JAMA 23-30 Dec 2009 Vol 302
2679 A look at the paper about Federal Drug Agency pre-market approval for cardiovascular devices. Now if you had something put into your cardiovascular system, what would you want to know? Firstly, that it prevented real adverse events. For the devices looked at here, ranging from stents to LV assist devices, that was known in 12% of cases. Secondly, that it had been tested in a randomised trial. That was the case in 27%. That some kind of blinding had been attempted: 14%. That there was more than one study of the device: 35%. So if a plausible specialist wants to stick anything into your arteries or your heart, all they need do is cite one dreadfully inadequate trial using a surrogate end-point. Rage, rage against the lying of the bright.
http://jama.ama-assn.org/cgi/content/abstract/302/24/2679
NEJM 24 Dec 2009 Vol 361
2518 Do we need any more coronary risk factors? And do we need more genetic studies of them? The usual response is a Thatcher-like No! No! No! "“ the final no being added just for emphasis. But you can't help liking this study of genetic variants associated with Lp(a) lipoprotein. A lot of data incorporated from previous studies in an Oxford department. Above all, this is genomics with a practical twist: if you adjust for the level of Lp(a) lipoprotein, then the association between the LPA genotype score and the risk of coronary disease disappears, proving that it really is mediated by this modifiable factor.
http://content.nejm.org/cgi/content/abstract/361/26/2518
2529 By contrast, to make of the finding that an early repolarisation pattern in the inferior leads of a standard ECG is associated with an increased risk of death from cardiac causes in middle aged Finnish subjects. These people live in Oulu, which is covered in ice and snow for half the year, so the finding needs replicating in warmer climes before we start thinking of any kind of screening or treatment. http://content.nejm.org/cgi/content/abstract/361/26/2518
2538 And for something even less likely to affect your practice, note that a sensitive cardiac troponin T assay can help to pick out patients with stable coronary disease with a higher risk of death or heart failure in coming years. Oddly enough, this is not mediated by a higher risk of myocardial infarction.
http://content.nejm.org/cgi/content/abstract/361/26/2538
Lancet 2 Jan 2010 Vol 375
31 One of the most expensive cardiovascular devices which has been promoted on the basis of a surrogate end-point is the implantable cardioverter-defibrillator for systolic heart failure with ventricular tachycardia. Sure, these machines cut in and shock away VT, but this makes no difference to mortality. And being shocked feels like being shocked. So the less they fire the better, and this trial shows that you can reduce their firing by performing VT pathway ablation before ICD implantation. But I wonder how many patients would actually consent to have an ICD at all if they knew the real odds.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61755-4/abstract
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