138 results on '"Jensen, Lisette Okkels"'
Search Results
2. The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent
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Nardin, Matteo, Pivato, Carlo Andrea, Cao, Davide, Sartori, Samantha, Zhang, Zhongjie, Vogel, Birgit, Nicolas, Johny, Chiarito, Mauro, Qiu, Hanbo, Chandrasekhar, Jaya, Spirito, Alessandro, Abizaid, Alexandre, Christiansen, Evald Høj, Colombo, Antonio, de Winter, Robbert J., Haude, Michael, Jakobsen, Lars, Jensen, Lisette Okkels, Krucoff, Mitchell W., Landmesser, Ulf, Saito, Shigeru, Suryapranata, Harry, De Luca, Giuseppe, Dangas, George, and Mehran, Roxana
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- 2023
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3. Impact of SARS-CoV-2 positivity on clinical outcome among STEMI patients undergoing mechanical reperfusion: Insights from the ISACS STEMI COVID 19 registry
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De Luca, Giuseppe, Debel, Niels, Cercek, Miha, Jensen, Lisette Okkels, Vavlukis, Marija, Calmac, Lucian, Johnson, Tom, Ferrer, Gerard Rourai, Ganyukov, Vladimir, Wojakowski, Wojtek, Kinnaird, Tim, von Birgelen, Clemens, Cottin, Yves, IJsselmuiden, Alexander, Tuccillo, Bernardo, Versaci, Francesco, Royaards, Kees-Jan, Berg, Jurrien ten, Laine, Mika, Dirksen, Maurits, Siviglia, Massimo, Casella, Gianni, Kala, Petr, Díez Gil, José Luis, Banning, Adrian, Becerra, Victor, De Simone, Ciro, Santucci, Andrea, Carrillo, Xavier, Scoccia, Alessandra, Amoroso, Giovanni, van't Hof, Arnoud WJ., Kovarnik, Tomas, Tsigkas, Grigorios, Mehilli, Julinda, Gabrielli, Gabriele, Rios, Xacobe Flores, Bakraceski, Nikola, Levesque, Sébastien, Cirrincione, Giuseppe, Guiducci, Vincenzo, Kidawa, Michał, Spedicato, Leonardo, Marinucci, Lucia, Ludman, Peter, Zilio, Filippo, Galasso, Gennaro, Fabris, Enrico, Menichelli, Maurizio, Garcia-Touchard, Arturo, Manzo, Stephane, Caiazzo, Gianluca, Moreu, Jose, Forés, Juan Sanchis, Donazzan, Luca, Vignali, Luigi, Teles, Rui, Benit, Edouard, Agostoni, Pierfrancesco, Ojeda, Francisco Bosa, Lehtola, Heidi, Camacho-Freiere, Santiago, Kraaijeveld, Adriaan, Antti, Ylitalo, Boccalatte, Marco, Deharo, Pierre, Martínez-Luengas, Iñigo Lozano, Scheller, Bruno, Varytimiadi, Efthymia, Moreno, Raul, Uccello, Giuseppe, Faurie, Benjamin, Gutierrez Barrios, Alejandro, Milewski, Marek, Bruwiere, Ewout, Smits, Pieter, Wilbert, Bor, Di Uccio, Fortunato Scotto, Parodi, Guido, Kedhi, Elvin, and Verdoia, Monica
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- 2021
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4. Association between QRS duration on prehospital ECG and mortality in patients with suspected STEMI
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Hansen, Rikke, Frydland, Martin, Møller-Helgestad, Ole Kristian, Lindholm, Matias Greve, Jensen, Lisette Okkels, Holmvang, Lene, Ravn, Hanne Berg, Kjærgaard, Jesper, Hassager, Christian, and Møller, Jacob Eifer
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- 2017
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5. 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
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Antonsen, Lisbeth, Thayssen, Per, Hansen, Henrik Steen, Junker, Anders, Veien, Karsten Tange, Hansen, Knud Nørregaard, Hougaard, Mikkel, and Jensen, Lisette Okkels
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- 2016
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6. International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions with Myocardial Ischemia - ISCHEMIA-CTO Trial - Rationale and Design.
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Råmunddal, Truls, Holck, Emil Nielsen, Karim, Salma, Eftekhari, Ashkan, Escaned, Javier, Ioanes, Dan, Walsh, Simon, Spratt, James, Veien, Karsten, Jensen, Lisette Okkels, Tilsted, Hans-Henrik, Terkelsen, Christian Juhl, Havndrup, Ole, Olsen, Niels Thue, Kajander, Olli A., Faurie, Benjamin, Lanematt, Peep, Jakobsen, Lars, Christiansen, Evald Høj, and Kajander, Olli
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Background: Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone.Methods and Design: This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization.Implications: This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO. [ABSTRACT FROM AUTHOR]- Published
- 2023
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7. TCT-420 Impact of Biolimus-Eluting Stents on Long-Term Outcome in Patients With Acute Coronary Syndromes: An Individual Patient Data Meta-Analysis of the SORT OUT Trials.
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Hougaard, Mikkel, Jensen, Lisette Okkels, Jakobsen, Lars, Eftekhari, Ashkan, Ellert-Gregersen, Julia, Støttrup, Nicolaj, Kahlert, Johhny, Freeman, Philip, Veien, Karsten Tange, Jensen, Rebekka Vibjerg, Lassen, Jens, Junker, Anders, and Christiansen, Evald
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ACUTE coronary syndrome - Published
- 2024
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8. Intravascular ultrasound assessment of fibrous cap remnants after coronary plaque rupture
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Jensen, Lisette Okkels, Mintz, Gary S., Carlier, Stephane G., Fujii, Kenichi, Moussa, Issam, Dangas, George, Mehran, Roxanna, Stone, Gregg W., Leon, Martin B., and Moses, Jeffrey W.
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Atherosclerotic plaque -- Complications and side effects ,Atherosclerotic plaque -- Research ,Connective tissues -- Analysis ,Intravascular ultrasonography -- Analysis ,Health - Published
- 2006
9. Impact of Functional Severity of Coronary Artery Disease on Arterial Versus Venous Graft Patency.
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Toth, Gabor G., Mizukami, Takuya, Collet, Carlos, Thuesen, Anne Langhoff, Casselman, Filip, Jensen, Lisette Okkels, De Bruyne, Bernard, and Barbato, Emanuele
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- 2022
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10. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial.
