Publications by authors named "Henrik Steen Hansen"

60 Publications

Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction: Rationale, Design, and Methodology of the HONEST Study.

Cardiology 2021 Feb 1:1-11. Epub 2021 Feb 1.

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

Background: Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland).

Methods: We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure.

Results: The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated.

Conclusion: The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.
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http://dx.doi.org/10.1159/000512417DOI Listing
February 2021

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

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Coron Artery Dis 2020 09;31(6):485-492

Department of Cardiology, Odense University Hospital, Odense.

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.

Methods: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.

Results: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.

Conclusion: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.
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http://dx.doi.org/10.1097/MCA.0000000000000875DOI Listing
September 2020

Gender but not diabetes, hypertension or smoking affects infarct evolution in ST-elevation myocardial infarction patients - data from the CHILL-MI, MITOCARE and SOCCER trials.

BMC Cardiovasc Disord 2019 07 3;19(1):161. Epub 2019 Jul 3.

Department of Clinical Physiology, Clinical Sciences, Lund University, Lund, Sweden.

Background: Infarct evolution rate and response to acute reperfusion therapy may differ between patients, which is important to consider for accurate management and treatment of patients with ST-elevation myocardial infarction (STEMI). The aim of this study was therefore to investigate the association of infarct size and myocardial salvage with gender, smoking status, presence of diabetes or history of hypertension in a cohort of STEMI-patients.

Methods: Patients (n = 301) with first-time STEMI from the three recent multi-center trials (CHILL-MI, MITOCARE and SOCCER) underwent cardiac magnetic resonance (CMR) imaging to determine myocardium at risk (MaR) and infarct size (IS). Myocardial salvage index (MSI) was calculated as MSI = 1-IS/MaR. Pain to balloon time, culprit vessel, trial treatments, age, TIMI grade flow and collateral flow by Rentrop grading were included as explanatory variables in the statistical model.

Results: Women (n = 66) had significantly smaller MaR (mean difference: 5.0 ± 1.5% of left ventricle (LV), p < 0.01), smaller IS (mean difference: 5.1 ± 1.4% of LV, p = 0.03), and larger MSI (mean difference: 9.6 ± 2.8% of LV, p < 0.01) compared to men (n = 238). These differences remained significant when adjusting for other explanatory variables. There were no significant effects on MaR, IS or MSI for diabetes, hypertension or smoking.

Conclusions: Female gender is associated with higher myocardial salvage and smaller infarct size suggesting a pathophysiological difference in infarct evolution between men and women.
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http://dx.doi.org/10.1186/s12872-019-1139-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6610840PMC
July 2019

Overlap between angina without obstructive coronary artery disease and left ventricular diastolic dysfunction with preserved ejection fraction.

PLoS One 2019 23;14(5):e0216240. Epub 2019 May 23.

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

Background: A link between angina with no obstructive coronary artery disease (CAD) and heart failure with preserved left ventricular ejection fraction has been proposed, but evidence in support of this is lacking. In a cross-sectional study, we investigated whether left ventricular diastolic function in women with angina pectoris and no obstructive CAD differed from a reference population.

Methods: We included 956 women with angina and <50% coronary artery stenosis at invasive coronary angiography. Women with cardiovascular risk factors, but no history of chest pain or cardiac disease served as controls (n = 214). Left ventricular diastolic function was assessed by transthoracic echocardiography.

Results: The women with angina were slightly older, had higher body mass index, higher heart rate, and more had diabetes compared with controls while systolic blood pressure was lower. In age-adjusted analyses, angina patients had significantly lower E/A (Estimated difference -0.13, 95% CI: -0.17; -0.08), higher left ventricular mass index (5.73 g/m2, 95% CI: 3.71; 7.75), left atrial volume index (2.34 ml/m2, 95% CI: 1.23; 3.45) and E/e' (0.68, 95% CI: 0.30; 1.05) and a larger proportion had higher estimated left ventricular filling pressure (17% versus 6%, p = 0.001). No between group differences were seen for e' or deceleration time. After adjustment for known cardiovascular risk factors, between group differences for echocardiographic parameters remained statistically significant.

