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Electronic letters published:
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Age and Routine Invasive Management of Acute Coronary Syndromes
A routine invasive management strategy for elderly patients with unstable angina?
Invasive strategies in the "old old"?
Cognition and functional status
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Richard G Bach, MD Washington University School of Medicine, Christopher P. Cannon and Eugene Braunwald
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rbach{at}im.wustl.edu Richard G Bach, et al.
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Dr. Masoodi raises two points regarding our analysis of outcome according to age among patients with non-ST-segment elevation acute coronary syndromes randomized to early invasive versus conservative management strategy. The first pertains to the lack of data on cognitive status of trial participants. While cognitive status was not specifically quantified among the baseline patient characteristics, it should be noted that to be included in the trial, the protocol dictated patients needed to be considered candidates for coronary angiography and revascularization, and patients were excluded who had any “clinically important neurological disorder” or who were unable to provide informed consent. It is thus likely that patients with significant cognitive impairment would have been excluded, appropriately, from the trial. We agree that cognitive status should be an important consideration when recommending management for any patient with a coronary syndrome, but would caution that degrees of cognitive impairment vary across a wide spectrum and the related management decisions remain largely subjective and challenging. The second observation is that age 65 is not considered elderly “in practical life except for research purposes.” While it is hard to argue with that perspective, age 65 has served as a milestone for many previous studies of age-related outcomes, and this can allow for comparison of treatment effects across trials. For example, by combining our results [1], with those from TIMI IIIB [2] and FRISC II [3], there is available data from 2724 patients of age >= 65 and 3422 patients of age < 65 randomized to a management strategy. Compared to conservative management, the invasive strategy resulted in a relative reduction of 6 to 12 month death or myocardial infarction of 37.5% (10.7% vs. 16.8%, p < 0.0001) for the older patients yet only 1.4% (8.2% vs. 8.4%, p = 0.90) for the younger patients. With respect to 6 to 12 month mortality among the 2249 patients of age >= 65 from FRISC II and TACTICS-TIMI 18 combined, allocation to the early invasive rather than conservative arm was associated with 27.5% fewer deaths at 6 to 12 months (4.2% vs. 5.8%, p = 0.099). We recognize that in an era of increasing life expectancy, to call a specific age “elderly” is arbitrary and non-physiologic. For that reason, we extended previous observations by including an analysis of age ranges from < 55 to > 75 years and showed that among the 278 patients in our trial over age 75, randomization to a routine early invasive rather than conservative strategy resulted in 42% fewer (20.1% vs. 30.2%, p = 0.05) occurrences of death, myocardial infarction or re- hospitalization for acute coronary syndrome, and a 33% lower – albeit non- significant – mortality rate (7.9% vs. 10.1%, p = 0.53) at 6 months. While we would expect that fewer of the most common morbid events for these elderly patients, recurrent myocardial infarctions and re- hospitalizations for unstable ischemia, should translate into an improved quality of life, a more detailed assessment of the effect of management strategy on functional status in the elderly awaits further study. Conflict of Interest:None declared |
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Armin Arbab-Zadeh, MD Univ. Texas Southwestern Medical Center at Dallas
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Armin.Arbab-Zadeh{at}utsouthwestern.edu Armin Arbab-Zadeh
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TO THE EDITOR: In their subgroup analysis of the TACTICS-TIMI 18 trial, the authors concluded a routine early invasive management strategy is superior to a more conservative one in elderly patients with unstable angina or non-ST-elevation myocardial infarction (1). However, the high incidence of major bleeding in patients in these elderly patients managed invasively should raise caution regarding such a management strategy in this population, particularly since the proposed benefit of such a treatment strategy is an improvement in morbidity, not mortality. Furthermore, since the publication of the original TACTICS trial (2), new data have emerged which question some of the benefits of routine invasive management in subjects with acute coronary syndromes. The difference in the incidence of myocardial infarction favoring a routine early invasive approach may be based on differences in the criteria used for diagnosing myocardial infarction: while an elevation of creatine kinase more than twice the upper limit of normal was sufficient for the diagnosis of "spontaneous" myocardial infarction in TACTICS and FRISC II (3), an elevation more