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Udesen, Nanna Junker, Møller, Jacob Eifer, Lindholm, Matias Greve, Eiskjær, Hans, Schäfer, Andreas, Werner, Nikos, Holmvang, Lene, Terkelsen, Christian Juhl, Jensen, Lisette Okkels, Junker, Anders, Schmidt, Henrik, Wachtell, Kristian, Thiele, Holger, Engstrøm, Thomas, Hassager, Christian, and DanGer Shock investigators
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Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far.Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies.Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%).Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock. [ABSTRACT FROM AUTHOR]- Published
- 2019
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11. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the...
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Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Engstrøm, Thomas, Hansen, Henrik Steen, Jensen, Svend Eggert, Bøtker, Hans Erik, Kahlert, Johnny, Lassen, Jens Flensted, and Christiansen, Evald Høj
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Background: In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9-coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.Methods: The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.Results: A total of 3,150 patients have been randomized and enrolled in the study.Conclusions: The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent. [ABSTRACT FROM AUTHOR]- Published
- 2019
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12. Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial).
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Maeng, Michael, Christiansen, Evald Høj, Raungaard, Bent, Kahlert, Johnny, Terkelsen, Christian Juhl, Kristensen, Steen Dalby, Carstensen, Steen, Aarøe, Jens, Jensen, Svend Eggert, Villadsen, Anton Boel, Lassen, Jens Flensted, Thim, Troels, Eftekhari, Ashkan, Veien, Karsten Tange, Hansen, Knud Nørregaard, Junker, Anders, Bøtker, Hans Erik, and Jensen, Lisette Okkels
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Abstract Objectives The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845) Central Illustration [ABSTRACT FROM AUTHOR]
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- 2019
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13. Prospective Comparison of FFR Derived From Coronary CT Angiography With SPECT Perfusion Imaging in Stable Coronary Artery Disease: The ReASSESS Study.
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Sand, Niels Peter Rønnow, Veien, Karsten Tange, Nielsen, Søren Steen, Nørgaard, Bjarne Linde, Larsen, Pia, Johansen, Allan, Hess, Søren, Deibjerg, Lone, Husain, Majed, Junker, Anders, Thomsen, Kristian Korsgaard, Rohold, Allan, and Jensen, Lisette Okkels
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Abstract Objectives This study sought to compare the per-patient diagnostic performance of coronary computed tomography angiography (CTA)-derived fractional flow reserve (FFR CT) with that of single-photon emission computed tomography (SPECT), using a fractional flow reserve (FFR) value of ≤0.80 as the reference for diagnosing at least 1 hemodynamically significant stenosis in a head-to-head comparison of patients with intermediate coronary stenosis as determined by coronary CTA. Background No previous study has prospectively compared the diagnostic performance of FFR CT and myocardial perfusion imaging by SPECT in symptomatic patients with intermediate range coronary artery disease (CAD). Methods This study was conducted at a single-center as a prospective study in patients with stable angina pectoris (N = 143). FFR CT and SPECT analyses were performed by core laboratories and were blinded for the personnel responsible for downstream patient management. FFR CT ≤0.80 distally in at least 1 coronary artery with a diameter ≥2 mm classified patients as having ischemia. Ischemia by SPECT was encountered if a reversible perfusion defect (summed difference score ≥2) or transitory ischemic dilation of the left ventricle (ratio >1.19) were found. Results The per-patient diagnostic performance for identifying ischemia (95% confidence interval [CI]), FFR CT versus SPECT, were sensitivity of 91% (95% CI: 81% to 97%) versus 41% (95% CI: 29% to 55%; p < 0.001); specificity of 55% (95% CI: 44% to 66%) versus 86% (95% CI: 77% to 93%; p < 0.001); negative predictive value of 90% (95% CI: 82% to 98%) versus 68% (95% CI: 59% to 77%; p = 0.001); positive predictive value of 58% (95% CI: 48% to 68%) versus 67% (95% CI: 51% to 82%; p = NS); and accuracy of 70% (95% CI: 62% to 77%) versus 68% (95% CI: 60% to 75%; p = NS) respectively. Conclusions In patients with stable chest pain and CAD as determined by coronary CTA, the overall diagnostic accuracy levels of FFR CT and SPECT were identical in assessing hemodynamically significant stenosis. However, FFR CT demonstrated a significantly higher diagnostic sensitivity than SPECT. Graphical abstract [ABSTRACT FROM AUTHOR]
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- 2018
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14. Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study.
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Laursen, Peter Nørkjær, Holmvang, Lene, Lønborg, Jacob, Køber, Lars, Høfsten, Dan E., Helqvist, Steffen, Clemmensen, Peter, Kelbæk, Henning, Jørgensen, Erik, Lassen, Jens Flensted, Pedersen, Frants, Høi-Hansen, Thomas, Therkelsen, Christian Juhl, Tilsted, Hans-Henrik, Jensen, Lisette Okkels, Nepper-Christensen, Lars, Sadjadieh, Golnaz, and Engstrøm, Thomas
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Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality.Results: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001).Conclusions: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population. [ABSTRACT FROM AUTHOR]- Published
- 2018
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15. Uncovered Culprit Plaque Ruptures in Patients With ST-Segment Elevation Myocardial Infarction Assessed by Optical Coherence Tomography and Intravascular Ultrasound With iMap.
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Hougaard, Mikkel, Hansen, Henrik Steen, Thayssen, Per, Antonsen, Lisbeth, and Jensen, Lisette Okkels
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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 2 [interquartile range (IQR): 4.8 to 9.3 mm 2 ] to 3.6 mm 2 [IQR: 2.8 to 8.0 mm 2 ]; p = 0.012). Proximal segments with uncovered PR had greater plaque volumes (62.1 mm 3 [IQR: 50.2 to 83.6 mm 3 ] vs. 38.7 mm 3 [IQR: 29.6 to 47.6 mm 3 ], respectively; p < 0.001), vessel volumes (110.7 mm 3 [IQR: 92.3 to 128.1 mm 3 ] vs. 76.0 mm 3 [IQR: 63.8 to 100.3 mm 3 ], 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. [ABSTRACT FROM AUTHOR]
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- 2018
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16. 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).
