Vaccines in Health Workers; Aspirin to Prevent CVD: It’s TTHealthWatch!

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week’s topics include COVID vaccines in healthcare workers, the proper dose of aspirin for CVD prevention, heart disease in women, and the final results of the SPRINT trial.

Program notes:

0:34 American College of Cardiology

0:47 COVID vaccination in healthcare providers

1:49 Most in the hospital setting

2:42 Final SPRINT analysis

3:47 Tighter control beneficial

4:47 Worsening of kidney function

5:48 When people have side effects

6:15 Comparative effectiveness of two aspirin doses

7:15 Why did they drop their dose?

8:17 Other benefits to aspirin therapy

8:40 Cardiovascular disease in women

9:40 Ischemic heart disease the major cause of death

10:43 Heart failure increasing

11:26 Psychosocial issues

12:22 End

Transcript:

Elizabeth Tracey: What do we know from the final analysis of the SPRINT trial?

Rick Lange, MD: COVID vaccine effectiveness among healthcare professionals.

Elizabeth: What is the burden of cardiovascular disease for women worldwide?

Rick: And aspirin dosing in cardiovascular disease.

Elizabeth: That’s what we’re talking about this week on TT HealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, we should note for our listeners that this week is the American College of Cardiology meeting, so that’s why three out of four of the studies we’re talking about are heart-related. But in keeping with current events, why don’t we turn first to one of yours? This is a look at COVID vaccination in healthcare providers and how efficacious is it? That’s Morbidity and Mortality Weekly Report.

Rick: We’ve previously talked about the studies and I’m going to focus on the two mRNA, messenger RNA vaccines — that is the Pfizer vaccine and the Moderna — that were studied in about 30,000 individuals in each group at a population at large. Now we have effectiveness data in healthcare professionals that are obviously at a higher risk of developing infection.

This is data from the first 3 months where the vaccines were available, from January to March of 2021, at 33 different U.S. sites. The long and the short is that those two vaccines, the effectiveness 2 weeks after the first dose in preventing infection, 82%, and 2 weeks after the second dose, 94%. Even in those individuals that did develop infection, most of those were mild infections. I think there was only one person hospitalized that had been vaccinated. About two-thirds of these individuals were frontline healthcare providers in the hospital setting and the rest of them in the clinic setting.

Elizabeth: Clearly compelling and uplifting data, I would say. What’s interesting to me is that there’s still a population of even healthcare workers who are resistant to obtaining a vaccination.

Rick: Elizabeth, I’ve read about that. That’s not our experience here in El Paso. That may be tempered by the fact that we had two surges. One of them overwhelmed our ability to provide healthcare, so in our community the uptake of COVID vaccination has been very high.

Elizabeth: Well, I would like to have this data be used to encourage people to go ahead and get a vaccine because rate of vaccination, of course, is declining nationwide.

Rick: Yep. Any listeners haven’t taken the vaccine, the effectiveness is proven in multiple different populations. We’ve now administered this to over 131 million people across the United States and we’ve shown that it’s effective and it’s safe as well.

Elizabeth: Let’s turn to our cardiovascular topics for this week, to the New England Journal of Medicine. This is the final analysis of the SPRINT trial. For those who are not familiar with it, this was a trial that was examining the benefits of intensive versus standard blood pressure control.

Originally, this trial assigned just under 9,400 participants who were at increased risk for cardiovascular disease, but did not have diabetes or previous stroke, to adhere to an intensive treatment target of a systolic blood pressure less than 120 mm Hg or a standard treatment target. That was a systolic blood pressure less than 140 mm Hg.

Their primary outcome was a composite, including MI, other acute coronary syndromes, stroke, or death from cardiovascular causes, and then there were additional outcomes.

They had a median follow-up of 3.3 years, and during that time, the rate of their primary outcome was 1.77% per year in the intensive group versus 2.4% per year in the standard treatment group. So clearly it was beneficial; however, there were serious adverse events of hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope that were more frequent in the intensive treatment group.

The upshot of the whole thing clearly is that for those who are at increased cardiovascular risk, keeping their systolic blood pressure to less than 120 mm Hg does result in a lower rate of major adverse cardiovascular events and all-cause mortality.

Rick: We need to talk about the specific patient populations, “Who were those people?” Well, if you have clinical cardiovascular disease already, chronic kidney disease, or if you look at all your risk factors and your risk of having cardiovascular disease, 10-year risk is high, that’s the individuals that were included in the study.

The complication rate was higher in those that had the intensive therapy, specifically those people that had hypotension, or low blood pressure, or those that had syncope — that is, they fainted and were hospitalized for such — and those that had worsening of their kidney function.

There are concerns that if you targeted this very intensive therapy to diabetics, for example, or people that have known cerebrovascular disease, that lowering the blood pressure too much increases the risk of having complications.

They had similar results at 3 years as they did at 1 year, so I guess I’m not terribly surprised at all about that, but it’s good to confirm that. They looked at different subgroups in terms of gender, in terms of age — race as well. What they determined was that all groups benefited from the more intensive therapy once we have the caveats we’ve previously mentioned.

Elizabeth: One of the things that occurs to me is you’re well aware, and I’ve borne witness to this too, that there is substantial pushback among patients when practitioners attempt to get them on really intensive blood pressure-lowering regimens. In this group of people, they’re probably already on some other meds. So I’m just wondering, what’s your strategy for overcoming resistance?