than three times the upper limit of normal was required for the diagnosis of myocardial infarction in association with percutaneous intervention. It is now clear that periprocedural enzyme elevations are associated with a similar prognosis as are "spontaneous" myocardial infarctions (4). Therefore, the consensus statement of the European Society of Cardiology and the American College of Cardiology defines any cardiac marker elevation in association with percutaneous intervention as myocardial infarction (5). Furthermore, although 94% of interventions in the invasive arm of TACTICS were performed with a concomitant 2b/3a inhibitor, only 59% of these performed in the conservatively managed subjects had the benefit of 2b/3a inhibition, which likely further favored the invasive management strategy. When similar criteria were applied, as was done in RITA III, the most recent trial comparing a routine invasive with a routine conservative approach in patients with unstable angina, no difference in the incidence of myocardial infarction was detected (6). The most consistent benefit of a routine early invasive strategy in acute coronary syndromes is freedom from recurrent ischemic events. In the subgroup analysis by Bach et al, it was rehospitalization for acute coronary syndrome within 30 days, an advantage which was no longer present at 6 months. Whether this benefit outweighs the dramatic increase in major bleeding in patients > 75 years of age is questionable, particularly since contemporary aggressive lipid lowering management has likewise been shown to reduce ischemic events after coronary syndromes (7). In summary, currently available data are insufficient to support a routine early invasive strategy in elderly patients with non-ST-segment elevation acute coronary syndromes. Until new data emerge, a management guided by risk stratification appears to be most reasonable in this population. References: 1.Bach RG, Cannon CP, Weintraub WS, DiBattiste PM, Demopoulos LA, Anderson HV, DeLucca PT, Mahoney EM, Murphy SA, Braunwald E. The effect of routine, early invasive management on outcome for elderly patients with non-ST- segment elevation acute coronary syndromes. Ann Intern Med. 2004;141:186- 195. 2.Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann F-J, Robertson DH, DeLucca PT, DiBattiste PM, Gibson M, Braunwald E. Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor Tirofiban. N Engl J Med. 2001;344:1879-1887. 3.Invasive compared with non-invasive treatment in unstable coronary- artery disease: FRISC II prospective randomised multicentre study. FRISC II Investigators. Lancet. 1999;354:708-715. 4.Ioannidis JPA, Karvouni E, Katritis DG. Mortality risk conferred by small elevations of creatinine kinase-MB isoenzyme after percutaneous intervention. J Am Coll Cardiol. 2003;42:1406-1411. 5.Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial infarction redefined - A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol. 2000;36:959-969. 6.Fox KAA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TRD, Wheatley DJ, Pocock SJ. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Lancet. 2002;360:743-751. 7.Intensive versus moderate lipid lowering with statins after coronary syndromes. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM. N Engl J Med. 2004;350:495- 504. Armin Arbab-Zadeh MD University of Texas Southwestern Medical Center Dallas, TX 75390-9047 Conflict of Interest:None declared |
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Roy E Fried, MD, MHS none
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rfried{at}ericksonmail.com Roy E Fried
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Bach et. al. found an early invasive strategy superior in the elderly with acute coronary syndromes, including their 278 subjects older than 75 years. This age stratum contains both old and "old old" patients, with distinct levels of frailty, physiologic reserve and possibly, distinct levels of potential net benefit from invasive strategies, particularly those that can cause bleeding or adverse CNS events. It would be helpful to know the authors' point estimates and confidence intervals for major outcomes for subjects grouped into 5 year age groups beginning at age 75. Conflict of Interest:None declared |
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Nasseer A Masoodi, MD None
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haadin{at}yahoo.com Nasseer A Masoodi
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In this article, the authors have made no mention in baseline characteristics about the Cognitive status of the patients especially those above the age of 75. Cognitive impairment plays a vital role in charting the plan of care, more so when invasive procedures are considered. It will be more convincing if authors can mention how many patients were above the age of 75 in both the groups. Age of 65 is no more considered elderly in practical life except for research purposes. Since there is no startling difference in the mortality between two groups, it would have been more prudent if morbidities compared included delerium and functional status between the two groups. Nasseer A Masoodi MD Conflict of Interest:None declared |
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