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Jensen, Lisette Okkels, Vikman, Saila, Antonsen, Lisbeth, Kosonen, Petteri, Niemelä, Matti, Christiansen, Evald Høj, Kervinen, Kari, Erglis, Andrejs, Harnek, Jan, Kumsars, Indulis, Thuesen, Leif, and Niemelä, Kari
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INTIMAL hyperplasia , *ULTRASONIC imaging , *PERCUTANEOUS coronary intervention , *CORONARY restenosis , *CORONARY heart disease treatment , *THERAPEUTICS , *MEDICAL equipment , *HYPERPLASIA , *CARDIOVASCULAR system , *CELL physiology , *COMPARATIVE studies , *CORONARY arteries , *DEGENERATION (Pathology) , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL care , *MEDICAL cooperation , *METALS , *RESEARCH , *SURGICAL stents , *TIME , *EVALUATION research , *TREATMENT effectiveness , *PREDICTIVE tests , *ACQUISITION of data , *DRUG-eluting stents - Abstract
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±2.2mm2 vs. 7.6±2.4mm2, p<0.001) and intimal hyperplasia area (2.6±2.0mm2 vs. 5.0±2.2mm2, 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 5.0mm2 (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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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17. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.
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Verheye, Stefan, Vrolix, Mathias, Kumsars, Indulis, Erglis, Andrejs, Sondore, Dace, Agostoni, Pierfrancesco, Cornelis, Kristoff, Janssens, Luc, Maeng, Michael, Slagboom, Ton, Amoroso, Giovanni, Jensen, Lisette Okkels, Granada, Juan F., and Stella, Pieter
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Objectives The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Background Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. Methods In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Results Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. Conclusions This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. [ABSTRACT FROM AUTHOR]
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- 2017
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18. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy.
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Yamaji, Kyohei, Brugaletta, Salvatore, Sabaté, Manel, Iñiguez, Andrés, Jensen, Lisette Okkels, Cequier, Angel, Hofma, Sjoerd H., Christiansen, Evald Høj, Suttorp, Maarten, van Es, Gerrit Anne, Sotomi, Yohei, Onuma, Yoshinobu, Serruys, Patrick W., Windecker, Stephan, and Räber, Lorenz
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Objectives This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES). Background Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes. Methods In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status. Results Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm 2 vs. 5.72 ± 1.77 mm 2 ; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm 2 vs. 5.55 ± 1.77 mm 2 ; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72). Conclusions In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803 ) [ABSTRACT FROM AUTHOR]
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- 2017
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19. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV.
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Jensen, Lisette Okkels, Thayssen, Per, Christiansen, Evald Høj, Maeng, Michael, Ravkilde, Jan, Hansen, Knud Nørregaard, Hansen, Henrik Steen, Krusell, Lars, Kaltoft, Anne, Tilsted, Hans Henrik, Berencsi, Klara, Junker, Anders, Lassen, Jens Flensted, and SORT OUT IV Investigators
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EVEROLIMUS , *DRUG efficacy , *RAPAMYCIN , *DRUG-eluting stents , *THROMBOSIS , *MEDICATION safety , *CORONARY heart disease surgery , *CARDIOVASCULAR system , *COMPARATIVE studies , *IMMUNOSUPPRESSIVE agents , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL care , *MEDICAL cooperation , *PROSTHETICS , *RESEARCH , *SURGICAL complications , *SURVIVAL , *TIME , *EVALUATION research , *TREATMENT effectiveness , *DISEASE incidence , *BLIND experiment , *RETROSPECTIVE studies , *KAPLAN-Meier estimator , *PHARMACODYNAMICS - Abstract
Background: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.Objectives: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.Methods: Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.Results: At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).Conclusions: At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877). [ABSTRACT FROM AUTHOR]- Published
- 2016
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20. 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...
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Jensen, Lisette Okkels, Thayssen, Per, Maeng, Michael, Ravkilde, Jan, Hansen, Henrik Steen, Jensen, Svend Eggert, Bøtker, Hans Erik, Berencsi, Klára, Lassen, Jens Flensted, and Christiansen, Evald Høj
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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. [ABSTRACT FROM AUTHOR]- Published
- 2015
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21. Influence of multivessel disease with or without additional revascularization on mortality in patients with ST-segment elevation myocardial infarction.
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Jensen, Lisette Okkels, Terkelsen, Christian Juhl, Horváth-Puhó, Erzsébet, Tilsted, Hans-Henrik, Maeng, Michael, Junker, Anders, Lassen, Jens Flensted, Thuesen, Leif, Sørensen, Henrik Toft, and Thayssen, Per
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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. [ABSTRACT FROM AUTHOR]
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- 2015
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22. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus...
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Høfsten, Dan Eik, Kelbæk, Henning, Helqvist, Steffen, Kløvgaard, Lene, Holmvang, Lene, Clemmensen, Peter, Torp-Pedersen, Christian, Tilsted, Hans-Henrik, Bøtker, Hans Erik, Jensen, Lisette Okkels, Køber, Lars, and Engstrøm, Thomas
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Background In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, ischemic postconditioning has been shown to reduce infarct size, but the effect on clinical outcome has not been tested in a large randomized trial. In addition, deferring stent implantation in the infarct-related lesion 1 to 3 days after acute opening of the infarct-related artery could have protective effects, by reducing the risk of injury caused by distal embolization and microvascular obstruction. Finally, a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery. Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain. Study design The DANAMI 3 trial program was designed to investigate 3 different randomized treatment strategies in patients with ST-segment elevation myocardial infarction: (1) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure; (2) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death, hospitalization for heart failure, reinfarction, and repeat revascularization; and (3) treatment of the culprit lesion only versus fractional flow reserve–guided complete revascularization in patients with multivessel disease, with a primary end point of death, reinfarction, and repeat revascularization. Summary The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization. [ABSTRACT FROM AUTHOR]
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- 2015
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23. TCT-791 Do Women Have Less Effect of Mircoaxial Flow Pump in Infarct Related Cardiogenic Shock: A Secondary Analysis of the Danger Shock Trial.
