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Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years.

Publication ,  Journal Article
Chan, MY; Sun, J-L; Newby, LK; Lokhnygina, Y; White, HD; Moliterno, DJ; Théroux, P; Ohman, EM; Simoons, ML; Mahaffey, KW; Pieper, KS ...
Published in: Int J Cardiol
July 31, 2013

BACKGROUND: Data are limited on whether clinical trials have randomized higher-risk patients over time and how trends in risk profiles and evidence-based pharmacotherapies have influenced trial outcomes. We quantified changes in baseline risk, treatment, and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) randomized in 9 phase 3 clinical trials of antithrombotic therapy over 15 years. METHODS: We studied 58,771 patients in GUSTO IIb, PURSUIT, PARAGON-A, PARAGON-B, PRISM, PRISM-PLUS, GUSTO IV-ACS, SYNERGY, and EARLY ACS. Patient-level data were mapped to 3 pre-specified 5-year randomization periods. Temporal trends in GRACE score-predicted mortality were compared with trends in observed mortality. RESULTS: Over time, in-hospital and discharge use of thienopyridines (p=0.001), statins (p<0.0001), and angiotensin-converting enzyme inhibitors (p<0.0001) increased, and hospital length-of-stay decreased (p=0.024). Blood transfusion use increased (8.3% [1994-98], 10.7% [1999-2003], 13% [2004-08], p=0.0002) despite stable rates of severe bleeding (0.9% [1994-98], 1.4% [1999-2003] and 1.1% [2004-08], p=0.127) and coronary artery bypass grafting (12.4% [1994-98], 13.7% [1999-2003] 13.1% [2004-08], p=0.880). Although predicted 6-month mortality increased (6.9% [1994-98], 9.0% [1999-2003], 7.9% [2004-08], p=0.017), observed 6-month mortality decreased (6.7% [1994-98], 5.8% [1999-2003], 5.1% [2004-08], p=0.025). Thirty-day myocardial infarction rates remained stable (9.2% [1994-98], 9.3% [1999-2003], 10% [2004-08], p=0.539). CONCLUSIONS: Despite enrolling higher-risk patients into these NSTE ACS trials, with better treatment, observed mortality declined over the past 15 years. The appropriateness of increased blood transfusion despite unchanged bleeding rates deserves further study.

Duke Scholars

Published In

Int J Cardiol

DOI

EISSN

1874-1754

Publication Date

July 31, 2013

Volume

167

Issue

2

Start / End Page

548 / 554

Location

Netherlands

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Myocardial Infarction
  • Length of Stay
  • Humans
  • Clinical Trials, Phase III as Topic
  • Cardiovascular System & Hematology
  • Acute Coronary Syndrome
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Chan, M. Y., Sun, J.-L., Newby, L. K., Lokhnygina, Y., White, H. D., Moliterno, D. J., … Harrington, R. A. (2013). Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years. Int J Cardiol, 167(2), 548–554. https://doi.org/10.1016/j.ijcard.2012.01.065
Chan, Mark Y., Jie-Lena Sun, L Kristin Newby, Yuliya Lokhnygina, Harvey D. White, David J. Moliterno, Pierre Théroux, et al. “Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years.Int J Cardiol 167, no. 2 (July 31, 2013): 548–54. https://doi.org/10.1016/j.ijcard.2012.01.065.
Chan MY, Sun J-L, Newby LK, Lokhnygina Y, White HD, Moliterno DJ, et al. Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years. Int J Cardiol. 2013 Jul 31;167(2):548–54.
Chan, Mark Y., et al. “Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years.Int J Cardiol, vol. 167, no. 2, July 2013, pp. 548–54. Pubmed, doi:10.1016/j.ijcard.2012.01.065.
Chan MY, Sun J-L, Newby LK, Lokhnygina Y, White HD, Moliterno DJ, Théroux P, Ohman EM, Simoons ML, Mahaffey KW, Pieper KS, Giugliano RP, Armstrong PW, Califf RM, Van de Werf F, Harrington RA. Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years. Int J Cardiol. 2013 Jul 31;167(2):548–554.
Journal cover image

Published In

Int J Cardiol

DOI

EISSN

1874-1754

Publication Date

July 31, 2013

Volume

167

Issue

2

Start / End Page

548 / 554

Location

Netherlands

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Myocardial Infarction
  • Length of Stay
  • Humans
  • Clinical Trials, Phase III as Topic
  • Cardiovascular System & Hematology
  • Acute Coronary Syndrome
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology