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4. Impact of atrial fibrillation on outcome in takotsubo syndrome: Data from the international Takotsubo registry

Author

El-Battrawy, I., Cammann, V. L., Kato, K., Szawan, K. A., Di Vece, D., Rossi, A., Wischnewsky, M., Hermes-Laufer, J., Gili, S., Citro, R., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, F., Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Arroja, J. D., Banning, A., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Juhani Airaksinen, K. E., Napp, L. C., Budnik, M., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., Kozel, M., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Kobayashi, Y., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Opolski, G., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, C., Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Duru, F., Borggrefe, M., Ghadri, J. R., Akin, I., Templin, C., Galiuto L. (ORCID:0000-0002-6831-479X), Crea F. (ORCID:0000-0001-9404-8846), El-Battrawy, I., Cammann, V. L., Kato, K., Szawan, K. A., Di Vece, D., Rossi, A., Wischnewsky, M., Hermes-Laufer, J., Gili, S., Citro, R., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, F., Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Arroja, J. D., Banning, A., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Juhani Airaksinen, K. E., Napp, L. C., Budnik, M., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., Kozel, M., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Kobayashi, Y., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Opolski, G., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, C., Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Duru, F., Borggrefe, M., Ghadri, J. R., Akin, I., Templin, C., Galiuto L. (ORCID:0000-0002-6831-479X), and Crea F. (ORCID:0000-0001-9404-8846)

Abstract

BACKGROUND: Atrial fibrillation (AF) is a major risk factor for mortality. The prevalence, clinical correlates, and prognostic impact of AF in Takotsubo syndrome (TTS) have not yet been investigated in a large patient cohort. This study aimed to investigate the prevalence, clinical correlates, and prognostic impact of AF in patients with TTS. METHODS AND RESULTS: Patients with TTS were enrolled from the International Takotsubo Registry, which is a multinational network with 26 participating centers in Europe and the United States. Patients were dichotomized according to the presence or absence of AF at the time of admission. Of 1584 patients with TTS, 112 (7.1%) had AF. The mean age was higher (P<0.001), and there were fewer women (P=0.046) in the AF than in the non-AF group. Left ventricular ejection fraction was significantly lower (P=0.001), and cardiogenic shock was more often observed (P<0.001) in the AF group. Both in-hospital (P<0.001) and long-term mortality (P<0.001) were higher in the AF group. Multivariable Cox regression analysis revealed that AF was independently associated with higher long-term mortality (hazard ratio, 2.31; 95% CI, 1.50– 3.55; P<0.001). Among patients with AF on admission, 42% had no known history of AF before the acute TTS event, and such patients had comparable in-hospital and long-term outcomes compared with those with a history of AF. CONCLUSIONS: In patients presenting with TTS, AF on admission is significantly associated with increased in-hospital and long-term mortality rates. Whether antiarrhythmics and/or cardioversion are beneficial in TTS with AF should thus be tested in a future trial. REGISTRATION: URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01947621.

Published
2021

5. Prognostic impact of acute pulmonary triggers in patients with takotsubo syndrome: new insights from the International Takotsubo Registry

Author

Kato, K., Cammann, V. L., Napp, L. C., Szawan, K. A., Micek, J., Dreiding, S., Levinson, R. A., Petkova, V., Wurdinger, M., Patrascu, A., Sumalinog, R., Gili, S., Clarenbach, C. F., Kohler, M., Wischnewsky, M., Citro, R., Vecchione, C., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, Francesca, Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Roffi, M., Banning, A., Wolfrum, M., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Budnik, M., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., El-Battrawy, I., Akin, I., Kozel, M., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Sano, M., Ishibashi, I., Takahara, M., Himi, T., Kobayashi, Y., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Opolski, G., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Borggrefe, M., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, Clara, Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Ghadri, J. R., Templin, C., D'Ascenzo F., Galiuto L. (ORCID:0000-0002-6831-479X), Di Mario C., Crea F. (ORCID:0000-0001-9404-8846), Kato, K., Cammann, V. L., Napp, L. C., Szawan, K. A., Micek, J., Dreiding, S., Levinson, R. A., Petkova, V., Wurdinger, M., Patrascu, A., Sumalinog, R., Gili, S., Clarenbach, C. F., Kohler, M., Wischnewsky, M., Citro, R., Vecchione, C., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, Francesca, Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Roffi, M., Banning, A., Wolfrum, M., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Budnik, M., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., El-Battrawy, I., Akin, I., Kozel, M., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Sano, M., Ishibashi, I., Takahara, M., Himi, T., Kobayashi, Y., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Opolski, G., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Borggrefe, M., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, Clara, Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Ghadri, J. R., Templin, C., D'Ascenzo F., Galiuto L. (ORCID:0000-0002-6831-479X), Di Mario C., and Crea F. (ORCID:0000-0001-9404-8846)

