A totally misinformed article on ALXN:
thestreet.com
The ALXN trial in CPB has numerous measures, only one of which is CK-MB. Sure if you are trying to decide if someone who comes into the ER has had a MI you might prefer to use troponin as a better early indication. However, the key issue in the ALXN trial is cognitive damage caused by the bypass. If they can show similar results to their earlier trial nobody will care what the CK-MB level does or does not mean.
Here's a very recent abstract trying to measure ischemia after different types of surgery, showing troponin and CK-MB levels were consonant:
Ann Thorac Surg 2000 Dec;70(6):2023-8 Books
Markers of myocardial ischemia after minimally invasive and conventional coronary operation.
Kilger E, Pichler B, Weis F, Goetz A, Lamm P, Schutz A, Muehlbayer D, Frey L
Department of Anesthesiology, Ludwig-Maximilian-University of Munich, Germany. erichkilger@ana.med.uni-muenchen.de
[Medline record in process]
BACKGROUND: The purpose of this study was to evaluate the course of serum markers of myocardial tissue damage after two different types of minimally invasive coronary surgical procedures (MICS) as compared with conventional coronary artery bypass grafting (CABG). METHODS: We enrolled 87 patients with one- or two-vessel disease scheduled for one of the three procedures: minimally invasive direct coronary artery bypass grafting (MIDCABG) by lateral thoracotomy (n = 29), the OCTOPUS method by median sternotomy (n = 27), and CABG (n = 31). Creatine kinase activity (CK), creatine kinase MB activity (CK-MB act), creatine kinase MB mass concentration (CK-MB mass), myoglobin concentration (MG), and cardiac troponin I concentration (cTnI) were measured perioperatively until the second postoperative day. RESULTS: Creatine kinase-MB, CK-MB mass, and cTnI were significantly higher after CABG and were nearly maintained within the normal range in MICS. Creatine kinase and MG were significantly lower in the OCTOPUS group than in the MIDCABG or CABG groups. CONCLUSIONS: Minimally invasive coronary surgical procedures cause less myocardial injury than CABG as indicated by specific serum markers. However, higher CK and MG reflect more substantial skeletal muscle trauma during MIDCABG operation compared with OCTOPUS procedures.
And then there is the off-the-wall comment from the Leerink Swan analyst:
"The vast majority of clinical trials fail, so in a down market, it's not that difficult to make a short case for anything."
It is certainly not the case that the "vast majority" of clinical trials fail.
Peter |
