Publications by authors named "Per Thayssen"

115 Publications

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

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

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

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

Influence of multivessel disease with or without additional revascularization on mortality in patients with ST-segment elevation myocardial infarction.

Am Heart J 2015 Jul 2;170(1):70-8. Epub 2015 Apr 2.

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

Background: In patients with ST-segment elevation myocardial infarction (STEMI), timely reperfusion with primary percutaneous coronary intervention (PCI) is the preferred treatment. In primary PCI patients with multivessel disease, it is unclear whether culprit vessel PCI only is the preferred treatment. We compared mortality among (1) STEMI patients with single-vessel disease and those with multivessel disease and (2) multivessel disease patients with and without additional revascularization of nonculprit lesions within 2 months after the index PCI.

Methods: From January 2002 to June 2009, all patients presenting with STEMI and treated with primary PCI were identified from the Western Denmark Heart Registry, which covers a population of 3.0 million. The hazard ratio (HR) for death was estimated using a Cox regression model, controlling for potential confounding.

Results: The study cohort consisted of 8,822 patients: 4,770 (54.1%) had single-vessel disease and 4,052 (45.9%) had multivessel disease. Overall, 1-year cumulative mortality was 7.6%, and 7-year cumulative mortality was 24.0%. Multivessel disease was associated with higher 7-year mortality (adjusted HR 1.45 [95% CI 1.30-1.62], P < .001). Among patients with multivessel disease, lack of additional revascularization beyond the culprit lesion was associated with higher 7-year mortality (adjusted HR 1.50 [95% CI 1.25-1.80], P < .001). In patients with multivessel disease who underwent additional revascularization, 7-year mortality (adjusted HR 1.01 [95% CI 0.84-1.22], P = .89) was similar compared to patients with single-vessel disease.

Conclusion: In STEMI patients, multivessel disease was associated with a higher mortality compared to single-vessel disease. In multivessel disease patients, additional revascularization was associated with a higher survival compared with culprit vessel PCI only.
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http://dx.doi.org/10.1016/j.ahj.2015.03.020DOI Listing
July 2015

Quantitative myocardial perfusion by O-15-water PET: individualized vs. standardized vascular territories.

Eur Heart J Cardiovasc Imaging 2015 Sep 5;16(9):970-6. Epub 2015 May 5.

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

Aims: Reporting of quantitative myocardial blood flow (MBF) is typically performed in standard coronary territories. However, coronary anatomy and myocardial vascular territories vary among individuals, and a coronary artery may erroneously be deemed stenosed or not if territorial demarcation is incorrect. So far, the diagnostic consequences of calculating individually vs. standardly assessed MBF values have not been reported. We examined whether individual reassignment of vascular territories would improve the diagnostic accuracy of MBF with regard to the detection of significant coronary artery disease (CAD).

Methods And Results: Forty-four patients with suspected CAD were included prospectively and underwent coronary CT-angiography and quantitative MBF assessment with O-15-water PET followed by invasive, quantitative coronary angiography, which served as reference. MBF was calculated in the vascular territories during adenosine stress according to a standardized 17-segment American Heart Association model and an individualized model, using CT-angiography to adjust the coronary territories to their feeding vessels. Individually defined territories deviated from standard territories in 52% of patients. However, MBF in the three coronary territories defined by standard and individualized models did not differ significantly, except in one patient, in whom the MBF of an individualized coronary territory deviated sufficiently as to change the test from a false positive to a true negative result in this particular territory.

Conclusion: Disparity between standardized and individualized vascular territories was present in half of the patients, but had little clinical impact. Still, caution should be taken not always to rely on standard territories, as this may at times cause misinterpretation.
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http://dx.doi.org/10.1093/ehjci/jev111DOI Listing
September 2015

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

A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial).

Catheter Cardiovasc Interv 2015 Dec 6;86(7):1161-7. Epub 2015 May 6.

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

Objective: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.

Background: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.

Methods: We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.

Results: At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).

Conclusion: EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
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http://dx.doi.org/10.1002/ccd.25875DOI Listing
December 2015

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

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

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

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

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

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

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

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

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

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

Am J Cardiol 2015 Feb 11;115(3):298-302. Epub 2014 Nov 11.

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

We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover, during the last 4 years, ZES had fewer MACE, TVR, and stent thrombosis events among nondiabetic patients. In conclusion, SES remains superior to ZES in patients with diabetes throughout the 5-year follow-up, however, among nondiabetic patients, SES demonstrated a highly dynamic performance with favorable initial results followed by a late catch-up that included an overall higher risk of stent thrombosis.
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http://dx.doi.org/10.1016/j.amjcard.2014.10.038DOI Listing
February 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

Stent thrombosis is the primary cause of ST-segment elevation myocardial infarction following coronary stent implantation: a five year follow-up of the SORT OUT II study.

PLoS One 2014 19;9(11):e113399. Epub 2014 Nov 19.

