References
- Papers of special note have been highlighted as:
- • of interest
- •• of considerable interest
- Medical Research Council. Streptomycin treatment of pulmonary tuberculosis. BMJ. 1948;2:769–782.
• First historical trial to have used randomization for selection of cases and controls.
- Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med. 1982;72:233–240.
- Edwards FH, Shahian DM, Grau-Sepulveda MV, et al. Composite outcomes in coronary bypass surgery versus percutaneous intervention. Ann Thorac Surg. 2014;97(6):1983–1990.
- Serruys PW, Ong AT, van Herwerden LA, et al. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005;46:575–581.
- Taggart DP. Surgery is the best intervention for severe coronary artery disease. BMJ. 2005;330:785–786.
•• Article provides strong arguments for the superiority of cabg in multivessel disease.
- Taggart DP. PCI or CABG in coronary artery disease? Lancet. 2009;373(9670):1150–1152.
•• Discusses pci against cabg with arguments for the superiority of cabg in multivessel disease as opposed to historical trials.
- Taggart DP. Incomplete revascularization: appropriate and inappropriate. Eur J Cardiothorac Surg. 2012;41(3):542–543.
- Taggart DP, Ferguson TB Lecture. Coronary artery bypass grafting is still the best treatment for multivessel and left main disease, but patients need to know. Ann Thorac Surg. 2006;82(6):1966–1975.
•• This famous lecture looks at historical data for revascularization and how results from previous trials were skewed against cabg.
- McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999;23:1210–1214.
- van der Linden W. Pitfalls in randomized surgical trials. Surgery. 1980;87(3):258–262.
•• Discusses shortcomings of RCTs.
- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141–145.
- Djulbegovic B. The paradox of equipoise: the principle that drives and limits therapeutic discoveries in clinical research. Cancer Control. 2009;16(4):342–347.
- Miller FG, Brody H. A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep. 2003;33(3):19–28.
- Novitzky D, Shroyer AL, Collins JF, et al.; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. A study design to assess the safety and efficacy of on-pump versusoff-pump coronary bypass grafting: the ROOBY trial. Clin Trials. 2007;4(1):81–91.
- Shroyer AL, Grover FL, Hattler B, et al.; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009;361(19):1827–1837.
•• Historical trial comparing onpump and offpump.
- Hattler B, Messenger JC, Shroyer AL, et al.; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012;125(23):2827–2835.
- Lamy A, Devereaux PJ, Prabhakaran D, et al.; CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med. 2013;368(13):1179–1188.
- Lamy A, Devereaux PJ, Prabhakaran D, et al.; CORONARY Investigators. Off-pump or on-pump coronary-artery bypass grafting at 30 days. N Engl J Med. 2012;366(16):1489–1497.
- Puskas JD, Thourani VH, Kilgo P, et al. Off-pump coronary artery bypass disproportionately benefits high-risk patients. Ann Thorac Surg. 2009;88(4):1142–1147.
•• Article analyses predictive risk of mortality scores for cabg patients and shows that only high risk patients are likely to benefit, a possible explanation why trials have not shown much survival differences between offpump and onpump results.
- Diamond GA, Forrester JS. Clinical trials and statistical verdicts: probable grounds for appeal. Ann Intern Med. 1983;98:385–394.
- Browner W, Newman T. Are all significant P values created equal? The analogy between diagnostic tests and clinical research. JAMA. 1987;257:2459–2463.
- Kappetein AP, Head SJ, Morice MC, et al. Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial. Eur J Cardiothorac Surg. 2013;43(5):1006–1013.
•• Landmark trial comparing pci and cabg.
- Farkouh ME, Domanski M, Sleeper LA, et al. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012;367(25):2375–2384.
- Taggart DP, D’Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001;358:870–875.
•• Landmark review paper that shows superior survival for bilateral internal thoracic arteries despite lack of recommendations.
- Lytle BW, Blackstone EH, Sabik JF, et al. The effect of bilateral internal thoracic artery grafting on survival during 20 postoperative years. Ann Thorac Surg. 2004;78:2005–2014.
•• Landmark observational study of bilateral internal thoracic arteries.
- Weiss AJ, Zhao S, Tian DH, et al. A meta-analysis comparingbilateral internal mammary artery with left internal mammary artery for coronary artery bypass grafting. Ann Cardiothorac Surg. 2013;2(4):390–400.
- Yi G, Shine B, Rehman SM, et al. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014;130(7):539–545.
- Taggart DP, Altman DG, Gray AM, et al.; on behalf of ART Investigators. Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART). Eur Heart J. 2010;31:2470–2481.
•• Landmark observational study of bilateral internal thoracic arteries.
- Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014;29:4.
- Dahabreh IJ, Sheldrick RC, Paulus JK, et al. Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes. Eur Heart J. 2012;33(15):1893–1901.
- Kuss O, Legler T, Börgermann J. Treatments effects from randomized trials and propensity score analyses were similar in similar populations in an example from cardiac surgery. J Clin Epidemiol. 2011;64(10):1076–1084.
- Luthra S. The scientific foundation, rationale and argument for a nonfrequentist Bayesian analysis in clinical trials in coronary artery disease. Heart Lung Circ. 2015;24(6):614–616.
•• Landmark observational study of bilateral internal thoracic arteries.
- Atkins D, Best D, Briss PA, et al.; GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490.
- Balshem H, Helfand M, Schunemann H, et al., et al. GRADE guidelines 3. Rating the quality of evidence – introduction. J Clin Epidemiol. 2011;64:401–406.