메뉴 건너뛰기




Volumn 71, Issue 25, 2018, Pages 2957-2969

Critical Appraisal of the 2018 ACC Scientific Sessions Late-Breaking Trials From a Statistician's Perspective

Author keywords

clinical trials; conference presentations; critical appraisal

Indexed keywords

ALIROCUMAB; ANTITHROMBOCYTIC AGENT; ATORVASTATIN; CLOPIDOGREL; METOPROLOL; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; TICAGRELOR;

EID: 85046622487     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2018.04.015     Document Type: Review
Times cited : (21)

References (32)
  • 1
    • 84919768013 scopus 로고    scopus 로고
    • Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial
    • Boutron, I., Altman, D.G., Hopewell, S., Vera-Badillo, F., Tannock, I., Ravaud, P., Impact of spin in the abstracts of articles reporting results of randomized controlled trials in the field of cancer: the SPIIN randomized controlled trial. J Clin Oncol 32 (2014), 4120–4126.
    • (2014) J Clin Oncol , vol.32 , pp. 4120-4126
    • Boutron, I.1    Altman, D.G.2    Hopewell, S.3    Vera-Badillo, F.4    Tannock, I.5    Ravaud, P.6
  • 2
    • 84908322310 scopus 로고    scopus 로고
    • Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY Outcomes trial. Am Heart J
    • Schwartz GG, Bessac L, Berdan LG, et al. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY Outcomes trial. Am Heart J 2014;168:682–9.e1.
    • (2014) , vol.168 , pp. 682-9.e1
    • Schwartz, G.G.1    Bessac, L.2    Berdan, L.G.3
  • 3
    • 43249093045 scopus 로고    scopus 로고
    • More on subgroup analyses in clinical trials
    • Pocock, S.J., Lubsen, J., More on subgroup analyses in clinical trials. N Engl J Med 358 (2008), 2076–2077.
    • (2008) N Engl J Med , vol.358 , pp. 2076-2077
    • Pocock, S.J.1    Lubsen, J.2
  • 4
    • 85034813185 scopus 로고    scopus 로고
    • Multiple Endpoints in Clinical Trials: Guidance for Industry
    • Food and Drug Administration College Park, Maryland
    • Food and Drug Administration. Multiple Endpoints in Clinical Trials: Guidance for Industry. 2017, Food and Drug Administration, College Park, Maryland.
    • (2017)
  • 5
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assmann, S.F., Pocock, S.J., Enos, L.E., Kasten, L.E., Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 355 (2000), 1064–1069.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assmann, S.F.1    Pocock, S.J.2    Enos, L.E.3    Kasten, L.E.4
  • 6
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine—reporting of subgroup analyses in clinical trials
    • Wang, R., Lagakos, S.W., Ware, J.H., Hunter, D.J., Drazen, J.M., Statistics in medicine—reporting of subgroup analyses in clinical trials. N Engl J Med 357 (2007), 2189–2194.
    • (2007) N Engl J Med , vol.357 , pp. 2189-2194
    • Wang, R.1    Lagakos, S.W.2    Ware, J.H.3    Hunter, D.J.4    Drazen, J.M.5
  • 7
    • 85017341929 scopus 로고    scopus 로고
    • Evolocumab and clinical outcomes in patients with cardiovascular disease
    • Sabatine, M.S., Giugliano, R.P., Keech, A.C., et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med 376 (2017), 1713–1722.
    • (2017) N Engl J Med , vol.376 , pp. 1713-1722
    • Sabatine, M.S.1    Giugliano, R.P.2    Keech, A.C.3
  • 8
    • 85048276071 scopus 로고    scopus 로고
    • ClinicalTrials.gov. Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST). October 5. Available at: Accessed March 23, 2018
    • ClinicalTrials.gov. Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST). October 5, 2011. Available at: http://clinicaltrials.gov/ct/show/NCT01446965?order=1. Accessed March 23, 2018.
    • (2011)
  • 9
    • 84955454921 scopus 로고    scopus 로고
    • Challenging issues in clinical trial design: part 4 of a 4-part series on statistics for clinical trials
    • Pocock, S.J., Clayton, T.C., Stone, G.W., Challenging issues in clinical trial design: part 4 of a 4-part series on statistics for clinical trials. J Am Coll Cardiol 66 (2015), 2886–2898.
    • (2015) J Am Coll Cardiol , vol.66 , pp. 2886-2898
    • Pocock, S.J.1    Clayton, T.C.2    Stone, G.W.3
  • 10
    • 85044949566 scopus 로고    scopus 로고
    • Effect of loading dose of atorvastatin prior to planned percutaneous coronary intervention on major adverse cardiovascular events in acute coronary syndrome: the SECURE-PCI randomized clinical trial