Abstract

Aims: Acute pulmonary disorders are known physical triggers of takotsubo syndrome (TTS). This study aimed to investigate prevalence of acute pulmonary triggers in patients with TTS and their impact on outcomes. Methods and results: Patients with TTS were enrolled from the International Takotsubo Registry and screened for triggering factors and comorbidities. Patients were categorized into three groups (acute pulmonary trigger, chronic lung disease, and no lung disease) to compare clinical characteristics and outcomes. Of the 1670 included patients with TTS, 123 (7%) were identified with an acute pulmonary trigger, and 194 (12%) had a known history of chronic lung disease. The incidence of cardiogenic shock was highest in patients with an acute pulmonary trigger compared with those with chronic lung disease or without lung disease (17% vs. 10% vs. 9%, P = 0.017). In-hospital mortality was also higher in patients with an acute pulmonary trigger than in the other two groups, although not significantly (5.7% vs. 1.5% vs. 4.2%, P = 0.13). Survival analysis demonstrated that patients with an acute pulmonary trigger had the worst long-term outcome (P = 0.002). The presence of an acute pulmonary trigger was independently associated with worse long-term mortality (hazard ratio 2.12, 95% confidence interval 1.33–3.38; P = 0.002). Conclusions: The present study demonstrates that TTS is related to acute pulmonary triggers in 7% of all TTS patients, which accounts for 21% of patients with physical triggers. The presence of acute pulmonary trigger is associated with a severe in-hospital course and a worse long-term outcome.

Published
2021

7. Impact of aspirin on takotsubo syndrome: a propensity score-based analysis of the InterTAK Registry

Author

D'Ascenzo, Francesca, Gili, S., Bertaina, M., Iannaccone, M., Cammann, V. L., Di Vece, D., Kato, K., Saglietto, A., Szawan, K. A., Frangieh, A. H., Boffini, B., Annaratone, M., Sarcon, A., Levinson, R. A., Franke, J., Napp, L. C., Jaguszewski, M., Noutsias, M., Munzel, T., Knorr, M., Heiner, S., Katus, H. A., Burgdorf, C., Schunkert, H., Thiele, H., Bauersachs, J., Tschope, C., Pieske, B. M., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Hasenfuss, G., Karakas, M., Koenig, W., Rottbauer, W., Said, S. M., Braun-Dullaeus, R. C., Banning, A., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Opolski, G., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Crea, Filippo, Dichtl, W., Franz, W. M., Empen, K., Felix, S. B., Delmas, C., Lairez, O., El-Battrawy, I., Akin, I., Borggrefe, M., Horowitz, J. D., Kozel, M., Tousek, P., Widimsky, P., Gilyarova, E., Shilova, A., Gilyarov, M., Biondi-Zoccai, G., Winchester, D. E., Ukena, C., Neuhaus, M., Bax, J. J., Prasad, A., Di Mario, C., Bohm, M., Gasparini, M., Ruschitzka, F., Bossone, E., Citro, R., Rinaldi, M., De Ferrari, G. M., Luscher, T., Ghadri, J. R., Templin, C., D'Ascenzo F., Galiuto L. (ORCID:0000-0002-6831-479X), Crea F. (ORCID:0000-0001-9404-8846), D'Ascenzo, Francesca, Gili, S., Bertaina, M., Iannaccone, M., Cammann, V. L., Di Vece, D., Kato, K., Saglietto, A., Szawan, K. A., Frangieh, A. H., Boffini, B., Annaratone, M., Sarcon, A., Levinson, R. A., Franke, J., Napp, L. C., Jaguszewski, M., Noutsias, M., Munzel, T., Knorr, M., Heiner, S., Katus, H. A., Burgdorf, C., Schunkert, H., Thiele, H., Bauersachs, J., Tschope, C., Pieske, B. M., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Hasenfuss, G., Karakas, M., Koenig, W., Rottbauer, W., Said, S. M., Braun-Dullaeus, R. C., Banning, A., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Opolski, G., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Crea, Filippo, Dichtl, W., Franz, W. M., Empen, K., Felix, S. B., Delmas, C., Lairez, O., El-Battrawy, I., Akin, I., Borggrefe, M., Horowitz, J. D., Kozel, M., Tousek, P., Widimsky, P., Gilyarova, E., Shilova, A., Gilyarov, M., Biondi-Zoccai, G., Winchester, D. E., Ukena, C., Neuhaus, M., Bax, J. J., Prasad, A., Di Mario, C., Bohm, M., Gasparini, M., Ruschitzka, F., Bossone, E., Citro, R., Rinaldi, M., De Ferrari, G. M., Luscher, T., Ghadri, J. R., Templin, C., D'Ascenzo F., Galiuto L. (ORCID:0000-0002-6831-479X), and Crea F. (ORCID:0000-0001-9404-8846)

