Publications by authors named "Karsten Tange Veien"

28 Publications

  • Page 1 of 1

Influence of plaque characteristics on early vascular healing in patients with ST-elevation myocardial infarction.

Cardiovasc Revasc Med 2020 Sep 24. Epub 2020 Sep 24.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: To compare the early vascular healing of ruptured plaques (RP) and non-ruptured plaques (NRP) one month after primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), using optical coherence tomography (OCT).

Background: Vascular healing and strut coverage are important factors in reducing the risk of stent thrombosis after PCI. Influence of underlying lesion characteristics and differences in healing response between RP and NRP are unknown.

Methods: Twenty-six STEMI-patients underwent PCI and implantation of a polymer-free drug-coated Biofreedom stent (BF-BES). OCT was performed pre-PCI, post-PCI and at 1-month follow-up. The patients were divided into two groups: RP = 15 and NRP = 11. OCT analyses of culprit lesion, post stent implantation at baseline and follow-up were performed to determine the difference in vascular healing based on presence of uncovered and/or malapposed stent struts and intraluminal filling defects.

Results: The stent coverage did not differ significantly between the two groups at 1-month follow-up with percentage of uncovered struts: RP 26.5% [IQR 15.0-49.0] and NRP 28.1% [IQR 15.5-38.8] for NRP (p = 0.78). At 1-month, RP showed an increased percentage of late acquired malapposed struts (1.4% [IQR 0.8-2.4] vs. 0.0% [IQR 0.0-1.4], p = 0.03) and a larger total malapposition area (1.3 mm [IQR 0.4-2.5] vs. 0.0 mm [IQR 0.0-0.9], p = 0.01), compared to NRP.

Conclusion: Three out of four struts were covered within one month after stenting. The vascular healing was comparable in RP and NRP on stent coverage. However, RP had more and larger late acquired malapposition areas.
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http://dx.doi.org/10.1016/j.carrev.2020.09.033DOI Listing
September 2020

Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial.

Trials 2020 May 23;21(1):415. Epub 2020 May 23.

Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.

Background: Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear.

Methods/design: The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis.

Discussion: DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines.

Trial Registration: Clinicaltrials.gov, NCT03778554. Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42, registered on 28 September 2018.
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http://dx.doi.org/10.1186/s13063-020-4214-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245032PMC
May 2020

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

Circulation 2020 06 21;141(25):2052-2063. Epub 2020 May 21.

Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.

Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; <0.0001).

Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040241DOI Listing
June 2020

O-Water Positron Emission Tomography of Myocardial Ischemia in Patients Referred for Percutaneous Coronary Intervention.

Cardiovasc Revasc Med 2020 Oct 7;21(10):1237-1243. Epub 2020 Mar 7.

Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address:

The diagnostic accuracy of non-invasive diagnostic methods for detecting coronary artery disease has increased in recent years. This study aimed to assess the diagnostic performance of O-water positron emission tomography (PET) in terms of stress myocardial blood flow (MBF) and myocardial flow reserve (MFR) in patients with single-vessel disease referred for percutaneous coronary intervention (PCI), using fractional flow reserve (FFR) value of ≤0.80 as the reference for a significant stenosis. We also assessed the influence of the index of microcirculatory resistance (IMR) on the diagnostic performance of PET. O-water PET FFR and IMR were measured before PCI in 26 patients with single-vessel disease. Stress MBF < 2.5 ml/min/g (95% confidence interval [CI]) had sensitivity 78% (95% CI: 52%-94%), specificity 50% (95% CI: 16%-84%), positive predictive value (PPV) 78% (95% CI: 63%-88%), negative predictive value (NPV) 50% (95% CI: 25%-75%), and accuracy 69% (95% CI: 48%-86%). MFR < 2.5 had sensitivity 72% (95% CI: 47%-90%), specificity 75% (95% CI: 35%-97%), PPV 87% (95% CI: 65%-96%), NPV 55% (95% CI: 34%-74%), and accuracy 73% (95% CI: 52%-88%). In patients with IMR > 24, stress MBF correlated with FFR (r = 0.651; p = 0.016) whereas stress MBF did not correlate with FFR in patients with IMR < 24. In conclusion, stress MBF and MFR had modest diagnostic performance compared to invasive FFR measurements in patients with single-vessel disease.
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http://dx.doi.org/10.1016/j.carrev.2020.03.010DOI Listing
October 2020

A case report: haemodynamic instability due to true dynamic left ventricular outflow tract obstruction and systolic anterior motion following resuscitation: reversal of haemodynamics on supportive veno-arterial extracorporeal membrane oxygenation.

