalu 84, 150 06, Prague 5, Czech Republic. · Department of Radiology, University Hospital Motol, Vuvalu 84, 150 06, Prague 5, Czech Republic. · Department of Cardiology, ALB FILS KLINIKEN GmbH, Eichertstrasse 3, 73035, Goeppingen, Germany. · Department of Radiology, ALB FILS KLINIKEN GmbH, Eichertstrasse 3, 73035, Goeppingen, Germany. · Department of Radiology, University of Leipzig Heart Centre, Strümpellstrasse 39, 04289, Leipzig, Germany. · Department of Cardiology, University of Leipzig Heart Centre, Strümpellstrasse 39, 04289, Leipzig, Germany. · MTA-SE Cardiovascular Imaging Center, Heart and Vascular Center, Semmelweis University, Varosmajor u 68, Budapest, 1122, Hungary. · Department of Cardiology, Southeastern Health and Social Care Trust, Upper Newtownards Road Ulster, Belfast, BT16 1RH, UK. · Department of Radiology, Southeastern Health and Social Care Trust, Upper Newtownards Road Ulster, Belfast, BT16 1RH, UK. · Department of Radiology, St. Vincent's University Hospital and National University of Ireland, Belfield Campus, 4, Dublin, Ireland. · Department of Cardiology, St. Vincent's University Hospital, Belfield Campus, 4, Dublin, Ireland. · Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy. · Department of Cardiology, Paul Stradins Clinical University Hospital, Pilsoņu Street 13, Riga, 1002, Latvia. · Department of Radiology, Paul Stradins Clinical University Hospital, Pilsoņu Street 13, Riga, 1002, Latvia. · Department of Cardiology, Lithuanian University of Health Sciences, Eivelniu 2, 50009, Kaunas, Lithuania. · Department of Radiology, Lithuanian University of Health Sciences, Eivelniu 2, 50009, Kaunas, Lithuania. · Department of Cardiology, Wojewodzki Szpital Specjalistyczny We Wroclawiu, Ul. Henryka Michala Kamienskiego, 51124, Wroclaw, Poland. · Department of Radiology, Wojewodzki Szpital Specjalistyczny We Wroclawiu, Ul. Henryka Michala Kamienskiego, 51124, Wroclaw, Poland. · Department of Cardiology, Centro Hospitalar de Vila Nova de Gaia, Rua Conceicao Fernandes, 4434 502, Vila Nova de Gaia, Portugal. · Department of Cardiology, Cardio Med Medical Center, 22 decembrie 1989, 540156, Targu-Mures, Romania. · Radiology Department Imaging Center, Institute of Cardiovascular Diseases of Vojvodina, Put dr Goldmana 4, Sremska Kamenica, Novi Sad, 212014, Serbia. · Department of Cardiology, Institute of Cardiovascular Diseases of Vojvodina, Put dr Goldmana 4, Sremska Kamenica, Novi Sad, 212014, Serbia. · Institute of Cardiovascular and Medical Sciences, University of Glasgow, University Place 126, Glasgow, G12 8TA, UK. · Department of Radiology, Aintree University Hospital, Longmoor Lane, Liverpool, L9 7AL, UK. · Department of Cardiology, Aintree University Hospital, Longmoor Lane, Liverpool, L9 7AL, UK. · Turku PET Centre, Turku University Hospital and University of Turku, Kiinamyllynkatu 4-8, 20120, Turku, Finland. · Heart Centre, Turku University Hospital, Kiinamyllynkatu 4-8, FI 20120, Turku, Finland. · Department of Radiology, The Institute of Cardiology in Warsaw, Ul. Alpejska 42, 04-628, Warsaw, Poland. · Department of Cardiology, The Institute of Cardiology in Warsaw, Ul. Alpejska 42, 04-628, Warsaw, Poland. · Department of Cardiology, Clinical Hospital Center Zemun, Vukova 9, Belgrade-Zemun, 11080, Serbia. · Department of Radiology, Basurto University Hospital, Avenida Montevideo 18, 48013, Bilbao, Spain. · Department of Cardiology, Basurto University Hospital, Avenida Montevideo 18, 48013, Bilbao, Spain. · Department of Cardiology, Royal Liverpool and Broadgreen University Hospitals, Prescot Street, Liverpool, L7 8XP, UK. · Department of Radiology, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy. marco.francone@uniroma1.it. · Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, V.le Regina Elena, 324 00161, Rome, Italy. marco.francone@uniroma1.it. ·Eur Radiol · Pubmed #31844958.