Conclusions: Patients with angina and no obstructive CAD had a more impaired left ventricular diastolic function compared with an asymptomatic reference population. This suggests some common pathophysiological pathway between the two syndromes.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0216240PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6532855PMC
January 2020

Influence of Ezetimibe on Plaque Morphology in Patients with ST Elevation Myocardial Infarction Assessed by Optical Coherence Tomography: An OCTIVUS Sub-Study.

Cardiovasc Revasc Med 2020 Nov 24;21(11):1417-1424. Epub 2019 Apr 24.

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

Aims: The aim of the trial was to examine the influence of ezetimibe on plaque morphology in patients with ST-segment Elevation Myocardial Infarction (STEMI) with respect to fibrous cap thickness (FCT) and arcs of lipid plaque, calcific plaque, and macrophages using Optical Coherence Tomography (OCT).

Methods And Results: In 87 statin naïve patients with STEMI treated with primary percutaneous intervention, a non-culprit study plaque in a non-infarct related coronary artery was assessed with OCT at baseline and after 12 months. Patients were treated with atorvastatin 80 mg and randomized (1:1) to ezetimibe 10 mg (n = 43) or placebo (n = 44). An increase in median FCT (ezetimibe 200 (140-260) μm to 240 (190-305) μm (p = 0.002) vs. placebo 205 (135-260) μm to 230 (180-270) μm (p < 0.001), between groups p = ns), a reduction in lipid arc (ezetimibe 1728.5 (1022.5-3904.7)° to 1164.5 (736.6-2580.1)° (p = 0.001) vs. placebo 1671.6 (978.3-2868.7)° to 1373.7 (791.2-2267.3)° (p = 0.019), between groups p = ns), and macrophage arc (ezetimibe 1730.3 (965.7-2984.4)° to 1324.8 (819.0-2819.7)° (p < 0.05) vs. placebo 1570.5 (794.7-3016.8)° to 1418.9 (584.1-2501.1)° (p < 0.01), between groups p = ns) were observed.

Conclusion: Aggressive LDL-lowering resulted in changes in OCT assessed plaque composition by increased FCT thickness and a reduction in lipid content and macrophage infiltration. Addition of ezetimibe 10 mg to atorvastatin 80 mg resulted in further LDL reduction, but no additional change in plaque composition was found.
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http://dx.doi.org/10.1016/j.carrev.2019.04.021DOI Listing
November 2020

Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial.

Am Heart J 2019 07 14;213:1-7. Epub 2019 Mar 14.

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

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

Methods: The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.

Results: A total of 3,150 patients have been randomized and enrolled in the study.

Conclusions: The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent.
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http://dx.doi.org/10.1016/j.ahj.2019.02.017DOI Listing
July 2019

Coronary microvascular dysfunction is associated with cardiac time intervals in women with angina and no obstructive coronary artery disease: An iPOWER substudy.

Echocardiography 2019 06 22;36(6):1110-1117. Epub 2019 Apr 22.

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

Background: Coronary microvascular dysfunction (CMD) may cause angina in the absence of obstructive coronary artery disease (CAD) and increases the risk of future adverse cardiovascular events. Transthoracic Doppler echocardiography (TTDE) with pharmacological stress can assess coronary flow velocity reserve (CFVR), a measure of coronary microvascular function. However, simpler methods would be preferable for diagnosing CMD. Therefore, we examined the relationship between CFVR and cardiac time intervals measured by TTDE in a cohort of women with angina and no obstructive CAD.

Methods: In a prospective cohort study, we included 389 women with angina, left ventricular ejection fraction > 45%, and no obstructive CAD. CMD was defined as CFVR < 2.0. The study population was divided into three groups according to cutoff values of CFVR < 2, 2 ≤ CFVR ≤ 2.5, and CFVR > 2.5. Isovolumic contraction time (IVCT), ejection time (ET), and isovolumic relaxation time (IVRT) were measured by tissue Doppler M-mode, and the myocardial performance index (MPI = (IVCT + IVRT)/ET) was calculated.

Results: Coronary microvascular dysfunction was associated with increasing age, hypertension, higher resting heart rate, and lower diastolic blood pressure. Moreover, CMD was associated with higher E/e' ratio (P = 0.002) and longer IVCT (P < 0.001), higher MPI (P < 0.001) and shorter ET (P = 0.002), but not with IVRT or conventional measures of left ventricular geometry, mass, and function. In multivariable analysis, longer IVCT (P < 0.001) and higher MPI (P = 0.002) remained associated with CMD.

Conclusion: In women with angina and no obstructive CAD, CMD is associated with longer IVCT and higher MPI indicating a link between CMD and subtle alternations of systolic and combined measures of cardiac time intervals.
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http://dx.doi.org/10.1111/echo.14356DOI Listing
June 2019

Myocardial first pass perfusion assessed by cardiac magnetic resonance and coronary microvascular dysfunction in women with angina and no obstructive coronary artery disease.

Scand J Clin Lab Invest 2019 Jul 20;79(4):238-246. Epub 2019 Mar 20.

b Department of Cardiology , Rigshospitalet, University of Copenhagen , Copenhagen , Denmark.

Coronary microvascular dysfunction (CMD) is associated with a poor prognosis even in absence of obstructive coronary artery disease. CMD can be assessed as a myocardial blood flow reserve by positron emission tomography (PETMBFR) and as coronary flow velocity reserve by transthoracic Doppler echocardiography (TTDECFVR). Impaired first-pass perfusion assessed by cardiac magnetic resonance (CMR) is an early sign of ischemia. We aimed to investigate the association between CMD and CMR first-pass perfusion. Women (n = 66) with angina pectoris and an invasive coronary angiogram (<50% stenosis) were assessed by TTDECFVR and in a subgroup of these (n = 54) also by PETMBFR. Semi-quantitative evaluation of first-pass perfusion at rest and adenosine stress was assessed by gadolinium CMR in all 66 women. Four measures of CMR perfusion reserve were calculated using contrast upslope, maximal signal intensity and both indexed to arterial input. Mean (standard deviation) age was 62 (8) years. Median (interquartile range) TTDECFVR was 2.3 (1.8;2.7) and PETMBFR was 2.7 (2.2;3.1). Using a cut-off of 2.0 for TTDECFVR and 2.5 for PETMBFR, 25 (38%) and 21 (39%) had CMD, respectively. CMR myocardial perfusion reserve from contrast upslope (CMR_MPRupslope) showed moderate but significant correlation with PETMBFR (R = .46, p < .001) while none of the other CMR variables were associated with CMD. A CMR_MPRupslope cut-off of 0.78 identified CMD, area under the curve 0.73 (p = .001). The results indicate that CMR_MPRupslope may be associated to PETMBFR; a measure of CMD. Further research is needed to validate and implement the use of CMR first pass perfusion in this population.
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http://dx.doi.org/10.1080/00365513.2019.1587670DOI Listing
July 2019

Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X trial.

Am Heart J 2018 08 5;202:49-53. Epub 2018 May 5.

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

Background: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention.

Methods: The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection will be derived from validated Danish registries. An event rate of 4.2% is assumed in each stent group. With a sample size of 1,570 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the Combo stent compared with the Orsiro stent with a predetermined noninferiority margin of 2.1%.

Conclusion: The SORT OUT X trial will determine whether the dual-therapy Combo stent is noninferior to the Orsiro stent with respect to clinically driven events (ClinicalTrials.govNCT03216733).
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http://dx.doi.org/10.1016/j.ahj.2018.04.019DOI Listing
August 2018

Longitudinal left ventricular function is globally depressed within a week of STEMI.

Clin Physiol Funct Imaging 2018 Apr 27. Epub 2018 Apr 27.

Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden.