Eur Heart J Case Rep 2018 Dec 27;2(4):yty134. Epub 2018 Nov 27.

Department of Cardiology, University Hospital of Odense, Sdr. Boulevard 29, Odense C, Denmark.

Background: Obstruction of the left ventricular outflow tract (LVOT) as seen in hypertrophic cardiomyopathy is a dynamic condition with a wide range of clinical presentations and symptoms.

Case Summary: We report the use of veno-arterial extracorporeal membrane oxygenation in a female patient who was resuscitated after out-of-hospital cardiac arrest. Soon after admission the patient developed critical haemodynamic compromise due to severe obstruction of the left ventricle outflow tract and systolic anterior motion (SAM) of the mitral valve. Veno-arterial extracorporeal membrane oxygenation restored haemodynamics and was weaned after 4 days without any haemodynamic compromise due to SAM. The patient was discharged from the intensive care unit at Day 13, and after 3 days at the coronary care unit, she was discharged to ambulatory follow-up with no sequelae.

Discussion: Veno-arterial extracorporeal membrane oxygenation restored haemodynamic stability in this patient with dynamic severe LVOT obstruction following cardiac arrest.
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http://dx.doi.org/10.1093/ehjcr/yty134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426033PMC
December 2018

Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).

JACC Cardiovasc Interv 2019 04;12(7):624-633

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).

Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.

Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.

Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).

Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).
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http://dx.doi.org/10.1016/j.jcin.2018.12.036DOI Listing
April 2019

Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting.

J Am Coll Cardiol 2018 12;72(22):2732-2743

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: The value of fractional flow reserve (FFR) evaluation of coronary artery stenosis in coronary artery bypass grafting (CABG) is uncertain, and stenosis assessments usually rely on visual estimates of lesion severity.

Objectives: This randomized clinical trial evaluated graft patency and clinical outcome after FFR-guided CABG versus angiography-guided CABG.

Methods: A total of 100 patients referred for CABG were randomly assigned to FFR-guided or angiography-guided CABG. Based on the coronary angiogram, a heart team made a graft plan for all patients, and FFR evaluations were performed. In FFR-guided CABG, coronary lesions with FFR >0.80 were deferred, and a new graft plan was designed accordingly, whereas the surgeon was blinded to the FFR values in patients who underwent angiography-guided CABG. The primary endpoint was graft failure in the percentage of all grafts after 6 months.

Results: Angiographic follow-up at 6 months was available for 72 patients (39 vs. 33 in the FFR-guided and angiography-guided groups, respectively). Graft failures of all grafts were similar in both groups (16% vs. 12%; p = 0.97). Rates of death, myocardial infarction, and stroke were also similar in the study groups, and no difference was seen in revascularization before angiographic follow-up. After 6 months, deferred lesions (n = 24) showed a significant reduction in mean FFR from index to follow-up (0.89 ± 0.05 vs. 0.81 ± 0.11; p = 0.002). Index FFR did not influence graft patency.

Conclusions: FFR-guided CABG had similar graft failure rates and clinical outcomes as angiography-guided CABG. However, FFR was reduced significantly after 6 months in deferred lesions. (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization [FARGO]; NCT02477371).
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http://dx.doi.org/10.1016/j.jacc.2018.09.043DOI Listing
December 2018

Impact of diabetes on clinical outcomes after revascularization with sirolimus-eluting and biolimus-eluting stents with biodegradable polymer from the SORT OUT VII trial.

Catheter Cardiovasc Interv 2019 03 23;93(4):567-573. Epub 2018 Sep 23.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) or Nobori biolimus-eluting stent (N-BES; Terumo, Tokyo, Japan) were compared.

