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  • 1.
    Andell, Pontus
    et al.
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    Karlsson, Sofia
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    Mohammad, Moman A.
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    Gotberg, Matthias
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Jensen, Jens
    Karolinska Inst, Soder Sjukhuset, Dept Clin Sci & Educ, Stockholm, Sweden.;Capio St Gorans Sjukhus, Unit Med, Stockholm, Sweden..
    Frobert, Ole
    Orebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden..
    Angeras, Oskar
    Sahlgrens Acad, Inst Med, Dept Mol & Clin Med, Gothenburg, Sweden.;Univ Gothenburg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Nilsson, Johan
    Umea Univ Hosp, Heart Ctr, Dept Cardiol, Umea, Sweden..
    Omerovic, Elmir
    Sahlgrens Acad, Inst Med, Dept Mol & Clin Med, Gothenburg, Sweden.;Univ Gothenburg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Persson, Jonas
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Div Cardiovasc Med, Stockholm, Sweden..
    Koul, Sasha
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    Erlinge, David
    Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden..
    Intravascular Ultrasound Guidance Is Associated With Better Outcome in Patients Undergoing Unprotected Left Main Coronary Artery Stenting Compared With Angiography Guidance Alone2017In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 10, no 5, article id e004813Article in journal (Refereed)
    Abstract [en]

    Background: Small observational studies have indicated better outcome with intravascular ultrasound (IVUS) guidance when performing unprotected left main coronary artery (LMCA) percutaneous coronary intervention (PCI), but the overall picture remains inconclusive and warrants further investigation. We studied the impact of IVUS guidance on outcome in patients undergoing unprotected LMCA PCI in a Swedish nationwide observational study.

    Methods and Results: Patients who underwent unprotected LMCA PCI between 2005 and 2014 because of stable coronary artery disease or acute coronary syndrome were included from the nationwide SCAAR (Swedish Coronary Angiography and Angioplasty Registry). Of 2468 patients, IVUS guidance was used in 621 (25.2%). The IVUS group was younger (median age, 70 versus 75 years) and had fewer comorbidities but more complex lesions. IVUS was associated with larger stent diameters (median, 4 mm versus 3.5 mm). After adjusting for potential confounders, IVUS was associated with significantly lower occurrence of the primary composite end point of all-cause mortality, restenosis, or definite stent thrombosis (hazard ratio, 0.65; 95% confidence interval, 0.50-0.84) and all-cause mortality alone (hazard ratio, 0.62; 95% confidence interval, 0.47-0.82). In 340 propensity score-matched pairs, IVUS was also associated with significantly lower occurrence of the primary end point (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80).

    Conclusions: IVUS was associated with an independent and significant outcome benefit when performing unprotected LMCA PCI. Potential mediators of this benefit include larger and more appropriately sized stents, perhaps translating into lower risk of subsequent stent thrombosis. Although residual confounding cannot be ruled out, our findings indicate a possible hazard when performing unprotected LMCA PCI without IVUS guidance.

  • 2. Bagai, Akshay
    et al.
    Huang, Zhen
    Lokhnygina, Yuliya
    Harrington, Robert A
    Armstrong, Paul W
    Strony, John
    White, Harvey D
    Leonardi, Sergio
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Van de Werf, Frans
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Tricoci, Pierluigi
    Mahaffey, Kenneth W
    Magnitude of troponin elevation and long-term clinical outcomes in acute coronary syndrome patients treated with and without revascularization.2015In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 8, no 6, article id e002314Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: In patients with non-ST-segment-elevation acute coronary syndrome (NSTE ACS), elevated troponin levels identify patients at high risk for adverse outcomes; however, it is unknown whether the magnitude of troponin elevation during hospitalization remains predictive of subsequent events in patients undergoing coronary revascularization.

