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Ann Thorac Surg 1999;67:396-403
© 1999 The Society of Thoracic Surgeons
a Mayo Clinic, Rochester, Minnesota, USA
b Bellevue Hospital, New York, New York, USA
c University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Accepted for publication June 27, 1998.
Address reprint requests to Dr Detre, BARI Coordinating Center, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto St, Pittsburgh, PA 15261
e-mail: cmullany{at}mayo.edu
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Abstract |
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Methods. In the Bypass Angioplasty Revascularization Investigation (BARI) trial, 1,829 patients with symptomatic multivessel coronary artery disease requiring revascularization were randomly assigned to undergo either CABG or PTCA.
Results. Seven hundred nine patients (39%) were 65 to 80 years old at baseline; the other 1,120 were younger than 65 years. The in-hospital 30-day mortality rate for PTCA and CABG in the younger patients was 0.7% and 1.1%, respectively, and that for patients 65 years or older was 1.7% and 1.7%, respectively. In older compared with younger patients, stroke was more common after CABG (1.7% versus 0.2%, p = 0.015) and heart failure or pulmonary edema was more common after PTCA (4.0 versus 1.3%, p = 0.011). In both age groups, CABG resulted in greater relief of angina and fewer repeat procedures. The 5-year survival rate in patients younger than 65 years was 91.5% for CABG and 89.5% for PTCA. In patients 65 years or older, the 5-year survival rate was 85.7% for CABG and 81.4% for PTCA. Cardiac mortality at 5 years was greater in patients assigned to the PTCA group than in those assigned to the CABG group. However, no significant treatment differences were noted in cardiac mortality when only nondiabetic patients were examined.
Conclusions. Within the context of the Bypass Angioplasty Revascularization Investigation trial, older patients with multivessel coronary disease do well with either PTCA or CABG. Compared with younger patients, older patients had less recurrent angina and were less likely to undergo repeat procedures, particularly among those assigned to undergo CABG. Cardiac mortality was greater in patients 65 years or older assigned to undergo PTCA; however, this difference was not noted when treated diabetic patients were excluded from analysis.
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The average age of patients undergoing revascularization by either method continues to increase. Because the procedure-related morbidity and mortality increase with age [13–15], comparisons of the outcome of PTCA and CABG in the elderly are important. In the present report, we determined the short- and long-term (5-year) outcome of patients younger than 65 years and those 65 years or older enrolled in the BARI trial.
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Statistical analysis
Baseline and procedural categoric data were compared using the 
2 test, and comparisons of continuous data were based on the t test or the Wilcoxon test. In-hospital complications were compared using Fisher’s exact test. Long-term survival, cardiac mortality, and freedom from repeat procedures were estimated using the Kaplan-Meier method [16]. Kaplan-Meier curves were compared using log-rank tests. The Cox model was used in a multivariate analysis to determine independent predictors of mortality [17]. Clinical site and year at study entry were always included into the Cox model, whereas factors that were associated with total mortality were selected using stepwise methods (age, gender, left ventricular function, coronary dominance, presence of diffuse lesions, congestive heart failure, hypertension, peripheral vascular disease, treated diabetes mellitus, chronic obstructive pulmonary disease, renal dysfunction, history of malignancy, and body surface area were selected). A p value less than 0.05 was considered statistically significant. All comparisons between PTCA and CABG were done according to the principle of intention to treat, except for analysis of postprocedural complications, which included only patients who received their assigned treatment.
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When the two treatment groups were combined, older patients had significantly higher total and cardiac mortality rates than younger patients (16.5% versus 9.5%, p = 0.001, for total mortality; 9.0% versus 4.9%, p = 0.001, for cardiac mortality). After adjustment for baseline factors, the relative risk of death (total mortality) was 1.80 (95% confidence interval, 1.38 to 2.36, p < 0.001) and the relative risk for cardiac mortality was 1.98 (95% confidence interval, 1.35 to 2.92, p < 0.001) for the older versus the younger patients.
The cause of late death was strikingly similar for the older and younger patients (Table 5). In particular, the proportion of cardiac deaths in both age groups was identical (49%). However, the elderly patients had a higher rate of cardiac contributory deaths rather than direct cardiac deaths than the younger patients.
