Publications by authors named "Lisbeth Antonsen"

25 Publications

  • Page 1 of 1

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

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

Culprit lesion morphology in patients with ST-segment elevation myocardial infarction assessed by optical coherence tomography.

Coron Artery Dis 2020 12;31(8):671-677

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

Aims: This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT).

Methods And Results: Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7-29.8] vs 11.3% [IQR 6.9-18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8-7.5) vs 8.1% (IQR 5.7-11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0-1.7) vs 2.2% (IQR 0.9-4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0-1) vs 1 (IQR 1-2) and 0 mm (IQR 0-2.7) vs 4.5 mm (IQR 2.3-7.7), P < 0.001].

Conclusions: One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.
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http://dx.doi.org/10.1097/MCA.0000000000000957DOI Listing
December 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

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

Intravascular ultrasound assessment of minimum lumen area and intimal hyperplasia in in-stent restenosis after drug-eluting or bare-metal stent implantation. The Nordic Intravascular Ultrasound Study (NIVUS).

Cardiovasc Revasc Med 2017 Dec 12;18(8):577-582. Epub 2017 May 12.

Heart Center, Tampere University Hospital, Tampere, Finland.

Introduction: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis.

Methods: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled.

Results: At the minimum lumen area site in the stented segment, the stent area (5.8±2.2mm vs. 7.6±2.4mm, p<0.001) and intimal hyperplasia area (2.6±2.0mm vs. 5.0±2.2mm, p<0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0mm (under expansion) was higher in DES (58.7% vs. 37.7%, p=0.008) compared to BMS. Intimal hyperplasia covered 55.4±33.3% of the stent length in the DES compared to 90.7±17.4% in the BMS group, p<0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n=84 (59.9%) vs. BMS n=15 (17.0%), p<0.001).

Conclusion: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia.
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http://dx.doi.org/10.1016/j.carrev.2017.05.010DOI Listing
December 2017

Stent implantation and vascular healing of a spontaneous coronary artery dissection assessed by optical coherence tomography in a patient with acute coronary syndrome.

Cardiovasc Revasc Med 2018 Apr - May;19(3 Pt B):376-379. Epub 2017 Sep 5.

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

A 60-year old woman with non-ST-segment elevation myocardial infarction, underwent coronary angiogram combined with optical coherence tomography (OCT) revealing a long dissection in the right coronary artery. The patient experienced peri-procedural chest pain, the electrocardiogram showed ST-segment elevations, and compromised coronary blood flow, why mechanical revascularization with percutaneous coronary intervention (PCI) was indicated. At 1-month follow-up, OCT revealed early, competent vascular healing, and a distal stenosis was treated with PCI. The patient has been asymptomatic since the procedure for three years.
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http://dx.doi.org/10.1016/j.carrev.2017.08.017DOI Listing
July 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

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

Early restenose in a polymer-free Biolimus A9-coated stent (BioFreedom): A case report based on optical coherence tomography.

Cardiovasc Revasc Med 2017 Apr - May;18(3):207-211. Epub 2016 Sep 6.

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

An 81-year-old male patient with a severe de novo coronary artery stenosis in the proximal left anterior descending artery was treated with a BioFreedom stent (3.5×11mm), three months later, the patient was re-admitted with chest pain and slightly increased troponin. The angiogram showed a significant in-stent restenosis in the recently treated lesion. Optical coherence tomography revealed a fully expanded stent without areas of incomplete stent apposition. Severe immature neointimal hyperplasia without formation of thrombosis was visualized, causing a severe in-stent restenosis. An underlying plaque rupture within the mid-proximal part of the in-stent restenosis was evident.
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http://dx.doi.org/10.1016/j.carrev.2016.08.015DOI 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

Optical coherence tomography plaque characterization in a patient with ST segment elevation myocardial infarction after cocaine intake.

Cardiovasc Revasc Med 2016 Apr-May;17(3):212-5. Epub 2016 Jan 22.

Department of Cardiology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense, Denmark.

A 28-year old man presented to the Emergency Department with malaise after cocaine intake. After arrival he developed retrosternal chest pain and the electrocardiogram showed ST segment elevations in V1-V2 and ST segment depressions in V5-V6. An acute coronary angiogram revealed a focal non-occlusive lesion with thrombus in the left anterior descending artery. Supplementary optical coherence tomography (OCT) detected plaque erosion with adherent thrombus to be the responsible underlying pathophysiological mechanism. The patient received an effective antithrombotic regimen. Repeat angiogram with additional OCT one month later documented thrombus resolution and complete restoration of the previously eroded coronary vascular surface area.
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http://dx.doi.org/10.1016/j.carrev.2016.01.008DOI Listing
February 2017

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

Influence of cardiogenic shock with or without the use of intra-aortic balloon pump on mortality in patients with ST-segment elevation myocardial infarction.