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Mangner, Norman, Hassager, Christian, Jensen, Lisette Okkels, Eiskjær, Hans, Polzin, Amin, Schulze, P. Christian, Skurk, Carsten, Nordbeck, Peter, Clemmensen, Peter, Panoulas, Vasileios, Zimmer, Sebastian, Schaefer, Andreas, Engstroem, Thomas, Holmvang, Lene, Junker, Anders, Schmidt, Henrik, Terkelsen, Christian, Linke, Axel, Westenfeld, Ralf, and Moeller, Jacob
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CARDIOGENIC shock , *SECONDARY analysis , *HAZARDS - Published
- 2024
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24. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial.
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Jensen, Lisette Okkels, Thayssen, Per, Maeng, Michael, Christiansen, Evald Høj, Ravkilde, Jan, Hansen, Knud Nørregaard, Kaltoft, Anne, Tilsted, Hans Henrik, Madsen, Morten, and Lassen, Jens Flensted
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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). [ABSTRACT FROM AUTHOR]
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- 2014
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25. Outcome and safety of same-day-discharge percutaneous coronary interventions with femoral access: A single-center experience.
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Antonsen, Lisbeth, Jensen, Lisette Okkels, and Thayssen, Per
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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. [Copyright &y& Elsevier]
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- 2013
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26. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)
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Jensen, Lisette Okkels, Thayssen, Per, Junker, Anders, Maeng, Michael, Tilsted, Hans-Henrik, Kaltoft, Anne, Hansen, Knud Nørregaard, Christiansen, Evald Høj, Kristensen, Steen Dalby, Ravkilde, Jan, Madsen, Morten, Sørensen, Henrik Toft, Thuesen, Leif, and Lassen, Jens Flensted
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DIABETES , *HEALTH outcome assessment , *MYOCARDIAL revascularization , *RAPAMYCIN , *SURGICAL stents , *ANGIOPLASTY - Abstract
Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients. [Copyright &y& Elsevier]
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- 2012
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27. 2-Year Patient-Related Versus Stent-Related Outcomes: The SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) Trial
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Jensen, Lisette Okkels, Thayssen, Per, Christiansen, Evald Høj, Tilsted, Hans Henrik, Maeng, Michael, Hansen, Knud Nørregaard, Kaltoft, Anne, Hansen, Henrik Steen, Bøtker, Hans Erik, Krusell, Lars Romer, Ravkilde, Jan, Madsen, Morten, Thuesen, Leif, and Lassen, Jens Flensted
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DRUG-eluting stents , *CLINICAL trials , *HEALTH outcome assessment , *MYOCARDIAL infarction , *RAPAMYCIN , *CORONARY artery stenosis , *REVASCULARIZATION (Surgery) - Abstract
Objectives: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). Background: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. Methods: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES. Results: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80). Conclusions: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877) [ABSTRACT FROM AUTHOR]
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- 2012
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28. 3-Year Clinical Outcomes in the Randomized SORT OUT III Superiority Trial Comparing Zotarolimus- and Sirolimus-Eluting Coronary Stents.
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Maeng, Michael, Tilsted, Hans-Henrik, Jensen, Lisette Okkels, Kaltoft, Anne, Kelbæk, Henning, Abildgaard, Ulrik, Villadsen, Anton B., Krusell, Lars Romer, Ravkilde, Jan, Hansen, Knud Nørregaard, Christiansen, Evald Høj, Aarøe, Jens, Jensen, Jan Skov, Kristensen, Steen Dalby, Bøtker, Hans Erik, Madsen, Morten, Thayssen, Per, Sørensen, Henrik Toft, Thuesen, Leif, and Lassen, Jens Flensted
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RAPAMYCIN ,HEALTH outcome assessment ,RANDOMIZED controlled trials ,MYOCARDIAL infarction ,REVASCULARIZATION (Surgery) ,THROMBOSIS ,DRUG-eluting stents ,FOLLOW-up studies (Medicine) - Abstract
Objectives: This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice. Background: The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear. Methods: The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis. Results: At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005). Conclusions: Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478) [ABSTRACT FROM AUTHOR]
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- 2012
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29. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients
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Egede, Rasmus, Jensen, Lisette Okkels, Hansen, Henrik Steen, Antonsen, Lisbeth, Hansen, Knud Nørregaard, Junker, Anders, and Thayssen, Per
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LIPIDS , *HEART diseases , *THERAPEUTICS , *ROSUVASTATIN , *ENDOTHELIUM , *HEART blood-vessels , *MYOCARDIAL infarction , *BRACHIAL artery , *BLOOD cholesterol - Abstract
Abstract: 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 40mg rosuvastatin. The FMD was assessed at baseline, 6months and after 12months 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±0.7mmol/l to 2.0±0.4mmol/l, p <0.001) vs. 49.0% in the high-dose group (from 3.1±1.0mmol/l to 1.6±0.7mmol/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 12months 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). [Copyright &y& Elsevier]
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- 2012
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30. Influence of Diabetes Mellitus on Clinical Outcomes Following Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction
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Jensen, Lisette Okkels, Maeng, Michael, Thayssen, Per, Tilsted, Hans Henrik, Terkelsen, Christian Juhl, Kaltoft, Anne, Lassen, Jens Flensted, Hansen, Knud Nørregaard, Ravkilde, Jan, Christiansen, Evald Høj, Madsen, Morten, Sørensen, Henrik Toft, and Thuesen, Leif
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MYOCARDIAL infarction treatment , *ANGIOPLASTY , *DIABETES , *CLINICAL trials , *HEALTH outcome assessment , *THROMBOSIS - Abstract
Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval [CI] 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death. [Copyright &y& Elsevier]
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- 2012
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31. 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)
