Posts Tagged ‘syntax trial is unethical’

As many of my long time readers know, that during the last month or so, I have been reviewing studies, and data on the Syntax trial as part of a presentation at my hospital.  This has been more time-consuming and angst-wrenching than I would have ever expected; the more data I reviewed, the more conflicted I became about the ethical questions involved in a study of this kind.

Granted, I have a sensitive nature, and as a nurse, patient advocacy is one of my primary goals.  But thankfully, I found that I am not alone in questioning the legitimacy of subjecting patients to a ‘non-inferiority’ trial.

“In our opinion, the Syntax study disregarded the safety of the patients, by including death and major complications of a primary end-point of a non-inferiority study.”
— Mantovani et. al (2010).
Mantovani et al. (2010) Non-inferiority randomized trials, an issue between science and ethics: the case of the Syntax study.  Scandinavian Cardiovascular Journal, 2010; 44: 321-324.  Mantovani et al. full text pdf.   They question the benefit of subjecting patients to unproven therapies using a trial design that really fails to prove much at all about the effectiveness of the proposed treatment, (in this case, PCI).  They have an excellent discussion (and definitions for the uninitiated) on trial designs and what they really mean, in real terms.
As they point out – studies with this kind of trial design – really don’t prove anything at all.  It was a methodology designed by pharmaceutical companies in order to get new drugs on the market (whether or not these newer, more expensive versions of existing drugs were an improvement over older, safer, cheaper versions or not.)
But in this case – the real results were the unintended ones! Despite a skewed set of accounting (weighing heavily in cardiology’s favor) the results were determinedly negative, showing worse patient outcomes with stents, more deaths, more serious adverse events with stents.
As I delved even further into the data,  I began to question the concept of patient ‘informed consent’ all together.  Can a patient really comprehend the risks involved and what these outcomes really mean in practical terms for something like this?  Would anyone in the study actually break it down in a honest and straight-forward (no BS) fashion to potential study participants?
And how do patients (lay public) understand all of this anyway?  Their perceptions might radically differ from what we (researchers) think we’ve presented.  And, in fact – there are some HUGE differences, as multiple studies attest.  What patients hear and understand is DRAMATICALLY different from what we might expect.
Somehow, I don’t expect that researchers said to patients (for example):
“Mr. X, you are 50 years old, with HTN, diabetes and severe CAD affecting all three major arteries.  Since your labs, and general health is otherwise unremarkable, according to experience and the STS risk calculator, your risk for death with bypass surgery is Y (pretty darn safe). However, we would like to put you in a study where you may receive anywhere from 3 to 20 stents with extensive exposure to nephrotoxic (kidney-harming) dye,  and radiation.  These stents may close either acutely (stent thrombosis) or over time, causing a potentially fatal heart attack.  Stent occlusion happens much more frequently then bypass graft occlusion.  Oh, and by the way – we aren’t doing this study to see if stents are better than bypass surgery (we already know it isn’t) – we are doing it to see how much worse it is – within acceptable margins, of course [whatever than may be].”
No, somehow – I don’t think it went down like that.
More on the Syntax Trial comparing PCI and CABG:
Syntax, part II: New guidelines for revascularization
More on PCI appropriateness  (we have an entire series on PCI here at Cartagena Surgery)

Read Full Post »