    METHODS AND RESULTS: We studied 12 635 patients with NSTE ACS in the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) study with at least 1 troponin measurement during index hospitalization. Cox proportional hazards regression was used to examine the relationship between peak troponin level (standardized as the ratio of peak troponin value measured during hospitalization and local laboratory upper reference limit [URL]) and revascularization on all-cause mortality at 2 years. Revascularization (percutaneous coronary intervention or coronary artery bypass graft) was performed during index hospitalization in 8586 patients (68.0%); revascularized patients had higher peak troponin ratios (median, 23 versus 9.5× URL). Among patients that did not undergo revascularization, the mortality rate at 2 years increased in a curvilinear fashion with increasing levels of peak troponin. In contrast, the mortality rate at 2 years remained constant irrespective of peak troponin levels among revascularized patients (P for interaction=0.004). This relationship was unchanged after multivariable adjustment.

    CONCLUSIONS: There is a differential relationship between the magnitude of troponin elevation and long-term mortality in ACS patients treated with and without revascularization. Although prognostically important in patients treated without revascularization, the prognostic implications of peak troponin level seem to be minimal in revascularized patients.

  • 3.
    Buccheri, Sergio
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Sarno, Giovanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Frobert, Ole
    Orebro Univ Hosp, Dept Cardiol, Orebro, Sweden.
    Gudnason, Thorarinn
    Landspitali Univ Hosp, Reykjavik, Iceland;Univ Iceland, Dept Cardiol, Reykjavik, Iceland;Univ Iceland, Cardiovasc Res Ctr, Reykjavik, Iceland.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Lindholm, Daniel P
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Maeng, Michael
    Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark.
    Olivecrona, Goran
    Lund Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice The TASTE Trial in Perspective2019In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 12, no 3, article id e007381Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Registry-based randomized clinical trials have emerged as useful tools to provide evidence on the comparative efficacy and safety of different therapeutic strategies. However, it remains unknown whether the results of registry-based randomized clinical trials have a sizable impact on daily clinical practice. We sought, therefore, to describe the temporal trends in thrombus aspiration (TA) use in Sweden before, during, and after dissemination of the TASTE trial (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) results.

    METHODS AND RESULTS: From January 1, 2006, to December 31, 2017, we included all consecutive patients with ST-segment-elevation myocardial infarction undergoing percutaneous revascularization in Sweden. All patients were registered in the Swedish Coronary Angiography and Angioplasty Registry. A total of 55 809 ST-segment-elevation myocardial infarction patients were included. TA use in Sweden substantially decreased after dissemination of TASTE results (from 39.8% to 11.8% during and after TASTE, respectively). Substantial variability in TA use across treating centers was observed before TASTE (TA use ranging from 0% to 70%), but after TASTE both the interhospital variability and the frequency of TA use were markedly reduced. A constant shift in medical practice was seen about 4 months after dissemination of the TASTE trial results. Time trends for all-cause mortality and definite stent thrombosis at 30 days were not associated with variations in TA use (P values >0.05 using the Granger test).

    CONCLUSIONS: In Sweden, the results of the TASTE trial were impactful in daily clinical practice and led to a relevant decrease in TA use in ST-segment-elevation myocardial infarction patients undergoing percutaneous revascularization.

  • 4. Guptill, Jeffrey T.
    et al.
    Mehta, Rajendra H.
    Armstrong, Paul W.
    Horton, John
    Laskowitz, Daniel
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Granger, Christopher B.
    Lopes, Renato D.
    Stroke After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction Timing, Characteristics, and Clinical Outcomes2013In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 6, no 2, p. 176-183Article in journal (Refereed)
    Abstract [en]

