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5. Randomized Trials Fit for the 21st Century: A Joint Opinion From the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation

Author

Bowman, Louise, Weidinger, Franz, Albert, Michelle A., Fry, Edward T.A., Pinto, Fausto J., Achenbach, Stephan, Bowman, Louise, Casadei, Barbara, Collins, Rory, Devereaux, Philip J., Douglas, Pamela S., Frobert, Ole, Goto, Shinya, Grines, Cindy, Harrington, Robert A., Haynes, Richard, Hochman, Judith S., James, Stefan, Kirchhof, Paulus, Komajda, Michel, Lam, Carolyn S.P., Landray, Martin, Maggioni, Aldo, McMurray, John, Medhurst, Nick, Neal, Bruce, Rydén, Lars, Thiele, Holger, Van Gelder, Isabelle, Wallentin, Lars, Yusuf, Salim, and Zannad, Faiez

Published
2023
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6. Remodeling of skeletal muscle myosin metabolic states in hibernating mammals.

Author

Lewis, Christopher T. A., Melhedegaard, Elise G., Ognjanovic, Marija M., Olsen, Mathilde S., Laitila, Jenni, Seaborne, Robert A. E., Gronset, Magnus, Changxin Zhang, Hiroyuki Iwamoto, Hessel, Anthony L., Kuehn, Michel N., Merino, Carla, Amigo, Nuria, Frobert, Ole, Giroud, Sylvain, Staples, James F., Goropashnaya, Anna V., Fedorov, Vadim B., Barnes, Brian, and Toien, Oivind

Published
2024
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7. Immobility-associated thromboprotection is conserved across mammalian species from bear to human

Author

Thienel, Manuela, primary, Müller-Reif, Johannes B., additional, Zhang, Zhe, additional, Ehreiser, Vincent, additional, Huth, Judith, additional, Shchurovska, Khrystyna, additional, Kilani, Badr, additional, Schweizer, Lisa, additional, Geyer, Philipp E., additional, Zwiebel, Maximilian, additional, Novotny, Julia, additional, Lüsebrink, Enzo, additional, Little, Gemma, additional, Orban, Martin, additional, Nicolai, Leo, additional, El Nemr, Shaza, additional, Titova, Anna, additional, Spannagl, Michael, additional, Kindberg, Jonas, additional, Evans, Alina L., additional, Mach, Orpheus, additional, Vogel, Matthias, additional, Tiedt, Steffen, additional, Ormanns, Steffen, additional, Kessler, Barbara, additional, Dueck, Anne, additional, Friebe, Andrea, additional, Jørgensen, Peter Godsk, additional, Majzoub-Altweck, Monir, additional, Blutke, Andreas, additional, Polzin, Amin, additional, Stark, Konstantin, additional, Kääb, Stefan, additional, Maier, Doris, additional, Gibbins, Jonathan M., additional, Limper, Ulrich, additional, Frobert, Ole, additional, Mann, Matthias, additional, Massberg, Steffen, additional, and Petzold, Tobias, additional

Published
2023
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8. 532 SEX-RELATED DIFFERENCES IN THROMBUS BURDEN IN ST-ELEVATION MYOCARDIAL INFARCTION PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION

Author

Manzi, Maria Virginia, primary, Buccheri, Sergio, additional, Jolly, Sanjit S, additional, Zijlstra, Felix, additional, Frobert, Ole, additional, Lagerqvist, Bo, additional, Mahmoud, Karim D, additional, Dzavik, Vladimir, additional, Barbato, Emanuele, additional, Sarno, Giovanna, additional, and James, Stefan, additional

Published
2022
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10. Randomized trials fit for the 21st century. A joint opinion from the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation

Author

Bowman, Louise, Weidinger, Franz, Albert, Michelle A., Fry, Edward T. A., Pinto, Fausto J., Achenbach, Stephan, Casadei, Barbara, Collins, Rory, Devereaux, Philip J., Douglas, Pamela S., Frobert, Ole, Goto, Shinya, Grines, Cindy, Harrington, Robert A., Haynes, Richard, Hochman, Judith S., Charney, Leon H., James, Stefan, Kirchhof, Paulus, Komajda, Michel, Lam, Carolyn S. P., Landray, Martin, Maggioni, Aldo, McMurray, John, Medhurst, Nick, Mehran, Roxana, Neal, Bruce, Rydén, Lars, Thiele, Holger, Van Gelder, Isabelle, Wallentin, Lars, Yusuf, Salim, Zannad, Faiez, and Repositório da Universidade de Lisboa