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The in-hospital and 30-day mortality rates for both procedures are remarkably low, particularly in the elderly. However, excluded from the trial were patients with left main coronary artery stenosis greater than 50% and other patients who were not eligible on angiographic grounds, usually because they had complicated coronary stenoses, occlusions, or other coronary anatomy unsuitable for PTCA. Other exclusions included patients who had had previous procedures or a failed PTCA. In patients 70 years or older, the in-hospital mortality rate for CABG and PTCA was, respectively, 0.6% (1 of 164) and 1.7% (3 of 175). Although previous studies have noted increased mortality and morbidity rates with both procedures in elderly patients [13, 20–22], procedural mortality rates in general have been declining in recent years, despite the increasing age of the population and the more extensive disease seen in this age group. The operative mortality rate for CABG in the United States, as reported to the database of the Society of Thoracic Surgeons [18], was 3.7% in 1988 and had fallen to 2.9% in 1996. In 1995 to 1996, the mortality rate by age group was 0.9% for 20 to 50 years, 1.0% for 51 to 60 years, 1.4% for 61 to 65 years, 1.8% for 66 to 70 years, and 3.0% for 71 to 80 years. This is in contrast to the surgical mortality rate of 5.2% for the Coronary Artery Surgery Study (CASS) registry patients 65 years or older [23]. During this same period, the in-hospital mortality for PTCA also declined considerably. In a recent report by Thompson and associates [24], the in-hospital mortality rate for patients 65 years or older declined from 3.3% in 1980 to 1989 to 1.4% in 1990 to 1992, even though the more recent groups of "elderly" patients had a higher incidence of myocardial infarction, previous CABG, and treated diabetes mellitus. It is therefore not surprising that within the context of the BARI trial, which excluded a significant number of patients with advanced disease, the 30-day mortality rate was not demonstrated to be influenced by advancing age.
Postoperative morbidity within both treatment groups was influenced by advancing years. Stroke is an important complication of CABG and was seen in 0.3% of patients younger than 60 years, 0.3% of those 60 to 69 years old, and 3.0% of those 70 years or older (p = 0.004). Important risk factors for stroke in previous studies have been hypertension, diabetes mellitus, prolonged bypass time, a calcified aorta, advanced age, and a known history of cerebrovascular disease [19, 25]. The total number of strokes in the BARI randomized surgical group was only seven, so it is difficult to draw conclusions regarding risk factors from the trial. However, 2 of the 7 patients 65 years or older in the surgical group who did have a stroke were found to have a calcified aorta at operation. Greater recognition of the importance of neurologic complications after CABG in the elderly is leading to refinement of operative techniques, including intraoperative transesophageal echocardiography in high-risk patients, careful and minimal handling of the aorta, and the use of the internal mammary artery in the elderly, thus avoiding a further aortic anastomosis. Limited revascularization using the left internal mammary artery to the left anterior descending coronary artery, with or without bypass, is a good alternative for the high-risk patient with known aortic calcification or extensive aortic atheroma.
Heart failure was more common in the elderly after the initial PTCA procedure than in the younger group. There was also a trend toward more postprocedural heart failure and a greater need for inotropic support in the older surgical patients. In a recent report of Medicare patients, preoperative heart failure was seen in 9.8% of 65 to 70 year olds compared with 17.1% in those older than 80 years [26]. In the same report, heart failure was more commonly seen in women, as we also observed in the BARI trial. This greater incidence of preoperative heart failure in the elderly, seen only in women and not in men, perhaps represents a gender difference in the manifestation of coronary ischemia. In patients 70 years or older, 7.9% of patients undergoing CABG and 7.4% of those undergoing PTCA also had postprocedural heart failure or pulmonary edema. This finding can be explained by the greater incidence of preoperative heart failure and unstable angina, the greater extent of coronary artery disease, and the need for hospital admission seen preoperatively in this older group. In addition, diastolic dysfunction is more common in the elderly.
To date, randomized studies comparing CABG and PTCA have shown the superior effect of CABG for relief of angina [4–6, 11, 12]. The BARI study would suggest that somewhat greater relief of angina was seen in the older surviving patients within both treatment groups. However, this was not statistically significant at all time intervals during follow-up. A similar effect was noted in the CASS study, with patients 65 years or older reporting greater relief of angina than younger patients [23]. Coupled with this trend toward greater relief of angina, we observed a decrease in the reintervention rate in the elderly patients in the CABG group. This decrease may be explained by several factors: greater relief of angina, different expectations, greater tolerance of recurrent angina when it does recur in the elderly, less tendency for reoperation in older patients, less overall physical activity on the part of the elderly, and more elderly patients being "censored" from the angina data because of earlier deaths.