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Antonsen, Lisbeth, Jensen, Lisette Okkels, Thayssen, Per, Christiansen, Evald Høj, Junker, Anders, Tilsted, Hans-Henrik, Terkelsen, Christian Juhl, Kaltoft, Anne, Maeng, Michael, Hansen, Knud Noerregaard, Ravkilde, Jan, Lassen, Jens Flensted, Madsen, Morten, Sørensen, Henrik Toft, and Thuesen, Leif
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TREATMENT effectiveness , *ANGIOPLASTY , *CORONARY heart disease treatment , *REGRESSION analysis , *REVASCULARIZATION (Surgery) , *CORONARY heart disease prevention , *MYOCARDIAL infarction , *ANGINA pectoris , *PREVENTION - Abstract
Patients ≥80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and “ventricular arrhythmia or congestive heart failure” in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time. [ABSTRACT FROM AUTHOR]
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- 2011
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32. Long-Term Outcomes After Percutaneous Coronary Intervention in Patients With and Without Diabetes Mellitus in Western Denmark
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Jensen, Lisette Okkels, Maeng, Michael, Thayssen, Per, Kaltoft, Anne, Tilsted, Hans Henrik, Lassen, Jens Flensted, Hansen, Knud Noerregaard, Bottcher, Morten, Rasmussen, Klaus, Madsen, Morten, Johnsen, Søren Paaske, Sørensen, Henrik Toft, and Thuesen, Leif
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CORONARY heart disease treatment , *PEOPLE with diabetes , *ANGIOPLASTY , *THROMBOSIS risk factors , *SURGICAL stents , *MYOCARDIAL revascularization , *CONFIDENCE intervals - Abstract
Patients with diabetes mellitus have worse outcomes after percutaneous coronary intervention than patients without diabetes mellitus. We compared the risk of stent thrombosis, myocardial infarction, death, and target lesion revascularization in diabetic and nondiabetic patients after implantation of drug-eluting stents or bare metal stents. In the Western Denmark Heart Registry, 12,347 consecutive patients (1,575 with and 10,772 without diabetes) were identified and followed up for 2 years. The 2-year risk of definite stent thrombosis was 0.52% in patients with diabetes mellitus and 0.71% in nondiabetic patients (adjusted relative risk [RR] 0.74, 95% confidence interval [CI] 0.41 to 1.34, p = 0.321). The 2-year risk of myocardial infarction was greater in the diabetic patients (6.9%) than in the nondiabetic patients (3.6%; adjusted RR 1.96, 95% CI 1.58 to 2.43; p <0.001). The all-cause 2-year mortality rate was almost twice as great for the diabetic patients compared to the nondiabetic patients (12.4% vs 6.7%; adjusted RR 1.91, 95% CI 1.63 to 2.23; p <0.001). The 2-year risk of target lesion revascularization was 8.5% in the diabetic patients and 6.8% in the nondiabetic patients (adjusted RR 1.28, 95% CI 1.10 to 1.49; p <0.001). In conclusion, 2 years after drug-eluting stent or bare metal stent implantation, diabetic patients had a greater risk than nondiabetic patients of myocardial infarction and death. Drug-eluting stent treatment reduced the risk of target lesion revascularization compared to bare metal stent treatment, regardless of diabetes status. [Copyright &y& Elsevier]
- Published
- 2010
- Full Text
- View/download PDF
33. Serial Intravascular Ultrasound Analysis of Peri-Stent Remodeling and Proximal and Distal Edge Effects After Sirolimus-Eluting or Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus
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Jensen, Lisette Okkels, Maeng, Michael, Mintz, Gary S., Christiansen, Evald Hoej, Hansen, Knud Noerregaard, Galloe, Anders, Kelbaek, Henning, Lassen, Jens Flensted, Thuesen, Leif, and Thayssen, Per
- Subjects
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INTRAVASCULAR ultrasonography , *CORONARY restenosis , *RAPAMYCIN , *PHARMACODYNAMICS , *PACLITAXEL , *SURGICAL stents , *PEOPLE with diabetes , *DISEASE risk factors , *DISEASES - Abstract
Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Scientific, Maple Grove, Minnesota) stents in diabetic patients. Seventy-four diabetic patients were randomly assigned to Cypher or Taxus stent implantation. Intravascular ultrasound of 5-mm long segments immediately proximal and distal to the stent was performed after the procedure and at the 8-month follow-up. The increase in peri-stent external elastic membrane (EEM) volume was more pronounced in the Taxus group (292.4 ± 132.6 to 309.5 ± 146.8 mm3) than in the Cypher group (274.4 ± 137.2 to 275.4 ± 140.1 mm3; p = 0.005). Peri-stent plaque volume increased in the Taxus group (152.5 ± 73.7 to 166.1 ± 85.1 mm3), but was unchanged in the Cypher group (153.5 ± 75.5 to 151.5 ± 75.8 mm3; p = 0.002). In proximal and distal reference segments, mean lumen area decreased within the entire 5-mm edge segment (proximal and distal) because of plaque progression (distal, 5.5 ± 3.6 to 5.8 ± 3.7 mm2; p = 0.097; proximal, 8.1 ± 2.7 to 8.7 ± 2.9 mm2; p = 0.006) without remodeling (change in EEM) in the Taxus group. Conversely, there were no significant changes in reference-segment EEM or plaque areas in the Cypher group. In conclusion, in diabetic patients, Taxus stent implantation was associated with increased (1) peri-stent EEM volume and peri-stent plaque, and (2) stent edge plaque progression accompanied by lumen reduction without remodeling. These findings were not seen in Cypher stents. [Copyright &y& Elsevier]
- Published
- 2009
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34. 2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents: Results From the WDHR (Western Denmark Heart Registry)
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Kaltoft, Anne, Jensen, Lisette Okkels, Maeng, Michael, Tilsted, Hans Henrik, Thayssen, Per, Bøttcher, Morten, Lassen, Jens Flensted, Krusell, Lars Romer, Rasmussen, Klaus, Hansen, Knud Nørregaard, Pedersen, Lars, Johnsen, Søren Paaske, Sørensen, Henrik Toft, and Thuesen, Leif
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SURGICAL stents , *METALS in medicine , *RAPAMYCIN , *PACLITAXEL , *HEALTH outcome assessment , *DISEASE risk factors , *DISEASE incidence - Abstract
Objectives: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). Background: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. Results: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. Conclusions: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients. [Copyright &y& Elsevier]
- Published
- 2009
- Full Text
- View/download PDF
35. Comparison of the Sirolimus-Eluting Versus Paclitaxel-Eluting Coronary Stent in Patients With Diabetes Mellitus: The Diabetes and Drug-Eluting Stent (DiabeDES) Randomized Angiography Trial † [†] A list of participating centers and investigators appears in the .