Background: Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention.

Methods: In total, 2525 patients were randomized to stent implantation with O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years.

Results: At 2 year, TLF did not differ between O-SES vs N-BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54-1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.76, 95% CI 0.28-2.06) and TLR occurred in 5,5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95).

Conclusion: TLF did not differ between O-SES- and N-BES-treated diabetic patients.
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http://dx.doi.org/10.1002/ccd.27891DOI Listing
March 2019

Prospective Comparison of FFR Derived From Coronary CT Angiography With SPECT Perfusion Imaging in Stable Coronary Artery Disease: The ReASSESS Study.

JACC Cardiovasc Imaging 2018 11 13;11(11):1640-1650. Epub 2018 Jun 13.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: This study sought to compare the per-patient diagnostic performance of coronary computed tomography angiography (CTA)-derived fractional flow reserve (FFR) with that of single-photon emission computed tomography (SPECT), using a fractional flow reserve (FFR) value of ≤0.80 as the reference for diagnosing at least 1 hemodynamically significant stenosis in a head-to-head comparison of patients with intermediate coronary stenosis as determined by coronary CTA.

Background: No previous study has prospectively compared the diagnostic performance of FFR and myocardial perfusion imaging by SPECT in symptomatic patients with intermediate range coronary artery disease (CAD).

Methods: This study was conducted at a single-center as a prospective study in patients with stable angina pectoris (N = 143). FFR and SPECT analyses were performed by core laboratories and were blinded for the personnel responsible for downstream patient management. FFR ≤0.80 distally in at least 1 coronary artery with a diameter ≥2 mm classified patients as having ischemia. Ischemia by SPECT was encountered if a reversible perfusion defect (summed difference score ≥2) or transitory ischemic dilation of the left ventricle (ratio >1.19) were found.

Results: The per-patient diagnostic performance for identifying ischemia (95% confidence interval [CI]), FFR versus SPECT, were sensitivity of 91% (95% CI: 81% to 97%) versus 41% (95% CI: 29% to 55%; p < 0.001); specificity of 55% (95% CI: 44% to 66%) versus 86% (95% CI: 77% to 93%; p < 0.001); negative predictive value of 90% (95% CI: 82% to 98%) versus 68% (95% CI: 59% to 77%; p = 0.001); positive predictive value of 58% (95% CI: 48% to 68%) versus 67% (95% CI: 51% to 82%; p = NS); and accuracy of 70% (95% CI: 62% to 77%) versus 68% (95% CI: 60% to 75%; p = NS) respectively.

Conclusions: In patients with stable chest pain and CAD as determined by coronary CTA, the overall diagnostic accuracy levels of FFR and SPECT were identical in assessing hemodynamically significant stenosis. However, FFR demonstrated a significantly higher diagnostic sensitivity than SPECT.
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http://dx.doi.org/10.1016/j.jcmg.2018.05.004DOI Listing
November 2018

One-year rehospitalisation after percutaneous coronary intervention: a retrospective analysis.

EuroIntervention 2018 Oct;14(8):926-934

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: The aim of the study was to evaluate the incidence and causes of rehospitalisation within one year after percutaneous coronary intervention (PCI) in a country where the National Health Service provides universal tax-supported healthcare, guaranteeing residents free hospital access.

Methods And Results: Between January 2010 and September 2014, 17,111 patients were treated with PCI in two University Hospitals in Western Denmark. Patients who were readmitted within one year after PCI were identified. The overall one-year readmission rate was 50.4%. The cause was angina/myocardial infarction (MI) in 4,282 patients (49.7%), and other reasons in 4,334 (50.3%). Predictors of angina/MI-related readmissions were female gender (odds ratio [OR] 1.15, 95% confidence interval [CI]: 1.07-1.25), diabetes (OR 1.14, 95% CI: 1.04-1.26), age (per 10-year increase) (OR 0.86, 95% CI: 0.83-0.88), and indication for index PCI (stable angina pectoris as reference): ST-segment elevation myocardial infarction (OR 1.34, 95% CI: 1.23-1.47) and non-ST-segment elevation myocardial infarction (OR 1.18, 95% CI: 1.08-1.29). Predictors for other readmissions were female gender (OR 1.09, 95% CI: 1.01-1.18), diabetes (OR 1.29, 95% CI: 1.18-1.42), age (OR 1.30, 95% CI: 1.26-1.34) and Charlson comorbidity index ≥3 (OR 3.03, 95% CI: 2.71-3.27).