The 5-year survival rate in patients younger than 65 years undergoing CABG in the CASS registry (1974 to 1980) was 91% compared with 91.5% in the current series. The operative mortality rate was the same (1.9% versus 1.1%) [23]. In contrast, in patients 65 years or older, the 5-year survival rate in the CASS surgical registry was 83% versus 90% in the BARI trial [23]. Some of this improvement may be related to a significant decline in the operative mortality rate between the two studies (5.2% versus 1.7%). Because of the many differences between the two series, it is difficult to make comparisons between the two groups of patients and to draw conclusions regarding any perceived differences in long-term survival. Although the BARI trial patients tended to be older and female and had more extensive coronary artery disease and a greater incidence of diabetes mellitus, the proportion of patients with unstable angina and a left ventricular ejection fraction less than 0.50 was the same in both series, and 13% of the CASS registry patients had left main stenosis. In contrast, 11% of patients in the CASS registry had single-vessel disease. Patients with significant left main stenosis and single-vessel disease were excluded from the BARI trial. Improvement in long-term survival may in part be due to the greater use of the left internal mammary artery as a conduit in bypassing coronary artery disease.
In older patients, subsequent cardiac mortality was significantly greater in patients assigned to undergo PTCA than in those assigned to undergo CABG. However, this difference was not seen once patients with diabetes were excluded from the analysis. A separate publication has addressed this issue [27], but it would appear that, within the context of the BARI trial, the preferred initial revascularization strategy of treated diabetic patients should be CABG, and if grafting of the left anterior descending coronary artery is necessary, it should be with the internal mammary artery. The results presented here would suggest that this is particularly so in the older age group.
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Appendix |
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Brown University, Rhode Island Hospital, Providence, Rhode Island George N. Cooper, MD, Thomas M. Drew, MD, William C. Feng, MD, Michael Gilson, MD, Mary Grogan, RN, Mark Macedo, RN, Linda Mercurio, MD, John Morgan, MD, Arun K. Singh, MD, Barry L. Sharaf, MD, Edward Thomas, MD, Janice Wheeler, RN, Harvey White, MD, David O. Williams, MD
Bellevue Hospital, New York University Medical Center, New York, New York Michael J. Attubato, MD, Stephen B. Colvin, MD, Frederick Feit, MD, Aubrey C. Galloway, MD, Kenneth Metzger, MD, Peter F. Pasternack, MD, Marino J. Rey, Greg H. Ribakove, Sonja Shapiro
Boston University Medical Center, Boston, Massachusetts Gabriel S. Aldea, MD, David P. Faxon, MD, Denise Fine, Gary Garber, MD, Beth Hankin, RN, Alice K. Jacobs, MD, Mary Mazur, RN, Rachel Powsner, Nicholas N. Ruocco, MD, Thomas J. Ryan, MD, Richard S. Sheman, MD, Donald A. Weiner, MD. Former participants: Michael Bettmann, MD, John Brush, MD, Jesse Currier, MD, James Fonger, MD, Roger Mills, MD, Gary Paone, MD, James Rothendler, MD