ABSTRACT: OBJECTIVE: To implement detailed EU cardiac computed tomography angiography (CCTA) quality criteria in the multicentre DISCHARGE trial (FP72007-2013, EC-GA 603266), we reviewed image quality and adherence to CCTA protocol and to the recommendations of invasive coronary angiography (ICA) in a pilot study. MATERIALS AND METHODS: From every clinical centre, imaging datasets of three patients per arm were assessed for adherence to the inclusion/exclusion criteria of the pilot study, predefined standards for the CCTA protocol and ICA recommendations, image quality and non-diagnostic (NDX) rate. These parameters were compared via multinomial regression and ANOVA. If a site did not reach the minimum quality level, additional datasets had to be sent before entering into the final accepted database (FADB). RESULTS: We analysed 226 cases (150 CCTA/76 ICA). The inclusion/exclusion criteria were not met by 6 of the 226 (2.7%) datasets. The predefined standard was not met by 13 of 76 ICA datasets (17.1%). This percentage decreased between the initial CCTA database and the FADB (multinomial regression, 53 of 70 vs 17 of 75 [76%] vs [23%]). The signal-to-noise ratio and contrast-to-noise ratio of the FADB did not improve significantly (ANOVA, p = 0.20; p = 0.09). The CTA NDX rate was reduced, but not significantly (initial CCTA database 15 of 70 [21.4%]) and FADB 9 of 75 [12%]; p = 0.13). CONCLUSION: We were able to increase conformity to the inclusion/exclusion criteria and CCTA protocol, improve image quality and decrease the CCTA NDX rate by implementing EU CCTA quality criteria and ICA recommendations. KEY POINTS: • Failure to meet protocol adherence in cardiac CTA was high in the pilot study (77.6%). • Image quality varies between sites and can be improved by feedback given by the core lab. • Conformance with new EU cardiac CT quality criteria might render cardiac CTA findings more consistent and comparable.

3 Article Characterisation of lesions undergoing ischaemia-driven revascularisation after complete revascularisation versus culprit lesion only in patients with STEMI and multivessel disease: a DANAMI-3-PRIMULTI substudy. 2019

De Backer, Ole / Lønborg, Jacob / Helqvist, Steffen / Warnøe, Julie / Kløvgaard, Lene / Holmvang, Lene / Pedersen, Frants / Tilsted, Hans-Henrik / Raungaard, Bent / Jørgensen, Erik / Køber, Lars / Høfsten, Dan Eik / Kelbæk, Henning / Engstrøm, Thomas. ·The Heart Center, Rigshospitalet, University of Copenhagen, Denmark. ·EuroIntervention · Pubmed #30666962.

ABSTRACT: AIMS: Treatment of the infarct-related artery only (IRA only) in ST-segment elevation myocardial infarction (STEMI) is associated with a significantly higher rate of ischaemia-driven revascularisation (ID-RV) during follow-up than fractional flow reserve-guided complete revascularisation (FFR-CRV). This study aimed to characterise all lesions which underwent ID-RV in the DANAMI-3-PRIMULTI trial with respect to location, stenosis grade and functional significance. METHODS AND RESULTS: The study included 627 patients with STEMI and multivessel disease; 313 patients were randomised to treatment of the IRA only versus 314 undergoing staged FFR-CRV during the index admission. Rates of admission for suspected cardiac ischaemia (17%) were similar in both groups; however, ID-RV was significantly less frequent in the FFR-CRV group than in the IRA-only group (5% vs. 17%; p<0.001). In both groups, the primary reason for ID-RV was related to non-culprit, non-treated lesions (N=71/82 lesions in IRA-only; N=13/26 in FFR-CRV). De novo lesions or revascularisation of previously treated lesions were rarely causes of ID-RV. In the IRA-only group, there was a trend towards a higher ID-RV rate for lesions with a higher stenosis grade and located in more proximal segments - in particular, ≥80% stenosis of the left anterior descending and right coronary artery also led to angina class IV/unstable angina. In the FFR-CRV group, an FFR value ≤0.80 was shown to be an appropriate threshold for revascularisation. CONCLUSIONS: FFR-CRV in STEMI is associated with a significantly lower rate of ID-RV at follow-up than treatment of the IRA only. This is due to a difference in non-culprit, non-treated lesions between both groups and not in de novo lesions or repeat revascularisation of previously treated lesions. Further considerations are warranted in case of high-grade non-culprit stenosis at proximal coronary segments, borderline FFR values and/or anticipated complex PCI.

