John Mandrola, MD

Disclosures

November 01, 2017

My favorite study presented at TCT 2017 thus far did not report on "hard" outcomes, such as stroke, heart attack, or death. Instead, at this major interventional cardiology meeting, attendees heard about making patients feel better.

Quality-of-life (QoL) measures are special because they are patient-reported, not doctor-reported.

In a late-breaking clinical-trial session, Dr Suzanne Baron (St Luke's Mid-America Heart Institute, Lee's Summit, MO), on behalf of the authors of EXCEL,[1] a randomized controlled trial that compared PCI vs CABG in left main coronary disease, reported substudy findings on quality of life in almost 1800 patients. (The EXCEL-QoL study was simultaneously published in the Journal of the American College of Cardiology.[2])

In the original publication of EXCEL, PCI and CABG did not significantly differ in the primary composite end point of death from any cause, stroke, or MI. In an editorial, Dr Eugene Braunwald (Brigham and Women's Hospital, Harvard, Boston, MA) wrote that left main disease "can now be managed equally well" by either technique.[3]

Others might not accept equipoise so readily. The NOBLE[4] trial, which also compared PCI vs CABG in patients with left main disease, found CABG superior to PCI. In NOBLE, lower rates of nonprocedural MI and repeat revascularization in the CABG arm drove the statistical benefit in the composite end point. And a review of Kaplan-Meier curves from both NOBLE and EXCEL suggest CABG might prove more durable over time.

But in absolute terms, and perhaps from a patient perspective, these differences are small. Quality of life, therefore, could have great influence over a patient's decision to have an operation or a stent procedure.

Patrice Wendling from the theheart.org | Medscape Cardiology has a full report.

My short take of the substudy's findings is that both PCI and CABG delivered disease-specific and overall improvement in quality of life through 3 years of follow-up. PCI had the edge at 1 month but angina frequency, dyspnea, physical functioning, and even depression were similar at 3 years.

One notable point about baseline characteristics in EXCEL was that angina frequency was low. About half the patients in both treatment arms had either no angina or angina once monthly. It's worth mentioning this, because it's harder to show differences in angina relief when it's already pretty low.

Comments

Cardiologists like to measure hard end points. Indeed, preventing heart attack, stroke, death, and readmissions to the hospital are important. But they aren't the only important outcomes for patients. Ask palliative-care or heart-failure doctors.

From its beginning, PCI pioneers promised to improve outcomes without the suffering inherent in recovering from open-heart surgery. The decision to perform PCI or CABG in patients with suitable anatomy has changed over time.

In the old days, before radial artery access, intravascular imaging techniques, and drug-eluting stents, the increased suffering from surgery easily paid off in terms of better long-term angina relief.

Now, with near equipoise in outcomes, the question becomes how these procedures stack up in quality-of-life scores.

Trial discussant Dr John Spertus (St Luke's Mid America Heart Institute), a leading outcomes researcher, and I may add, a consistent voice of reason, lauded the trialists for collecting this type of data. Spertus recently led an initiative to get the FDA to consider the patient-reported Kansas City Cardiomyopathy Questionnaire as an outcome measure used to approve medical devices. (That is a big change.)

Spertus said the quality-of-life signal from EXCEL was an "ideal opportunity to give patients a choice." The similar outcomes and quality of life gave him confidence that PCI (with suitable anatomy) was the preferred option. The panel of interventional cardiologists agreed. To be fair, I suspect some surgeons feel differently.

A thoughtful accompanying editorial[5] from Drs Daniel Mark and Manesh Patel (Duke University, Durham, NC) highlighted the difficulty in communicating treatment options for coronary disease. They cited previous work[6–9] that well documents the challenge of shared decision-making in this setting. These citations are worthy reads.

In 2012, Dr Erica Spatz (Yale University, New Haven, CT) and Spertus, writing in Circulation: Cardiovascular Quality and Outcomes, described three main challenges for improving the quality of healthcare[10]. The first two are obvious: better disease-specific outcomes and lower costs. The third challenge was delivering quality as determined from the patients' perspective. They note that patients may judge quality quite differently.

Remember, a shared decision involves both doctor and patient. These QoL findings are important not only for how they inform the patient but also for how they inform the physician. Although the coming digital revolution may change the asymmetry of power in the doctor-patient relationship, right now, how doctors feel about evidence affects the framing of their recommendations. And this framing exerts great influence over the patient's decision.

I took two lessons away from these important observations. The specific lesson is that both approaches to suitable left main disease delivered equally good quality of life. That's relevant.

The broader message, though, is that this study may herald the beginning of a new era in medicine. One in which patients get a say in judging the value of competing therapies. This is a good. A reason for optimism.

Good medicine extends well beyond composite end points.

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