Abstract

© The Author(s) 2022. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. When citing this article, a citation from any of the journals listed is appropriate. For commercial re-use, please contact journals.permissions@oup.com, Randomized controlled trials are the cornerstone for reliably evaluating therapeutic strategies. However, during the past 25 years, the rules and regulations governing randomized trials and their interpretation have become increasingly burdensome, and the cost and complexity of trials has become prohibitive. The present model is unsustainable, and the development of potentially effective treatments is often stopped prematurely on financial grounds, while existing drug treatments or non-drug interventions (such as screening strategies or management tools) may not be assessed reliably. The current ‘best regulatory practice’ environment, and a lack of consensus on what that requires, too often makes it unduly difficult to undertake efficient randomized trials able to provide reliable evidence about the safety and efficacy of potentially valuable interventions. Inclusion of underrepresented population groups and lack of diversity also remain among the challenges.

Published
2022

13. Short‐ and Long‐Term Clinical Outcomes for Patients With Takotsubo Syndrome and Patients With Myocardial Infarction: A Report From the Swedish Coronary Angiography and Angioplasty Registry

Author

Redfors, Björn, primary, Jha, Sandeep, additional, Thorleifsson, Sigurdur, additional, Jernberg, Tomas, additional, Angerås, Oskar, additional, Frobert, Ole, additional, Petursson, Petur, additional, Tornvall, Per, additional, Sarno, Giovanna, additional, Ekenbäck, Christina, additional, Ravn‐Fisher, Annika, additional, Y‐Hassan, Shams, additional, Lyon, Alexander R., additional, James, Stefan, additional, Erlinge, David, additional, and Omerovic, Elmir, additional

Published
2021
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15. Undiagnosed SARS-CoV-2 infection and outcome in patients with acute MI and no COVID-19 symptoms

Author

Akhtar, Zubair, primary, Chowdhury, Fahmida, additional, Aleem, Mohammad Abdul, additional, Ghosh, Probir Kumar, additional, Rahman, Mahmudur, additional, Rahman, Mustafizur, additional, Hossain, Mohammad Enayet, additional, Sumiya, Mariya Kibtiya, additional, Islam, A K M Monwarul, additional, Uddin, Mir Jamal, additional, MacIntyre, C Raina, additional, Cajander, Sara, additional, and Frobert, Ole, additional

Published
2021
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16. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale

Author

Frobert, Ole, Lagerqvist, Bo, Gudnason, ThoRarinn, Thuesen, Leif, Svensson, Roger, Olivecrona, GoRan K., and James, Stefan K.

Subjects
Angiography, Angioplasty, Heart attack, Blood clot, Thrombosis, Health
Abstract

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ahj.2010.08.040 Byline: Ole Frobert, Bo Lagerqvist, Thorarinn Gudnason, Leif Thuesen, Roger Svensson, Goran K. Olivecrona, Stefan K. James Abstract: In ST-elevation myocardial infarction (STEMI), distal embolization of thrombus material often precludes restoration of normal coronary artery flow. Small-scaled studies have demonstrated that intracoronary thrombus aspiration improves flow and myocardial perfusion, but only one larger randomized single-center study has suggested a survival benefit. Thrombus aspiration is widely used in clinical practice and is recommended by international guidelines despite limited evidence. Article History: Received 25 June 2010; Accepted 21 August 2010 Article Note: (footnote) RCT reg # NCT01093404.