4 Article Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization). 2017

Lønborg, Jacob / Engstrøm, Thomas / Kelbæk, Henning / Helqvist, Steffen / Kløvgaard, Lene / Holmvang, Lene / Pedersen, Frants / Jørgensen, Erik / Saunamäki, Kari / Clemmensen, Peter / De Backer, Ole / Ravkilde, Jan / Tilsted, Hans-Henrik / Villadsen, Anton Boel / Aarøe, Jens / Jensen, Svend Eggert / Raungaard, Bent / Køber, Lars / Høfsten, Dan Eik / Anonymous1360903. ·From the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark (J.L., T.E., S.H., L. Kløvgaard, L.H., F.P., E.J., K.S., O.D.B., H.-H.T., L. Køber, D.E.H.) · Department of Cardiology, Roskilde Hospital, Denmark (H.K.) · Department of Cardiology, Nykoebing Falster Hospital, Denmark (P.C.) · and Department of Cardiology, Aalborg University Hospital, Denmark (J.R., A.B.V., J.A., S.E.J., B.R.). ·Circ Cardiovasc Interv · Pubmed #28404623.

ABSTRACT: BACKGROUND: The impact of disease severity on the outcome after complete revascularization in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. The objective of this post hoc study was to evaluate the impact of number of diseased vessel, lesion location, and severity of the noninfarct-related stenosis on the effect of fractional flow reserve-guided complete revascularization. METHODS AND RESULTS: In the DANAMI-3-PRIMULTI study (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization), we randomized 627 ST-segment-elevation myocardial infarction patients to fractional flow reserve-guided complete revascularization or infarct-related percutaneous coronary intervention only. In patients with 3-vessel disease, fractional flow reserve-guided complete revascularization reduced the primary end point (all-cause mortality, reinfarction, and ischemia-driven revascularization; hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.17-0.64; CONCLUSIONS: The benefit from fractional flow reserve-guided complete revascularization in ST-segment-elevation myocardial infarction patients with multivessel disease was dependent on the presence of 3-vessel disease and noninfarct diameter stenosis ≥90% and was particularly pronounced in patients with both of these angiographic characteristics. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01960933.

5 Article Prognostic assessment of stable coronary artery disease as determined by coronary computed tomography angiography: a Danish multicentre cohort study. 2017

Nielsen, Lene H / Bøtker, Hans Erik / Sørensen, Henrik T / Schmidt, Morten / Pedersen, Lars / Sand, Niels Peter / Jensen, Jesper M / Steffensen, Flemming H / Tilsted, Hans Henrik / Bøttcher, Morten / Diederichsen, Axel / Lambrechtsen, Jess / Kristensen, Lone D / Øvrehus, Kristian A / Mickley, Hans / Munkholm, Henrik / Gøtzsche, Ole / Husain, Majed / Knudsen, Lars L / Nørgaard, Bjarne L. ·Department of Cardiology, Lillebaelt Hospital-Vejle, Kabbeltoft 25, DK-7100 Vejle, Denmark. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Cardiology, Hospital of South West Jutland, Esbjerg, Denmark. · Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. · Department of Cardiology, Regional Hospital Herning, Herning, Denmark. · Department of Cardiology, Odense University Hospital, Denmark. · Department of Cardiology, Svendborg Hospital, Denmark. · Department of Cardiology, Regional Hospital Silkeborg, Silkeborg, Denmark. ·Eur Heart J · Pubmed #27941018.