Cleveland Clinic Foundation, Cleveland, Ohio Eugene H. Blackstone, MD, Kathy Comella, RN, Delos M. Cosgrove III, MD, Alexander Dimas, MD, Stephen G. Ellis, MD, Irving Franco, MD, A. Michael Lincoff, MD, Floyd D. Loop, MD, Marsha Lowrie, RN, Bruce W. Lytle, MD, William Proudfit, MD, Russell Raymond, DO, Robert W. Stewart, MD, Paul C. Taylor, MD, Eric J. Topol, MD, Patrick L. Whitlow, MD. Former participants: John Frierson, MD, Fernando Grigera, MD, Bernadine Healy, MD, Jay Hollman, MD, Lisa Korcuska, Benjamin Robalino, MD, Amy Rogers, RN, Sharon Senick, Joyce Tedrick, RN, Kevin Vaska, MD
Duke University, Durham, North Carolina Thomas M. Bashore, MD, Virginia Bass, Robert Bauman, MD, Victor S. Behar, MD, Robert M. Califf, MD, Laura Drew, Donald Fortin, MD, Jennifer Grinell, Peter Hodgson, Rob Holeman, R. Edward Holeman, Robert H. Jones, MD, Yihong Kong, MD, Mitchell W. Krucoff, MD, Kerry Lee, PhD, Kenneth G. Morris, MD, E. Magnus Ohman, MD, H. Newland Oldham, Jr, MD, Robert H. Peter, MD, Harry R. Phillips, MD, Mary Ann Sellers, RN, Richard Stack, MD, James E. Tcheng, MD, Peter Van Tright, MD. Former participants: Elizabeth Bacon, Sandra Burks, RN, Stephanie Caminiti, RN, Terri Daniels, David Frid, MD, Heidi Gessner, Ellen Hampton, RN, Michael Miller, MD, David Pryor, MD, Peter Quigley, MD, Jay Rankin, MD, Joan Richard, RN, Leonard Santoro, Alan Tenaglia, MD
Harvard University, Beth Israel, Boston, Massachusetts Julian Aroesty, MD, Donald S. Baim, MD, Margaret G. Flatley, BS, Robert G. Johnson, MD, Beverly Lorell, MD, Robert L. Thurer, MD, Ronald M. Weintraub, MD. Former participants: Mary Cunnion, Tia Defeo-Fraulini, MS, Daniel Diver, MD, Raymond McKay, MD, Carolyn McCabe, Kelly Miller, RN, Robert D. Safian, MD, Ann Slater, RN
Maine Medical Center (Satellite to Harvard), Portland, Maine Warren D. Alpern, MD, Richard A. Anderson, MD, Pamela Birmingham, RN, Susan Bosworth-Farrell, RN, D. Joshua Cutler, MD, Desmond Donegan, MD, David Gurkey, Jane C. Kane, RN, Saul Katz, MD, Mirle A. Kellet, Jr, MD, Christopher A. L. Lutes, MD, Robert S. Kramer, MD, Costas Lambrew, MD, Jeremy R. Morton, MD, Edward Nowicki, MD, John O’Meara, Thomas Ryan, MD, Paul Sweeney, MD, Nancy Tooker, RN, Joan Tryzelaar, MD, Richard L. White, MD
University of Massachusetts, Worcester, Massachusetts Marie Borbone, RN, Mark Furnam, MD, John M. Moran, MD, Okike N. Okike, MD, A. Thomas Pezzella, MD, Karen Quist, Thomas J. VanderSalm, Bonnie H. Weiner, MD. Former participants: Joseph Benotti, MD, Daniel Bitran, MD, James Dalen, MD, John Gaca, MD, Jeffrey Leppo, MD, Michael K. Pasque, MD, Marilyn Shay, RN, Paul Wanta, RN, Theresa Wisnewski
Mayo Clinic, Rochester, Minnesota Peter B. Berger, MD, John Bresnahan, MD, Raymond Gibbons, MD, David Holmes, MD, Lisa Kelly, Stephen Kopecky, MD, Sylvia Matheson, Michael Mock, MD, Charles J. Mullany, MB, MS, Thomas A. Orszulak, MD, LouAnn Pierre, RN, Guy S. Reeder, MD, Charanjit S. Rihal, MD, Robert Rizza, MD, Hartzell V. Schaff, MD, Robert S. Schwartz, MD, Hugh C. Smith, MD. Former participants: David Bresnahan, MD, Bernard J. Gersh, MD, Fred Nobrega, MD, Mary Peterson, Ronald Vlietstra, MD
Medical College of Virginia, Richmond, Virginia Michael J. Cowley, MD, Albert J. Guerraty, MD, Kim Kelly Hall, RN, David D. Salter, MD, James Tatum, MD, George Vetrovec, MD, Andrew S. Wechsler, MD. Former participants: Chancy W. Crandall, MD, David DeBottis, MD, Germane DiSciascio, MD, Richard R. Lower, MD, Ann Maziarz, RN, Amar Nath, RN, Szabolcs Szentpetery, MD
University of Michigan, Ann Arbor, Michigan Eric Bates, MD, Steven F. Bolling, MD, Patricia Bruenger, BA, James Corbett, MD, G. Michael Deeb, MD, Theresa Johnson, RN, Marvin M. Kirsh, MD, Kathleen McNeely, David Muller, MB, BS, Bertram Pitts, MD, Maurene Stock, RN, Steven Werns, MD. Former participants: Linda Belzowski, RN, Diane Bondie, Karen Burek, RN, Steven Ellis, MD, Linda Lee, MD, Diane Scarpace, RN, Marcus Schwaiger, MD, Julie Shu, MD, Mack C. Stirling, MD, Peter Thomasma, Joseph Walton, MD