Abstract

Aims: The aim of the present study was to investigate the impact of aspirin on prognosis in takotsubo syndrome (TTS). Methods and results: Patients from the International Takotsubo (InterTAK) Registry were categorized into two groups based on aspirin prescription at discharge. A comparison of clinical outcomes between groups was performed using an adjusted analysis with propensity score (PS) stratification; results from the unadjusted analysis were also reported to note the effect of the PS adjustment. Major adverse cardiac and cerebrovascular events (MACCE: a composite of death, myocardial infarction, TTS recurrence, stroke or transient ischaemic attack) were assessed at 30-day and 5-year follow-up. A total of 1533 TTS patients with known status regarding aspirin prescription at discharge were included. According to the adjusted analysis based on PS stratification, aspirin was not associated with a lower hazard of MACCE at 30-day [hazard ratio (HR) 1.24, 95% confidence interval (CI) 0.50–3.04, P = 0.64] or 5-year follow-up (HR 1.11, 95% CI 0.78–1.58, P = 0.58). These results were confirmed by sensitivity analyses performed with alternative PS-based methods, i.e. covariate adjustment and inverse probability of treatment weighting. Conclusion: In the present study, no association was found between aspirin use in TTS patients and a reduced risk of MACCE at 30-day and 5-year follow-up. These findings should be confirmed in adequately powered randomized controlled trials. ClinicalTrials.gov Identifier: NCT01947621.