Conclusions: In an unselected patient cohort treated with PCI, half of the patients were rehospitalised within one year, highlighting the impact of comorbidity in patients with ischaemic heart disease.
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http://dx.doi.org/10.4244/EIJ-D-17-00800DOI Listing
October 2018

Single-centre experience with the Impella CP, 5.0 and RP in 109 consecutive patients with profound cardiogenic shock.

Eur Heart J Acute Cardiovasc Care 2018 Feb 17;7(1):53-61. Epub 2017 Nov 17.

1 Department of Cardiology, Cardio-Thoracic surgery and Anesthesiology, Odense University Hospital, Denmark.

Rationale: Short-term mechanical circulatory support is increasingly used in the management of cardiogenic shock, but data from controlled studies are sparse. Thus, real-life data on complication rates and predictors of adverse outcome are important.

Objective: The objective of this study was to analyse the experience with Impella devices in the management of profound cardiogenic shock.

Methods And Results: A retrospective study of 109 consecutive patients with severe shock after myocardial infarction, acute heart failure, or cardiac surgery. Possible device-related complications were registered and predictors of death while on Impella support and within 180 days were identified. In 79 patients (72%) cardiogenic shock was caused by myocardial infarction, acute heart failure in 16 (15%) and post-cardiotomy shock in 14 patients (13%). Thirty-five patients (32%) were comatose after cardiac arrest and in seven, the Impella was placed during chest compression. Mean age was 62±12 years, mean arterial pressure was 57±13 mmHg, pH 7.19±0.17 and lactate 7.5±5.7 mmol/l (range 1.8-30.0 mmol/l) at placement. During Impella therapy, 26 patients (28%) died among patients with myocardial infarction or acute heart failure. Of data available prior to placement lactate (hazard ratio 1.14, 95% confidence interval 1.04-1.25, P=0.004) was the only predictor of death on support. During support, five patients (5%) developed leg ischaemia requiring intervention. Bleeding from the Impella insertion site was seen in 14 patients (13%).

Conclusion: Impella treatment is feasible in profound cardiogenic shock at an acceptable rate of complications. Despite an aggressive approach to restore cardiac output, mortality was high. Besides the severity of lactic acidosis there were no strong predictors of early death.
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http://dx.doi.org/10.1177/2048872617743194DOI Listing
February 2018

Very low pacemaker rate following ACURATE neo transcatheter heart valve implantation.

EuroIntervention 2017 Dec;13(11):1273-1280

Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.

Aims: The aim of this study was to investigate whether minimising trauma to the aortic annulus and left ventricular outflow tract reduces the occurrence of new conduction disorders and the need for permanent pacemakers.

Methods And Results: A total of 175 patients (58% female, mean age 83±6 years) underwent transfemoral TAVI with the Boston Scientific ACURATE neo at three centres in Europe. Prosthesis size selection was based on perimeter-derived annular diameter. Predilatation was performed in all with a balloon 1.9±0.9 mm smaller than the perimeter-derived annular diameter. Post-dilatation was performed in 46 (26.3%) with a balloon 1.2±0.9 mm smaller than the perimeter-derived annular diameter. Eighteen patients (10.3%) developed a new left bundle branch block, 13 (7%) a new first-degree AV block, and four (2.3%) received a new permanent pacemaker. Paravalvular regurgitation was none/trace in 66 (37.7%), mild in 101 (57.7%) and moderate in eight (4.6%). At 30 days, the rate of any stroke was 1.7% (3/175), and one patient (0.6%) had died.

Conclusions: With careful selection of the balloon and the ACURATE neo prosthesis size, very low rates of new conduction disorders and permanent pacemaker implantation may be achieved without increasing the amount of paravalvular regurgitation.
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http://dx.doi.org/10.4244/EIJ-D-17-00252DOI Listing
December 2017

Lipid-core burden response to stent implantation assessed with near-infrared spectroscopy and intravascular ultrasound evaluation in patients with myocardial infarction.