Montreal Heart Institute, Montreal, Quebec, Canada Andre Arseneault, MD, Martial Bourassa, MD, Raoul Bonan, MD, Gilles Cote, MD, Jacques Crepeau, MD, Pierre De Guise, MD, Claudette Faille, Jean Gregoire, MD, Yves Leclere, MD, Jacques Lesperance, MD, L. Conrad Pelletier, MD, Susan Taillefer, Joan Trudel, RN. Former participants: Yves Castonguay, MD, Huguette Flageol, David D. Waters, MD, Lucette Whitton, RN
The Toronto Hospital, Toronto, Ontario, Canada Harold Aldridge, MD, Debbie Christie, Tirone E. David, MD, Christopher M. Feindel, MD, Bernard S. Goldman, MD, Charles Lazzam, MD, Irving Lipton, MD, Peter Liu, MD, Karen Mackie, RN, Michael McLoughlin, MD, Lynda L. Mickleborough, MD, Leonard Schwartz, MD, David Uden, MD, Richard D. Weisel, MD, Leon Zelovitsky, MD
New York Medical College, Valhalla, New York Albert DeLuca, MD, Richard Pooley, MD, Richard Moggio, MD, George E. Reed, MD, Mohan R. Sarabu, MD, Rosemary Steinberg, RN, Melvin B. Weiss, MD. Former participants: Doris Efstathakis, RN, Peter I. Praeger, MD, Michael V. Herman, MD, Kathleen Ryman, MD, Yonina Sait, PA, Eric D. Somberg, MD, Jonathan H. Stein, MD
St. Louis University, St. Louis, Missouri Sandra Aubuchon, RN, Frank J. Aguirre, MD, Richard G. Bach, MD, Bernard R. Chaitman, MD, Carol Huffman, LPN, George C. Kaiser, MD, Myra Kramer, Lawrence R. McBride, MD, Morton J. Kern, MD, Marcus Stonner, MD, Robert Wiens, MD, Vallee L. Willman, MD. Former participants: Hendrick B. Barner, MD, Ubeydullah Deligonui, MD, Jane Fehl, LPN, Kathy Galan, RN, Barbara Poole, Michelle Vandormael, MD
Jewish Hospital, St. Louis, Missouri Mary Caruso, RN, Patricia Cole, MD, Lynn Coulter, RN, Gail Eisenkramer, RN, Keith C. Fischer, MD, Jane Humphrey, RN, Thelma Jones, Ethel Kelly, Robert Kleiger, MD, Nicholas T. Kouchoukos, MD, Sandor J. Kovacs, MD, Ronald J. Krone, MD, Jean Moore, Peggy Rice, Michael W. Rich, MD, Ali Salim, MD, Anil Shah, MD, Lisa Spinner, RN, Rose Umstead, Thomas H. Wareing, MD, Juanita Weaver
Parallel Study: Institute of Clinical and Experimental Medicine, Prague, Czechoslovakia Alfred Belan, MD, Ruzena Jandova, MD, Jan Kasalicky, MD, Vladmir Kocandrle, MD, Josef Kovac, MD, Vera Lanska, Jan Pirk, MD, Vladimir Stanek, MD, Erhard Tchernoster, Ing, Michael Zelizko, MD
Former Site: Georgetown University, Washington, DC Larry Elliot, MD, Curtis E. Green, MD, Nevin M. Katz, MD, Kenneth Kent, MD, James Lavelle, MD, Charles Rackely, MD, Beverly Shriver, RN, Robert Wallace, MD
Coordinating Center: University of Pittsburgh, Pittsburgh, Pennsylvania Maria Mori Brooks, PhD, Sharon W. Crow, Katherine M. Detre, MD, PhD, Gail Garger, MSIS, Joel Greenhouse, PhD, Regina Hardison, Richard Holubkov, PhD, Sheryl F. Kelsey, PhD, Jeffrey P. Martin, Carol Ravotti, Alan D. Rosen, MS, Alan Sampson, PhD, Kim Sutton Tyrrell, RN. Former participants: William P. Amoroso, MPH, Lynette M. Anderson, Huiman X. Barnhart, Donald Borrebach, MS, Dave W. Burry, Mary Ann Carr, Meg Cooper, MEd, Robert L. Hardesty, MD, Diane F. Hursh, Larry Kamons, MSIS, Joyce Killinger, MS, Timothy E. Kuntz, MSIS, Emil A. Maurer, Joseph E. Melvin, Jennifer A. Metzler, Barbara L. Naydeck, Nancy H. Remaley, MSIS, Angela Spadaro, Ann Steenkiste, Barry F. Uretsky, MD, MS, John Wilson
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