ABSTRACT: Aims: To examine the 3.5 year prognosis of stable coronary artery disease (CAD) as assessed by coronary computed tomography angiography (CCTA) in real-world clinical practice, overall and within subgroups of patients according to age, sex, and comorbidity. Methods and results: This cohort study included 16,949 patients (median age 57 years; 57% women) with new-onset symptoms suggestive of CAD, who underwent CCTA between January 2008 and December 2012. The endpoint was a composite of late coronary revascularization procedure >90 days after CCTA, myocardial infarction, and all-cause death. The Kaplan-Meier estimator was used to compute 91 day to 3.5 year risk according to the CAD severity. Comparisons between patients with and without CAD were based on Cox-regression adjusted for age, sex, comorbidity, cardiovascular risk factors, concomitant cardiac medications, and post-CCTA treatment within 90 days. The composite endpoint occurred in 486 patients. Risk of the composite endpoint was 1.5% for patients without CAD, 6.8% for obstructive CAD, and 15% for three-vessel/left main disease. Compared with patients without CAD, higher relative risk of the composite endpoint was observed for non-obstructive CAD [hazard ratio (HR): 1.28; 95% confidence interval (CI): 1.01-1.63], obstructive one-vessel CAD (HR: 1.83; 95% CI: 1.37-2.44), two-vessel CAD (HR: 2.97; 95% CI: 2.09-4.22), and three-vessel/left main CAD (HR: 4.41; 95% CI :2.90-6.69). The results were consistent in strata of age, sex, and comorbidity. Conclusion: Coronary artery disease determined by CCTA in real-world practice predicts the 3.5 year composite risk of late revascularization, myocardial infarction, and all-cause death across different groups of age, sex, or comorbidity burden.

6 Article Bleeding episodes in "complete, staged" versus "culprit only" revascularisation in patients with multivessel disease and ST-segment elevation myocardial infarction: a DANAMI-3-PRIMULTI substudy. 2016

Sadjadieh, Golnaz / Engstrøm, Thomas / Helqvist, Steffen / Høfsten, Dan Eik / Køber, Lars / Pedersen, Frants / Clemmensen, Peter / Jørgensen, Erik / Saunamäki, Kari / Tilsted, Hans-Henrik / Kelbæk, Henning / Holmvang, Lene. ·Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark. ·EuroIntervention · Pubmed #27866133.

ABSTRACT: AIMS: The aim of this study was to evaluate whether a staged in-hospital complete revascularisation strategy increases the risk of serious bleeding events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. METHODS AND RESULTS: The DANAMI-3-PRIMULTI trial investigated whether a staged in-hospital complete revascularisation strategy improved outcome in patients with STEMI and multivessel disease. In this substudy, we investigated potential bleeding complications related to a second in-hospital procedure. Bleedings were assessed using BARC and TIMI criteria. Six hundred and twenty-seven (627) patients were randomised 1:1 to either PCI of the infarct-related artery (IRA) only (n=313) or complete revascularisation during a staged procedure before discharge (n=314). We found no significant difference in TIMI major+minor bleedings related to the primary PCI. There were neither major nor minor bleedings in relation to the second procedure in the complete revascularisation arm. There were significantly more in-hospital minimal+medical attention bleedings in the group randomised to complete revascularisation (61.5% vs. 49.5% in the IRA-PCI only group, p=0.003), but no difference in admission time or one-year mortality (2.2% complete revascularisation-group vs. 2.6% IRA-PCI only group, p=0.8). CONCLUSIONS: In multivessel diseased STEMI patients, a staged complete in-hospital revascularisation strategy or any second in-hospital procedure did not result in an increase in serious bleeding events.

7 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.

8 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).

9 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.

10 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.

11 Article Coronary computed tomography angiography without significant stenosis predicts favourable three-year prognosis. 2014

Kristiansen, Jeppe Maagaard / Zaremba, Tomas / Johansen, Martin Berg / Tilsted, Hans-Henrik / Jensen, Svend Eggert. ·Kardiologisk Afdeling, Aalborg Universitetshospital, Hobrovej 18-22, 9000 Aalborg, Denmark. jeppe_m_kristiansen@hotmail.com. ·Dan Med J · Pubmed #25162443.