Cardiovasc Revasc Med 2017 Apr - May;18(3):182-189. Epub 2016 Dec 27.

Department of Cardiology, Odense University Hospital, Denmark. Electronic address:

Introduction: Near-infrared spectroscopy (NIRS) is a new method to identify lipid core plaque (LCP). The LCP and vascular response were assessed with NIRS to examine whether LCP was compressed or redistributed during percutaneous coronary intervention with stent implantation.

Methods: In 25 patients with non-ST segment elevation myocardial infarction (NSTEMI) NIRS acquisition was performed after predilation, stent implantation with nominal pressure and high-pressure post-dilation with a non-compliant balloon. The intravascular ultrasound (IVUS) measures included volumes of external elastic membrane (EEM), lumen and plaque+media. The NIRS measures included lipid core burden index (LCBI) and maximum value of LCBI for any of the 4-mm segment (maxLCBI).

Results: From predilation to stent implantation and post-dilation EEM volume increased from 337±124mm to 369±136mm and to 397±144mm (p<0.001), while plaque volume decreased from 225±84mm to 202±85mm and to 192±81mm (p<0.001). Plaque shift to the proximal reference segment was found in 40% of the lesions. The maxLCBI decreased significantly from predilation to stent implantation (492±235 to 208±193 (p<0.001), whereas post dilation did not cause any further significant reduction. Also LCBI decreased significantly from predilation to stent implantation (173±103 to 68±67, p<0.001), without any further significant reduction during post-dilation. The LCBI did neither in the proximal nor in the distal reference segments change significantly during stent implantation or post-dilation.

Conclusion: Lumen enlargement was caused by vessel expansion, plaque compression and longitudinally plaque redistribution. Lipid-core burden at the stented segment was decreased.
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http://dx.doi.org/10.1016/j.carrev.2016.12.018DOI Listing
December 2017

Optical coherence tomography assessment of incidence, morphological characteristics, and spontaneous healing course of edge dissections following percutaneous coronary intervention with stent implantation in patients with non-ST segment elevation myocardial infarction.

Int J Cardiol 2016 Nov 14;223:466-474. Epub 2016 Aug 14.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Stenting-induced edge dissections (ED) can be assessed in detail by optical coherence tomography (OCT). This study sought to investigate the incidence, morphological characteristics, and spontaneous healing course of OCT-identified EDs following drug-eluting stent (DES) implantation in a non-ST segment elevation myocardial infarction (NSTEMI) patient-population.

Methods: Acute vessel wall injury at the 5-mm stent adjacent distal and proximal reference segments was assessed by post-procedure OCT and intravascular ultrasound (IVUS) in n=97 NSTEMI-patients (n=97 lesions). Six months OCT follow-up was available in 82 patients (including 35 untreated post-procedure EDs).

Results: The overall incidence of post-procedure OCT-detected ED was 38 per 97 patients (39.2%), and 47 per 182 stent edges (25.8%). None of the EDs were angiographically visualizable, while 10 (21.3%) were visible on concomitant IVUS-analysis. Morphologically, there was a significant difference in plaque type present at ED-edges vs. non-ED-edges when assessed with OCT; (1) lipid-rich and calcified plaques: 80.9% vs. 57.0%, (2) fibrous plaques: 17.0% vs. 26.7%, and (3) normal coronary vessels: 2.1% vs. 16.3%, p<0.01. Plaqueburden, assessed by IVUS, was substantially larger at ED-containing borders: 54.5±10.0% vs. 43.7±11.6%, p=0.01. Three dissections (8.6%) were incompletely healed at 6-month OCT follow-up. None of the EDs caused cardiac events during the 6-month follow-up, however, 1 ED-patient had target lesion revascularization with PCI and DES-implantation in extension of the scheduled OCT-control.

Conclusions: OCT-detected EDs were frequent after stent implantation due to NSTEMI, and the majority of these EDs healed without leading to an adverse prognosis at 6months.
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http://dx.doi.org/10.1016/j.ijcard.2016.08.245DOI Listing
November 2016

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.

