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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (2597)	1/17/2001 2:38:16 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Wilder, Thanks for the useful comment. I suppose the arguments that the shorts would use is that even if there is a statistically significant reduction in CK-MB it is not clear exactly what it means. In other words, how important to clinical outcome is a reduction in this measure? This same question would of course arise if they were using troponin as the endpoint. Indeed it is a valid question anytime you are looking at a surrogate endpoint. However, what upsets me is the old "grain of truth" attack. The fact that, as you pointed out, troponin may be a more sensitive measure (the Cheney anecdote) does not mean that CK-MB is a bad measure under these particular circumstances. Here both arms of the trial are undergoing an identical procedure except for the drug and they have measures of CK-MB both before and after the procedure. This is a much more tightly controlled setting than the normal ER use of the tests that the shorts are citing. Here's one of the abstracts cited by the Circulation article: JAMA 1997 Feb 12;277(6):461-6 Related Articles, Books, LinkOut Prognostic implication of creatine kinase elevation following elective coronary artery interventions. Kong TQ, Davidson CJ, Meyers SN, Tauke JT, Parker MA, Bonow RO Department of Internal Medicine, Division of Cardiology, Northwestern University Medical School, Chicago, Ill, USA. OBJECTIVE: To determine the prognostic significance of creatine kinase (CK) elevation following elective percutaneous transluminal coronary angioplasty (PTCA). DESIGN: Retrospective cohort study. SETTING: Tertiary care referral center. SUBJECTS: A total of 253 consecutive patients with total CK and CK-MB fraction (CK-MB) elevation (case patients) and 120 patients without CK elevation (controls). Control patients had undergone interventions during the same month and year using the same devices. MAIN OUTCOME MEASURES: In-hospital and late cardiac mortality, subsequent myocardial infarction, and the combined end point of cardiac mortality or myocardial infarction. RESULTS: Patient groups were similar with respect to age, sex, extent of coronary artery disease, left ventricular function, number of lesions treated by PTCA, and mean duration of follow-up (>3.5 years). Cardiac mortality was significantly greater (P=.02) for patients with CK elevation after PTCA. When patients were categorized according to peak CK elevation, cardiac mortality differed significantly among patient groups (P=.007), with increased cardiac mortality observed for patients with high (>3.0 times normal) and intermediate (1.5 to 3.0 times normal) CK elevations. In multivariate analyses, higher peak CK and lower ejection fraction were the most important predictors of increased cardiac mortality (both, P<.001); the relative risk for cardiac mortality was 1.05 (95% confidence interval, 1.03-1.08) per 100-U/L increment increase in CK. CONCLUSIONS: Creatine kinase elevation following elective PTCA is associated with increased late cardiac mortality. This increase in cardiac mortality is independent of clinical variables, severity of heart disease, coronary artery lesion characteristics, interventional devices, and procedural outcomes. Even patients with lesser degrees of CK elevation are at significantly increased risk for late cardiac death. Peter