Published
2010

17. Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease

Author

De Bruyne, Bernard, Fearon, William F., Pijls, Nico H.J., Barbato, Emanuele, Tonino, Pim, Piroth, Zsolt, Jagic, Nikola, Mobius-Winckler, Sven, Rioufol, Gilles, Witt, Nils, Kala, Petr, MacCarthy, Philip, Engström, Thomas, Oldroyd, Keith, Mavromatis, Kreton, Manoharan, Ganesh, Verlee, Peter, Frobert, Ole, Curzen, Nick, Johnson, Jane B., Limacher, Andreas, Nüesch, Eveline, and Jüni, Peter

Published
2014
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18. Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

Author

De Bruyne, Bernard, Pijls, Nico H.J., Kalesan, Bindu, Barbato, Emanuele, Tonino, Pim A.L., Piroth, Zsolt, Jagic, Nikola, Mobius-Winckler, Sven, Rioufol, Gilles, Witt, Nils, Kala, Petr, MacCarthy, Philip, Engström, Thomas, Oldroyd, Keith G., Mavromatis, Kreton, Manoharan, Ganesh, Verlee, Peter, Frobert, Ole, Curzen, Nick, Johnson, Jane B., Jüni, Peter, and Fearon, William F.

Published
2012
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21. Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV

Author

Kumsars, Indulis, primary, Holm, Niels Ramsing, additional, Niemelä, Matti, additional, Erglis, Andrejs, additional, Kervinen, Kari, additional, Christiansen, Evald Høj, additional, Maeng, Michael, additional, Dombrovskis, Andis, additional, Abraitis, Vytautas, additional, Kibarskis, Aleksandras, additional, Trovik, Thor, additional, Latkovskis, Gustavs, additional, Sondore, Dace, additional, Narbute, Inga, additional, Terkelsen, Christian Juhl, additional, Eskola, Markku, additional, Romppanen, Hannu, additional, Laine, Mika, additional, Jensen, Lisette Okkels, additional, Pietila, Mikko, additional, Gunnes, Pål, additional, Hebsgaard, Lasse, additional, Frobert, Ole, additional, Calais, Fredrik, additional, Hartikainen, Juha, additional, Aarøe, Jens, additional, Ravkilde, Jan, additional, Engstrøm, Thomas, additional, Steigen, Terje K, additional, Thuesen, Leif, additional, and Lassen, Jens F, additional

Published
2020
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23. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

Author

Frobert, Ole, Gotberg, Matthias, Erlinge, David, Akhtar, Zubair, Christiansen, Evald H., MacIntyre, Chandini R., Oldroyd, Keith G., Motovska, Zuzana, Erglis, Andrejs, Moer, Rasmus, Hlinomaz, Ota, Jakobsen, Lars, Engstrom, Thomas, Jensen, Lisette O., Fallesen, Christian O., Jensen, Svend E, Angeras, Oskar, Calais, Fredrik, Karegren, Amra, and Lauermann, Jorg

Subjects
*INFLUENZA vaccines, *MYOCARDIAL infarction, *CORONARY disease, *SEASONAL influenza, CARDIOVASCULAR disease related mortality
Abstract

Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease.Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis.Results: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively.Conclusions: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608. [ABSTRACT FROM AUTHOR]

Published
2021
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24. Relation between zero-stress state and branching order of porcine left coronary arterial tree

Author

Frobert, Ole, Gregersen, Hans, Bjerre, Jesper, Bagger, Jens P., and Kassab, Ghassan S.

Subjects
Swine -- Physiological aspects, Coronary arteries -- Physiological aspects, Heart -- Physiological aspects, Biological sciences
Abstract

A study was conducted to analyze the association between zero stress state and branching order of porcine left coronary arterial tree of pigs. the dissection of the left coronary arterial tree was carried out under a stereo dissection microscope. The influence of temperature on the opening angle was also examined. Experimental results indicated that the opening angle of the porcine left coronary artery tree differed linearly with the order number of its branches.

