Clinical and research issues regarding chronic advanced coronary artery disease Part II: Trial design, outcomes, and regulatory issues

American Heart Journal

Volumn 155, Issue 3, 2008, Pages 435-444

  Jolicoeur, E Marc ^a   Ohman, E Magnus ^a   Temple, Robert ^b   Stockbridge, Norman ^b   Smith, Sidney ^c   Mark, Daniel ^a   Califf, Robert M ^a   Henry, Timothy D ^d   Chaitman, Bernard R ^e   Granger, Christopher B ^a  

^a DUKE UNIVERSITY   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

^e SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; ATENOLOL; DILTIAZEM; GLYCERYL TRINITRATE; NIFEDIPINE; PROPRANOLOL DERIVATIVE;

ANGINA PECTORIS; ARTICLE; CHRONIC DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL; CORONARY ARTERY DISEASE; ELECTROCARDIOGRAPHY; EXERCISE TEST; FUNCTIONAL STATUS; HEART MUSCLE ISCHEMIA; HEART MUSCLE PERFUSION; HUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; ST SEGMENT;

CHRONIC DISEASE; CLINICAL TRIALS AS TOPIC; CONGRESSES AS TOPIC; CORONARY DISEASE; DECISION MAKING; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MYOCARDIAL REVASCULARIZATION; PLATELET AGGREGATION INHIBITORS; PRACTICE GUIDELINES AS TOPIC; TREATMENT OUTCOME;

EID: 39549115887     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2007.12.005     Document Type: Article

References (53)