ABSTRACT: INTRODUCTION: The objective of this study was to evaluate the incidence of death, cardiovascular events and the use of later non-scheduled imaging for coronary artery disease (CAD) in patients suspected for CAD and discharged without a need for further examination or treatment from an outpatient clinic following coronary computed tomography angiography (CCTA). MATERIAL AND METHODS: This was a retrospective cohort study among patients discharged from an outpatient clinic after CCTA at our institution during 2009 and 2010. Follow-up was performed using nationwide Danish registers. RESULTS: A total of 683 (68.2%) out of 1001 patients were discharged from the outpatient clinic after CCTA with no need for further examination. These patients were included in our study. After a median follow-up of 37 months, a low all-cause mortality of 3.7 per 1,000 person-years was found. There was only one case of acute myocardial infarction and no cases of death related to cardiovascular disease. A total of 5.0% of the patients later underwent non-scheduled imaging, predominantly invasive coronary angiography. No patients had revascularisation performed during the study period. CONCLUSION: Patients with suspected CAD discharged after CCTA with no need for further examination have a favourable cardiovascular prognosis. FUNDING: Not relevant. TRIAL REGISTRATION: Not relevant.

12 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).

13 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.

14 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.

15 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).

16 Article Moderate overweight is beneficial and severe obesity detrimental for patients with documented atherosclerotic heart disease. 2013

Azimi, Aziza / Charlot, Mette Gitz / Torp-Pedersen, Christian / Gislason, Gunnar H / Køber, Lars / Jensen, Lisette Okkels / Thayssen, Per / Ravkilde, Jan / Tilsted, Hans-Henrik / Lassen, Jens Flensted / Thuesen, Leif. ·Department of Cardiology, Gentofte Hospital, post 635, Niels Andersens Vej 65, Hellerup 2900, Denmark. Aziza.Azimi@regionh.dk ·Heart · Pubmed #23335496.

ABSTRACT: OBJECTIVE: Obesity is paradoxically associated with enhanced survival in patients with established cardiovascular disease. We explored this paradox further by examining the influence of obesity on survival in patients with verified atherosclerotic heart disease. DESIGN AND PATIENTS: This retrospective registry based cohort study included all patients from the Western Denmark Heart Registry with coronary atherosclerosis confirmed by coronary angiography from January 2000 to December 2010. Patients were divided into eight groups according to body mass index (BMI) based on WHO BMI classification. SETTING: Department of Cardiology, Copenhagen University Hospital Gentofte, Hellerup, Denmark. RESULTS: The study included 37 573 patients (70.7% men) with a mean age of (66.3 ± 11.1) years. During the 11 years of follow-up, 5866 (15.6%) patients died. Multivariable analysis confirmed that the risk of death was the lowest among the preobese patients (27.5 ≤ BMI<30 kg/m(2)) with adjusted HR of 0.82 (95% CI 0.71 to 0.95; p=0.008) and increased with both low (BMI<18.50 kg/m(2)) and very high (BMI ≥ 40 kg/m(2)) BMI, HR 2.04 (95% CI 1.63 to 2.57; p<0.001) and HR 1.35 (95% CI 1.05 to 1.72; p<0.01), respectively. Also the normal weight class I (18.5 ≤ BMI<23 kg/m(2)) had a significant risk of mortality HR 1.28 (95% CI 1.13 to 1.45; p<0.001). Obese classes I and II did not differ from the reference group (23 ≤ BMI<25 kg/m(2)). CONCLUSIONS: Overweight atherosclerotic heart disease patients have improved survival compared with normal weight patients. Underweight and severely obese patients have increased mortality. Our results lean more towards an overweight paradox than an obesity paradox.

17 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.

18 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).

19 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.