Published
1998

26. Impact of Thrombus Aspiration on Mortality, Stent Thrombosis, and Stroke in Patients With ST-Segment-Elevation Myocardial Infarction : A Report From the Swedish Coronary Angiography and Angioplasty Registry

Author

Angeras, Oskar, Haraldsson, Inger, Redfors, Bjorn, Frobert, Ole, Petursson, Petur, Albertsson, Per, Ioanes, Dan, Odenstedt, Jacob, Olsson, Hans, Witt, Nils, Ruck, Andreas, Millgard, Jonas, Nilsson, Johan, Persson, Jonas, Soderbom, Mans, Wedel, Hans, Erlinge, David, James, Stefan, Ramunddal, Truls, and Omerovic, Elmir

Subjects
myocardial infarction, Kardiologi, thrombectomy, Cardiac and Cardiovascular Systems, cardiovascular diseases, primary percutaneous coronary intervention
Abstract

Background-Thrombus aspiration is still being used in a substantial number of patients despite 2 large randomized clinical trials showing no favorable effect of routine thrombus aspiration during primary percutaneous coronary intervention in patients with STsegment- elevation myocardial infarction. The aim of this observational study was to evaluate the impact of thrombus aspiration on mortality, stent thrombosis, and stroke using all available data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Methods and Results-We identified 42 829 consecutive patients registered in SCAAR between January 2005 and September 2014 who underwent percutaneous coronary intervention for ST-segment-elevation myocardial infarction. Thrombus aspiration was used in 25% of the procedures. We used instrumental variable analysis with administrative healthcare region as the treatmentpreference instrumental variable to evaluate the effect of thrombus aspiration on mortality, stent thrombosis, and stroke. Thrombus aspiration was not associated with mortality at 30 days (risk reduction: -1.2; 95% confidence interval [CI], -5.4 to 3.0; P=0.57) and 1 year (risk reduction: -2.4; 95% CI, -7.6 to 3.0; P=0.37). Thrombus aspiration was associated with a lower risk of stent thrombosis both at 30 days (risk reduction: -2.7; 95% CI, -4.1 to -1.4; P

Published
2018

30. TCT-621 Comparison of Quantitative Flow Ratio and Instantaneous Wave-Free Ratio for Immediate Assessment of Non-Culprit Lesions in Patients With ST-Segment Elevation Myocardial Infarction An iSTEMI Substudy

Author

Sejr-Hansen, Martin, primary, Westra, Jelmer, additional, Thim, Troels, additional, Christiansen, Evald, additional, Eftekhari, Ashkan, additional, Kristensen, Steen Dalby, additional, Jakobsen, Lars, additional, Götberg, Matthias, additional, Frobert, Ole, additional, van der Hoeven, Nina, additional, Holm, Niels, additional, and Maeng, Michael, additional

Published
2018
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31. CLINICAL IMPACT OF DIRECT STENTING AND INTERACTION WITH THROMBUS ASPIRATION IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: THROMBECTOMY TRIALISTS COLLABORATION

Author

Mahmoud, Karim D., primary, Jolly, Sanjit, additional, James, Stefan, additional, Dzavik, Vladimir, additional, Cairns, John, additional, Yusuf, Salim, additional, Olivecrona, Goran, additional, Renlund, Henrik, additional, Gao, Peggy, additional, Lagerqvist, Bo, additional, Alazzoni, Ashraf, additional, Kedev, Sasko, additional, Stankovic, Goran, additional, Meeks, Brandi, additional, Frobert, Ole, additional, and Zijlstra, Felix, additional

Published
2018
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32. Short- and Long-Term Clinical Outcomes for Patients with Takotsubo Syndrome Versus Myocardial Infarction: A Report from the Swedish Coronary Angiography and Angioplasty Registry

Author

Redfors, Björn, primary, Jha, Sandeep, additional, Thorleifsson, Sigurdur, additional, Jernberg, Tomas, additional, Angerås, Oskar, additional, Frobert, Ole, additional, Petrusson, Petur, additional, Tornvall, Per, additional, Sarno, Giovanna, additional, Ekenbäck, Christina, additional, Ravn-Fisher, Annika, additional, Younis-Hassan, Shams, additional, Lyon, Alexander, additional, James, Stefan, additional, Erlinge, David, additional, and Omerovic, Elmir, additional

Published
2018
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35. TCT-216 Agreement between iFR and FFR in staged follow-up evaluation of non-culprit stenoses after ST-segment elevation myocardial infarction (iSTEMI substudy)

Author

Thim, Troels, primary, Götberg, Matthias, additional, Frobert, Ole, additional, Nijveldt, Robin, additional, van Royen, Niels, additional, Baptista, Sergio, additional, Koul, Sasha, additional, Kellerth, Thomas, additional, Botker, Hans Erik, additional, Christiansen, Evald, additional, Jakobsen, Lars, additional, Kristensen, Steen Dalby, additional, and Maeng, Michael, additional

