Results From SPRINT
Michelle L. O'Donoghue, MD, MPH: I'm Dr Michelle O'Donoghue, coming to you from the 2015 American Heart Association (AHA) annual meeting in Orlando, Florida. With me today is Dr Marc Sabatine, chair of the TIMI study group, professor of medicine at Harvard Medical School, and cardiologist at Brigham and Women's Hospital. Thanks for joining me today, Marc.
The big talk of the AHA meeting no doubt has been the Systolic Blood Pressure Intervention Trial (SPRINT).
Marc S. Sabatine, MD, MPH: Absolutely. It's a dynamite trial with really interesting data. I think it is somewhat akin to other studies in terms of risk-factor modification that have answered questions about how aggressive to be for targets. There has been a lot of controversy with guidelines for risk-factor modification. In fact, the hypertension guidelines have recently been more lenient despite not having enough data.
The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial suggested that, at least in patients with diabetes, lower blood pressure targets were not beneficial. However, now with SPRINT in patients without diabetes, we saw a really big benefit. I think that this is consistent with the epidemiologic data, so I'm convinced.
Dr O'Donoghue: You alluded to the recentJoint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-8 guidelines, which moved away from more aggressive blood pressure control, particularly for individuals who are over the age of 60 years. After seeing the results of SPRINT, how is that going to change your personal practice in terms of how you manage blood pressure for your older patients?
Dr Sabatine: I think for patients with so-called prehypertension, we know from epidemiologic studies that they are at increased risk. We didn't have trial data to suggest that lowering blood pressure was better, but now we do. Now, for those patients, I think that you do want to drive systolic blood pressure down to around 120 mm Hg or so, if you can.
Dr O'Donoghue: It was reassuring that there was a great deal of consistency regardless of age when looking at the SPRINT subgroup results. Even for the older individuals in the trial, there appeared to be as much benefit, if not even a trend towards a little bit more.
In the future, we'll need to see a bit more of the granularity in terms of possible adverse effects within different subgroups. In particular, we need to examine the risk for hypotension or syncope and see whether or not that is increased in the elderly and what that benefit-risk profile looks like.
Dr Sabatine: In terms of the burden on the patients, I think that you're right. There will be more adverse effects, as was reported in the paper. The rates may differ, depending on certain subgroups. The difference in blood pressure medications was just one medication between the two groups, so it's not that they need to go from four medications to seven medications to achieve that.
It is interesting. You would've thought that the patients with diabetes would be the group that would have benefited more. We always think about them as the higher-risk patients. And that's the group where the data are quite weak and not supportive. In contrast, the data are most supportive among patients without diabetes.
Is ACCORD Discordant From SPRINT?
Dr O’Donoghue: Exactly; you're touching upon the results of ACCORD. A lot of people have been discussing this in the meeting. Are the results of ACCORD discordant with the results of SPRINT? I suppose in many ways they are; in particular, with regard to the mortality benefit. But there is some directional consistency, at least, in terms of the myocardial infarction and stroke signal. What is your take on that?
Dr Sabatine: "Is ACCORD discordant?" I like that play of words there. At face value, with one trial being negative and the other being positive, they appear to be discordant. But I do think that you're right. The myocardial infarction signal is very similar in both trials; it's about a 15% reduction.
Stroke risk reduction was really good in ACCORD and was okay in SPRINT but not quite as powerful. Heart failure outcomes weren't evaluated in ACCORD but were very powerful in SPRINT. Cardiovascular death is a little harder to reconcile, with a point estimate just slightly above 1 in ACCORD. The confidence intervals were wide, so I think at the extremes it could be consistent with as much as a 27% reduction. In SPRINT, there was a robust benefit, but it could be as little as 15%, so I probably would split the difference and say that there's probably about a 20% risk reduction—some trials were just luckier than others.
Dr O'Donoghue: To the point that you mentioned earlier, normally for our patients with diabetes, we've become accustomed to thinking about more aggressive blood pressure control. For the next iteration of the JNC guidelines, they'll have their work cut out for them in terms of whether or not they now recommend more aggressive blood pressure control for the patients without diabetes, based on the results of SPRINT, and wait for more data for patients with diabetes in order to endorse more aggressive blood pressure control. That's going to be a tough one to sort out.
Dr Sabatine: Right. It runs counter to how we think about risk stratification for patients. I would imagine that they would embrace the results of SPRINT, which was a very well done trial with very clear results. However, because SPRINT included patients without diabetes, how we should be treating patients with diabetes is something we will need to try to tease out.
Dr O'Donoghue: Thank you so much for joining me today, Marc. This has been great.
Dr Sabatine: Thanks for having me.
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Cite this: Michelle L. O'Donoghue, Marc S. Sabatine. Reconciling SPRINT and ACCORD: Dr Marc Sabatine Interviewed - Medscape - Nov 19, 2015.