Sixty percent of stroke volume (SV) is generated by atrioventricular plane displacement (AVPD) in a healthy left ventricle (LV). The aims were to determine the effect of ST-elevation myocardial infarction (STEMI) on AVPD and contribution of AVPD to SV and to study the relationship between AVPD and infarct size (IS) and location. Patients from CHILL-MI and MITOCARE studies with cardiovascular magnetic resonance within a week of STEMI (n = 177, 59 ± 11 years) and healthy controls (n = 20, 62 ± 11 years) were included. Left ventricular volumes were quantified in short-axis images. AVPD was measured in six locations in long-axis images. Longitudinal contribution to SV was calculated as AVPD multiplied by the short-axis epicardial area. Patients (IS 17 ± 10% of LV) had decreased ejection fraction (48 ± 8%) compared to controls (60 ± 5%, P<0·001). Global AVPD was decreased in patients (11 ± 2 mm versus 15 ± 2 mm in controls, P<0·001) and this held true for both infarcted and remote segments. AVPD contribution to SV was lower in patients (58 ± 9%) than in controls (64 ± 8%) (P<0·001). There was a weak negative correlation between IS and AVPD (r =0·06) but no differences in global AVPD linked to infarct location. Decrease in global and regional AVPD occur even in remote myocardium within 1 week of STEMI. Global AVPD decrease is independent of MI location, and MI size has only minor effect. Longitudinal pumping is slightly lower compared to controls but remains to be the main component to SV even after STEMI. These results highlight the difficulty in determining infarct location and size from longitudinal measures of LV function.
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http://dx.doi.org/10.1111/cpf.12521DOI Listing
April 2018

Electrocardiographic scores of severity and acuteness of myocardial ischemia predict myocardial salvage in patients with anterior ST-segment elevation myocardial infarction.

J Electrocardiol 2018 Mar - Apr;51(2):195-202. Epub 2017 Nov 13.

Department of Medicine, Division of Cardiology, Nykøbing F Hospital, Nykøbing F, Denmark; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Eppendorf, Germany.

Background: Terminal "QRS distortion" on the electrocardiogram (ECG) (based on Sclarovsky-Birnbaum's Grades of Ischemia Score) is a sign of severe ischemia, associated with adverse cardiovascular outcome in ST-segment elevation myocardial infarction (STEMI). In addition, ECG indices of the acuteness of ischemia (based on Anderson-Wilkins Acuteness Score) indicate myocardial salvage potential. We assessed whether severe ischemia with or without acute ischemia is predictive of infarct size (IS), myocardial salvage index (MSI) and left ventricular ejection fraction (LVEF) in anterior versus inferior infarct locations.

Methods: In STEMI patients, the severity and acuteness scores were obtained from the admission ECG. Based on the ECG patients were assigned with severe or non-severe ischemia and acute or non-acute ischemia. Cardiac magnetic resonance (CMR) was performed 2-6days after primary percutaneous coronary intervention (pPCI). LVEF was measured by echocardiography 30days after pPCI.

Results: ECG analysis of 85 patients with available CMR resulted in 20 (23%) cases with severe and non-acute ischemia, 43 (51%) with non-severe and non-acute ischemia, 17 (20%) with non-severe and acute ischemia, and 5 (6%) patients with severe and acute ischemia. In patients with anterior STEMI (n=35), ECG measures of severity and acuteness of ischemia identified significant and stepwise differences in myocardial damage and function. Patients with severe and non-acute ischemia had the largest IS, smallest MSI and lowest LVEF. In contrast, no difference was observed in patients with inferior STEMI (n=50).

Conclusions: The applicability of ECG indices of severity and acuteness of myocardial ischemia to estimate myocardial damage and salvage potential in STEMI patients treated with pPCI, is confined to anterior myocardial infarction.
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http://dx.doi.org/10.1016/j.jelectrocard.2017.11.002DOI Listing
February 2019

Sex-Related Differences in Vasomotor Function in Patients With Angina and Unobstructed Coronary Arteries.