    • Berwanger, O., Santucci, E., de Barros e Silva, P., et al. Effect of loading dose of atorvastatin prior to planned percutaneous coronary intervention on major adverse cardiovascular events in acute coronary syndrome: the SECURE-PCI randomized clinical trial. JAMA 319 (2018), 1331–1340.
    • (2018) JAMA , vol.319 , pp. 1331-1340
    • Berwanger, O.1    Santucci, E.2    de Barros e Silva, P.3
  • 11
    • 84985963205 scopus 로고    scopus 로고
    • The primary outcome fails—what next?
    • Pocock, S.J., Stone, G.W., The primary outcome fails—what next?. N Engl J Med 375 (2016), 861–870.
    • (2016) N Engl J Med , vol.375 , pp. 861-870
    • Pocock, S.J.1    Stone, G.W.2
  • 12
    • 67649977705 scopus 로고    scopus 로고
    • Outcome based subgroup analysis: a neglected concern
    • Hirji, K.F., Fagerland, M.W., Outcome based subgroup analysis: a neglected concern. Trials, 10, 2009, 33.
    • (2009) Trials , vol.10 , pp. 33
    • Hirji, K.F.1    Fagerland, M.W.2
  • 13
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
    • Yusuf, S., Wittes, J., Probstfield, J., Tyroler, H.A., Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 266 (1991), 93–98.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 14
    • 85048300372 scopus 로고    scopus 로고
    • Ticagrelor vs clopidogrel after fibrinolytic therapy in patients with ST-elevation myocardial infarction: a randomized clinical trial
    • TREAT Study Group. Ticagrelor vs clopidogrel after fibrinolytic therapy in patients with ST-elevation myocardial infarction: a randomized clinical trial. JAMA Cardiol 3 (2018), 391–399.
    • (2018) JAMA Cardiol , vol.3 , pp. 391-399
  • 15
    • 84907355595 scopus 로고    scopus 로고
    • Is the panic about beta-blockers in perioperative care justified?
    • Lüscher, T.F., Gersh, B., Landmesser, U., Ruschitzka, F., Is the panic about beta-blockers in perioperative care justified?. Eur Heart J 35 (2014), 2442–2444.
    • (2014) Eur Heart J , vol.35 , pp. 2442-2444
    • Lüscher, T.F.1    Gersh, B.2    Landmesser, U.3    Ruschitzka, F.4
  • 16
    • 84908283604 scopus 로고    scopus 로고
    • 2014 ESC/ESA guidelines on non-cardiac surgery: cardiovascular assessment and management
    • Kristensen, S.D., Knuuti, J., Saraste, A., et al. 2014 ESC/ESA guidelines on non-cardiac surgery: cardiovascular assessment and management. Eur Heart J 35 (2014), 2383–2431.
    • (2014) Eur Heart J , vol.35 , pp. 2383-2431
    • Kristensen, S.D.1    Knuuti, J.2    Saraste, A.3
  • 17
    • 44349168172 scopus 로고    scopus 로고
    • POISE Study Group. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet
    • POISE Study Group. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008;371:1839–47.
    • (2008) , vol.371 , pp. 1839-47
  • 18
    • 84929884068 scopus 로고    scopus 로고
    • Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials
    • Giustino, G., Baber, U., Sartori, S., et al. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol 65 (2015), 1298–1310.
    • (2015) J Am Coll Cardiol , vol.65 , pp. 1298-1310
    • Giustino, G.1    Baber, U.2    Sartori, S.3
  • 19
    • 85043381536 scopus 로고    scopus 로고
    • 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial
    • Hahn, J.-Y., Song, Y.B., Oh, J.-H., et al., for the SMART-DATE Investigators. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial. Lancet 391 (2018), 1274–1284.
    • (2018) Lancet , vol.391 , pp. 1274-1284
    • Hahn, J.-Y.1    Song, Y.B.2    Oh, J.-H.3
  • 20
    • 85028610685 scopus 로고    scopus 로고
    • Challenges in the design and interpretation of noninferiority trials: insights from recent stent trials
    • Macaya, F., Ryan, N., Salinas, P., Pocock, S.J., Challenges in the design and interpretation of noninferiority trials: insights from recent stent trials. J Am Coll Cardiol 70 (2017), 894–903.
    • (2017) J Am Coll Cardiol , vol.70 , pp. 894-903
    • Macaya, F.1    Ryan, N.2    Salinas, P.3    Pocock, S.J.4
  • 21
    • 85048288661 scopus 로고    scopus 로고
    • Lower cardiovascular risk associated with SGLT-2i in >400,000 patients: the CVD-REAL 2 study
    • [E-pub ahead of print]