20 Article Comparison of outcomes of patients ≥ 80 years of age having percutaneous coronary intervention according to presentation (stable vs unstable angina pectoris/non-ST-segment elevation myocardial infarction vs ST-segment elevation myocardial infarction). 2011

Antonsen, Lisbeth / Jensen, Lisette Okkels / Thayssen, Per / Christiansen, Evald Høj / Junker, Anders / Tilsted, Hans-Henrik / Terkelsen, Christian Juhl / Kaltoft, Anne / Maeng, Michael / Hansen, Knud Noerregaard / Ravkilde, Jan / Lassen, Jens Flensted / Madsen, Morten / Sørensen, Henrik Toft / Thuesen, Leif. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. dr_lissie@hotmail.com ·Am J Cardiol · Pubmed #21890087.

ABSTRACT: Patients ≥ 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥ 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥ 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥ 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time.

21 Article Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III Substudy). 2011

Maeng, Michael / Jensen, Lisette O / Tilsted, Hans-Henrik / Kaltoft, Anne / Kelbaek, Henning / Abildgaard, Ulrik / Villadsen, Anton / Aarøe, Jens / Thayssen, Per / Krusell, Lars R / Christiansen, Evald H / Bøtker, Hans E / Kristensen, Steen D / Ravkilde, Jan / Madsen, Morten / Sørensen, Henrik T / Rasmussen, Klaus / Thuesen, Leif / Lassen, Jens F. ·Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. ·Am J Cardiol · Pubmed #21864817.

ABSTRACT: Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first-generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated with an increased risk of major adverse cardiac events (18.3% vs 4.8%, hazard ratio 4.05, 95% confidence interval 1.86 to 8.82), myocardial infarction (4.7% vs 0.6%, hazard ratio 8.09, 95% confidence interval 1.01 to 64.7), target vessel revascularization (14.2% vs 3.0%, hazard ratio 4.99, 95% confidence interval 1.90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated with a considerable increased risk of adverse events in patients with diabetes at 18-month follow-up.

22 Article Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial. 2011

Jensen, Lisette Okkels / Maeng, Michael / Thayssen, Per / Villadsen, Anton / Krusell, Lars / Botker, Hans Erik / Pedersen, Knud Erik / Aaroe, Jens / Christiansen, Evald Hoej / Vesterlund, Thomas / Hansen, Knud Noerregaard / Ravkilde, Jan / Tilsted, Hans Henrik / Lassen, Jens Flensted / Thuesen, Leif. ·Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk ·EuroIntervention · Pubmed #21729834.

ABSTRACT: AIMS: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients. METHODS AND RESULTS: In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001). CONCLUSIONS: In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.

23 Article Small dense LDL particles--a predictor of coronary artery disease evaluated by invasive and CT-based techniques: a case-control study. 2011

Toft-Petersen, Anne P / Tilsted, Hans H / Aarøe, Jens / Rasmussen, Klaus / Christensen, Thorkil / Griffin, Bruce A / Aardestrup, Inge V / Andreasen, Annette / Schmidt, Erik B. ·Department of Cardiology, Center for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark. ·Lipids Health Dis · Pubmed #21262005.

ABSTRACT: BACKGROUND: Coronary angiography is the current standard method to evaluate coronary atherosclerosis in patients with suspected angina pectoris, but non-invasive CT scanning of the coronaries are increasingly used for the same purpose. Low-density lipoprotein (LDL) cholesterol and other lipid and lipoprotein variables are major risk factors for coronary artery disease. Small dense LDL particles may be of particular importance, but clinical studies evaluating their predictive value for coronary atherosclerosis are few. METHODS: We performed a study of 194 consecutive patients with chest pain, a priori considered of low to intermediate risk for significant coronary stenosis (>50% lumen obstruction) who were referred for elective coronary angiography. Plasma lipids and lipoproteins were measured including the subtype pattern of LDL particles, and all patients were examined by coronary CT scanning before coronary angiography. RESULTS: The proportion of small dense LDL was a strong univariate predictor of significant coronary artery stenosis evaluated by both methods. After adjustment for age, gender, smoking, and waist circumference only results obtained by traditional coronary angiography remained statistically significant. CONCLUSION: Small dense LDL particles may add to risk stratification of patients with suspected angina pectoris.

