No Late Quality of Life Trade-offs With PCI in Left Main Disease: EXCEL-QOL Substudy

DENVER, CO—Coronary artery bypass graft surgery and PCI for the treatment of left main disease are both associated with “clinically meaningful and statistically significant improvements” in angina frequency, physical limitations, and treatment satisfaction, among other measures, according to a new quality-of-life (QoL) substudy of the EXCEL trial.

At 12 and 36 months, there were no significant differences between PCI- and CABG-treated patients in QoL scores assessing angina frequency and stability, dyspnea with activity, and other dimensions of general health, including mobility, pain/discomfort, self-care, and anxiety/depression. Not surprisingly, the PCI-treated patients scored higher on several QoL metrics at 1 month.    

Presented this week at TCT 2017, the EXCEL-QOL substudy complements clinical findings presented last year, according to investigators.

“Taken together with the 3-year clinical data from EXCEL, these results suggest that PCI and CABG provide comparable intermediate-term outcomes for appropriately selected patients with [left main coronary artery disease],” report Suzanne Baron, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), and colleagues online October 30, 2017, in the Journal of the American College of Cardiology.

Speaking during a morning press conference, Baron said the results were surprising, noting that in the FREEDOM and SYNTAX trials, two studies that compared PCI versus CABG surgery, the relief of anginal symptoms was greater with cardiac surgery. In those studies, evidence of better QoL with bypass surgery was starting to emerge by the 3-year mark.

“So this is actually one of the first trials that has shown that long-term anginal benefit between PCI and CABG is no different,” said Baron.

Arnold Seto, MD (Long Beach VA Medical Center, Long Beach, CA), who was not involved in the study, said the QoL results are in the line with the overall clinical data showing no significant difference in MACE rates between PCI and CABG surgery. Given the more invasive nature of surgery, “this [QoL] study was very consistent with the early morbidity that everybody recognizes is associated with CABG,” he said.

Quality of Life Data in EXCEL

Last year, EXCEL and NOBLE investigators attempted to address whether patients with left main coronary disease would be best served by CABG or PCI. The results were somewhat mixed, with study investigators reporting conflicting findings.  

In the EXCEL-QOL substudy released today, which was limited to the first 1,800 patients, the researchers observed significant improvements in Seattle Angina Questionnaire-Angina Frequency (SAQ-AF) scores at 1 month for both CABG- and PCI-treated patients. In the PCI patients, disease-specific and generic health status measures improved at 1 month, which then were sustained at 12 and 36 months. There was a slight decline in QoL at 1 month in the CABG group, but health-status scores had rebounded by 12 and 36 months.

Regarding the between-group differences, the PCI-treated patients had higher scores, reflective of greater improvement, on several SAQ subscales at 1 month compared with CABG, but by 12 and 36 months there were no significant differences between the two groups.

Similar time-related trends were observed when investigators assessed QoL using the Rose Dyspnea Scale (RDS), which measures dyspnea with activity. The rate of improvement in dyspnea was more rapid with PCI, but again there were no differences between groups at 12 and 36 months. PCI-treated patients reported better physical and mental health status at 1 month, including less depressive symptoms at 1 year, although any differences in these generic health markers disappeared by 36 months.

Benefit Early, No Difference Late

To TCTMD, Baron said individuals with coronary artery disease want to know if they’re going to “feel better” after either procedure, but also want to know they won’t pay a long-term price if they choose to feel better faster with PCI. “We do know there is an increased risk of repeat revascularization [with PCI], but we can now tell them it won’t necessarily, at least with the 3-year data we have, affect their quality of life,” said Baron. 

To TCTMD, Seto said the decision-making process for patients with coronary artery disease can be emotional. While CABG is associated with increased early morbidity, he reassures them that it is a very routine operation and most will be back on their feet by 5 or 6 weeks. Still, patients often have an “inherent fear of open-heart surgery” and will generally take any option short of surgery if the procedures are equivalent, said Seto.

“I think the EXCEL trial goes a long way toward showing that [PCI and CABG] are equivalent in patients left main disease and a low-to-intermediate SYNTAX scores,” he said. “In that respect, now with the quality-of-life measures showing no difference, except for the [early] upfront difference, this will really drive people towards using PCI as the preferred revascularization technique.”  

Seto said the QoL data could have “gone the other way,” where the increased rates of revascularization with PCI led to worsened QoL metrics. The study reassures that the early benefit of PCI wasn’t associated with a later penalty, he added.  

David Cohen, MD (Saint Luke’s Mid America Heart Institute), senior investigator of the EXCEL-QOL substudy, said the results highlight how far PCI has come in that “it can not only stand toe-to-toe with bypass surgery but give patients a much more rapid recovery.” For him, the importance of looking at QoL endpoints beyond angina is critical. 

“There was a benefit not only early, but all the way out to a year of less depression in patients treated with PCI,” said Cohen. “Depression is a pretty serious thing for these patients. It’s an additional benefit we had not necessarily anticipated.”

Cindy Grines, MD (Northwell Health, North Shore University Hospital, Manhasset, NY), who was not involved in the study, said physicians can often overlook the prolonged recovery associated with CABG surgery. With bypass, there can be postoperative pain, reoperations for bleeding, postsurgical atrial fibrillation, as well as prolonged ICU and hospital stays.    

“If you take that in conjunction and compare it with rehospitalizations or repeat revascularizations, they wind up being quite similar,” said Grines. “The point I’m trying to make is that it all depends on the endpoints we’re looking at in these trials. In my opinion, and in a patient’s opinion, if you can have a rapid recovery and be equally healthy at 3 years, I think there’s a good role for PCI.”

Age, however, remains a determining factor when deciding on PCI versus CABG surgery for left main disease, noted Leif Thuesen, MD (Aalborg University Hospital, Denmark). The long-term data still favor surgery for reducing the risk of death, but for older patients QoL improvements may be more important. 

Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who chaired the morning press conference, didn’t want to oversell PCI given the equivalent outcomes at 3 years, and adopting the role of “devil’s advocate,” noted that there was a trend toward better all-cause mortality outcomes with surgery in EXCEL. Countering this, Baron said the rates of cardiovascular mortality were essentially identical between the PCI- and CABG-treated patients, suggesting the benefit in terms of noncardiovascular mortality might be statistical “noise.”  

‘Technical Jungle of Evidence-Based Medicine’

In an editorial accompanying the study, Daniel Mark, MD, and Manesh Patel, MD (Duke Clinical Research Institute, Durham, NC), state that because PCI and CABG outcomes were essentially a toss-up in EXCEL, as well as in the subsequent meta-analysis that included EXCEL and NOBLE, individual patient preferences will tilt the decision toward one revascularization approach over the other.

“However, for patients to develop a personal preference for complex mixtures of unfamiliar medical outcomes requires both an understanding of their likelihood of such outcomes as well as the likely effects on symptoms, functioning, and subjective well-being associated with each,” they write.

For Mark and Patel, this new analysis suggests parity in terms of angina relief and QoL between PCI and surgery, although they point out that only 10% of the study cohort reported daily angina at the time of randomization (30% had weekly angina and 60% monthly symptoms). The primary determinant of improved QoL after PCI is angina frequency prior to the procedure, they note. If the patient didn’t have angina before revascularization, treatment is unlikely to improve QoL. 

The bottom line, they state, is that for patients to truly understand why a treatment strategy will work for “people like them,” patients must immerse themselves in the “technical jungle of evidence-based medicine.” In many instances, they simply give up and let the physician decide.