Int J Cardiol Heart Vasc 2015 Mar 30;6:19-24. Epub 2014 Dec 30.

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

Background: Cardiogenic shock is a serious complication of a ST-segment elevation myocardial infarction (STEMI). We compared short- and long-term mortality among (1) STEMI patients with and without cardiogenic shock and (2) STEMI patients with cardiogenic shock with and without the use of an intra-aortic balloon pump (IABP).

Methods: From January 1, 2002 to December 31, 2010, all patients presenting with STEMI and treated with primary percutaneous coronary intervention (PCI) were identified. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounding.

Results: The study cohort consisted of 4293 STEMI patients: 286 (6.7%) with and 4007 (93.3%) without cardiogenic shock. Compared with patients without cardiogenic shock, patients with cardiogenic shock were older, and more likely to have diabetes mellitus, multi-vessel disease, anterior myocardial infarction (MI) or bundle-branch block MI and a reduced creatinine clearance. Among patients with cardiogenic shock vs. without shock, 30-day cumulative mortality was 57.3% vs. 4.5% (p < 0.001), one-year cumulative mortality was 60.7% vs. 8.2% (p < 0.001) and five-year mortality was 65.0% vs. 18.9% (p < 0.001). STEMI with cardiogenic shock was associated with higher 30-day mortality (adjusted HR = 12.89 [95% CI: 9.72-16.66]), 1-year mortality (adjusted HR = 8.83 [95% CI: 7.06-11.05]) and five-year mortality (adjusted HR = 6.39 [95% CI: 5.22-7.80]). IABP was used in 71 (25%) patients with cardiogenic shock and was associated with improved 30-day outcome (adjusted HR = 0.48 [95% CI: 0.28-0.83]).

Conclusion: Patients with STEMI and cardiogenic shock had substantial short- and long-term mortality that may be improved with IABP implantation. More studies on use of IABP in such patients are warranted.
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http://dx.doi.org/10.1016/j.ijcha.2014.12.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5497164PMC
March 2015

Large coronary intramural hematomas: a case series and focused literature review.

Cardiovasc Revasc Med 2015 Mar 31;16(2):116-23. Epub 2014 Oct 31.

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

Isolated spontaneous coronary intramural hematoma is a unique subset of spontaneous coronary artery dissection that is characterized by a hemorrhage limited to the medial-adventitial layers, causing subsequent hematoma formation without visible intimal flaps. It is an infrequent and serious coronary vessel wall pathology, with poorly understood underlying pathogenic mechanisms. Affected individuals may present with a broad spectrum of symptoms ranging from acute coronary syndromes (ACS) to cardiogenic shock or even sudden cardiac death. The disease entity causes challenges in terms of both diagnostics and treatment strategy. Coronary intramural hematomas can also occur iatrogenically, as a complication to percutaneous coronary intervention (PCI). Coronary angiography (CAG) has limited diagnostic value in the absence of intimal dissections, and lesions are often angiographically ambiguous. Intravascular ultrasound (IVUS) is an important diagnostic tool in establishing the correct diagnosis, as it provides a complete vessel wall assessment, and enables morphometric information regarding the magnitude and severity of the underlying hematoma. Due to the rarity of this clinical scenario, no randomized, controlled trials exist to guide treatment, and no consensus regarding management is available. Currently, treatment strategies are based on a case-by-case clinical assessment, and experiences described in previous, limited retrospective studies and case reports.
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http://dx.doi.org/10.1016/j.carrev.2014.10.009DOI Listing
March 2015

Peri-stent contrast staining, major evaginations and severe malapposition after biolimus-eluting stent implantation: a case report based on coronary optical frequency domain imaging.

Cardiovasc Revasc Med 2014 Nov-Dec;15(8):424-7. Epub 2014 Apr 26.

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

Peri-stent contrast staining and late acquired malapposition represent pathological vessel wall healing patterns following percutaneous coronary intervention with stent implantation. Earlier studies have described these abnormal vessel wall responses commonly present after implantation of first-generation drug-eluting stents. These coronary vascular changes can cause flow disturbance and thereby dispose for later thrombotic events. This case report, based on coronary optical frequency domain imaging, describes peri-stent contrast staining, major evaginations and severe malapposition occurring 18months after third-generation biolimus-eluting stent implantation.
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http://dx.doi.org/10.1016/j.carrev.2014.04.006DOI Listing
September 2015

Impact of renal insufficiency on mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

BMC Cardiovasc Disord 2014 Feb 7;14:15. Epub 2014 Feb 7.

Department of Cardiology, Odense University Hospital, Sdr, Boulevard 29, 5000 Odense, Denmark.