24 Article Patients with previous definite stent thrombosis have a reduced antiplatelet effect of aspirin and a larger fraction of immature platelets. 2010

Würtz, Morten / Grove, Erik L / Wulff, Lise N / Kaltoft, Anne K / Tilsted, Hans H / Jensen, Lisette O / Hvas, Anne-Mette / Kristensen, Steen D. ·Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. ·JACC Cardiovasc Interv · Pubmed #20723855.

ABSTRACT: OBJECTIVES: This study sought to evaluate the platelet response to aspirin and the immature platelet fraction in patients with previous stent thrombosis (ST). BACKGROUND: ST is a potentially fatal complication of coronary stenting. A reduced platelet response to aspirin increases the risk of cardiovascular events. METHODS: We included 117 patients previously undergoing percutaneous coronary intervention. A total of 39 patients had suffered ST and 78 patients served as controls matched at a 1:2 ratio with respect to age, sex, stent type, and percutaneous coronary intervention indication. All patients were treated with aspirin 75 mg once daily. Platelet function was assessed by multiple electrode aggregometry in citrated and hirudinized blood and by VerifyNow Aspirin Assay (Accumetrics, San Diego, California). Flow cytometric determination of the immature platelet fraction was performed to evaluate platelet turnover. Platelet activation was evaluated by soluble serum P-selectin. Compliance was confirmed by serum thromboxane B(2). RESULTS: All patients were fully compliant, which was confirmed by suppressed levels of serum thromboxane B(2). Platelet aggregation was increased in patients with previous ST when assessed by multiple electrode aggregometry induced by collagen (p(citrated blood) = 0.003; p(hirudinized blood) < 0.0001) and by arachidonic acid (p(citrated blood) = 0.16; p(hirudinized blood) = 0.04), respectively. Similarly, platelet aggregation assessed by VerifyNow was higher in ST cases (p = 0.12). A trend toward an increased immature platelet fraction among cases was seen (p = 0.13), whereas P-selectin levels (p = 0.56) did not differ between groups. CONCLUSIONS: Overall, patients with previous ST had a reduced antiplatelet effect of aspirin, which might be explained by an increased platelet turnover.

25 Article Paclitaxel and sirolimus eluting stents versus bare metal stents: long-term risk of stent thrombosis and other outcomes. From the Western Denmark Heart Registry. 2010

Jensen, Lisette Okkels / Tilsted, Hans Henrik / Thayssen, Per / Kaltoft, Anne / Maeng, Michael / Lassen, Jens Flensted / Hansen, Knud Noerregaard / Madsen, Morten / Ravkilde, Jan / Johnsen, Søren Paaske / Sørensen, Henrik Toft / Thuesen, Leif. ·Department of Cardiology, Odense University Hospital, Denmark. okkels@dadlnet.dk ·EuroIntervention · Pubmed #20542774.

ABSTRACT: AIMS: Stent thrombosis is a serious complication of percutaneous coronary intervention (PCI). We examined the incidence of stent thrombosis and other outcomes in patients treated with PCI and paclitaxeleluting stents (PES), sirolimus-eluting stents (SES) or bare-metal stents (BMS). METHODS AND RESULTS: All patients who underwent PES, SES or BMS implantation from January 2002 to June 2005 were identified in the population-based Western Denmark Heart Registry. All were followed for 36 months. Cox regression analysis was used to estimate relative risk (RR), controlling for covariates. A total of 12,374 patients were treated with stents: 1,298 with PES, 2,202 with SES and 8,847 with BMS. The three-year incidence of definite stent thrombosis was similar in the DES group (1.1%) and in the BMS group (0.7%) (adjusted relative risk [RR]: 1.24; 95% confidence interval [CI]: 0.85-1.81). Very late definite stent thrombosis occurred more frequently in DES-treated patients (adjusted RR: 2.89, 95% CI: 1.48- 5.65). The three-year mortality rate did not differ significantly between the two groups. Target lesion revascularisation (TLR) was lower in DES-treated patients than in BMS-treated patients (adjusted RR: 0.71, 95% CI: 0.63-0.81). CONCLUSIONS: An increased risk of very late definite stent thrombosis was observed in DES-treated patients compared with BMS-treated patients, but a similar mortality was detected. TLR continued to be lower among patients receiving DES.