AT TCT 2017

DENVER (FRONTLINE MEDICAL NEWS) – Several key validated measures of health status were significantly more favorable a full year after percutaneous coronary intervention using an everolimus-eluting stent than with coronary artery bypass surgery in patients with unprotected left main CAD in the prespecified quality-of-life analysis of the landmark EXCEL trial.

By 3 years of follow-up, there was no longer a difference between the PCI and CABG groups in terms of the various quality-of-life measures, Suzanne J. Baron, MD, reported at the Transcatheter Cardiovascular Therapeutics annual educational meeting. Nor as previously reported was there any significant difference in the primary composite endpoint comprised of all-cause mortality, stroke, or MI.

The results were hailed by cardiologists at the meeting, which was sponsored by the Cardiovascular Research Foundation, as a major advance for the strategy of PCI using contemporary stents in treating patients with left main disease and low- or intermediate-complexity CAD based upon SYNTAX scores.

“My take away from this is that these results provide an ideal opportunity to give patients a choice about which choice they would want: An earlier recovery with angioplasty versus really similar outcomes long-term with either procedure. For me, these EXCEL results make me feel that angioplasty for less complex coronary disease is really probably the preferred option,” said John A. Spertus, MD , director of health outcomes research at Saint Luke’s Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City.

“The faster recovery with PCI, the similar angina relief after 3 years, and also the less depression with PCI, which is an important finding, I think – all this goes in favor of PCI for left main disease,” commented Evald H. Christiansen, MD , a cardiologist at Aarhus (Denmark) University and senior investigator in the NOBLE trial ( Lancet. 2016 Dec 3;388[10061]:2743-52 ), which randomized patients to CABG or a stent that’s no longer marketed.

The previously published clinical outcomes of EXCEL ( N Engl J Med. 2016 Dec 8;375[23]:2223-35 ) were based upon a median 3 years of follow-up. Dr. Baron presented updated outcomes in which all study participants had completed the full 3 years of follow-up. The results were little changed: The primary composite endpoint of all-cause mortality, stroke, or MI occurred in 15.2% of the group treated with the everolimus-eluting Xience stent and was closely similar at 14.7% of the CABG patients, while the 12.5% repeat revascularization rate in the PCI arm was significantly greater than the 7.4% rate with CABG.

But the prespecified EXCEL quality-of-life substudy with assessments at baseline, 1 month, 1 year, and 3 years in 1,788 participants is all new information. Among the highlights: The proportion of patients with clinically significant depression as defined by a Patient Health Questionnaire 8 (PHQ-8) score of 10 or more was 21% at baseline in both groups; 8% in the PCI group, compared with 19% in the CABG arm at 1 month; and 8% in the PCI arm versus 12% with CABG at 12 months of follow-up, with the differences at both time points being significant. By 3 years, the rate was 8%-9% in both groups, reported Dr. Baron of Saint Luke’s Mid America Health Institute and the University of Missouri-Kansas City.

“We now have a new treatment for depression: PCI,” quipped session moderator Gregg W. Stone, MD , professor of medicine at Columbia University in New York, who was lead investigator in EXCEL.

Also, scores on the SF-12 physical summary scale improved sharply from a baseline of 39 points in the PCI group during the first month of follow-up while worsening in the CABG group, such that at 1 month the between-group difference averaged 8.2 points. The gap narrowed over the next 11 months, and by 1 year the CABG patients had caught up.

Scores on the Seattle Angina Questionnaire and the Rose Dyspnea Scale were significantly better in the PCI group than the CABG arm at 1 month, but at 12 and 36 months the two groups were indistinguishable in these domains.

Dr. Spertus, who is credited with inventing both the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire, said that in the context of EXCEL he puts more stock in the SF-12 and PHQ-8 results than the angina and dyspnea measures.

“I think many patients would appreciate the faster recovery with PCI that was more evident in the general health status measures,” the cardiologist said. “I think it is the pain and physical limitations of recovering from a bypass that was so much better captured in a generic measure rather than a disease-specific measure like the Seattle Angina Questionnaire.”

Jonathan Hill, MD , an interventional cardiologist at King’s College London, said the EXCEL quality-of-life substudy provides a valuable picture of the real-life impact of sternotomy.

“We mustn’t underplay that, the months and even up to a year of your life for recovery from the revascularization procedure, compared with days of recovery time with PCI. Patients want the option of PCI if it’s available. This data really vindicates that decision making,” he said.

Cindy Grines, MD , concurred.

“I think we minimize the recovery period from CABG. People talk a lot about outcomes at 3 years and 5 years, but look at this prolonged recovery. I think that’s very, very important,” said Dr. Grines, chair of cardiology at Hofstra University, Hempstead, N.Y.

The updated full 3-year data show a trend, albeit not statistically significant, for higher all-cause mortality in the PCI group, by a margin of 8% versus 5.8% with CABG. When asked about it, Dr. Baron said she and her coinvestigators took a closer look and determined that the cardiovascular death rate was virtually identical in the two groups.

“You have to wonder if this was just a random signal regarding the non-cardiovascular-associated deaths,” she added.

The EXCEL trial was supported by Abbott Vascular. Dr. Baron reported serving as a consultant to Edwards Lifesciences and St. Jude Medical.