    Background-Stroke is a rare but potentially devastating complication of acute myocardial infarction. Little is known about stroke timing, characteristics, and clinical outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PCI). Methods and Results-We studied 5372 patients enrolled in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. We analyzed stroke incidence, type, timing, and association with the prespecified 90-day clinical outcomes. Cox proportional hazards modeling was performed to assess the relationship between stroke and outcomes, after adjusting baseline characteristics and analyzing stroke as a time-dependent covariate. Stroke occurred in 69 primary patients with PCI (1.3%). A third of strokes were ischemic (n=23; 33%), 12% (n=8) were hemorrhagic, and the remaining 55% (n=38) were of uncertain type. The median (25th, 75th percentile) time of stroke occurrence was 6 (3, 14) days. Overall, 43% of strokes occurred within 48 hours of PCI, and all hemorrhagic strokes occurred within 48 hours. Stroke was associated with an increased risk of 90-day death (unadjusted hazard ratio [HR], 8.0; 95% confidence interval [CI], 4.8-13.5), congestive heart failure (unadjusted HR, 3.2; 95% CI, 1.3-7.8), and 30-day hospital readmission (unadjusted HR, 3.2; 95% CI, 2.0-5.1). After adjustment, stroke was still strongly associated with 90-day death (adjusted HR, 5.6; 95% CI, 3.2-9.8) and the combination end point of death, congestive heart failure, or cardiogenic shock at 90 days (adjusted HR, 2.4; 95% CI, 1.2-4.7). Conclusions-Stroke is an infrequent complication in the setting of ST-segment elevation myocardial infarction treated with primary PCI but is associated with increased morbidity and mortality. Studies to determine mechanisms that may be responsible for strokes that occur >48 hours from primary PCI are warranted.

  • 5.
    Kolte, Dhaval
    et al.
    Brown Univ, Dept Med, Div Cardiol, Providence, RI 02912 USA..
    Sardar, Partha
    Univ Utah, Dept Med, Div Cardiol, Salt Lake City, UT 84112 USA..
    Khera, Sahil
    New York Med Coll, Dept Med, Westchester Med Ctr, Div Cardiol, Valhalla, NY 10595 USA..
    Zeymer, Uwe
    Inst Herzinfarktforsch Ludwigshafen, Dept Cardiol, Ludwigshafen, Germany..
    Thiele, Holger
    Univ Hosp Schleswig Holstein, Univ Heart Ctr Lubeck, Med Clin 2, Dept Cardiol, Kiel, Germany.;German Cardiovasc Res Ctr DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany..
    Hochadel, Matthias
    Inst Herzinfarktforsch Ludwigshafen, Dept Cardiol, Ludwigshafen, Germany..
    Radovanovic, Dragana
    Univ Zurich, AMIS Plus Data Ctr, Zurich, Switzerland..
    Erne, Paul
    Univ Zurich, AMIS Plus Data Ctr, Zurich, Switzerland..
    Hambraeus, Kristina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Center for Clinical Research Dalarna. Falun Cent Hosp, Dept Cardiol, Falun, Sweden..
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Claessen, Bimmer E.
    Univ Amsterdam, Acad Med Ctr, Dept Cardiol, Amsterdam, Netherlands..
    Henriques, Jose P. S.
    Univ Amsterdam, Acad Med Ctr, Dept Cardiol, Amsterdam, Netherlands..
    Mylotte, Darren
    Natl Univ Ireland, SAOLTA Healthcare Grp, Galway Univ Hosp, Dept Cardiol, Galway, Ireland..
    Garot, Philippe
    Hop Prive Jacques Cartier, Inst Cardiovasc Paris Sud, Ramsay Gen Sante, Dept Cardiol, Massy, France..
    Aronow, Wilbert S.
    New York Med Coll, Dept Med, Westchester Med Ctr, Div Cardiol, Valhalla, NY 10595 USA..
    Owan, Theophilus
    Univ Utah, Dept Med, Div Cardiol, Salt Lake City, UT 84112 USA..
    Jain, Diwakar
    New York Med Coll, Dept Med, Westchester Med Ctr, Div Cardiol, Valhalla, NY 10595 USA..
    Panza, Julio A.
    New York Med Coll, Dept Med, Westchester Med Ctr, Div Cardiol, Valhalla, NY 10595 USA..
    Frishman, William H.
    New York Med Coll, Dept Med, Westchester Med Ctr, Div Cardiol, Valhalla, NY 10595 USA..
    Fonarow, Gregg C.
    Univ Calif Los Angeles, David Geffen Sch Med, Dept Med, Div Cardiol, Los Angeles, CA 90095 USA..
    Bhatt, Deepak L.
    Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Dept Med,Div Cardiol, Boston, MA USA..
    Aronow, Herbert D.
    Brown Univ, Dept Med, Div Cardiol, Providence, RI 02912 USA..
    Abbott, J. Dawn
    Brown Univ, Dept Med, Div Cardiol, Providence, RI 02912 USA..
    Culprit Vessel-Only Versus Multivessel Percutaneous Coronary Intervention in Patients With Cardiogenic Shock Complicating ST-Segment-Elevation Myocardial Infarction: A Collaborative Meta-Analysis2017In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 10, no 11, article id e005582Article in journal (Refereed)
    Abstract [en]