Published
2017
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36. Thrombus aspiration in patients with large anterior myocardial infarction : A Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia trial substudy

Author

Calais, Fredrik, Lagerqvist, Bo, Leppert, Jerzy, James, Stefan K., and Frobert, Ole

Subjects
Kardiologi, Cardiac and Cardiovascular Systems, cardiovascular diseases
Abstract

Background The TASTE trial did not demonstrate clinical benefit of thrombus aspiration (TA). High-risk patients might benefit from TA. Methods The TASTE trial was a multicenter, randomized, controlled, open-label trial obtaining end points from national registries. Patients (n = 7,244) with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) were randomly assigned 1: 1 to TA and PCI or to PCI alone. We assessed the 1-year clinical effect of TA in a subgroup with potentially large anterior STEMI: mid or proximal left anterior descending coronary artery infarct lesion, thrombolysis in myocardial infarction 0 to 2 flow, and symptom onset to PCI time = 5 hours. In this substudy, patient eligibility criteria corresponded to that of the INFUSE-AMI study. Results In total, 1,826 patients fulfilled inclusion criteria. All-cause mortality at 1 year of patients randomized to TA did not differ from those randomized to PCI only (hazard ratio [HR] 1.05, 95% CI 0.74-1.49, P = .77). Rates of rehospitalization for myocardial infarction, heart failure, and stent thrombosis did not differ between groups (HR 0.87, 95% CI 0.51-1.46, P = .59; HR 1.10 95% CI 0.77-1.58, P = .58; and HR 0.75, 95% CI 0.30-1.86, P = .53, respectively). This was also the case for the combined end point of all-cause mortality and rehospitalization for myocardial infarction, heart failure, or stent thrombosis (HR 1.00, 95% CI 0.79-1.26, P = .99). Conclusion In patients with STEMI and large area of myocardium at risk, TA did not affect outcome within 1 year.

Published
2016

37. Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Five Year Clinical Outcome in The Nordic-Baltic Bifurcation Study III

Author

Niemelä, Matti, Holm, Niels R, Kervinen, Kari, Erglis, Andrejs, Maeng, Michael, Kumsars, Indulis, Jegere, Sanda, Steigen, Terje K, Eskola, Markku, Mäkikallio, Timo, Aaberge, Lars, Jensen, Lisette Okkels, Airaksinen, Juhani, Pietilä, Mikko, Frobert, Ole, Ravkilde, Jan, Jensen, Svend Eggert, Jensen, Jan S, Helqvist, Steffen, James, Stefan, Miettinen, Heikki, Lassen, Jens F, Thuesen, Leif, and Christiansen, Evald H

Abstract

Background- It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. Methods and Results- We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. Conclusions- MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.

Published
2015

39. Stent thrombosis in new-generation drug-eluting stents in patients with STEMI undergoing primary PCI:A report from SCAAR

Author

Sarno, Giovanna, Lagerqvist, Bo, Nilsson, Johan, Frobert, Ole, Hambraeus, Kristina, Varenhorst, Christoph, Jensen, Ulf J., Tödt, Tim, Götberg, Matthias, and James, Stefan K.

Subjects
ST-segment elevation myocardial infarction, percutaneous coronary intervention, cardiovascular diseases, drug-eluting stent(s)
Abstract