    • Kosiborod, M., Lam, C.S.P., Kohsaka, S., et al. Lower cardiovascular risk associated with SGLT-2i in >400,000 patients: the CVD-REAL 2 study. J Am Coll Cardiol, 2018 Mar 11 [E-pub ahead of print].
    • (2018) J Am Coll Cardiol
    • Kosiborod, M.1    Lam, C.S.P.2    Kohsaka, S.3
  • 22
  • 23
    • 84888266883 scopus 로고    scopus 로고
    • Making inferences on treatment effects from real world data: propensity scores, confounding by indication, and other perils for the unwary in observational research
    • Freemantle, N., Marston, L., Walters, K., Wood, J., Reynolds, M.R., Petersen, I., Making inferences on treatment effects from real world data: propensity scores, confounding by indication, and other perils for the unwary in observational research. BMJ, 347, 2013, f6409.
    • (2013) BMJ , vol.347 , pp. f6409
    • Freemantle, N.1    Marston, L.2    Walters, K.3    Wood, J.4    Reynolds, M.R.5    Petersen, I.6
  • 24
    • 0034702184 scopus 로고    scopus 로고
    • Randomized trials or observational tribulations?
    • Pocock, S.J., Elbourne, D.R., Randomized trials or observational tribulations?. N Engl J Med 342 (2000), 1907–1909.
    • (2000) N Engl J Med , vol.342 , pp. 1907-1909
    • Pocock, S.J.1    Elbourne, D.R.2
  • 25
    • 85019731757 scopus 로고    scopus 로고
    • Lower risk of heart failure and death in patients initiated on SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study
    • Kosiborod, M., Cavender, M.A., Fu, A.Z., et al. Lower risk of heart failure and death in patients initiated on SGLT-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study. Circulation 136 (2017), 249–259.
    • (2017) Circulation , vol.136 , pp. 249-259
    • Kosiborod, M.1    Cavender, M.A.2    Fu, A.Z.3
  • 26
    • 84889351499 scopus 로고    scopus 로고
    • Introduction to Meta-Analysis
    • Wiley Chichester, West Sussex, United Kingdom
    • Borenstein, M., Hedges, L.V., Higgins, J.P.T., Rothstein, H.R., Introduction to Meta-Analysis. 2009, Wiley, Chichester, West Sussex, United Kingdom.
    • (2009)
    • Borenstein, M.1    Hedges, L.V.2    Higgins, J.P.T.3    Rothstein, H.R.4
  • 27
    • 0033198316 scopus 로고    scopus 로고
    • Random-effects meta-analyses are not always conservative
    • Poole, C., Greenland, S., Random-effects meta-analyses are not always conservative. Am J Epidemiol 150 (1999), 469–475.
    • (1999) Am J Epidemiol , vol.150 , pp. 469-475
    • Poole, C.1    Greenland, S.2
  • 28
    • 84944800184 scopus 로고    scopus 로고
    • Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes
    • Zinman, B., Wanner, C., Lachin, J.M., et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 373 (2015), 2117–2128.
    • (2015) N Engl J Med , vol.373 , pp. 2117-2128
    • Zinman, B.1    Wanner, C.2    Lachin, J.M.3
  • 29
    • 85034766786 scopus 로고    scopus 로고
    • Canagliflozin and cardiovascular and renal events in type 2 diabetes
    • Neal, B., Perkovic, V., Mahaffey, K.W., et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 377 (2017), 644–657.
    • (2017) N Engl J Med , vol.377 , pp. 644-657
    • Neal, B.1    Perkovic, V.2    Mahaffey, K.W.3
  • 30
    • 85048257944 scopus 로고    scopus 로고
    • ClinicalTrials.gov. Multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events (DECLARE-TIMI58). November 21. Available at: Accessed March 23, 2018
    • ClinicalTrials.gov. Multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events (DECLARE-TIMI58). November 21, 2012. Available at: http://clinicaltrials.gov/ct/show/NCT01730534?order=1. Accessed March 23, 2018.
    • (2012)
  • 31
    • 85042008156 scopus 로고    scopus 로고
    • DECLARE-TIMI 58: participants’ baseline characteristics
    • Raz, I., Mosenzon, O., Bonaca, M.P., et al. DECLARE-TIMI 58: participants’ baseline characteristics. Diabetes Obes Metab 20 (2018), 1102–1110.
    • (2018) Diabetes Obes Metab , vol.20 , pp. 1102-1110
    • Raz, I.1    Mosenzon, O.2    Bonaca, M.P.3
  • 32
    • 77950273246 scopus 로고    scopus 로고
    • CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials
    • Moher, D., Hopewell, S., Schulz, K.F., et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 340, 2010, c869.
    • (2010) BMJ , vol.340 , pp. c869
    • Moher, D.1    Hopewell, S.2    Schulz, K.F.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.