In Focus | There have been questions regarding the benefits of non-culprit percutaneous coronary intervention (PCI), and choosing the best approach can be confusing—especially in the wake of competing study results and shifting guidelines. In a recent interview with Rick McGuire, CardioSource WorldNews executive editor, John Spertus, MD, MPH, FACC, Director of the Health Outcomes Research and Saint Luke’s Mid America Heart Institute and professor at the University of Missouri, Kansas City, MO, provided insight into what he called the “shifting playing filed” of PCI.

A specific point of contention is the impact of multivessel revascularization on health-status outcomes in patients with STEMI and multivessel coronary disease. Among ST elevation myocardial infarction patients, 40-65% have one or more significant coronary stenosis in addition to their culprit lesions.

“Historically, we thought that treating the additional vessels led to increased risks for the patient and increased death. It did not seem wise, and the clinical understanding was that, if a patient comes in with a completely occluded coronary artery, open that artery,” Dr. Spertus said.

It was thought that patients need time to heal, then reevaluated if they continue to have symptoms, or if they, in any way, are not doing well after their culprit artery has been opened, then consider addressing other high-risk lesions. “And that thinking has been embraced for a long time,” Spertus said. But “there have been new studies questioning that. And, in many ways, we’ve gotten much better at angioplasty over the years. We have better technologies and more skill. We’re much faster at opening the culprit artery than we used to be in these historical studies.”

As a result of these advancements, he said, cardiologists have tried to push the envelope, saying, “‘Look, I’ve got the patient on the table. All the equipment is in place. I easily opened up this proximal LAD,’ or ‘I see this other problem. Why don’t I just tackle that at the same time?’”

“Such procedures are staged during hospitalization to preemptively treat these other blockages before the patient leaves the hospital,” Spertus said. “But the cardiology community has been struggling with what’s the right way to go. The guidelines are being changed.”

The 2013 guidelines said no to multivessel angioplasty at the time of the initial primary PCI, based on the potential for harm.

“The previous ACC/AHA/SCAI guidelines said it was Class 3. There are very few Class 3 recommendations,” he said. Dr. Spertus also cited the Choosing Wisely® Campaign, an effort by the American Board of Internal Medicine to educate physicians and patients about overutilization of medical resources. The ACC, an early partner of the campaign, originally listed complete revascularization in the setting of STEMI as one of five things physicians and patients should question. In September 2014, the ACC withdrew this Choosing Wisely recommendation based on evidence that complete revascularization of all significantly blocked arteries leads to better outcomes in some patients with STEMI.

Now, a focused update of the guidelines, multivessel primary PCI has been given a Class 2B recommendation.¹ “So not 2A,” said Dr. Spertus, “but it’s moved a step away from that Class 3.” (See Table 1 and Table 2.)

“Certainly, that seems judicious to me,” he said of the new guidelines. “It’s hard when there have now been at least two clinical trials suggesting improvements in major adverse cardiac events over time with doing multivessel revascularization.”

“Our own study—the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status (TRIUMPH) study—looks at a new dimension and domain to try and say that this is actually harmful to patients even though the emerging evidence suggests that it actually might be quite beneficial.2 And I’m excited to see that dialogue enriched and we’ll learn from that,” he said.

Of the TRIUMPH study, published in the November 10th issue of JACC, Dr. Spertus said: “We enrolled consecutive heart attack patients from 24 different hospitals throughout the United States. The real goal was to understand patient’s recovery after they left the hospital for their myocardial infarction (MI). So we enrolled STEMI and non-STEMI patients. We followed them for 1 year with serial health status assessments at 1, 6 and 12 months; we wanted to understand their symptoms, their function, and quality of life.”

“For this particular study, we were interested in those patients who had multiple other blocked vessels beyond the culprit when they were treated for a STEMI. So it’s a unique and important subset. It’s a very unresolved question,” he said.

Moving Quality of Life Front and Center

One limitation of many studies, he said, is their focus on mortality or reinfarction. “But one of the principle advantages of treating another blocked artery is alleviating the patient’s angina and improving their quality of life. Those are critical benefits of percutaneous revascularization. This is the real goal for treating our patients.”

Thus, Spertus and colleagues wondered whether multivessel revascularization at the time of the original procedure led to improved health status over the next year compared to individuals undergoing only culprit-artery PCI. “This was not a randomized trial,” he said. “It was an observational study,” but they used “a lot of sophisticated statistical methods to try and compare apples to apples.”

What they saw was that patients who had multivessel revascularization had significantly better angina control over the following year. They also had significantly better quality of life over the same period than those patients whose other blocked arteries were not addressed.

One aspect that can be quantified, understood, and eventually recognized, he argued, is that some patients will have a greater quality of life benefit from multivessel revascularization, but some may not. A more conservative approach can be taken with the latter group with more aggressive treatment for those more likely to benefit.

For Spertus, even though multivessel revascularization has its benefits, it is important “to evaluate patients’ perception of their systems and quality of life.” To his knowledge, the TRIUMPH study is the first that has done so; he hopes future studies will be designed with this in mind, as well.

Fundamentally, the goal for cardiologists is to have their patients live longer and feel better. In recent years, there have been such dramatic improvements in survival—the most important outcome—that it can be challenging to distinguish differences among the new innovations in survival.

“So what do we do?” he asked. When comparing approaches, he said, consider survival as a key endpoint but combine it with other things: “We combine survival with re-hospitalization. We combine survival with bleeding. We combine survival with repeat procedures. A lot of those other events aren’t nearly as bad as death, and what we haven’t done is say, ‘Well why don’t we start paying a lot of attention to capturing how our patients are feeling?’”

“I mean,” he continued, “if one of our goals is to make them feel better, to have a fuller quality of life, to have fewer symptoms, we ought to be designing our trials for that outcome if we don’t have the power within death alone to detect differences, because we can still define ways to treat patients and improve their outcomes. There is nothing wrong with making patients feel better, even if you don’t make them live longer.”

For Spertus, if given the option between the same survival but the variable is quality of life versus a lot of symptoms and a poor quality of life, he would want the former. “It baffles me that the larger scientific cardiovascular community, through clinical trials, hasn’t embraced health status as an equally meaningful goal of therapy and outcome; I mean, for 20 years, we’ve been talking about it.”

He noted that there are studies in which the only benefit of the intervention is in quality of life. He cited the COURAGE study as an example. “It didn’t alter death, didn’t alter MI. Significant improvement for the patient for a year or 2 with symptom control and quality of life. You haven’t seen angioplasty completely go away in stable coronary disease because it didn’t affect death and MI. We continue to support and embrace it, because it improves quality of life. And so if our behavior embraces the value of quantifying and improving patients’ quality of life, then our trial design should also emphasize that, as well.”

Footnotes

1. Levine GN, O’Gara PT, Bates ER, et al. J Am Coll Cardiol. 2015;[online before print]
2. Jang J-S, Spertus JA, Arnold SV, et al. J Am Coll Cardiol. 2015;66:2104-13.

Keywords: CardioSource WorldNews, Percutaneous Coronary Intervention, Coronary Disease, Coronary Stenosis, Myocardial Infarction

< Back to Listings