Schmidtmann, I. (Irene)

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2018 - 20202

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    Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial
    (2020) Rauch-Kroehnert, U. (Ursula); Bonacchini, L. (Luca); Schmidtmann, I. (Irene); Genth-Zotz, S. (Sabine); Manolis, A. (Athanasios); Harjola, V.P. (Veli-Pekka); Konstantinides, S.V. (Stavros V.); Schellong, S. (Sebastian); Becattini, C. (Cecilia); Schwaiblmair, M. (Martin); Beyer-Westendorf, J. (Jan); Ruiz-Artacho, P. (Pedro); Bauersachs, R.M. (Rupert M.); Wild, P.S. (Philipp S.); Jiménez, D. (David); Brachmann, J. (Johannes); Ageno, W. (Walter); Held, M. (Matthias); Stahrenberg, R. (Raoul); Iogna-Prat, L. (Lorenzo); Duerschmied, D. (Daniel); Empen, K. (Klaus); Ficker, J.H. (Joachim H.); Lankeit, M. (Mareike); Fonseca, C. (Candida); Bernardi, E. (Enrico); Espinola-Klein, C. (Christine); Westerweel, P.E. (Peter); Meyer, A. (Andreas); Lange, T.J. (Tobias J.); Mustonen, P. (Pirjo); Czihal, M. (Michael); Christ, M. (Michael)
    Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for >_3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of a = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
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    Predictive value for cardiovascular events of common carotid intima media thickness and its rate of change in individuals at high cardiovascular risk - Results from the PROG-IMT collaboration
    (Public Library of Science, 2018) Blankenberg, S. (Stefan); Landecho, M.F. (Manuel F.); Tremoli, E. (Elena); Harald-Johnsen, S. (Stein); Xie, W. (Wuxiang); Srinivasan, S.R. (Sathanur R.); Liu, J. (Jing); Völzke, H. (Henry); Sacco, R.L. (Ralph L.); Friera, A. (Alfonso); Willeit, J. (Johann); Engström, G. (Gunnar); Dörr, M. (Marcus); Rosvall, M. (Maria); Beloqui, O. (Óscar); Bokemark, L. (Lena); Okazaki, S. (Shuhei); Gabriel, R. (Rafael); Dekker, J.M. (Jacqueline M.); Schmidtmann, I. (Irene); Stehouwer, C.D.A. (Coen D. A.); Hofman, A. (Albert); Plichart, M. (Matthieu); Mathiesen, E.B. (Ellisiv B.); Lin, H.J. (Hung-Ju); Baldassarre, D. (Damiano); Gao, L. (Lu); Poppert, H. (Holger); Rundek, T. (Tatjana); Bickel, H. (Horst); McLachlan, S. (Stela); Parraga, G. (Grace); Staub, D. (Daniel); Thompson, S.G. (Simon G.); Willeit, P. (Peter); Zhao, D. (Dong); Berenson, G. (Gerald); Kitagawa, K. (Kazuo); Espinola-Klein, C. (Christine); Castelnuovo, S. (Samuela); Izzo, R. (Raffaele); Suarez, C. (Carmen); Ducimetiere, P. (Pierre); Kiechl, S. (Stefan); Amato, M. (Mauro); Hedblad, B. (Bo); Lorenz, M.W. (Matthias W.); Steinmetz, H. (Helmuth); Bergström, G. (Göran); Kavousi, M. (Maryam); Iglseder, B. (Bernhard); Wannarong, T. (Thapat); Desvarieux, M. (Moise); Ronkainen, K. (Kimmo); Catapano, A. (Alberico); Empana, J.P. (Jean Philippe); Schmidt, C. (Caroline); Arfan-Ikram, M. (M.); Polak, J.F. (Joseph F.); Sirtori, C.R. (Cesare R.); Price, J.F. (Jackie F.); Sitzer, M. (Matthias); Uthoff, H. (Heiko); Bots, M.L. (Michiel L.); Schminke, U. (Ulf); Sander, D. (Dirk); Norata, G.D. (Giuseppe Danilo); Tuomainen, T. (Tomipekka); Groot, E. (Eric) de; Chien, K.L. (Kuo-Liong); Yanez, D.N. (David N.); Kauhanen, J. (Jussi); Luca, N. (Nicola) de; Nijpels, G. (Giel); Franco, O.H. (Oscar H.); Lind, L. (Lars); Grigore, L. (Liliana); Ziegelbauer, K. (Kathrin); Veglia, F. (Fabrizio); Su, T.C. (Ta-Chen); Rozza, F. (Francesco)
    Aims Carotid intima media thickness (CIMT) predicts cardiovascular (CVD) events, but the predictive value of CIMT change is debated. We assessed the relation between CIMT change and events in individuals at high cardiovascular risk. Methods and results From 31 cohorts with two CIMT scans (total n = 89070) on average 3.6 years apart and clinical follow-up, subcohorts were drawn: (A) individuals with at least 3 cardiovascular risk factors without previous CVD events, (B) individuals with carotid plaques without previous CVD events, and (C) individuals with previous CVD events. Cox regression models were fit to estimate the hazard ratio (HR) of the combined endpoint (myocardial infarction, stroke or vascular death) per standard deviation (SD) of CIMT change, adjusted for CVD risk factors. These HRs were pooled across studies. In groups A, B and C we observed 3483, 2845 and 1165 endpoint events, respectively. Average common CIMT was 0.79mm (SD 0.16mm), and annual common CIMT change was 0.01mm (SD 0.07mm), both in group A. The pooled HR per SD of annual common CIMT change (0.02 to 0.43mm) was 0.99 (95% confidence interval: 0.95–1.02) in group A, 0.98 (0.93–1.04) in group B, and 0.95 (0.89–1.04) in group C. The HR per SD of common CIMT (average of the first and the second CIMT scan, 0.09 to 0.75mm) was 1.15 (1.07–1.23) in group A, 1.13 (1.05–1.22) in group B, and 1.12 (1.05–1.20) in group C. Conclusions We confirm that common CIMT is associated with future CVD events in individuals at high risk. CIMT change does not relate to future event risk in high-risk individuals.