Department of Medicine, Copenhagen University Hospital Glostrup, Glostrup, Denmark.

Background: The widespread use of coronary stents has exposed a growing population to the risk of stent thrombosis, but the importance in terms of risk of ST-segment elevation myocardial infarctions (STEMIs) remains unclear.

Methods: We studied five years follow-up data for 2,098 all-comer patients treated with coronary stents in the randomized SORT OUT II trial (mean age 63.6 yrs. 74.8% men). Patients who following stent implantation were readmitted with STEMI were included and each patient was categorized ranging from definite- to ruled-out stent thrombosis according to the Academic Research Consortium definitions. Multivariate logistic regression was performed on selected covariates to assess odds ratios (ORs) for definite stent thrombosis.

Results: 85 patients (4.1%), mean age 62.7 years, 77.1% men, were admitted with a total of 96 STEMIs, of whom 60 (62.5%) had definite stent thrombosis. Notably, definite stent thrombosis was more frequent in female than male STEMI patients (81.8% vs. 56.8%, p =  .09), and in very late STEMIs (p = 0.06). Female sex (OR 3.53 [1.01-12.59]) and clopidogrel (OR 4.43 [1.03-19.01]) was associated with increased for definite stent thrombosis, whereas age, time since stent implantation, use of statins, initial PCI urgency (STEMI [primary PCI], NSTEMI/unstable angina [subacute PCI] or stable angina [elective PCI]), and glucose-lowering agents did not seem to influence risk of stent thrombosis.

Conclusion: In a contemporary cohort of coronary stented patients, stent thrombosis was evident in more than 60% of subsequent STEMIs.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113399PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4237454PMC
December 2015

Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study.

BMC Cardiovasc Disord 2014 Aug 13;14:100. Epub 2014 Aug 13.

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

Background: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available.

Methods: We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases.

Results: Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation.

Conclusions: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients treated with drug-eluting stents. The increase was statistically significant within the first 3 months after drug-eluting stent implantation but not after 3 to 12 months.
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http://dx.doi.org/10.1186/1471-2261-14-100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4135343PMC
August 2014

Intracoronary injection of CD34-cells in chronic ischemic heart failure: 7 years follow-up of the DanCell study.

Cardiology 2014 12;129(2):69-74. Epub 2014 Aug 12.

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

Objectives: Seven years ago, the DanCell study was carried out to test the hypothesis of improvement in left ventricular ejection fraction (LVEF) following repeated intracoronary injections of autologous bone marrow-derived stem cells (BMSCs) in patients suffering from chronic ischemic heart failure. In this post hoc analysis, the long-term effect of therapy is assessed.

Methods: 32 patients [mean age 61 (SD ± 9), 81% males] with systolic dysfunction (LVEF 33 ± 9%) received two repeated intracoronary infusions (4 months apart) of autologous BMSCs (1,533 ± 765 × 10(6) BMSCs including 23 ± 11 × 10(6) CD34(+) cells and 14 ± 7 × 10(6) CD133(+) cells). Patients were followed for 7 years and deaths were recorded.

Results: During follow-up, 10 patients died (31%). In univariate regression analysis, the total number of BMSCs, CD34(+) cell count and CD133(+) cell count did not significantly correlate with survival (hazard ratio: 0.999, 95% CI: 0.998-1.000, p = 0.24; hazard ratio: 0.94, 95% CI: 0.88-1.01, p = 0.10, and hazard ratio: 0.96, 95% CI: 0.87-1.07, p = 0.47, respectively). After adjustment for baseline variables in multivariate regression analysis, the CD34(+) cell count was significantly associated with survival (hazard ratio: 0.90, 95% CI: 0.82-1.00, p = 0.04).

Conclusions: Intracoronary injections of a high number of CD34(+) cells may have a beneficial effect on chronic ischemic heart failure in terms of long-term survival.
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http://dx.doi.org/10.1159/000363133DOI Listing
February 2015

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

JACC Cardiovasc Interv 2014 Aug 30;7(8):840-8. Epub 2014 Jul 30.

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

Objectives: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.

Background: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.

Methods: We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).

Results: At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).

Conclusions: At 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).
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http://dx.doi.org/10.1016/j.jcin.2014.02.014DOI Listing
August 2014

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

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

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

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

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

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

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

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

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

Lancet 2014 Jun 14;383(9934):2047-2056. Epub 2014 Mar 14.

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

Background: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.

Methods: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.

Findings: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period.

Interpretation: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.

Funding: Cordis and Medtronic.
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http://dx.doi.org/10.1016/S0140-6736(14)60405-0DOI Listing
June 2014

Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents.

Scand Cardiovasc J 2014 Jun 26;48(3):148-55. Epub 2014 Feb 26.

Department of Cardiology, Gentofte University Hospital , Hellerup , Denmark.

