November 19, 2019 Advisory Board's take: What will this news mean for providers (and our understanding of value)?

A large, federally funded study found bypass surgeries and stents are not more effective than cholesterol-lowering drugs or healthy habits at preventing heart attacks and deaths, researchers announced Saturday at the American Heart Association (AHA) annual meeting—findings that call into question the care of thousands of patients with blocked coronary arteries, the New York Times reports.

Coronary artery disease affects about 9.4 million Americans, according to the Wall Street Journal. For years, providers and researchers have debated how to treat patients with narrowed coronary arteries who are not experiencing acute symptoms. Currently, bypass surgeries, which redirect blood around a blockage, and stents, which are small mesh cages used to prop open blocked arteries, are both standard treatments for coronary artery disease. They are common even among patients who have no symptoms or who only feel chest pain when they exert themselves, according to the Journal.

Study details

For the latest study, which the Journal reports is the most rigorous to date, researchers conducted a clinical trial over a four-year period involving 5,179 participants from 37 countries with moderate or severe ischemia, a condition in which there is not enough blood flow to the heart muscle.

Judith Hochman, the study's chair and the senior associate dean for clinical sciences at the New York University Grossman School of Medicine, said the researchers excluded patients from the study if they either did not have narrowing in their arteries or had a blockage in their main artery, which supplies blood to a large portion of the heart. The researchers did not focus on patients admitted to the hospital with a heart attack, as these patients typically receive a bypass, angioplasty, or stenting to quickly open a blocked artery, according to HealthDay.

Researchers randomly assigned participants to undergo a procedural intervention—either bypass surgery or a stent procedure—in combination with intensive medical therapy, or the medical therapy alone. The medical therapy included drugs to lower cholesterol and blood pressure, as well as lifestyle therapy including dietary changes, and smoking cessation.  

Following treatment, the researchers monitored whether the patients experienced a:

  • Cardiovascular-related death;
  • Heart attack;
  • Heart failure;
  • Hospitalization for unstable chest pain; or
  • Resuscitation after cardiac arrest.

The researchers are seeking funding to follow the participants for a longer period of time.

Findings

The researchers found no difference in the overall rate of the five disease-related events between the groups. Hochman said the invasive procedures "did not demonstrate a reduced risk over a median 3.3 years" when compared with medical and lifestyle therapy.

However, the researchers noted the groups began to show differences at various points in time. For instance, Hochman said the researchers found the group who underwent bypass surgeries and stents experienced heart attacks or other events at a higher rate six months into their treatment—5.3% vs. 3.4% for the medical therapy group—which suggests participants might have experienced complications from the procedures, according to Hochman.

However, the researchers found the group of participants who underwent invasive procedures fared better after four years. Participants who had bypass surgeries and stent procedures experienced heart attacks and other events at a rate of 13.3% after four years, while participants who received intensive medical and lifestyle therapy experienced heart attacks and other events at a rate of 15.5%. Hochman said these differences will receive further study.

The researchers also found 50% of patients who underwent invasive treatment for frequent chest pain no longer had symptoms a year after their treatment, while 20% of patients who received intensive medical and lifestyle therapy did not experience symptoms. Therefore, researchers said bypass surgery and stents are likely better than medical treatments at relieving the symptoms of patients with frequent angina, or chest pain, but they do not change their odds of death or other events.

Discussion

Hochman said the findings should encourage patients to have more discussions about their treatment options with providers. She said, "Statins and aspirin are critically important. We need to understand better how to get people to modify their risk factors." She noted lifestyle changes are difficult to make and sustain.

Some cardiologists have said the findings will likely change medical practice.

Alice Jacobs, director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Boston Medical Center, said, "Based on the trial results to date, I as a clinician would feel comfortable advising my patient not to undergo the invasive strategy if their angina was absent or controlled or it was tolerated."

Glenn Levine, director of cardiac care at Baylor College of Medicine and a member of the AHA's guidelines committee, said the study's results will be incorporated into treatment guidelines.