Circ Cardiovasc Interv 2016 07;9(7)

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.).

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.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003610DOI Listing
July 2016

Intra- and interobserver reliability and intra-catheter reproducibility using frequency domain optical coherence tomography for the evaluation of morphometric stent parameters and qualitative assessment of stent strut coverage.

Cardiovasc Revasc Med 2015 Dec 10;16(8):469-77. Epub 2015 Sep 10.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Purpose: Frequency-domain optical coherence tomography (FD-OCT) is a high-resolution imaging tool (~10-15 μm), which enables near-histological in-vivo images of the coronary vessel wall. The use of the technique is increasing, both for research- and clinical purposes. This study sought to investigate the intra- and interobserver reliability, as well as the intra-catheter reproducibility of quantitative FD-OCT-assessment of morphometric stent parameters and qualitative FD-OCT-evaluation of strut coverage in 10 randomly selected 6-month follow-up Nobori® biolimus-eluting stents (N-BESs).

Methods: Ten N-BESs (213 cross sectional areas (CSAs) and 1897 struts) imaged with OCT 6 months post-implantation were randomly selected and analyzed by 2 experienced analysts, and the same 10 N-BESs were analyzed by one of the analysts 3 months later. Further, 2 consecutive pullbacks randomly performed in another 10 N-BESs (219 CSAs and 1860 struts) were independently assessed by one of the analysts.

Results: The intraobserver variability with regard to relative difference of mean luminal area and mean stent area at the CSA-level was very low: 0.1%±1.4% and 0.5%±3.2%. Interobserver variability also proved to be low: -2.1%±3.3% and 2.1%±4.6%, and moreover, very restricted intra-catheter variation was observed: 0.02%±6.8% and -0.18%±5.2%. The intraobserver-, interobserver- and intra-catheter reliability for the qualitative evaluation of strut coverage was found to be: kappa (κ)=0.91 (95% confidence interval (CI): 0.88-0.93, p<0.01), κ=0.88 (95% CI: 0.85-0.91, p<0.01), and κ=0.73 (95% CI: 0.68-0.78, p<0.01), respectively.

Conclusions: FD-OCT is a reproducible and reliable imaging tool for quantitative evaluation of stented coronary segments, and for qualitative assessment of strut coverage.
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http://dx.doi.org/10.1016/j.carrev.2015.08.010DOI Listing
December 2015

Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Nobori Stent Implantation in Patients With Non-ST-Segment-Elevation Myocardial Infarction (OCTACS) Trial: Difference in Strut Coverage and Dynamic Malapposition Patterns at 6 Months.

Circ Cardiovasc Interv 2015 Aug;8(8):e002446

From the Department of Cardiology, Odense University Hospital, Odense, Denmark (L.A., P.T., H.S.H., A.J., K.T.V., K.N.H., M.H., L.O.J.); and Departments of Cardiology, Columbia University Medical Center and Cardiovascular Research Foundation, New York, NY (A.M., G.S.M.).

Background: Incomplete strut coverage has been documented an important histopathologic morphometric predictor for later thrombotic events. This study sought to investigate whether optical coherence tomography (OCT)-guided percutaneous coronary intervention with Nobori biolimus-eluting stent implantation in patients with non-ST-segment-elevation myocardial infarction would provide improved strut coverage at 6 months in comparison with angiographic guidance only.

Methods And Results: One hundred patients were randomized 1:1 to either OCT-guided or angio-guided Nobori biolimus-eluting stent implantation. Postprocedure OCT was performed in all patients. In the OCT-guided group, prespecified criteria indicating additional intervention were related to (1) stent underexpansion, (2) strut malapposition, (3) edge dissection(s), and (4) residual stenosis at the distal or proximal reference segment(s). A final OCT was performed in case of reintervention. Six-month OCT follow-up was available in 85 patients. Twenty-three (46%) OCT-guided patients had additional postdilation or stenting. The percentage of acutely malapposed struts was substantially lower in the OCT-guided group (3.4% [interquartile range, 0.3-7.6] versus 7.8% [interquartile range, 2.3-19.4]; P<0.01). At 6-month follow-up, the OCT-guided group had a significantly lower proportion of uncovered struts; 4.3% [interquartile range, 1.2-9.8] versus 9.0% [interquartile range, 5.5-14.5], P<0.01. Furthermore, OCT-guided patients had significantly more completely covered stents: 17.5% versus 2.2%, P=0.02. The percentages of malapposed struts and struts being both uncovered and malapposed at follow-up were comparable between groups.

