PCI Fails in Stable Disease Again: REVIVED-BCIS - Medscape

The scene brought memories of the before time. The vast Barcelona room here at the European Society of Cardiology (ESC) meeting overflowed with attendees eagerly awaiting results of the REVIVED-BCIS trial, yet another test of percutaneous coronary intervention (PCI) vs medical therapy.

Divaka Perera, MD, the principal investigator, from King's College London, skillfully introduced his trial. Patients with severe multivessel coronary artery disease amenable to PCI and left ventricular dysfunction (left ventricular ejection fraction ≤ 35%) and viable myocardium were randomly assigned to PCI or guideline-directed therapy. The primary endpoint was death or heart failure hospitalization.

Perera first described the evidence gap. Most PCI vs coronary artery bypass graft surgery (CABG) trials excluded patients with left ventricular dysfunction. The STICH trial compared CABG to medical therapy in patients with ischemic cardiomyopathy and failed to find a difference in mortality at 5 years. One likely reason was higher early mortality in the surgery arm. After the first few years, the survival curves favored surgery and at 10 years of follow-up, the results turned positive for surgery.

He then explained the potential advantage of PCI as a revascularization strategy—mainly that there would be no early mortality signal.

As has become the custom in highly anticipated trials, Perera teased the audience by first showing the Kaplan-Meier curve of the medical therapy arm. He paused for a few seconds to let the tension build, then clicked the remote. An audible groan came from the masses when the PCI curve overlapped exactly with the medical therapy curve.

No difference. The hazard ratio was 0.99—about as close to 1.0 as you could get. There was also no difference in the secondary outcome of left ventricular ejection fraction. And at 2 years, quality-of-life scores were also not significantly different.

Comments

I am not sure how many more experiments we will need to convince cardiologists that PCI outside of acute plaque rupture and myocardial infarction has minimal to no value.

Here is a list of previous trials that assessed clinical outcomes and found no benefit for PCI in patients with stable coronary artery disease (CAD):

• MASS-II PCI trial (2004): PCI vs medical therapy;

• COURAGE (2007): PCI added to optimal medical therapy vs medical therapy alone;

• BARI-2D (2009): PCI added to optimal medical therapy vs medical therapy alone in patients with diabetes;

• ISCHEMIA (2020): an early invasive strategy, mostly with PCI, in patients with moderate to severe ischemia;

• ISCHEMIA-CKD (2020): an early invasive strategy in patients with moderate to severe ischemia and chronic kidney disease.

We can now add to that list the REVIVED-BCIS trial, which enrolled patients most likely to benefit from PCI: those with anatomy amenable to intervention as well as viable myocardium. Yet not even a hint of benefit.

The problem with PCI isn't the stent or the procedural technique; these have greatly advanced over the years. The problem with PCI in stable disease is that PCI is a focal treatment for a systemic disease and modern guideline-directed therapy is really good.

Patients with ischemic cardiomyopathy now benefit from a three-tiered therapeutic approach: high-potency statin drugs combined with antiplatelets for CAD, four classes of drugs for heart failure due to impaired left ventricular function, and implantable cardioverter defibrillators with or without cardiac resynchronization. Each has been shown to reduce clinical outcomes; together they make for a strong control arm.

None of the criticisms of REVIVED-BCIS that I heard here at ESC persuade me.

As for it being underpowered and possibly having type 2 error, I would point to the wide confidence intervals around a 0.99 hazard ratio. There is no false-negative there.

As for accusations of selection bias, with enrolled patients being those not offered surgery, I would point to the fact that most of these patients had no or minimal angina and class I or II heart failure. Stable and minimally symptomatic older patients are unlikely to be offered (or accept) bypass surgery.

As for not knowing the details of the coronary anatomy or the contention that the CAD was not severe enough, I would point to the scoring of CAD severity. The authors used the British Cardiovascular Intervention Society jeopardy score, which ranges from 0 to 12 (12 represents the entire heart being perfused by stenotic vessels). The median score in the trial was 10 of 12.

Another concern focused on whether the 3.4-year follow-up was too short. In STICH, it took a decade to see improvement with surgery over medical therapy. But STICH enrolled younger patients, aged 59 to 60 years. The median age of patients in REVIVED-BCIS was about  70 years. I don't think a 10-year horizon in septuagenarians with severe CAD and left ventricular dysfunction is practical.

Conclusion

Whenever I write about yet another nonsignificant trial in the PCI space, the colloquial phrase credited to Max Planck comes to mind: "Science progresses one funeral at a time." The only hope for reversing the utterly sclerotic clogged-pipe frame of treating atherosclerotic disease is the retirement of the current generation.

Sure, at podiums in congresses, and perhaps in places like Denmark, clinicians don't feel compelled to "fix" stable blockages.

But the vast majority of this profession struggles with not making causal inferences between the before-and-after PCI images. "How can the after image not be better? Look at it. The vessel is perfect! Damn the evidence. I helped this patient."

Imagine U.S. cardiology sessions 20 years from now. The clinicians of the future, unencumbered by our dogmas, will have sessions on how and why this generation was able to ignore this much evidence. I hope to live long enough to see this. It will make me smile.

In the meantime, we should celebrate the success of modern medical and device therapies. It's really good.

For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook

Meeting hashtag: #ESCCongress

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. Follow John on Twitter.