    Background The optimal revascularization strategy in patients with multivessel disease presenting with cardiogenic shock complicating ST-segment-elevation myocardial infarction remains unknown. Methods and Results Databases were searched from 1999 to October 2016. Studies comparing immediate/single-stage multivessel percutaneous coronary intervention (MV-PCI) versus culprit vessel-only PCI (CO-PCI) in patients with multivessel disease, ST-segment-elevation myocardial infarction, and cardiogenic shock were included. Primary end point was short-term (in-hospital or 30 days) mortality. Secondary end points included long-term mortality, cardiovascular death, reinfarction, and repeat revascularization. Safety end points were in-hospital stroke, renal failure, and major bleeding. The meta-analysis included 11 nonrandomized studies and 5850 patients (1157 MV-PCI and 4693 CO-PCI). There was no significant difference in short-term mortality with MV-PCI versus CO-PCI (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.81-1.43; P=0.61). Similarly, there were no significant differences in long-term mortality (OR, 0.84; 95% CI, 0.54-1.30; P=0.43), cardiovascular death (OR, 0.72; 95% CI, 0.42-1.23; P=0.23), reinfarction (OR, 1.65; 95% CI, 0.84-3.26; P=0.15), or repeat revascularization (OR, 1.13; 95% CI, 0.76-1.69; P=0.54) between the 2 groups. There was a nonsignificant trend toward higher in-hospital stroke (OR, 1.64; 95% CI, 0.98-2.72; P=0.06) and renal failure (OR, 1.30; 95% CI, 0.98-1.72; P=0.06), with no difference in major bleeding (OR, 1.47; 95% CI, 0.39-5.63; P=0.57) with MV-PCI when compared with CO-PCI. Conclusions This meta-analysis of nonrandomized studies suggests that in patients with cardiogenic shock complicating ST-segment-elevation myocardial infarction, there may be no significant benefit with single-stage MV-PCI compared with CO-PCI. Given the limitations of observational data, randomized trials are needed to determine the role of MV-PCI in this setting.

  • 6.
    Koul, Sasha
    et al.
    Lund Univ, Skane Univ Hosp Lund, Dept Cardiol, Lund, Sweden;Lund Univ, Skane Univ Hosp Lund, Dept Clin Sci, Lund, Sweden.
    Smith, J. Gustav
    Lund Univ, Skane Univ Hosp Lund, Dept Cardiol, Lund, Sweden;Lund Univ, Skane Univ Hosp Lund, Dept Clin Sci, Lund, Sweden.
    Götberg, Matthias
    Lund Univ, Skane Univ Hosp Lund, Dept Cardiol, Lund, Sweden;Lund Univ, Skane Univ Hosp Lund, Dept Clin Sci, Lund, Sweden.
    Omerovic, Elmir
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Alfredsson, Joakim
    Linkoping Univ, Dept Cardiol, Linkoping, Sweden;Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden.
    Venetsanos, Dimitrios
    Linkoping Univ, Dept Cardiol, Linkoping, Sweden;Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden.
    Persson, Jonas
    Danderyd Hosp, Dept Clin Sci, Div Cardiovasc Med, Danderyd, Sweden.
    Jensen, Jens
    Capio St Goran Hosp, Karolinska Inst, Dept Med, Stockholm, Sweden.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Redfors, Björn
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Erlinge, David
    Lund Univ, Skane Univ Hosp Lund, Dept Cardiol, Lund, Sweden;Lund Univ, Skane Univ Hosp Lund, Dept Clin Sci, Lund, Sweden.
    No Benefit of Ticagrelor Pretreatment Compared With Treatment During Percutaneous Coronary Intervention in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention2018In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 11, no 3, article id e005528Article in journal (Refereed)
    Abstract [en]