Background: Chronic kidney disease is associated with increased risk of mortality. We examined the impact of moderate and severe renal insufficiency (RI) on short- and long-term mortality among unselected patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).

Methods: From January 1, 2002 to December 31, 2010 all patients with STEMI treated with primary PCI were identified. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounders. RI was defined as creatinine clearance (CrCl) < 60 mL/min (moderate RI: CrCl ≤30 < 60 mL/min and severe RI: CrCl < 30 mL/min).

Results: The study cohort consisted of 4,116 patients of whom 898 (21.8%) had RI and 3,218 (78.2%) had a CrCl ≥ 60 mL/min. Compared to patients without RI, patients with RI were older, more often female and more likely to have diabetes mellitus, hypertension and to present with a higher Killip class.Among patients with a preserved kidney function and patients with RI, 30-day all-cause mortality was 3.5% vs. 20.9% (log-rank p < 0.001); 1-year all-cause mortality was 5.7% vs. 29.4% (log-rank p < 0.001); 5-year all-cause mortality was 13.4% vs. 47.4% (log-rank p < 0.001). Moderate and severe RI were associated with higher 1-year mortality compared to patients with a preserved renal function (CrCl ≤30 < 60 mL/min: adjusted HR 2.71 [95% CI 2.09-3.51], p < 0.001), and (CrCl < 30 mL/min: adjusted HR 7.09 [4.82-10.44], p < 0.001).

Conclusion: In unselected STEMI patients treated with primary PCI, moderate and severe RI were associated with increased risk of mortality.
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http://dx.doi.org/10.1186/1471-2261-14-15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3922030PMC
February 2014

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

Catheter Cardiovasc Interv 2014 May 30;83(6):864-72. Epub 2013 Sep 30.

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

Objective: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients.

Background: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH).

Methods: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume.

Results: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling.

Conclusion: In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.
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http://dx.doi.org/10.1002/ccd.25180DOI Listing
May 2014

Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris: a substudy of the SORT OUT IV trial.

EuroIntervention 2014 Jun;10(2):212-23

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

Aims: The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES).

Methods And Results: We performed a post hoc subgroup analysis of data from SORT OUT IV. Of 2,705 patients, 1,178 (43.5%) patients had ACS and were treated with EES (n=580) or SES (n=598), and 1,527 (56.5%) patients had SAP and were treated with EES (n=773) or SES (n=754). The primary composite endpoint was major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI), stent thrombosis, or target vessel revascularisation within 18 months. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for the endpoints. At 18-month follow-up, patients with ACS had higher rates of MACE compared to patients with SAP (8.1% versus 6.7%; HR=1.23, 95% CI: 0.93-1.62). MACE did not differ significantly between ACS patients treated with EES or SES (7.3% versus 8.9%; HR=0.81, 95% CI: 0.54-1.22) nor between SAP patients treated with EES or SES (6.9% versus 6.5%; HR=1.05, 95% CI: 0.71-1.55).

Conclusions: EES and SES performed similarly with respect to MACE at 18-month follow-up in patients with ACS and SAP.
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http://dx.doi.org/10.4244/EIJV10I2A35DOI Listing
June 2014

Outcome and safety of same-day-discharge percutaneous coronary interventions with femoral access: a single-center experience.

Am Heart J 2013 Mar 24;165(3):393-9. Epub 2013 Jan 24.

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

Background: Ongoing development in percutaneous coronary intervention (PCI) techniques and closing devices facilitates same-day-discharge in patients undergoing uncomplicated PCI procedures. We examined the safety and outcome in low-risk patients discharged the same day as PCI with femoral access was performed.

Methods: From January 1, 2010, through December 31, 2010, the outcomes of same-day discharge in 355 (19.6%) of in total 1,809 patients undergoing PCI were analyzed. Composite end point included major adverse cardiac or cerebral events and/or bleeding/vascular complications within 24 hours and 30 days. Major adverse cardiac and cerebral events were defined as cardiac death, myocardial infarction, stroke, coronary artery bypass grafting, or repeat PCI.

Results: The mean age of the study population was 64.5 years (40.0-93.0 years), 17.3% of the patients were ≥75 years old. The indication for PCI was: stable angina pectoris (n = 277, 78.0%) and unstable angina pectoris/non-ST-segment elevation myocardial infarction (n = 78, 22.0%). In all patients femoral access was used, and the puncture site was closed with the closing-device AngioSeal. No major adverse cardiac and cerebral events were seen within 24 hours or 30 days except in 1 patient who had target lesion revascularization done as PCI 4 days post-procedure. Three patients had bleeding/vascular complications; 2 patients were re-admitted within 24 hours due to access-site hematomas, which were treated with manual compression and bed-rest regimes. One patient developed a pseudoaneurysm within 12 hours post-procedure.