Published
2020

8. Age-Related Variations in Takotsubo Syndrome

Author

Cammann, V. L., Szawan, K. A., Stahli, B. E., Kato, K., Budnik, M., Wischnewsky, M., Dreiding, S., Levinson, R. A., Di Vece, D., Gili, S., Citro, R., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, F., Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Roffi, M., Banning, A., Wolfrum, M., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Napp, L. C., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., El-Battrawy, I., Akin, I., Polednikova, K., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Kobayashi, Y., Shoji, T., Ishibashi, I., Takahara, M., Himi, T., Din, J., Al-Shammari, A., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Borggrefe, M., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, C., Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Ghadri, J. R., Opolski, G., Templin, C., Galiuto L. (ORCID:0000-0002-6831-479X), Crea F. (ORCID:0000-0001-9404-8846), Cammann, V. L., Szawan, K. A., Stahli, B. E., Kato, K., Budnik, M., Wischnewsky, M., Dreiding, S., Levinson, R. A., Di Vece, D., Gili, S., Citro, R., Bossone, E., Neuhaus, M., Franke, J., Meder, B., Jaguszewski, M., Noutsias, M., Knorr, M., Heiner, S., D'Ascenzo, F., Dichtl, W., Burgdorf, C., Kherad, B., Tschope, C., Sarcon, A., Shinbane, J., Rajan, L., Michels, G., Pfister, R., Cuneo, A., Jacobshagen, C., Karakas, M., Koenig, W., Pott, A., Meyer, P., Roffi, M., Banning, A., Wolfrum, M., Cuculi, F., Kobza, R., Fischer, T. A., Vasankari, T., Airaksinen, K. E. J., Napp, L. C., Dworakowski, R., Maccarthy, P., Kaiser, C., Osswald, S., Galiuto, Leonarda, Chan, C., Bridgman, P., Beug, D., Delmas, C., Lairez, O., Gilyarova, E., Shilova, A., Gilyarov, M., El-Battrawy, I., Akin, I., Polednikova, K., Tousek, P., Winchester, D. E., Galuszka, J., Ukena, C., Poglajen, G., Carrilho-Ferreira, P., Hauck, C., Paolini, C., Bilato, C., Kobayashi, Y., Shoji, T., Ishibashi, I., Takahara, M., Himi, T., Din, J., Al-Shammari, A., Prasad, A., Rihal, C. S., Liu, K., Schulze, P. C., Bianco, M., Jorg, L., Rickli, H., Pestana, G., Nguyen, T. H., Bohm, M., Maier, L. S., Pinto, F. J., Widimsky, P., Felix, S. B., Braun-Dullaeus, R. C., Rottbauer, W., Hasenfuss, G., Pieske, B. M., Schunkert, H., Borggrefe, M., Thiele, H., Bauersachs, J., Katus, H. A., Horowitz, J. D., Di Mario, C., Munzel, T., Crea, Filippo, Bax, J. J., Luscher, T. F., Ruschitzka, F., Ghadri, J. R., Opolski, G., Templin, C., Galiuto L. (ORCID:0000-0002-6831-479X), and Crea F. (ORCID:0000-0001-9404-8846)

Abstract

Background: Takotsubo syndrome (TTS) occurs predominantly in post-menopausal women but is also found in younger patients. Objectives: This study aimed to investigate age-related differences in TTS. Methods: Patients diagnosed with TTS and enrolled in the International Takotsubo Registry between January 2011 and February 2017 were included in this analysis and were stratified by age (younger: ≤50 years, middle-age: 51 to 74 years, elderly: ≥75 years). Baseline characteristics, hospital course, as well as short- and long-term mortality were compared among groups. Results: Of 2,098 TTS patients, 242 (11.5%) patients were ≤50 years of age, 1,194 (56.9%) were 51 to 74 years of age, and 662 (31.6%) were ≥75 years of age. Younger patients were more often men (12.4% vs. 10.9% vs. 6.3%; p = 0.002) and had an increased prevalence of acute neurological (16.3% vs. 8.4% vs. 8.8%; p = 0.001) or psychiatric disorders (14.1% vs. 10.3% vs. 5.6%; p < 0.001) compared with middle-aged and elderly TTS patients. Furthermore, younger patients had more often cardiogenic shock (15.3% vs. 9.1% vs. 8.1%; p = 0.004) and had a numerically higher in-hospital mortality (6.6% vs. 3.6% vs. 5.1%; p = 0.07). At multivariable analysis, younger (odds ratio: 1.60; 95% confidence interval: 0.86 to 3.01; p = 0.14) and older age (odds ratio: 1.09; 95% confidence interval: 0.66 to 1.80; p = 0.75) were not independently associated with in-hospital mortality using the middle-aged group as a reference. There were no differences in 60-day mortality rates among groups. Conclusions: A substantial proportion of TTS patients are younger than 50 years of age. TTS is associated with severe complications requiring intensive care, particularly in younger patients.