BACKGROUND: Some concerns still have not been resolved about the long-term safety of drug-eluting stents (DES) in patients with acute STEMI. OBJECTIVES: The aim of this study was to evaluate the stent thrombosis (ST) rate up to 3 years in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (n-DES) compared with bare-metal stents (BMS) and old-generation drug-eluting stents (o-DES) enrolled in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). METHODS: From January 2007 to January 2013, 34,147 patients with STEMI were treated by PCI with n-DES (n = 4,811), o-DES (n = 4,271), or BMS (n = 25,065). The risks of early/late (up to 1 year) and very late definite ST (after 1 year) were estimated. RESULTS: Cox regression landmark analysis showed a significantly lower risk of early/late ST in patients treated with n-DES (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.43 to 0.99; p = 0.04) and o-DES (HR: 0.60; 95% CI: 0.41 to 0.89; p = 0.01) compared with the BMS group. The risk of very late ST was similar between the n-DES and BMS groups (HR: 1.52; 95% CI: 0.78 to 2.98; p = 0.21), whereas a higher risk of very late ST was observed with o-DES compared with BMS (HR: 2.88; 95% CI: 1.70 to 4.89; p < 0.01). CONCLUSIONS: Patients treated with n-DES have a lower risk of early/late ST than patients treated with BMS. The risk of very late ST is low and comparable between n-DES and BMS up to 3 years of follow-up, whereas o-DES treatment is associated with an increased risk of very late ST. The current STEMI guidelines might require an update in light of the results of this and other recent studies.

Published
2014

41. TCT-25 Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Five Year Clinical Outcome in The Nordic-Baltic Bifurcation Study III

Author

Niemela, Matti J., primary, Holm, Niels R., additional, Kervinen, Kari, additional, Erglis, Andrejs, additional, Maeng, Michael, additional, Kumsars, Indulis, additional, Jegere, Sanda, additional, Steigen, Terje, additional, Eskola, Markku J., additional, Makikallio, Timo H., additional, Aaberge, Lars, additional, Jensen, Lisette Okkels, additional, Airaksinen, Juhani, additional, Pietila, Mikko, additional, Frobert, Ole, additional, Ravkilde, Jan, additional, Jensen, Svend Eggert, additional, Jensen, Jan S., additional, Helqvist, Steffen, additional, James, Stefan, additional, Miettinen, Heikki, additional, Lassen, Jens F., additional, Thuesen, Leif, additional, and Christiansen, Evald H., additional

Published
2015
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45. TCT-26 Randomized Comparison Of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation In Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting. Three Year Clinical Outcome In The Nordic-Baltic Bifurcation Study III

Author

Holm, Niels R., primary, Kervinen, Kari, additional, Niemela, Matti J., additional, Erglis, Andrejs, additional, Kumsars, Indulis, additional, Steigen, Terje, additional, Christiansen, Evald H., additional, Eskola, Markku, additional, Romppanen, Hannu, additional, Dombrovskis, Andis, additional, Frobert, Ole, additional, Åberge, Lars, additional, Gunnes, Pål, additional, Airaksinen, Juhani, additional, Hervold, Anders, additional, Jegere, Sanda, additional, Trovik, Thor, additional, Jensen, Lisette Okkels, additional, Maeng, Michael, additional, Makikallio, Timo, additional, Pietila, Mikko, additional, Sjögren, Iwar, additional, Thayssen, Per, additional, Vikman, Saila, additional, Lassen, Jens F., additional, and Thuesen, Leif, additional

Published
2013
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48. Randomized Comparison of Final Kissing Balloon Dilatation Versus No Final Kissing Balloon Dilatation in Patients With Coronary Bifurcation Lesions Treated With Main Vessel Stenting

Author

Niemelä, Matti, primary, Kervinen, Kari, additional, Erglis, Andrejs, additional, Holm, Niels R., additional, Maeng, Michael, additional, Christiansen, Evald H., additional, Kumsars, Indulis, additional, Jegere, Sanda, additional, Dombrovskis, Andis, additional, Gunnes, Pål, additional, Stavnes, Sindre, additional, Steigen, Terje K., additional, Trovik, Thor, additional, Eskola, Markku, additional, Vikman, Saila, additional, Romppanen, Hannu, additional, Mäkikallio, Timo, additional, Hansen, Knud N., additional, Thayssen, Per, additional, Åberge, Lars, additional, Jensen, Lisette O., additional, Hervold, Anders, additional, Airaksinen, Juhani, additional, Pietilä, Mikko, additional, Frobert, Ole, additional, Kellerth, Thomas, additional, Ravkilde, Jan, additional, Aarøe, Jens, additional, Jensen, Jan S., additional, Helqvist, Steffen, additional, Sjögren, Iwar, additional, James, Stefan, additional, Miettinen, Heikki, additional, Lassen, Jens F., additional, and Thuesen, Leif, additional

Published
2011
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