- Author
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Maeng, Michael, Jensen, Lisette Okkels, Galloe, Anders Michael, Thayssen, Per, Christiansen, Evald Hoej, Hansen, Knud Nørregaard, Helqvist, Steffen, Botker, Hans Erik, Lassen, Jens Flensted, and Thuesen, Leif
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- *
SURGICAL stents , *RAPAMYCIN , *PACLITAXEL , *CORONARY heart disease surgery , *ANGIOGRAPHY , *PEOPLE with diabetes , *MEDICAL care - Abstract
The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 ± 0.54 vs 0.44 ± 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent. [Copyright &y& Elsevier]
- Published
- 2009
- Full Text
- View/download PDF
36. TCT-151 Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared With the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial
- Author
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Hansen, Kirstine, Jensen, Lisette Okkels, Maeng, Michael, Christensen, Martin Kirk, Kahlert, Johnny, Jakobsen, Lars, Junker, Anders, Freeman, Phillip, Noori, Manijeh, Ellert, Julia, Raungaard, Bent, Terkelsen, Christian, Hansen, Henrik, and Christiansen, Evald
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- *
PERCUTANEOUS coronary intervention , *TREATMENT effectiveness , *POLYMERS - Published
- 2021
- Full Text
- View/download PDF
37. Intravascular Ultrasound Assessment of Expansion of the Sirolimus-Eluting (Cypher Select) and Paclitaxel-Eluting (Taxus Express-2) Stent in Patients With Diabetes Mellitus
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Jensen, Lisette Okkels, Maeng, Michael, Mintz, Gary S., Christiansen, Evald Hoej, Hansen, Knud Noerregaard, Galloe, Anders, Kelbaek, Henning, Hansen, Henrik Steen, Joergensen, Erik, Lassen, Jens Flensted, Thuesen, Leif, and Thayssen, Per
- Subjects
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PEOPLE with diabetes , *DIABETES , *SURGICAL stents , *HYPERPLASIA , *CORONARY restenosis - Abstract
Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of this study was to evaluate DES expansion in patients with diabetes. Ninety-five patients with diabetes were randomized to Cypher Select (n = 48) or Taxus Express-2 (n = 47) stent implantation. Intravascular ultrasound was performed after stent implantation. Stent expansion was defined as the ratio of measured to predicted minimum stent diameter. There was a trend for lower stent expansion in the Cypher Select stent group (0.74 ± 0.08 vs 0.78 ± 0.11 in the Taxus Express-2 stent group, p = 0.061). Cypher Select stents achieved a final minimal stent cross-sectional area of 5.5 ± 1. 8 mm2, compared with 6.4 ± 1.9 mm2 for Taxus Express-2 stents (p = 0.015). For stents with nominal diameters ≥2.75 mm (Cypher Select n = 40, Taxus Express-2 n = 38), 42.5% of the Cypher Select stents and 10.5% of the Taxus Express-2 stents did not achieve a final minimum stent area of 5 mm2 (p = 0.002). Insulin treatment (relative risk 0.31, 95% confidence interval 0.10 to 0.95, p = 0.041) and stent type (relative risk 0.15, 95% CI 0.04 to 0.53, p = 0.003) were independent predictors of not achieving a minimum stent area >5.0 mm2. In conclusion, an important percentage of DES in patients with diabetes fail to achieve the manufacturers'' predicted final minimal stent diameter. Cypher Select stent and insulin treatment were independent predictors of not achieving a minimum stent area >5.0 mm2. [Copyright &y& Elsevier]
- Published
- 2008
- Full Text
- View/download PDF
38. Comparison of Intravascular Ultrasound and Angiographic Assessment of Coronary Reference Segment Size in Patients With Type 2 Diabetes Mellitus
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Jensen, Lisette Okkels, Thayssen, Per, Mintz, Gary S., Egede, Rasmus, Maeng, Michael, Junker, Anders, Galloee, Anders, Christiansen, Evald Hoej, Pedersen, Knud Erik, Hansen, Henrik Steen, and Hansen, Knud Noerregaard
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- *
ANGIOGRAPHY , *TYPE 2 diabetes , *MEDICAL radiography , *BLOOD vessels - Abstract
During percutaneous coronary intervention, the reference segment is assessed angiographically. This report described the discrepancy between angiographic and intravascular ultrasound (IVUS) assessment of reference segment size in patients with type 2 diabetes mellitus. Preintervention IVUS was used to study 62 de novo lesions in 41 patients with type 2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/external elastic membrane (EEM) CSA. Using IVUS, the reference lumen diameter was 2.80 ± 0.42 mm and the reference EEM diameter was 4.17 ± 0.56 mm. The angiographic reference diameter was 2.63 ± 0.36 mm. Mean difference between the IVUS EEM diameter and angiographic reference diameter was 1.56 ± 0.55 mm. The mean difference between the IVUS reference lumen diameter and angiographic reference lumen diameter was 0.18 ± 0.44 mm. Plaque burden in the reference segment correlated inversely with the difference between IVUS and quantitative coronary angiographic reference lumen diameter (slope = −0.12, 95% confidence interval −0.17 to −0.07, p <0.001), but it was not related to the absolute angiographic reference lumen diameter. Thus, reference segment diameters in type 2 diabetic patients were larger using IVUS than angiography, especially in the setting of larger plaque burden. In conclusion, these findings combined with inadequate remodeling may explain the angiographic appearance of small arteries in diabetic patients. [Copyright &y& Elsevier]
- Published
- 2008
- Full Text
- View/download PDF
39. Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions
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Jensen, Lisette Okkels, Maeng, Michael, Kaltoft, Anne, Thayssen, Per, Hansen, Hans Henrik Tilsted, Bottcher, Morten, Lassen, Jens Flensted, Krussel, Lars Romer, Rasmussen, Klaus, Hansen, Knud Noerregaard, Pedersen, Lars, Johnsen, Soeren Paaske, Soerensen, Henrik Toft, and Thuesen, Leif
- Subjects
- *
SURGICAL stents , *THROMBOSIS risk factors , *MYOCARDIAL infarction , *DEATH - Abstract
Objectives: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). Background: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used. Results: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67). Conclusions: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents. [Copyright &y& Elsevier]