    Background-The effects of ticagrelor pretreatment in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) is debated. This study investigated the effects of ticagrelor pretreatment on clinical outcomes in this patient group.

    Methods and Results-Patients with ST-segment-elevation myocardial infarction undergoing primary PCI were included from October 2010 to October 2014 in Sweden. Screening was done using the SWEDEHEART register (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). A total of 7433 patients were included for analysis with 5438 patients receiving ticagrelor pretreatment and 1995 patients with ticagrelor given only in the catheterization laboratory. The primary end point of the study was 30-day event rates of a composite of all-cause mortality, myocardial infarction (MI), and stent thrombosis. Secondary end points were mortality, MI, or stent thrombosis alone and major in-hospital bleeding. Crude event rates showed no difference in 30-day composite end point (6.2% versus 6.5%; P=0.69), mortality (4.5% versus 4.7%; P=0.86), MI (1.6% versus 1.7%; P=0.72), or stent thrombosis (0.5% versus 0.4%; P=0.80) with ticagrelor pretreatment. Three different statistical models were used to correct for baseline differences. No difference in the composite end point, mortality, MI, or stent thrombosis was seen between the 2 groups after statistical adjustment. No increase in in-hospital major bleeding rate was observed with ticagrelor pretreatment.

    Conclusions-Ticagrelor pretreatment versus ticagrelor given in the catheterization laboratory in patients with ST-segment-elevation myocardial infarction undergoing primary PCI did not improve the composite end point of all-cause mortality or MI or stent thrombosis or its individual components at 30 days.

  • 7.
    Popma, Christopher J.
    et al.
    Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA..
    Sheng, Shi
    Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Vasc Surg, Union Hosp, Wuhan 430074, Peoples R China..
    Korjian, Serge
    Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA..
    Daaboul, Yazan
    Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA..
    Chi, Gerald
    Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA..
    Tricoci, Pierluigi
    Duke Clin Res Inst, Durham, NC USA..
    Huang, Zhen
    Duke Clin Res Inst, Durham, NC USA..
    Moliterno, David J.
    Univ Kentucky, Dept Med, Gill Heart Inst, Lexington, KY 40506 USA..
    White, Harvey D.
    Auckland City Hosp, Green Lane Cardiovasc Serv, Dept Cardiol, Auckland, New Zealand..
    Van de Werf, Frans
    Univ Leuven, Dept Cardiol, Leuven, Belgium..
    Harrington, Robert A.
    Stanford Univ, Dept Med, Stanford, CA 94305 USA..
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
    Armstrong, Paul W.
    Univ Alberta, Dept Med, Div Cardiol, Edmonton, AB, Canada..
    Aylward, Philip E.
    Flinders Univ & Med Ctr, Cardiac & Crit Care Serv, Dept Med, South Australian Hlth & Med Res Inst, Adelaide, SA, Australia..
    Strony, John
    Merck & Co Inc, Merck Clin Res, Whitehouse Stn, NJ USA..
    Mahaffey, Kenneth W.
    Stanford Univ, Dept Med, Stanford, CA 94305 USA..
    Gibson, C. Michael
    Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA..
    Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the Assessment of Stent Thrombosis Results From the TRACER Angiographic Substudy2016In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 9, no 5, article id e003114Article in journal (Refereed)
    Abstract [en]

