Clyde W. Yancy, MD, MSc: Hi. This is Clyde Yancy. I am from Northwestern University in Chicago, and I'm delighted to be here at the American Heart Association meeting with my friends who are as enthused and as excited as I am about the results of the SPRINT trial.[1,2]
I'm joined by Vera Bittner from the University of Alabama at Birmingham; Dr Curtis, with whom I've collaborated on innumerable projects; and Pat O'Gara, former president of the American College of Cardiology. All of us are interested in SPRINT and how it can be translated to the rest of the community, so let's have a conversation.
Why don't we go one by one and give our top-line view about where we are with SPRINT. Vera, what are your big thoughts about SPRINT?
Benefit to Safety Ratio
Vera A. Bittner, MD, MSPH: I was excited about the reductions in the hard outcomes. What I'm a little bit fuzzy about is the benefit-to-safety ratio, which I think will depend on how close you get monitored. I looked at the protocol, and ostensibly the number of visits was the same in both arms, but during the presentation they also talked about as-needed visits, and so I would love to know how closely the intensive arm was monitored compared with the control arm. It was obviously unblinded because you can't treat to a target and not know which group they were in. The question is: Will the benefit-to-risk ratio be the same when we translate that to a regular primary care or cardiology practice in the community?
Dr Yancy: Obviously when you get away from the construct of a clinical trial and you don't have as much infrastructure support, there will be more events. Anne?
Anne B. Curtis, MD: We have to remember that the patients had other cardiovascular risk factors, and often established cardiovascular disease. I think one of the important take-home points is the effect the protocol had on heart failure because what really drove the endpoint was a difference in heart failure. So it sounds like the higher the blood pressure, the worse it is for the heart, right? I think what we are learning is whether we can safely aim for a lower target than we've used before. If a patient is tolerating drugs well, if they're not maximally tolerated doses, and their systolic blood pressure is running around 135 mm Hg or 140 mm Hg, we can push the drug a little harder. I think that's easy enough to do under those circumstances.
Dr Yancy: Pat, what are your big ideas about SPRINT?
Patrick T. O'Gara, MD: It's interesting, Clyde. I think that it'll take a massive educational program among not only cardiologists but also all of the medical providers who deal with hypertension, ranging from primary care practitioners to obstetricians/gynecologists in terms of women's health. There will be no question that in SPRINT-eligible patients there will be high desirability of trying to treat them more intensively, but I think that will run up against the reality of additional medications, the potential for side effects, cost, drug-drug interactions, and the other adverse events that come with polypharmacy, with which we're quite aware.
In terms of how this plays out in practice, I'd be interested in something like a postmarketing surveillance study. I'm not surprised by the heart failure outcome. I'm a little disappointed about the stroke outcome, but maybe the time horizon over which observations were made was too short to make the same observation about stroke. It's a surprise in that it goes in the opposite direction of what we have come to understand about the hazards of intensive blood pressure lowering on other populations of patients. This needs to be sorted out a little bit in practice, I think.
Dr Yancy: Pat really is getting to the part that I think is fascinating because just a few years ago it was all about treating according to the numbers getting everybody's blood pressure down. I think that once again we are prompting the community to have the conversation. It's just like when the cholesterol guidelines came out, Vera, the most important thing was to have a conversation and decide if you are that person who needs to be on lipid-lowering therapy. Now we can ask: Are you that person who needs to not only be on antihypertensive therapy but to have a goal of 120/80 mm Hg? I'm very uncomfortable that the spin on this is that everybody's blood pressure needs to get to 120/80 mm Hg. I'm concerned that some practitioners won't slow down long enough to realize that it really is a selective patient population. All it takes is one or two misadventures, and then it disqualifies all of the work that was done to finally answer a very important question.