Published
2020

28. D-dimer and risk of thromboembolic and bleeding events in patients with atrial fibrillation : observations from the ARISTOTLE trial

Author

Christersson, Christina, Wallentin, Lars, Andersson, Ulrika, Alexander, J. H., Ansell, J., De Caterina, R., Gersh, B. J., Granger, C. B., Hanna, M., Horowitz, J. D., Huber, K., Husted, S., Hylek, E. M., Lopes, R. D., Siegbahn, Agneta, Christersson, Christina, Wallentin, Lars, Andersson, Ulrika, Alexander, J. H., Ansell, J., De Caterina, R., Gersh, B. J., Granger, C. B., Hanna, M., Horowitz, J. D., Huber, K., Husted, S., Hylek, E. M., Lopes, R. D., and Siegbahn, Agneta

Abstract

BackgroundD-dimer is related to adverse outcomes in arterial and venous thromboembolic diseases. ObjectivesTo evaluate the predictive value of D-dimer level for stroke, other cardiovascular events, and bleeds, in patients with atrial fibrillation (AF) treated with oral anticoagulation with apixaban or warfarin; and to evaluate the relationship between the D-dimer levels at baseline and the treatment effect of apixaban vs. warfarin. MethodsIn the ARISTOTLE trial, 18201 patients with AF were randomized to apixaban or warfarin. D-dimer was analyzed in 14878 patients at randomization. The cohort was separated into two groups; not receiving vitaminK antagonist (VKA) treatment and receiving VKA treatment at randomization. ResultsHigher D-dimer levels were associated with increased frequencies of stroke or systemic embolism (hazard ratio [HR][Q4 vs. Q1]1.72, 95% confidence interval [CI]1.14-2.59, P=0.003), death (HR[Q4 vs. Q1]4.04, 95%CI3.06-5.33) and major bleeding (HR[Q4 vs. Q1]2.47, 95%CI1.77-3.45, P<0.0001) in the no-VKA group. Similar results were obtained in the on-VKA group. Adding D-dimer level to the CHADS(2) score improved the C-index from 0.646 to 0.655 for stroke or systemic embolism, and from 0.598 to 0.662 for death, in the no-VKA group. D-dimer level improved the HAS-BLED score for prediction of major bleeds, with an increase in the C-index from 0.610 to 0.641. There were no significant interactions between efficacy and safety of study treatment and D-dimer level. ConclusionIn anticoagulated patients with AF, the level of D-dimer is related to the risk of stroke, death, and bleeding, and adds to the predictive value of clinical risk scores. The benefits of apixaban were consistent, regardless of the baseline D-dimer level.

Published
2014
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31. Standard vs. intensified management of heart failure to reduce healthcare costs: results of a multicentre, randomized controlled trial.

Author

Scuffham, P. A., Ball, J., Horowitz, J. D., Wong, C., Newton, P. J., Macdonald, P., McVeigh, J., Rischbieth, A., Emanuele, N., Carrington, M. J., Reid, C. M., Chan, Y. K., and Stewart, S.

Abstract

Aims To determine if an intensified form of heart failure management programme (INT-HF-MP) based on individual profiling is superior to standard management (SM) in reducing health care costs during 12-month follow-up (primary endpoint). Methods and results A multicentre randomized trial involving 787 patients (full analysis set) discharged from four tertiary hospitals with chronic HF who were randomized to SM (n=391) or INT-HF-MP (n=396). Mean age was 74 ± 12 years, 65% had HF with a reduced ejection fraction (31.4 ± 8.9%) and 14% were remote-dwelling. Study groups were well matched. According to Green, Amber, Red Delineation of rIsk And Need in HF (GARDIAN-HF) profiling, regardless of location, patients in the INT-HF-MP received a combination of face-to-face (home visits) and structured telephone support (STS); only 9% ('low risk') were designated to receive the same level of management as the SM group. The median cost in 2017 Australian dollars (A$1 equivalent to ∼EUR €0.7) of applying INT-HF-MP was significantly greater than SM ($152 vs. $121 per patient per month; P<0.001), However, at 12 months, there was no difference in total health care costs for the INT-HF-MP vs. SM group (median $1579, IQR $644 to $3717 vs. $1450, IQR $564 to $3615 per patient per month, respectively). This reflected minimal differences in all-cause mortality (17.7% vs. 18.4%; P=0.848) and recurrent hospital stay (18.6±26.5 vs. 16.6±24.8 days; P=0.199) between the INT-HF-MP and SM groups, respectively. Conclusion During 12-months follow-up, an INT-HF-MP did not reduce healthcare costs or improve health outcomes relative to SM. [ABSTRACT FROM AUTHOR]

Published
2017
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