J Am Coll Cardiol 2017 Nov;70(19):2349-2358

Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany.

Background: Coronary vasomotor dysfunction is an important mechanism for angina in patients with unobstructed coronary arteries.

Objectives: The purpose of this study was to determine sex differences in the prevalence and clinical presentation of vasomotor dysfunction in a European population and to examine sex differences in the dose of acetylcholine leading to a positive acetylcholine provocation test (ACH test).

Methods: Between 2007 and 2014, we included 1,379 consecutive patients with stable angina, unobstructed coronaries and ACH test performed for epicardial vasospasm or coronary microvascular dysfunction (CMD) due to microvascular spasm. The predictive value of sex, risk factors, symptoms, and noninvasive test results was analyzed by means of logistic regression.

Results: The mean patient age was 62 years, and 42% were male. There were 813 patients (59%) with a pathological ACH test, 33% for CMD and 26% for epicardial vasospasm. A pathological test was more common in females (70% vs. 43%; p < 0.001). In a multivariable logistic regression model the sex difference was statistically significant with a female-male odds ratio for CMD and epicardial vasospasm of 4.2 (95% confidence interval: 3.1 to 5.5; p < 0.001) and 2.3 (95% confidence interval: 1.7 to 3.1; p < 0.001), respectively. Effort-related symptoms, but neither risk factors nor noninvasive stress tests, contributed to predicting a pathological test. Female patients were more sensitive to acetylcholine with vasomotor dysfunction occurring at lower ACH doses compared with male patients.

Conclusions: Vasomotor dysfunction is frequent in patients with angina and unobstructed coronaries in a European population. Female patients have a higher prevalence of vasomotor dysfunction (especially CMD) compared with male patients. A pathological ACH test was observed at lower ACH doses in women compared with men.
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http://dx.doi.org/10.1016/j.jacc.2017.09.016DOI Listing
November 2017

Ventricular repolarization alterations in women with angina pectoris and suspected coronary microvascular dysfunction.

J Electrocardiol 2018 Jan - Feb;51(1):15-20. Epub 2017 Aug 17.

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

Objectives: CMD could be the explanation of angina pectoris with no obstructive CAD and may cause ventricular repolarization changes. We compared T-wave morphology and QTc interval in women with angina pectoris with a control group as well as the associations with CMD.

Methods: Women with angina pectoris and no obstructive coronary artery disease (n=138) and age-matched controls were compared in regard to QTc interval and morphology combination score (MCS) based on T-wave asymmetry, flatness and presence of T-wave notch. CMD was assessed as a coronary flow velocity reserve (CFVR) by transthoracic echocardiography.

Results: Women with angina pectoris had significantly longer QTc intervals (429±20ms) and increased MCS (IQR) (0.73 [0.64-0.80]) compared with the controls (419±20ms) and (0.63 [(0.53-0.73]), respectively (both p<0.001). CFVR was associated with longer QTc interval (p=0.02), but the association was attenuated after multivariable adjustment (p=0.08).

Conclusion: This study suggests that women with angina pectoris have alterations in T-wave morphology as well as longer QTc interval compared with a reference population. CMD might be an explanation.
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http://dx.doi.org/10.1016/j.jelectrocard.2017.08.017DOI Listing
February 2019

Uncovered Culprit Plaque Ruptures in Patients With ST-Segment Elevation Myocardial Infarction Assessed by Optical Coherence Tomography and Intravascular Ultrasound With iMap.

JACC Cardiovasc Imaging 2018 06 19;11(6):859-867. Epub 2017 Jul 19.

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

Objectives: This study assessed the incidence and course of healing of uncovered plaque ruptures (PR) following primary percutaneous coronary intervention.

Background: The infarct-related occlusion is frequently located at the lesion site with maximum thrombus burden, whereas the culprit PR may be situated more proximally or distally.