Conclusions: OCT-guided optimization of Nobori biolimus-eluting stent implantation improves strut coverage at 6-month follow-up in comparison with angiographic guidance alone.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02272283.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.002446DOI Listing
August 2015

Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial.

Lancet 2015 Apr 16;385(9977):1527-35. Epub 2015 Jan 16.

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.

Background: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent.

Methods: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448.

Findings: Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months.

Interpretation: The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients.

Funding: Medtronic Cardiovascular and Biosensors Interventional Technologies.
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http://dx.doi.org/10.1016/S0140-6736(14)61794-3DOI Listing
April 2015

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

Int J Cardiol 2015 Mar 27;182:272-8. Epub 2014 Dec 27.

Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ijcard.2014.12.088DOI Listing
March 2015

[A combination of cardiac arrest and cerebral haemorrhage treated with extracorporeal membrane oxygenation].

Ugeskr Laeger 2014 Dec;176(25A)

Kardiologisk Afdeling, Aarhus Universitetshospital, Skejby, Brendstrupgårdsvej 100, 8200 Aarhus N.

A 46-year-old, healthy woman with sudden hemiplegia and nausea suffered cardiac arrest during transport to the hospital. This was treated en route with LUCAS-2. A computed tomography ruled out cerebral haemorrhage, and an electricardiogramme showed inferior myocardial infarction. During percutaneous intervention the patient had another cardiac arrest. Despite revascularization she was very unstable and received more than 20 cardioversions of ventricular fibrillation. In the catheterization laboratory, the patient was connected to a heart lung machine (extracorporeal membrane oxygenation) while treated with LUCAS-2. After two months of hospitalization, the patient was able to walk and had minor cognitive impairment.
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December 2014

Nitroglycerine induced acute myocardial infarction in a patient with myocardial bridging.

Case Rep Cardiol 2014 4;2014:289879. Epub 2014 Mar 4.

Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgårdsvej 100, 8200 Aarhus N, Denmark.

Muscle overlying an intramyocardial segment of a coronary artery is termed a myocardial bridge. The intramyocardial segment, the tunneled artery, is compressed during systole. The condition is generally benign but may occasionally cause myocardial ischemia, infarction, arrhythmia, or sudden cardiac death. We present a case regarding a 52-year-old man with exercise-induced angina who was diagnosed with a myocardial bridge overlying the left anterior descending artery. He was initially treated with beta-blockers and later received coronary bypass graft surgery.
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http://dx.doi.org/10.1155/2014/289879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4006562PMC
May 2014

Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial.

Circ Cardiovasc Interv 2014 Apr 8;7(2):216-24. Epub 2014 Apr 8.

From the Department of Cardiology, Odense University Hospital, Odense, Denmark (P.T., K.N.H., H.S.H., A.J., K.T.V., L.O.J.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.F.L., E.H.C., L.T.); and Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark (S.E.J., J.R.).

Background: Contrast-induced nephropathy (CIN) is a serious condition in patients with ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. We compared the risk of acute CIN and the influence of preventive strategies in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Methods And Results: A total of 720 patients were randomized in the Prevention of Contrast-induced Nephropathy in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (CINSTEMI) trial. Patients were randomly assigned in a 1:1:1:1 ratio to receive hydration with sodium chloride together with 1 of 4 prophylactic regimes (1) N-acetylcysteine (NAC), (2) sodium bicarbonate (NaHCO3) infusion, (3) NAC in combination with NaHCO3, or (4) hydration with sodium chloride infusion alone. Patients in cardiogenic shock were excluded. Acute CIN was defined as an increase in serum creatinine concentration >25% from the baseline value within a 3-day period. Overall, CIN occurred in 141 (21.9%) patients. The prevention treatment with NAC, NaHCO3, or the combined NAC and NaHCO3 did not reduce the rate of CIN significantly compared with hydration with intravenous sodium chloride infusion alone (20.1% versus 20.1% versus 20.8% versus 26.5%; P=NS). However, an increase in serum creatinine >25% from the baseline value to 30 day was significantly lower in patients treated with combined NAC and NaHCO3 (18.7% versus 19.1% versus 9.2% versus 21.3%; P=0.033).