- Published
- 2007
- Full Text
- View/download PDF
40. Accuracy of Electrocardiographic-Gated Versus Nongated Volumetric Intravascular Ultrasound Measurements of Coronary Arterial Narrowing
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Jensen, Lisette Okkels and Thayssen, Per
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INTRAVASCULAR ultrasonography , *ELECTROCARDIOGRAPHY , *HEART disease diagnosis , *CARDIAC patients , *CORONARY disease - Abstract
Intravascular ultrasound (IVUS) allows precise measurements of plaque plus media (P+M) volume and neointimal hyperplasia after coronary artery stenting. Conventional IVUS volumetric analysis is performed mostly without electrocardiographically gated acquisition, and the IVUS images are selected at 1-mm intervals, whereas the electrocardiographically gated approach consists of images in end-diastole. The accuracy in the luminal, P+M, and external elastic membrane (EEM) volumes between 2 pullbacks with the electrocardiographically gated and nongated approaches has not previously been compared. In 15 patients, 19 segments were studied with electrocardiographically gated and nongated IVUS systems. Two identical pullbacks were performed with each system using the same IVUS catheter. Volumes of the lumen, EEM, and P+M obtained using the electrocardiographically gated pullback technique did not differ significantly from the corresponding volumes obtained using the nongated pullback technique (lumen: 109.7 ± 47.7 vs 109.2 ± 45.0 mm3, p = NS; EEM: 242.6 ± 109.2 vs 235.0 ± 108.1 mm3, p = NS; P+M: 134.8 ± 67.7 vs 129.8 ± 69.1 mm3, p = NS). No significant differences were seen in changes between 2 electrocardiographically gated and 2 nongated pullbacks (lumen: 0.37 ± 1.76 vs −0.23 ± 2.32 mm3, p = NS; EEM: 0.25 ± 3.22 vs −0.94 ± 4.27 mm3, p = NS; P+M: −0.18 ± 3.42 vs −0.74 ± 3.88 mm3, p = NS). In conclusion, in moderate atherosclerotic or stented coronary arteries, electrocardiographically gated IVUS acquisition is not superior in accuracy to conventional nongated IVUS acquisition. [Copyright &y& Elsevier]
- Published
- 2007
- Full Text
- View/download PDF
41. Short- and long-term influence of diet and simvastatin on brachial artery endothelial function
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Jensen, Lisette Okkels, Thayssen, Per, Pedersen, Knud Erik, and Haghfelt, Torben
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CORONARY disease , *HEART diseases , *HYPERCHOLESTEREMIA , *ISCHEMIA - Abstract
Abstract: Background: Endothelium-dependent dilation (EDD) has often been studied in patients with hypercholesterolemia without overt coronary atherosclerosis where an improvement after statin treatment has been documented within few weeks. The aim of the study was to assess the short-term effect of diet as well as short- and long-term effect of simvastatin on EDD in patients with hypercholesterolemia and ischemic heart disease. Methods: In 43 male patients with hypercholesterolemia and ischemic heart disease, EDD of the brachial artery was measured at baseline, after 3 months on a lipid-lowering diet, and after another 1, 3 and 12 months on simvastatin at 40 mg/day. Results: Three months changes in EDD were neither influenced by diet nor short-term simvastatin therapy (4.9% vs. 4.9% vs. 4.8%, p =ns). Twelve months simvastatin treatment, however, significantly improved EDD by 32.7% (4.9% vs. 6.5%, p =0.007). By regression analysis an individual adjusted increase in EDD during the simvastatin treatment period was seen (coefficient 0.132 a month, p =0.002). A significant reduction in total cholesterol of 31.0% (6.1±0.8 vs. 4.2±0.7, p <0.001) and LDL cholesterol of 42.6% (4.0±0.8 vs. 2.2±0.6, p <0.001) was observed. Conclusion: EDD is improved after long-term simvastatin therapy; however, neither did 3 months diet or 3 months simvastatin therapy has influence on the EDD. [Copyright &y& Elsevier]
- Published
- 2006
- Full Text
- View/download PDF
42. Low variation and high reproducibility in plaque volume with intravascular ultrasound
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Jensen, Lisette Okkels, Thayssen, Per, Pedersen, Knud Erik, Stender, Steen, and Haghfelt, Torben
- Subjects
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ANGIOGRAPHY , *ATHEROSCLEROSIS , *ELECTROCARDIOGRAPHY , *HEART diseases - Abstract
Background: Intravascular ultrasound (IVUS) has several advantages compared to angiography when evaluating coronary atherosclerosis in the vessel wall. Methods: The accuracy, reproducibility, and short-time spontaneous variation in volume of vessel, plaque and lumen were studied by electrocardiographic-gated three-dimensional (3D) IVUS in 20 male patients with ischaemic heart disease (IHD). Results: The study lesions were angiographically insignificant, with a length of the analysed segment on 11.4±5.9 mm. At baseline the mean minimal lumen diameter was 2.41±0.59 mm, minimal lumen area 4.82±2.38 mm2, and maximal plaque burden 65.61±9.57%. Mean reference diameter was 3.1±0.6 mm. No significant changes were observed in volumes of total vessel, lumen or plaque. The coefficient of variation (CV) for two volume measurements at baseline was: vessel 0.8%, plaque 1.3%, and lumen 1.4%. For measurements recorded at baseline and after 12.6±1.5 weeks, CV was respectively 3.5%, 3.3% and 6.6%. Reproducibility and interobserver and intraobserver variation showed very high correlations. A linear correlation was present in percent changes over 12.6±1.5 weeks between vessel volume and lumen volume (r=0.804; p<0.001) and between percent changes in plaque volume and vessel volume (r=0.581; p=0.007). No correlation was found between changes in plaque volume and lumen volume (r=0.015; p=0.950). Conclusion: ECG-gated 3D IVUS is a highly reproducible method when applied on coronary artery atherosclerosis. CV for lumen volume over 12.6±1.5 weeks is twice that of plaque volume indicating the superiority of the 3D IVUS compared to coronary angiography (CAG). [Copyright &y& Elsevier]
- Published
- 2004
- Full Text
- View/download PDF
43. TCT-267 Impact of Microaxial Flow Pump on Central Hemodynamics and Use of Vasoactive Drugs During Intensive Care After Infarct-Related Cardiogenic Shock: A Secondary Analysis of the Danger Shock Trial.