Rick: Well, Elizabeth, the only resistance I have with my patients — you know I still have an active patient population — is when people have side effects. They’re going to be resistant to having an intensive blood pressure-lowering strategy if they’re experiencing hypotension, that is low blood pressure, or if they’re experiencing syncope. But short of that, without side effects, most of the patients that I take care of want their blood pressure to be in a range that’s more normal.

Elizabeth: Okay. Let’s turn to your next one. That’s also in the New England Journal.

Rick: The [preliminary?] results are somewhat interesting, but actually, the study itself is really probably the most interesting part of this. It’s a study that looked at the comparative effectiveness of aspirin dosing in cardiovascular disease that tried to use what’s called a very pragmatic design. What these study investigators did is they looked at over 15,000 patients that were already taking aspirin. They allowed them to enroll online and to be followed up either online or with telephone calls. They simply randomized them — because they were already taking aspirin — to take 325 a day or 81 mg a day.

It was a low-cost study. They had a large patient population, 15,000. They followed them for over 2 years and what they found was that the 81 mg and the 325 mg had similar cardiovascular outcomes and similar complication rates.

Here’s the downside of it. It is open label, and when they started the trial, about 80% to 85% of these people were already taking 81 mg. Then they randomized them to 81 or 325 and about 40% of the people that were randomized to 325 dropped down to 81 milligrams again. We don’t have an explanation of why that happened. Were they having more complications or more bleeding, or did they feel more uncomfortable, or did the physician do it or patient do it? So it has these limitations as well.

Elizabeth: Well, yeah. And this old, perennial question of aspirin use, we just seem to revisit it again and again, and I’m not terribly persuaded that this is the final answer.

Rick: Yeah. And Elizabeth, when we look at the randomized trials, people taking 325 mg versus 81 mg had a higher bleeding complication rate. I’m surprised that they had the same complication rate. I attribute that to the fact that there was a lot of crossover in this trial.

Elizabeth: Based on this then, what are you going to talk to your patients about?

Rick: I’m going to have them take 81 mg. I think it’s less important to quibble about the dose and more important to make sure that the right people are on it and those that are low-risk don’t get on it.

Elizabeth: And I would just note that we have covered, right here in this space, many studies that have demonstrated the benefit of aspirin, frequently at that higher dose, with regard to skin cancer prevention, for example. I wonder if this isn’t still a moving target, because there are other benefits to aspirin therapy — unclear which is the right dose.

Rick: Your point’s well-taken. I have a very cardiovascular-centric perspective. Aspirin not only prevents skin cancer, but GI cancer as well, and they may benefit from the larger dose. So your point’s well-taken, Elizabeth.

Elizabeth: More to come, undoubtedly. Finally, let’s turn to the Lancet, and this is a truly ginormous paper that’s assessing the burden of cardiovascular disease in women worldwide. I was unaware they put a number on this, that cardiovascular disease is the leading cause — I did know this — of mortality for women. I did not know that it was responsible for 35% of the total deaths in women in 2019.

Clearly we have seen, over the last several decades, a drop in the cardiovascular disease burden overall in countries that have high incomes. However, now this has been slowing in high-income regions and in 2017 cardiovascular disease mortality actually increased in women in the USA and in Canada.

They note that most healthcare providers and patients still tend to underestimate the cardiovascular risk in women. They note numbers of other things relative to the research, that much of it is in men, and so there need to be specific things that take a look at this in women. With regard to cardiovascular disease, it’s the ischemic heart disease that’s the primary cause of cardiovascular disease mortality in women. We know what many of the risk factors are, of course. High blood pressure is by far the most common. Other things — high LDL cholesterol, high-fasting plasma glucose, and high BMI.

I think one of the tables that I like the best was they convened different panels and they came up with a table of key points and recommendations by disease. A term that was new to me, myocardial infarction in the absence of obstructive coronary artery disease, called MINOCA, and then there’s another thing, INACA, ischemic with non-obstructive coronary arteries. That’s another term I was not familiar with.

Then heart failure, of course, in women, this is increasing for everybody worldwide, but it turns out that there’s an overwhelming increase in heart failure with preserved ejection fraction, clearly pointing to places where we need to do some more research.

Rick: As you said, a large paper: 50 pages. It addresses the fact that there’s really no current established global policy to coordinate prevention and treatment of cardiovascular disease in women. Sometimes it presents differently in men than women. The biology and the physiology can be different, and so that’s why this paper, I think, it’s really a good one.

It also highlights the fact that there are sex-specific risk factors that are unique to women, for example, premature menopause or having diabetes during gestation, hypertensive disorders of pregnancy, preterm delivery, polycystic ovary disease. These are unique to women and their risk factors for cardiovascular disease.

It also addresses the psychosocial risk factors of abuse, socio-economic deprivation, poor health literacy, and environmental risk factors as well, so I appreciate the comprehensiveness of this particular paper. There will be more women dying of cardiovascular disease than cancer. It’s an issue that needs to come to the forefront.

Elizabeth: A couple other things I noted in here, one that we talked about before we started recording, that in women with hypertension the risk, if they go on HRT, of a cardiovascular event is 12 times higher, so that’s a little key takeaway for the clinical folks among us, right? Don’t put your women with hypertension on HRT, it sounds like.

Rick: And for those that aren’t familiar with HRT, it’s hormonal replacement therapy.

Elizabeth: Right. We’ll recommend this paper to those who have time to read 50 pages plus. On that note, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.