A growing number of countries and geographical regions are involved in major clinical
trials. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart
Failure is the largest trial in acutely decompensated heart failure (HF) with patients
from 5 geographical regions: North America (NA), Latin America (LA), Western Europe
(WE), Central Europe (CE), and Asia-Pacific (AP). Data from the 5 geographical areas
were compared including baseline characteristics, medications, 30-day outcomes (mortality
and mortality or HF hospitalization), and 180-day mortality. Of the 7,141 study patients,
3,243 (45.4%) were from NA (average of 15.2 patients/site), 1,762 (24.7%) from AP
(28.4 patients/site), 967 (13.5%) from CE (20.2 patients/site), 665 (9.3%) from LA
(17.1 patients/site), and 504 (7.1%) from WE (14.4 patients/site). There were marked
differences in co-morbidities, clinical profile, medication use, length of stay, 30-day
event rates, and 180-day mortality by region. Compared with NA, the adjusted risk
for death or HF hospitalization at 30 days was significantly lower in CE (odds ratio
[OR] 0.46, 95% CI 0.33 to 0.64), WE (OR 0.52 95% CI 0.35 to 0.75), and AP (OR 0.62
95% CI 0.48 to 0.79) and numerically lower in LA (OR 0.77, 95% CI 0.57 to 1.04) with
similar results for 180-day mortality. In conclusion, in patients with acutely decompensated
HF, major differences in baseline characteristics, treatments, length of the hospital
stay, and 30-day HF rehospitalization rates, and 180-day mortality were found in patients
enrolled from different geographical areas.
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References
- Ethical and scientific implications of the globalization of clinical research.N Engl J Med. 2009; 360: 816-823
- Globalization of clinical trials how should we interpret differences in outcomes?.J Am Coll Cardiol. 2011; 58: 923-924
- International differences in treatment effect: do they really exist and why?.Eur Heart J. 2013; 34: 1846-1852
- Site selection in global clinical trials in patients hospitalized for heart failure: perceived problems and potential solutions.Heart Fail Rev. 2014; 19: 135-152
- Ticagrelor versus clopidogrel in patients with acute coronary syndromes.N Engl J Med. 2009; 361: 1045-1057
- Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial.Circulation. 2011; 124: 544-554
- Spironolactone for heart failure with preserved ejection fraction.N Engl J Med. 2014; 370: 1383-1392
- International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial.Eur J Heart Fail. 2014; 16: 614-624
- Influence of global region on outcomes in heart failure beta-blocker trials.J Am Coll Cardiol. 2011; 58: 915-922
- Geographic differences in heart failure trials.Eur J Heart Fail. 2015; 17: 893-905
- Effect of nesiritide in patients with acute decompensated heart failure.N Engl J Med. 2011; 365: 32-43
- Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure results from the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) program.J Am Coll Cardiol. 2008; 52: 1640-1648
- Regional differences in the characteristics and treatment of patients participating in an international heart failure trial. The Assessment of Treatment with Lisinopril and Survival (ATLAS) trial investigators.J Card Fail. 1998; 4: 3-8
- Transatlantic similarities and differences in major natural history endpoints of heart failure after acute myocardial infarction: a propensity-matched study of the EPHESUS trial.Int J Cardiol. 2010; 143: 309-316
- Global variation in clinical profile, management, and post-discharge outcomes among patients hospitalized for worsening chronic heart failure: findings from the ASTRONAUT trial.Eur J Heart Fail. 2015; 17: 591-600
- Rationale and design of the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial (ASCEND-HF).Am Heart J. 2009; 157: 271-277
- Implications of geographical variation on clinical outcomes of cardiovascular trials.Am Heart J. 2012; 164: 303-312
- Differences in treatment, outcomes, and quality of life among patients with heart failure in Canada and the United States.JACC Heart Fail. 2013; 1: 523-530
- Predictors of clinical outcomes in acute decompensated heart failure: acute study of clinical effectiveness of nesiritide in decompensated heart failure outcome models.Am Heart J. 2015; 170: 290-297
- Differences in drug treatment of chronic heart failure between European countries.Eur Heart J. 1999; 20: 666-672
- International variations in the clinical, diagnostic, and treatment characteristics of emergency department patients with acute heart failure syndromes.Eur J Heart Fail. 2010; 12: 1253-1260
- Acute decompensated heart failure syndromes (ATTEND) registry. A prospective observational multicenter cohort study: rationale, design, and preliminary data.Am Heart J. 2010; 159: 949-955 e1
- EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF pilot).Eur J Heart Fail. 2013; 15: 808-817
- Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial.Circulation. 2015; 131: 34-42
- Heart failure as a general pandemic in Asia.Eur J Heart Fail. 2015; 17: 884-892
- Systolic heart failure in South Asians.Int J Clin Pract. 2011; 65: 1274-1282
- Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF).Circ Cardiovasc Qual Outcomes. 2013; 6: 534-542
- Relationship between hospital readmission and mortality rates for patients hospitalized with acute myocardial infarction, heart failure, or pneumonia.JAMA. 2013; 309: 587-593
- Are we targeting the right metric for heart failure? Comparison of hospital 30-day readmission rates and total episode of care inpatient days.Am Heart J. 2013; 165: 987-994.e1
- Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF.Circ Heart Fail. 2013; 6: 727-732
Article info
Publication history
Published online: March 19, 2016
Accepted:
March 8,
2016
Received in revised form:
March 8,
2016
Received:
December 29,
2015
Footnotes
See page 1777 for disclosure information.
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Copyright
© 2016 Elsevier Inc. All rights reserved.