1. Aaberge L., Nordstrand K., Dragsund M., et al. Transmyocardial revascularization with CO2 laser in patients with refractory angina pectoris: clinical results from the Norwegian randomized trial. J Am Coll Cardiol 35 (2000) 1170-1177
2. Burkhoff D., Schmidt S., Schulman S.P., et al. Transmyocardial laser revascularisation compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomised trial. Lancet 354 (1999) 885-890
3. Oesterle S.N., Sanborn T.A., Ali N., et al. Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Lancet 356 (2000) 1705-1710
4. Schofield P.M., Sharples L.D., Caine N., et al. Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial. Lancet 353 (1999) 519-524
5. Leon M.B., Kornowski R., Downey W.E., et al. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol 46 (2005) 1812-1819
6. Horvath K.A., Aranki S.F., Cohn L.H., et al. Sustained angina relief 5 years after transmyocardial laser revascularization with a CO2 laser. Circulation 104 (2001) I-81
7. Henry T.D., Satran D., Johnson R.J., et al. Natural history of patients with refractory angina. J Am Coll Cardiol 47 (2006) 231 (abstract)
8. Campeau L. Letter: grading of angina pectoris. Circulation 54 (1976) 522-523
9. Allen K.B., Dowling R.D., Fudge T.L., et al. Comparison of transmyocardial revascularization with medical therapy in patients with refractory angina. N Engl J Med 341 (1999) 1029-1036
10. Kandzari D.E., Lam L.C., Eisenstein E.L., et al. Advanced coronary artery disease: appropriate end points for trials of novel therapies. Am Heart J 142 (2001) 843-851
11. Spertus J. Selecting end points in clinical trials: what evidence do we really need to evaluate a new treatment?. Am Heart J 142 (2001) 745-747
12. Goldman L., Cook E.F., Mitchell N., et al. Pitfalls in the serial assessment of cardiac functional status. How a reduction in "ordinary" activity may reduce the apparent degree of cardiac compromise and give a misleading impression of improvement. J Chronic Dis 35 (1982) 763-771
13. Arora R.R., Chou T.M., Jain D., et al. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol 33 (1999) 1833-1840
14. McHorney C.A., Ware Jr. J.E., and Raczek A.E. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 31 (1993) 247-263
15. McHorney C.A., Ware Jr. J.E., Lu J.F., et al. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 32 (1994) 40-66
16. Hlatky M.A., Boineau R.E., Higginbotham M.B., et al. A brief self-administered questionnaire to determine functional capacity (The Duke Activity Status Index). Am J Cardiol 64 (1989) 651-654
17. Spertus J.A., Winder J.A., Dewhurst T.A., et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 25 (1995) 333-341
18. Stewart R.A., Kittelson J., and Kay I.P. Statistical methods to improve the precision of the treadmill exercise test. J Am Coll Cardiol 36 (2000) 1274-1279
19. Bogaty P., Poirier P., Boyer L., et al. What induces the warm-up ischemia/angina phenomenon: exercise or myocardial ischemia?. Circulation 107 (2003) 1858-1863
20. Bogaty P., Kingma Jr. J.G., Robitaille N.M., et al. Attenuation of myocardial ischemia with repeated exercise in subjects with chronic stable angina: relation to myocardial contractility, intensity of exercise and the adenosine triphosphate-sensitive potassium channel. J Am Coll Cardiol 32 (1998) 1665-1671
21. Chaitman B.R., Pepine C.J., Parker J.O., et al. Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial. JAMA 291 (2004) 309-316
22. Chaitman B.R., Skettino S.L., Parker J.O., et al. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol 43 (2004) 1375-1382
23. Rana J.S., Mannam A., Donnell-Fink L., et al. Longevity of the placebo effect in the therapeutic angiogenesis and laser myocardial revascularization trials in patients with coronary heart disease. Am J Cardiol 95 (2005) 1456-1459
24. Stone P.H., Gibson R.S., Glasser S.P., et al. Comparison of propranolol, diltiazem, and nifedipine in the treatment of ambulatory ischemia in patients with stable angina. Differential effects on ambulatory ischemia, exercise performance, and anginal symptoms. The ASIS Study Group. Circulation 82 (1990) 1962-1972
25. Pehrsson S.K., Ringqvist I., Ekdahl S., et al. Monotherapy with amlodipine or atenolol versus their combination in stable angina pectoris. Clin Cardiol 23 (2000) 763-770
26. Fox K.M., Mulcahy D., Findlay I., et al. The Total Ischaemic Burden European Trial (TIBET). Effects of atenolol, nifedipine SR and their combination on the exercise test and the total ischaemic burden in 608 patients with stable angina. The TIBET Study Group. Eur Heart J 17 (1996) 96-103
27. Rice K.R., Gervino E., Jarisch W.R., et al. Effects of nifedipine on myocardial perfusion during exercise in chronic stable angina pectoris. Am J Cardiol 65 (1990) 1097-1101
28. Hung J., Lamb I.H., Connolly S.J., et al. The effect of diltiazem and propranolol, alone and in combination, on exercise performance and left ventricular function in patients with stable effort angina: a double-blind, randomized, and placebo-controlled study. Circulation 68 (1983) 560-567