Blood Pressure Measurement 101
Dr Bittner: The other thing is that we have to reteach people how to measure blood pressure. Maybe I'm indicting our own clinic, but we don't measure blood pressure three times and average it and let people sit there quietly. They come in right out of the Birmingham traffic, and the blood pressure cuff is thrown on, and that's the number that we deal with. I'm not so sure that you can do these very fine titrations if you don't have an accurate measurement, so we'll probably have to take a step back to blood pressure measurement 101.
Dr Yancy: Don't you think patient engagement is going to be very important here? This is the only way this is going to work. Right, Pat?
Dr O'Gara: Absolutely. To your point, Vera, maybe we should make sure that patients have a blood pressure cuff at home, which would be more accurate for the evaluation of their blood pressure over a longer period of time rather than the hectic environment of a clinic visit when the provider him or herself is usually not the person taking the blood pressure. There are lots of things of a simple nature that we can do better.
Dr Curtis: An important point is about the polypharmacy because we know that at the beginning of this trial, the patients were on 1.8 medications, on average, and they added another one. How many patients do we have in our clinics who say, "Doc, I don't like taking drugs," right? I've never been a believer in combination therapies. I don't usually use them. I titrate individually. But now I wonder about patient acceptance—the more drugs you throw at them, the harder it's going to be for them to swallow that. Didn't mean that pun. But we may need to find ways to simplify regimens so that patients will accept them in order to get to the targets.
Dr Yancy: This is going to rejuvenate a lot of the themes we've seen in the past: ambulatory blood pressure monitoring and/or home blood pressure recording, combination therapy, different kinds of patient aids to facilitate remembering things.
Implications for Guidelines
Pat, before we finish up, you and I spent a lot of time writing guidelines. Now this information has to be incorporated in some third-party statement (away from the investigators) in a way that the community can access it and say, "This is what I should do when and how." How best do you use information like this in a guideline? Do you pause for a moment and consider it but go with the database we already have, or do you dive in and immediately start rewriting things?
Dr O'Gara: I think you have to avoid the reflex of diving in and revising things immediately. Fortunately, in our community, we have large constituencies of experts who can look at this and instruct us about its validity, its accuracy, and whether or not it can be duplicated and the other types of things for which evidence needs to be digested by a greater number of eyes.
As frustrated as our communities are about the length of time between a landmark study and the appearance of a change in recommendations for patient diagnosis or treatment, this is a very good example of the need to pause. We are in the process of revising the hypertension guidelines because of all of the disagreement around the 150 mm Hg systolic mark in patients who are 60 years of age or older, for example. Now this comes in on the other end of the spectrum. How can any group of writing committee members get their heads around this in a short period of time?
Dr Yancy: I agree with you. This is one guideline statement that we need to get right because the potential public health impact is substantial. And we could make a really big positive difference if we take the time and deploy this correctly. If we rush into it, maybe not so much.
Dr Bittner: Remember that they're still doing closeout visits, so the trial hasn't even finished yet. The paper has been written up, but they're still doing closeout visits. They're looking at the cognitive effects and things like that, so it would be nice to have some of those data before you scramble and change the guidelines.
Dr Yancy: You could even argue that maybe the most important piece of SPRINT hasn't come forward yet because the cognitive data, particularly in the older patient in whom we're modifying blood pressure substantially, are pretty important. But I'm encouraged that at least injurious falls were surprisingly not an issue. They did happen, but they happened equally in both arms. There are some more events that we have to pay attention to, such as syncope and renal insufficiency, but it looks like in the right patient this is tolerable and it might work. Anne, I'm on the same page as you are. Anything that can reduce the burden of heart failure, let's go ahead and make that happen.
Anyway, it's been a good opportunity to have a conversation with some good friends and try to put this in context. I hope those of you who are listening have a better appreciation for what we've heard here at the American Heart Association meeting with the results of the landmark trial SPRINT. Thank you very much.
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Cite this: Hypertension Management After SPRINT: Fast Forward or Pause? - Medscape - Nov 18, 2015.