William Boden, scientific director of the clinical trials network at VA Boston Healthcare System, who was a member of the study's leadership committee, said, "We have to finally get past the whining about how hard optimal medical therapy is and begin in earnest to educate our patients as to what works and is effective and what isn't" (McKay, Wall Street Journal, 11/16; Thompson, HealthDay/U.S. News & World Report, 11/18; Kolata, New York Times, 11/16; Marchione, AP/PBS News Hour, 11/17).

Advisory Board's take

Julie Bass, Senior Consultant, Cardiovascular Roundtable and Manasi Kapoor, Director, Research

We've seen a few big cardiovascular (CV) trial completions over the past few years with some unexpected—and perhaps less than satisfying—results. Think ORBITA (which compared PCI treatment to a placebo), CABANA (which compared catheter ablation to medical therapy), and now, ISCHEMIA. These trial results have sparked many questions about appropriate treatments for CV patients—and could have a sizeable impact on the future utilization of health care services.

At this point, it's hard to evaluate the potential impact of this trial on CV programs. We haven't yet seen a drastic change to clinical guidelines as a result of the other major trials mentioned above (but this could change). Yet, we've found that they are already raising questions regarding appropriate use, and will likely lead to increased scrutiny from payers, providers, and regulators. Financially, if they cause a shift in clinical practice, these trials may have a serious impact on cardiovascular revenues (which we know are already under pressure).

In the wake of this study, we'd encourage CV programs to carefully consider their current strategy for the treatment of patients with stable ischemic heart disease (SIHD) and promote physician-patient shared decision making in the creation of future care plans. Regardless of the ultimate impact of the ISCHEMIA study on the overall rate of procedural interventions, it is important for CV programs to stay up-to-date with clinical guidelines and make adjustments to how cases are treated based on the most recent findings. This will help ensure that programs can anticipate future scrutiny over appropriateness and install mechanisms to ensure that treatments meet this scrutiny before they become required.

What this trial says about the difficulty of discerning medical value

Beyond the practical CV implications, this trial elucidates some interesting ideas about how we assess the value of different treatment options. We know that, as an industry, we often look only to see if treatments are safe and effective—without fully appreciating the value of that treatment compared to other options (or no treatment at all).

We recently held a summit focused on value with leaders across the industry and convened a panel which sought to understand how we compare the relative value of medical, procedural, and lifestyle interventions. We see three major lessons from that conversation which have implications on our understanding of the ISCHEMIA trial:

  1. We need more resources to actually generate evidence about value: Generally, from a clinical efficacy standpoint, there is a dearth of data to compare the effectiveness of procedural therapies versus pharmaceutical therapies. There are limited resources to conduct randomized control trials (RCTs), let alone do comparative effectiveness research or head-to-head trials comparing the relative value of different interventions. This ISCHEMIA trial shows us that when we do actually have the ability to conduct these head-to-head trials, the evidence can be surprising.
  2. We can't afford to overlook issues about patient behavior and adherence: While studies like ISCHEMIA help move towards more nuanced conversations about relative value, they focus primarily on comparing clinical efficacy. Clinical efficacy, of course, is hugely important and should be a key factor in comparing therapies, but it should not be the only factor. Physicians have brought up the need to incorporate the patient's goals and patient activation levels into the discussion as well. For example, physicians might recommend a procedure over a medical-only intervention because they have more control over the procedure, whereas it can be harder to monitor adherence with a medication regimen. In this ISCHEMIA trial, the design compared the procedure with medicine versus medicine alone, so adherence was a variable in both cases. However, it's worth understanding the vital role adherence often plays in judgements of value.
  3. We need multidisciplinary decision-making: Programs should continue to promote multidisciplinary decision making to ensure adherence to latest treatment guidelines, but also to fully evaluate and present the tradeoffs for various interventions (procedural vs. pharmaceuticals vs. lifestyle interventions) to patients.

To see more about what we discussed at the summit, watch our new video overviewing the day. Then, to learn more about how you can create a high-value cardiovascular program across care sites, view our report on Creating the Seamless CV Network.

Watch the Video Download the Report

Topics