Conclusions: Treatment with NAC or NaHCO3 did not reduce the rate of acute CIN significantly. Combined treatment with NAC and NaHCO3 may reduce the risk of renal dysfunction after 30 days.

Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01160627.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.113.000653DOI Listing
April 2014

[Successful conservative therapy of chylopericardium after coronary artery by-pass grafting].

Ugeskr Laeger 2012 Jun;174(25):1743-4

Hjertemedicinsk Afdeling, Sygehus Lillebælt, Vejle Sygehus, 7100 Vejle, Denmark.

Chylopericardium after thoracic duct injury is a rare but serious complication of thoracic surgery with mortality rates above 50% without intervention. Complications of chylopericardium are malnutrition, immunosuppression, electrolyte derangement and tamponade. This case describes a 67-year-old male who developed chylopericardium after coronary artery by-pass grafting and was successfully treated with conservative therapy consisting of pericardiocentesis and a low fat diet. If conservative therapy fails, thoracic surgery is almost always effective.
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June 2012

[Percutaneous mitral plasty in Denmark].

Ugeskr Laeger 2011 Mar;173(10):720

Hjertemedicinsk Klinik B, Rigshospitalet, 2100 København Ø, Denmark.

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March 2011

[Natriuretic peptides as cardiac markers in clinical practice].

Ugeskr Laeger 2010 Jul;172(30):2111-6

Kardiologisk Afdeling, Vejle Sygehus, 7100 Vejle.

Cardiac natriuretic peptides, BNP and NT-proBNP can be used to screen for left ventricular systolic dysfunction in patients with symptoms suggestive of heart failure. Using the cut-off values recommended in the article, the sensitivity and negative predictive values are high in patients aged < 75 years, but have lower sensitivity at older age. In addition, natriuretic peptides are prognostic markers for mortality and cardiovascular hospitalization. BNP/NT-proBNP measurement may also be of value in follow-up on heart failure patients.
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July 2010

[Antiplatelet treatment after acute and chronic ischemic heart and brain events is insufficient according to recommendations].

Ugeskr Laeger 2008 Mar;170(14):1147-51

Vejle Sygehus, Medicinsk og Klinisk Biokemisk Afdeling, Vejle.

Introduction: Antiplatelet therapy is important in secondary prophylaxis in patients with ischemic heart, brain and vascular diseases. The aim of this study was to investigate the number of patients in Vejle County admitted to hospital in the second half of 2003 with acute and chronic heart, brain and vascular diseases to evaluate the kind of secondary prophylaxis and its duration. Moreover, the study registered the number of patients with diabetes mellitus treated with antiplatelet therapy.

Materials And Methods: The study included 2345 patients with ischemic heart, brain and vascular diseases, and patients with diabetes mellitus. Patients' data and information about medication were obtained from the hospital electronic database and public health insurance of Vejle County. Antiplatelet therapy was registered up to one year after onset of the disease.

Results: 1121 patients were admitted with cardiac diseases (including patients with angina pectoris), 624 patients had cerebral diseases, and 600 had diabetes mellitus. Acetylsalicylic acid (ASA) and a combination of ASA and clopidogrel were the most frequent forms of antiplatelet medication. Patients with diabetes and ischemic brain diseases made up 75% of those for whom medication was not registered.

Conclusion: The study shows that in nearly all disease groups no antiplatelet therapy was registered for a very large number of % patients (up to 75%). A considerable number % of patients (up to 56%) with ischemic heart disease did not receive sufficient antiplatelet treatment according to Danish recommendations.
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March 2008