29. Steg P., Bhatt D.L., Wilson P.W.F., et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA 297 (2007) 1197-1206
30. Manca C., Bianchi G., Effendy F.N., et al. Comparison of five different stress testing methods in the ECG diagnosis of coronary artery disease. Correlation with coronary arteriography. Cardiology 64 (1979) 325-332
31. Maeder M., Wolber T., Atefy R., et al. Impact of the exercise mode on exercise capacity: bicycle testing revisited. Chest 128 (2005) 2804-2811
32. Pepine C.J., Cohn P.F., Deedwania P.C., et al. Effects of treatment on outcome in mildly symptomatic patients with ischemia during daily life. The Atenolol Silent Ischemia Study (ASIST). Circulation 90 (1994) 762-768
33. Rogers W.J., Bourassa M.G., Andrews T.C., et al. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: outcome at 1 year for patients with asymptomatic cardiac ischemia randomized to medical therapy or revascularization. The ACIP Investigators. J Am Coll Cardiol 26 (1995) 594-605
34. Von A.T. Prognostic significance of transient ischemic episodes: response to treatment shows improved prognosis. Results of the Total Ischemic Burden Bisoprolol Study (TIBBs) follow-up. J Am Coll Cardiol 28 (1996) 20-24
35. Borzak S., Fenton T., Glasser S.P., et al. Discordance between effects of anti-ischemic therapy on ambulatory ischemia, exercise performance and anginal symptoms in patients with stable angina pectoris. The Angina and Silent Ischemia Study Group (ASIS). J Am Coll Cardiol 21 (1993) 1605-1611
36. Crawford M.H., Bernstein S.J., Deedwania P.C., et al. ACC/AHA guidelines for ambulatory electrocardiography: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the Guidelines for Ambulatory Electrocardiography). Circulation 100 (1999) 886-893
37. Gibbons R.J., Abrams J., Chatterjee K., et al. ACC/AHA 2002 guideline update for the management of patients with chronic stable angina-summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina). Circulation 107 (2003) 149-158
38. Simons M., Bonow R.O., Chronos N.A., et al. Clinical trials in coronary angiogenesis: issues, problems, consensus: an expert panel summary. Circulation 102 (2000) e73-e86
39. Erbs S., Linke A., Adams V., et al. Transplantation of blood-derived progenitor cells after recanalization of chronic coronary artery occlusion: first randomized and placebo-controlled study. Circ Res 97 (2005) 756-762
40. Masuda D., Nohara R., Hirai T., et al. Enhanced external counterpulsation improved myocardial perfusion and coronary flow reserve in patients with chronic stable angina; evaluation by(13)N-ammonia positron emission tomography. Eur Heart J 22 (2001) 1451-1458
41. Jerosch-Herold M., Seethamraju R.T., Swingen C.M., et al. Analysis of myocardial perfusion MRI. J Magn Reson Imaging 19 (2004) 758-770
42. Kim HW, Klem I, Kim RJ. Detection of myocardial ischemia by stress perfusion cardiovascular magnetic resonance. Cardiol Clin 2007;25:57-70, vi.
43. Hendel R.C., Patel M.R., Kramer C.M., et al. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology
44. Nandalur K.R., Dwamena B.A., Choudhri A.F., et al. Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. J Am Coll Cardiol 50 (2007) 1343-1353
45. Galinanes M., Loubani M., Sensky P.R., et al. Efficacy of transmyocardial laser revascularization and thoracic sympathectomy for the treatment of refractory angina. Ann Thorac Surg 78 (2004) 122-128
46. Laham R.J., Sellke F.W., Edelman E.R., et al. Local perivascular delivery of basic fibroblast growth factor in patients undergoing coronary bypass surgery: results of a phase I randomized, double-blind, placebo-controlled trial. Circulation 100 (1999) 1865-1871
47. Ferreira-Gonzalez I., Permanyer-Miralda G., Domingo-Salvany A., et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 334 (2007) 786
48. Freemantle N., and Calvert M. Composite and surrogate outcomes in randomised controlled trials. BMJ 334 (2007) 756-757
49. Effect of nicorandil on coronary events in patients with stable angina: the Impact of Nicorandil in Angina (IONA) randomised trial. Lancet 359 (2002) 1269-1275
50. McGettigan P., and Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 296 (2006) 1633-1644
51. Food and Drug Administration, Center for Drug Evaluation and Research. March 2nd 2006, Available from: URL:. http://www.fda.gov/Cder/guidance/3774dft.htm Accessed Dec 18th, 2006
52. Brass E.P., Lewis R.J., Lipicky R., et al. Risk assessment in drug development for symptomatic indications: a framework for the prospective exclusion of unacceptable cardiovascular risk. Clin Pharmacol Ther 79 (2006) 165-172
53. Frazier O.H., March R.J., and Horvath K.A. The Transmyocardial Carbon Dioxide Laser Revascularization Study Group. Transmyocardial revascularization with a carbon dioxide laser in patients with end-stage coronary artery disease. N Engl J Med 341 (1999) 1021-1028