Conclusions: Same-day-discharge after uncomplicated PCI using femoral access is safe when patients are properly selected. The strategy may improve and benefit health costs in the future.
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http://dx.doi.org/10.1016/j.ahj.2012.11.009DOI Listing
March 2013

Outcomes after primary percutaneous coronary intervention in octogenarians and nonagenarians with ST-segment elevation myocardial infarction: from the Western Denmark heart registry.

Catheter Cardiovasc Interv 2013 May 12;81(6):912-9. Epub 2013 Feb 12.

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

Background: Elderly patients with ST segment elevation myocardial infarction (STEMI) constitute a particular risk group in relation to primary percutaneous coronary intervention (PPCI).

Objective: We examined the proportion of octogenarians and nonagenarians undergoing PPCI in Western Denmark, and their short- and long-term mortality rates.

Methods: From 2002 to 2009 all consecutive patients ≥ 80 years with STEMI treated with PPCI were identified in the population based Western Denmark Heart Registry. Cox regression analysis was used to compute hazard ratios, controlling for potential confounding.

Results: A total of 1,322 elderly (1,213 octogenarians and 109 nonagenarians), corresponding to 11.6% of the total PPCI treated STEMI population were treated with PPCI between 2002 and 2009. The annual proportion of octogenarians referred for PPCI increased from n = 52 (6.2%) in 2002 to n = 172 (11.8%) in 2009 (P < 0.01), while it remained unchanged in nonagenarians: n = 6 (0.6%) in 2002 to n = 13 (0.8%) in 2009 (P = ns). For octogenarians and nonagenarians, 30-day mortality was 17.2% versus 25.8% (log-rank P = 0.028), 1-year mortality was 27.6% versus 32.5% (log-rank P = 0.18) and 5-year mortality 53.6% versus 57.3% (log-rank P = 0.087), respectively. Adjusted 30-day hazard ratio (HR) = 1.59 (95% confidence interval = CI: 1.07-2.36), 1-year HR = 1.34 (CI: 0.95-1.90), and 5-year mortality HR = 1.39 (CI: 1.04-1.85) was higher in nonagenarians compared with octogenarians.

Conclusion: The annual proportion of octogenarians with STEMI treated with PPCI doubled from 2002 to 2009, while the proportion of nonagenarians remained unchanged. Although nonagenarians had the highest short- and long-term mortality, we found the outcome acceptable with a 5-year survival of more than 40% in both groups.
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http://dx.doi.org/10.1002/ccd.24591DOI Listing
May 2013

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

Am J Cardiol 2011 Nov 3;108(10):1395-400. Epub 2011 Sep 3.

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

Patients ≥ 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥ 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥ 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥ 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time.
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http://dx.doi.org/10.1016/j.amjcard.2011.06.062DOI Listing
November 2011

Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients.

Int J Cardiol 2012 Jul 23;158(3):376-9. Epub 2011 Feb 23.

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

Background: The healthy endothelium plays a key roll in vascular regulation. This function can be examined non-invasively by use of B-mode ultrasound on the brachial artery. The aim of this study was to measure the effect of low-dose and high-dose lipid-lowering treatment with rosuvastatin on the endothelial function evaluated with endothelium-dependent and endothelium-independent flow-mediated dilatation (FMD).

Methods: 87 Statin-naive patients with ST-segment elevation myocardial infarction (STEMI) were randomized to 5mg or 40 mg rosuvastatin. The FMD was assessed at baseline, 6 months and after 12 months of follow-up by use of B-mode ultrasound of the brachial artery.

Results: Baseline low-density lipoprotein (LDL) cholesterol level was reduced by 31.8% in the low-dose group (from 3.1 ± 0.7 mmol/l to 2.0 ± 0.4 mmol/l, p<0.001) vs. 49.0% in the high-dose group (from 3.1 ± 1.0 mmol/l to 1.6 ± 0.7 mmol/l, p<0.001) (between groups p=0.001). Treatment with low-dose rosuvastatin did not change the endothelium-dependent FMD (-1.4 ± 8.2%, p=0.32) whereas the endothelium-dependent FMD increased significantly in the high-dose group (3.7 ± 11.0%, p=0.045) (between group p=0.029). No significant changes in endothelium-independent FMD were seen.

Conclusion: In the present study treatment of statin-naive STEMI patients with high-dose rosuvastatin for 12 months resulted in a significant increase in endothelium-dependent FMD of the brachial artery whereas no significant change was seen in the low-dose rosuvastatin group (Clinicaltrials.gov Identifier: NCT01223625).
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http://dx.doi.org/10.1016/j.ijcard.2011.01.071DOI Listing
July 2012