Methods: Uncovered PR in segments adjacent to the stent were identified by optical coherence tomography and intravascular ultrasound using iMap (Boston Scientific, Marlborough, Massachusetts) within 48 h and after 12 months. The percentages of necrotic core, fibrotic tissue, lipid tissue, and calcific tissue were determined.

Results: Eleven uncovered PR were found in 10 of 77 patients (13.0%). Eight of these ruptures (10.4%) were identified as culprit and were located proximal to the stent. Two patients were treated before follow-up due to recurrent symptoms. After 12 months, 3 PR had healed incompletely without causing symptoms. The lumen area at the PR site was reduced (7.5 mm [interquartile range (IQR): 4.8 to 9.3 mm] to 3.6 mm [IQR: 2.8 to 8.0 mm]; p = 0.012). Proximal segments with uncovered PR had greater plaque volumes (62.1 mm [IQR: 50.2 to 83.6 mm] vs. 38.7 mm [IQR: 29.6 to 47.6 mm], respectively; p < 0.001), vessel volumes (110.7 mm [IQR: 92.3 to 128.1 mm] vs. 76.0 mm [IQR: 63.8 to 100.3 mm], respectively; p < 0.001), and greater percentages of necrotic core (34.0% [IQR: 29.0% to 44.5%] vs. 20.5% (IQR: 10.0% to 29.0%]; p < 0.001). Conversely, percentages of fibrotic tissue were lower (44.0% [IQR: 32.0% to 47.0%] vs. 56.0% [IQR: 46.0% to 66.0%]; p = 0.001), whereas no differences were found for lipid tissue and calcific tissue.

Conclusions: Uncovered culprit ruptures detected by optical coherence tomography were common following primary percutaneous coronary intervention and were found to be associated with significant lumen reduction during the healing process.
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http://dx.doi.org/10.1016/j.jcmg.2017.03.019DOI Listing
June 2018

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

Influence of ezetimibe in addition to high-dose atorvastatin therapy on plaque composition in patients with ST-segment elevation myocardial infarction assessed by serial: Intravascular ultrasound with iMap: the OCTIVUS trial.

Cardiovasc Revasc Med 2017 Mar 28;18(2):110-117. Epub 2016 Nov 28.

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

Background: The aim of this study was to examine the influence of ezetimibe in addition to atorvastatin on plaque composition in patients with first-time ST-segment Elevation Myocardial Infarction treated with primary percutaneous intervention.

Methods: Eighty-seven patients were randomized (1:1) to ezetimibe 10mg or placebo in addition to Atorvastatin 80mg. Intravascular ultrasound with iMap was performed at baseline and after 12months in a non-infarct-related artery. Primary endpoint was change in necrotic core (NC). Secondary endpoints were total atheroma volume (TAV) and percentage atheroma volume (PAV).

Results: NC did not change significantly: ezetimibe group 24.9 (11.9, 51.3) mm to 24.9 (15.3, 54.5) mm, p=0.76, placebo group 29.4 (16.3, 78.5) mm to 32.0 (16.0, 88.7) mm, p=0.30, (p=0.35 between groups). TAV was reduced in the ezetimibe group only: ezetimibe (200.0 (135.6, 311.9) mm to 189.3 (126.4, 269.1) mm, p<0.001) compared to placebo group (218.4 (163.5, 307.9) mm to 212.2 (149.9, 394.8) mm, p=0.07) (p=0.56 between groups). PAV was reduced in the ezetimibe group only (40.1±8.6% to 39.2±9.0%, p=0.036) compared to placebo group (43.3±9.4% to 42.2±10.7%, p=0.07), p=0.91 between groups.

Conclusions: Ezetimibe in addition to atorvastatin therapy did not influence NC content, but was associated with regression of coronary atherosclerosis.
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http://dx.doi.org/10.1016/j.carrev.2016.11.010DOI Listing
March 2017

Transthoracic Doppler echocardiography compared with positron emission tomography for assessment of coronary microvascular dysfunction: The iPOWER study.

Int J Cardiol 2017 Feb 7;228:435-443. Epub 2016 Nov 7.