Objective: Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late-occurring increase in event rates. Therefore, the long-term outcome follow-up is of major clinical interest.

Design: In total, 2.098 unselected patients with ST-segment elevation myocardial infarction (STEMI), non-STEMI, stable or unstable angina pectoris were randomized to receive Cypher™ (n = 1.065) or Taxus™ (n = 1.033) stents and were followed for 5 years.

Results: The primary end-point; the composite of cardiac death, myocardial infarction and target vessel revascularization (major adverse cardiac event, MACE), occurred in 467 patients (22.3%); Cypher™ n = 222 (20.8%), Taxus™ n = 245 (23.7%), ns. Definite and probable stent thrombosis occurred in 107 patients (5.1%); Cypher™ n = 51 (4.8%), Taxus™ n = 56 (5.4%), ns. No statistically significant differences were found in the elements of the primary end-point or in other secondary end-points between the two stent groups. After one year, the annual rates of stent thrombosis and MACE remained constant.

Conclusions: During 5-year follow-up, the Cypher™ and the Taxus™ coronary stents had similar clinical outcome with no signs of increasing rates of adverse events over time.
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http://dx.doi.org/10.3109/14017431.2014.883461DOI Listing
June 2014

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

Immediate mobilization after coronary angiography or percutaneous coronary intervention following hemostasis with the AngioSeal vascular closure device (the MOBS study).

Eur J Cardiovasc Nurs 2014 Oct 13;13(5):466-72. Epub 2013 Dec 13.

Department of Cardiology, Odense University Hospital, Denmark.

Background: In patients undergoing coronary angiography or percutaneous coronary intervention (PCI), the standard post procedure regime includes immobilization and bed rest despite the use of vascular closure devices.

Aim: In the Mobilization after Coronary Angiography or Percutaneous Coronary Intervention (MOBS) study we compared bleeding complications after cardiac catheterization with femoral artery access after mobilization immediately off the angiographic table or standard care with1 hour (MOBS I after a diagnostic angiogram) or 2 hours of bed rest before mobilization (MOBS II after PCI).

Methods: Bleeding complications were defined as major (requiring surgery of the femoral artery, transfusion or increased hospital stay) and minor (hematoma <5 × 5 cm(2), oozing from the puncture site or minor bleeding that could be compressed manually).

Results: In the MOBS I cohort (100 patients were mobilized immediately and 100 patients followed standard care) no major bleeding complications were seen. In the immediate mobilization group 2.0% experienced minor bleeding compared to 4.0% in the standard care group (p=0.41). In the MOBS II cohort after PCI (158 patients were mobilized immediately and 161 patients followed standard care), major bleeding complication rates did not differ significantly between the two groups: immediate mobilization group 26.6% vs. standard care group 28.0%, p=0.78. The majority of bleeding complications were due to oozing: immediate mobilization group 22.8% vs. standard care group 20.5%, p=0.62.

Conclusions: Immediate mobilization after a coronary angiogram or PCI with the femoral access site closed by the closure device AngioSeal was not associated with increased bleeding risk compared to standard care with bed rest.
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http://dx.doi.org/10.1177/1474515113516702DOI Listing
October 2014

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

Catheter Cardiovasc Interv 2014 Jun 5;83(7):1035-42. Epub 2013 Dec 5.

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

Objectives: We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention (PCI) with drug-eluting stents (DES) or bare-metal stents (BMS).

Background: The use of DES compared with BMS during PCI has reduced the risk of restenosis in native coronary artery lesions. In saphenous vein grafts (SVG) the outcome after DES compared with BMS is insufficiently described.

Methods: From January 1, 2002 to December 31, 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants. Stent failure was defined as clinically driven target lesion revascularization, graft occlusion without intervention, or stent thrombosis.

Results: The study cohort consisted of 529 patients with 755 SVG lesions (348 DES patients with 510 lesions and 181 BMS patients with 245 lesions). Mean age did not differ between patients with DES-treated lesions compared to patients with BMS-treated lesions (67.5 ± 9.1 years vs. 67.6 ± 9.3 years; P = 0.85). The median follow-up time was 3.0 years (25th-75th percentile: 1.4-5.1 years). One-year (n = 27 (8.2%) vs. n = 12 (6.7%), log rank P = 0.60) and 3-year cumulative mortality (n = 31 (18.8%) vs. n = 59 (21.8%), log rank P = 0.64) did not differ significantly between DES- and BMS-treated patients. One-year cumulative stent failure was seen in 39 (6.6%) DES-treated lesions vs. 24 (10.8%) BMS-treated lesions (P = 0.088), and 3-year cumulative stent failure in 48 (15.4%) vs. 34 (18.8%) lesions (P = 0.25), respectively.

Conclusion: In SVG lesions, DES showed no long-term benefit compared to BMS in rates of all-cause mortality or stent failure.
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http://dx.doi.org/10.1002/ccd.25279DOI Listing
June 2014