    Background-Stent thrombosis (ST) is an important end point in cardiovascular clinical trials. Adjudication is traditionally based on clinical event committee (CEC) review of case report forms and source documentation rather than angiograms. However, the degree to which this method of adjudication is concordant with the review of independent angiographic core laboratories (ACLs) has not been studied. This report represents the first assessment of variability between local investigators (LIs), a CEC, and an ACL. Methods and Results-Serial angiograms of 329 patients with acute coronary syndrome without ST-segment-elevation who underwent percutaneous coronary intervention at entry in the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRACER) and who met criteria for possible ST subsequent to the index event were reviewed by an ACL. The ACL was blinded to the assessment by both LIs and the CEC regarding the presence or absence of ST. CEC adjudication was based on Academic Research Consortium definitions of ST, using case report form data and source documents, including catheterization laboratory reports. The ACL, CEC, and LIs agreed on the presence or absence of ST in 52.9% events (kappa=0.32; 95% confidence interval, 0.26-0.39). The ACL and CEC agreed on 82.7% of events (kappa=0.57; 95% confidence interval, 0.47-0.67); the ACL and LIs agreed on 61.1% of events (kappa=0.25; 95% confidence interval, 0.16-0.34); and the CEC and LIs agreed on 62% of events (kappa=0.28; 95% confidence interval, 0.21-0.36). Conclusions-ST reporting by an ACL, a CEC, and LIs is discordant. The assessment of ST is more often detected by direct review of angiograms by an ACL.

  • 8.
    Ritsinger, Viveca
    et al.
    Karolinska Univ Hosp, Dept Med, Karolinska Inst, Cardiol Unit, Stockholm, Sweden.;Dept Res & Dev, Region Kronoberg, Sweden..
    Saleh, Nawsad
    Karolinska Univ Hosp, Dept Med, Karolinska Inst, Cardiol Unit, Stockholm, Sweden..
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Norhammar, Anna
    Karolinska Univ Hosp, Dept Med, Karolinska Inst, Cardiol Unit, Stockholm, Sweden..
    High Event Rate After a First Percutaneous Coronary Intervention in Patients With Diabetes Mellitus: Results From the Swedish Coronary Angiography and Angioplasty Registry2015In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 8, no 6, article id e002328Article in journal (Refereed)
    Abstract [en]

    Background-Patients with diabetes mellitus have reduced longevity after acute coronary syndromes and revascularization. However, knowledge of the long-term complication rates and patterns from an everyday life setting is lacking. Methods and Results-Consecutive patients undergoing percutaneous coronary intervention included in the Swedish Coronary Angiography Angioplasty Registry (SCAAR) between 2006 and 2010 and with no previous revascularization were prospectively followed up for combined cardiovascular events (first of all-cause mortality, myocardial infarction, stroke, and heart failure) until December 31, 2010. The mean follow-up period was 920 days (SD, 530 days). Differences in background and procedural characteristics were adjusted for in a multivariate Cox regression model. Of 58 891 patients, mean age 67 years, 19% had diabetes mellitus; 27% of them were on diet treatment, 33% on oral glucose lowering, and 40% on insulin treatment. At admission, cardiovascular risk factors, multiple coronary vessel, and left main stem disease were more frequent in patients with diabetes mellitus and their revascularization was less often complete. The adjusted risk for combined cardiovascular events was higher in patients on insulin (hazard ratio [95% confidence interval], 1.63 [1.55-1.72]), on oral treatment (1.23 [1.15-1.31]), and on diet alone (1.21 [1.12-1.29]) compared with patients without diabetes mellitus. Insulin-treated patients ran an increased risk of restenosis (1.54 [1.39-1.71]) and stent thrombosis (1.56 [1.25-1.96]). Conclusions-The prognosis after a first percutaneous coronary intervention is more severe in patients with diabetes mellitus, in particular, in patients treated with insulin, with higher rates of mortality, cardiovascular events, and stent thrombosis over the following 5 years.

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