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

Background: Coronary microvascular function can be assessed by transthoracic Doppler echocardiography as a coronary flow velocity reserve (TTDE CFVR) and by positron emission tomography as a myocardial blood flow reserve (PET MBFR). PET MBFR is regarded the noninvasive reference standard for measuring coronary microvascular function but has limited availability. We compared TTDE CFVR with PET MBFR in women with angina pectoris and no obstructive coronary artery disease and assessed repeatability of TTDE CFVR.

Methods: From a cohort of women with angina and no obstructive coronary artery stenosis at invasive coronary angiography, TTDE CFVR by dipyridamole induced stress and MBFR by rubidium-82 PET with adenosine was successfully measured in 107 subjects. Repeatability of TTDE CFVR was assessed in 10 symptomatic women and in 10 healthy individuals.

Results: MBFR was systematically higher than CFVR. Median MBFR (interquartile range, IQR) was 2.68 (2.29-3.10) and CFVR (IQR) was 2.31 (1.89-2.72). Pearson's correlation coefficient was 0.36 (p<0.01). Limits of agreement (2·standard deviation) assessed by the Bland-Altman (confidence interval, CI) method was 1.49 (1.29;1.69) and unaffected by time-interval between examinations. Results were similar when adjusting for rate pressure product or focusing on perfusion of the left anterior descending artery region. Limits of agreement (CI) for repeated CFVR in 10 healthy individuals and in 10 women with angina was 0.44 (0.21;0.68) and 0.48 (0.22; 0.74), respectively.

Conclusion: CFVR had a good repeatability, but the agreement between CFVR and MBFR was modest. Divergence could be due to methodology differences; TTDE estimates flow velocities whereas PET estimates myocardial blood flow.
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http://dx.doi.org/10.1016/j.ijcard.2016.11.004DOI Listing
February 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

Coronary Microvascular Function and Cardiovascular Risk Factors in Women With Angina Pectoris and No Obstructive Coronary Artery Disease: The iPOWER Study.

J Am Heart Assoc 2016 Mar 15;5(3):e003064. Epub 2016 Mar 15.

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

Background: The majority of women with angina-like chest pain have no obstructive coronary artery disease when evaluated with coronary angiography. Coronary microvascular dysfunction is a possible explanation and associated with a poor prognosis. This study evaluated the prevalence of coronary microvascular dysfunction and the association with symptoms, cardiovascular risk factors, psychosocial factors, and results from diagnostic stress testing.

Methods And Results: After screening 3568 women, 963 women with angina-like chest pain and a diagnostic coronary angiogram without significant coronary artery stenosis (<50%) were consecutively included. Mean age (SD) was 62.1 (9.7). Assessment included demographic and clinical data, blood samples, questionnaires, and transthoracic echocardiography during rest and high-dose dipyridamole (0.84 mg/kg) with measurement of coronary flow velocity reserve (CFVR) by Doppler examination of the left anterior descending coronary artery. CFVR was successfully measured in 919 (95%) women. Median (IQR) CFVR was 2.33 (1.98-2.76), and 241 (26%) had markedly impaired CFVR (<2). In multivariable regression analysis, predictors of impaired CFVR were age (P<0.01), hypertension (P=0.02), current smoking (P<0.01), elevated heart rate (P<0.01), and low high-density lipoprotein cholesterol (P=0.02), but these variables explained only a little of the CFVR variation (r(2)=0.09). CFVR was not associated with chest pain characteristics or results from diagnostic stress testing.

Conclusion: Impaired CFVR was detected in a substantial proportion, which suggests that coronary microvascular dysfunction plays a role in the development of angina pectoris. CFVR was associated with few cardiovascular risk factors, suggesting that CFVR is an independent parameter in the risk evaluation of these women. Symptom characteristics and results from stress testing did not identify individuals with impaired CFVR.
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http://dx.doi.org/10.1161/JAHA.115.003064DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4943278PMC
March 2016

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

J Am Coll Cardiol 2016 Feb;67(7):751-62

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

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).
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http://dx.doi.org/10.1016/j.jacc.2015.11.051DOI Listing
February 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

Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention: Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome VII trial.