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Junker Udesen, Nanna Louise, Beske, Rasmus, Jensen, Lisette Okkels, Eiskjær, Hans, Mangner, Norman, Polzin, Amin, Schulze, P. Christian, Skurk, Carsten, Nordbeck, Peter, Clemmensen, Peter, Panoulas, Vasileios, Zimmer, Sebastian, Schaefer, Andreas, Engstroem, Thomas, Holmvang, Lene, Junker, Anders, Schmidt, Henrik, Terkelsen, Christian, Linke, Axel, and Westenfeld, Ralf
- Subjects
- *
CARDIOGENIC shock , *CRITICAL care medicine , *SECONDARY analysis , *HEMODYNAMICS , *DRUG utilization - Published
- 2024
- Full Text
- View/download PDF
44. High sensitive C-reactive protein and interleukin 6 are not related to neointimal hyperplasia in paclitaxel eluting stents or bare metal stents. An intravascular ultrasound study
- Author
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Klitkou, Jakob, Jensen, Lisette Okkels, Hansen, Henrik Steen, and Thayssen, Per
- Subjects
- *
C-reactive protein , *INTERLEUKIN-6 , *HYPERPLASIA , *PACLITAXEL - Abstract
Abstract: Implantation of coronary stents after percutaneous coronary intervention (PCI) may result in an inflammatory response with an increase in high sensitive C-reactive protein (Hs-CRP) and interleukin 6 (IL-6). In 25 patients Hs-CRP and IL-6 increased after coronary artery stenting, however, the increase in the inflammatory response did not differ between PES and BMS stents. The inflammatory response did not predict neointima hyperplasia measured by intravascular ultrasound after 6 months. [Copyright &y& Elsevier]
- Published
- 2007
- Full Text
- View/download PDF
45. TCT-197 Early Vascular Healing after Implantation of a Biolimus-Coated BioFreedom stent or a Sirolimus Eluting Orsiro stent in Patients with ST-segment Elevation Myocardial Infarction.
- Author
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Hansen, Kirstine, Jensen, Lisette Okkels, Maeng, Michael, Antonsen, Lisbeth, Maehara, Akiko, Jakobsen, Lars, Ellert, Julia, Terkelsen, Christian, Ahlehoff, Ole, Thim, Troels, christian oliver fallesen, Carstensen, Steen, Hansen, Knud Nørregaard, Veien, Karsten, and Christiansen, Evald
- Subjects
- *
MYOCARDIAL infarction , *RAPAMYCIN - Published
- 2018
- Full Text
- View/download PDF
46. TCT-737 Very Late Stent Thrombosis after Revascularization with Biodegradable Polymer Drug-Eluting Stents. From the SORT OUT VII Trial.
- Author
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Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Hansen, Knud, Kahlert, Johnny, Jensen, Svend Eggert, Ellert, Julia, Terkelsen, Christian, Botker, Hans Erik, Kristensen, Steen Dalby, Hansen, Henrik, Lassen, Jens, Veien, Karsten, and Christiansen, Evald
- Subjects
- *
DRUG-eluting stents , *BIODEGRADABLE nanoparticles , *THROMBOSIS - Published
- 2018
- Full Text
- View/download PDF
47. TCT-90 Clinical Outcomes Three Year After Revascularization With a Biodegradable Polymer Ultra-thin Strut Sirolimus-eluting Stent and a Biodegradable Polymer Biolimus-eluting Stent. From the SORT OUT VII trial.
- Author
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Ellert, Julia, Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Terkelsen, Christian, Hansen, Knud, Kahlert, Johnny, Jensen, Svend Eggert, Bøtker, Hans Erik, Hansen, Henrik, Aaroe, Jens, Kristensen, Steen Dalby, Lassen, Jens, Veien, Karsten, and Christiansen, Evald
- Subjects
- *
BIODEGRADABLE nanoparticles , *DRUG-eluting stents , *DRUG coatings - Published
- 2018
- Full Text
- View/download PDF
48. TCT-740 3-year Clinical Outcomes of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients with Acute Coronary Syndroms (a SORT OUT VI Substudy).
- Author
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Raungaard, Bent, Jensen, Lisette Okkels, Jensen, Svend Eggert, Hansen, Henrik, Thuesen, Leif, Aaroe, Jens, Villadsen, Anton, Veien, Karsten, Junker, Anders, Madsen, Morten, Maeng, Michael, Kristensen, Steen Dalby, and Christiansen, Evald
- Subjects
- *
DRUG-eluting stents , *ACUTE coronary syndrome , *PATIENTS - Published
- 2017
- Full Text
- View/download PDF
49. TCT-451 Two-year outcomes after revascularization with a biodegradable polymer ultra-thin strut sirolimus eluting stent and a biodegradable polymer biolimus-eluting stent. From the SORT OUT VII trial.
- Author
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Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Hansen, Knud Noerregaard, Kahlert, Johnny, Jensen, Svend Eggert, Bøtker, Hans Erik, Hansen, Henrik, Lassen, Jens Flensted, and Christiansen, Evald
- Subjects
- *
MYOCARDIAL revascularization , *BIODEGRADABLE materials , *MEDICAL polymers , *RAPAMYCIN , *DRUG-eluting stents , *CLINICAL trials - Published
- 2016
- Full Text
- View/download PDF
50. TCT-321 Definite and probable stent thrombosis after revascularization with drug-eluting stents with a biodegradable polymer. From the randomized SORT OUT VII Trial.
- Author
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Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Hansen, Knud Noerregaard, Kahlert, Johnny, Jensen, Svend Eggert, Bøtker, Hans Erik, Hansen, Henrik, Lassen, Jens Flensted, and Christiansen, Evald
- Subjects
- *
CARDIOVASCULAR disease treatment , *THROMBOSIS , *REVASCULARIZATION (Surgery) , *DRUG-eluting stents , *BIODEGRADABLE materials , *RANDOMIZED controlled trials - Published
- 2016
- Full Text
- View/download PDF
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