Am Heart J 2015 Aug 22;170(2):210-5. Epub 2015 May 22.

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

Background: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population.

Design: The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%.

Conclusion: The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event.
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http://dx.doi.org/10.1016/j.ahj.2015.05.009DOI Listing
August 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

Structural and Functional Coronary Artery Abnormalities in Patients With Vasospastic Angina Pectoris.

Circ J 2015 18;79(7):1431-8. Epub 2015 Jun 18.

Department of Cardiology, Robert Bosch Krankenhaus.

Coronary spasm is involved in many clinical scenarios, such as stable angina, acute coronary syndrome, sudden cardiac death, non-ischemic cardiomyopathy, arrhythmia and syncope. In recent years, imaging tools such as computerized tomographic angiography, intravascular ultrasound or optical coherence tomography have been applied to study the coronary pathology in patients with vasospastic angina. Patients with vasospastic angina represent a heterogeneous cohort of patients with regard to the extent of concomitant coronary atherosclerosis. They share the common pathophysiological phenomenon of vascular smooth muscle hyperreactivity leading to spasm caused by various factors that may also overlap. Focal coronary spasm is related to epicardial atherosclerosis and in the presence of obstructive coronary artery disease it may be useful to treat the lesion to prevent further spasm. The aim of this article is to review structural and functional coronary artery abnormalities in patients with vasospastic angina.
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http://dx.doi.org/10.1253/circj.CJ-15-0520DOI Listing
April 2016

Very late stent thrombosis caused by neoatherosclerotic plaque rupture.

EuroIntervention 2015 Apr 22;10(12):e1-3. Epub 2015 Apr 22.

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

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http://dx.doi.org/10.4244/EIJV10I12A251DOI Listing
April 2015

Effect of intravenous TRO40303 as an adjunct to primary percutaneous coronary intervention for acute ST-elevation myocardial infarction: MITOCARE study results.

Eur Heart J 2015 Jan 1;36(2):112-9. Epub 2014 Sep 1.

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

Aim: The MITOCARE study evaluated the efficacy and safety of TRO40303 for the reduction of reperfusion injury in patients undergoing revascularization for ST-elevation myocardial infarction (STEMI).

Methods: Patients presenting with STEMI within 6 h of the onset of pain randomly received TRO40303 (n = 83) or placebo (n = 80) via i.v. bolus injection prior to balloon inflation during primary percutaneous coronary intervention in a double-blind manner. The primary endpoint was infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and for troponin I (TnI) over 3 days. Secondary endpoints included measures of infarct size using cardiac magnetic resonance (CMR) and safety outcomes.

Results: The median pain-to-balloon time was 180 min for both groups, and the median (mean) door-to-balloon time was 60 (38) min for all sites. Infarct size, as measured by CK and TnI AUCs at 3 days, was not significantly different between treatment groups. There were no significant differences in the CMR-assessed myocardial salvage index (1-infarct size/myocardium at risk) (mean 52 vs. 58% with placebo, P = 0.1000), mean CMR-assessed infarct size (21.9 g vs. 20.0 g, or 17 vs. 15% of LV-mass) or left ventricular ejection fraction (LVEF) (46 vs. 48%), or in the mean 30-day echocardiographic LVEF (51.5 vs. 52.2%) between TRO40303 and placebo. A greater number of adjudicated safety events occurred in the TRO40303 group for unexplained reasons.

Conclusion: This study in STEMI patients treated with contemporary mechanical revascularization principles did not show any effect of TRO40303 in limiting reperfusion injury of the ischaemic myocardium.
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http://dx.doi.org/10.1093/eurheartj/ehu331DOI Listing
January 2015

[In Process Citation].

Ugeskr Laeger 2014 May;176(11)

Forskning & Sundhedspolitik, Hjerteforeningen, Hauser Plads 10, 1127 København K.

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May 2014