EXCEL: PCI, CABG Offer Similar Quality of Life at 3 Years

Patrice Wendling

October 31, 2017

DENVER, CO — Although PCI treatment of left main disease carries a higher risk of repeat revascularizations, quality of life (QoL) is comparable to CABG surgery through 3 years, according to new results from EXCEL[1].

Not surprisingly, PCI resulted in significantly better health status on all QoL scales at 1 month. But by 12 and 36 months, there were no significant differences between PCI and CABG in QoL measures assessing angina, dyspnea, or general health concerns like pain, mobility, and depression.

Dr Suzanne J Baron

"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," Dr Suzanne J Baron (St Luke's Mid America Heart Institute, Lee's Summit, MO) reported in a late-breaking trial session here at TCT 2017 and in the Journal of the American College of Cardiology.

At last year's meeting, the question of whether drug-eluting stents should be preferred over CABG in patients with left main disease met with conflicting data from EXCEL and NOBLE.

Perhaps the most provocative finding in the new substudy is the lack of a significant signal for greater anginal relief with CABG, a benefit that emerged at 3 years and remained at 5 years in both the FREEDOM and SYNTAX trials, Baron told theheart.org | Medscape Cardiology.

The 5-year health status assessment for EXCEL has been canceled due to budget constraints, but "my guess is we wouldn't see that much difference at 5 years, but it's hard to know, and we may never know," she added.

Dr Davide Capodanno (University of Catania, Italy) was among several panelists who congratulated the authors for bringing patient-reported outcomes to the main arena, "because there is more and more understanding that these kinds of outcomes are as important as clinical outcomes."

He said the earlier recovery with PCI is not surprising but agreed "the novelty here is that if you put these results into the perspective of FREEDOM and SYNTAX, you see that these angina differences have been really blunted and nullified in this trial."

"We remember with the [plain-old-balloon angioplasty] POBA era, the [bare-metal stent] era, the first-generation routine stent era, there was this difference in anginal relief with CABG, and now it's blunted, disappeared actually. So it's very beautiful to see this in the natural history of what we do with PCI," he added.

EXCEL randomized 1905 patients with low or intermediate-risk SYNTAX scores (<32) to a second-generation everolimus-eluting stent (Xience, Abbott Vascular) or CABG with or without pulmonary bypass.

With complete 3-year clinical follow-up now available, outcomes remained relatively unchanged in terms of the primary outcome or its components, although there was a significantly higher rate of repeat revascularizations with PCI vs bypass surgery (12.5% vs 7.5%; P<0.01) and a trend for higher all-cause mortality (8.0% vs 5.8%; P=0.08).

This trend was highlighted in a press briefing on the study, with Baron remarking that rates of cardiovascular mortality were roughly identical between the PCI and CABG groups and that the benefit for all-cause mortality with CABG might be a statistical blip.

Among the 1788 patients in the QoL substudy, PCI-treated patients had higher scores on several Seattle Angina Questionnaire (SAQ) subscales at 1 month compared with CABG, but there were no significant differences by 12 and 36 months.

Similar to the SAQ findings, 60% of PCI-treated patients vs 44% of CABG-treated patients had dyspnea at 1 month as measured by the Rose Dyspnea Scale (P<0.01), but those differences were no longer significant by 12 months (49% vs 46%; P=0.40) and 36 months (43% vs 42%; P=0.77).

PCI-treated patients also had more rapid improvements on generic health-status measures including the 12-item Short Form Health Survey physical and mental summary components.

Using the more specific Patient Health Questionnaire (PHQ)-8, a truncated version of the PHQ-9, the percentage of patients categorized as having clinically significant depression was significantly lower with PCI than CABG at 1 month (8% vs 19%; P<0.01) and at 12 months (8% vs 12%; P=0.03) but not at 36 months (9% vs 8%; P=0.77).

Panelist and NOBLE principal investigator Dr Evald Christiansen (Aarhus University Hospital, Denmark) said they did not collect QoL outcomes in NOBLE but that the current data will be helpful when presenting left main treatment strategies to patients.

"I think this goes in favor of PCI in left main disease, and also the less depression with PCI is an important finding," he said.

In subgroup analyses at 3 years, there was a suggestion of an interaction between angina relief and baseline SYNTAX score, but it was in a counterintuitive direction, with CABG appearing to provide greater benefit among patients with a low SYNTAX score and no difference in those with intermediate or high SYNTAX scores (mean treatment effect of PCI vs CABG -3.3, 0.8, and -0.2 points, respectively), Baron said. However, this finding did not achieve the prespecified statistical significance level of P=0.01 (P for interaction=0.03), and all other subgroup analyses including baseline angina frequency were negative, she added.

Cappadano said play of chance of could justify why the low-risk SYNTAX score shows a counterintuitive effect for CABG but that it is important to look further at the subgroup analyses.

Overall, panelist Dr John Spertus (St Luke's Mid America Heart Institute) said the substudy provides physicians with an ideal opportunity to give patients a choice between an earlier recovery with angioplasty vs very similar outcomes in the long term with angioplasty or bypass.

"So for me, this helps me feel that angioplasty for less complex coronary disease is really probably the preferred option," he said.

He noted that patient- and clinician-reported outcomes that measure how patients feel or function were recognized earlier this year as medical device development tools (MDDT) by the US Food and Drug administration, which recently designated the 23-item Kansas City Cardiomyopathy Questionnaire as an MDDT for use in patient-reported heart-failure outcomes.

Dr Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, NY), who chaired the press briefing, observed that guidelines are usually driven by clinical end points, not quality of life. "But hopefully we can change that, because I do think it's an incredibly important area for our patients to bring the patient into this shared decision-making."

Finally, Drs Daniel B Mark and Manesh R Patel (Duke Clinical Research Institute, Durham, NC) write in an accompanying editorial[2] that what patients want to know is the overall treatment experiences and responses "for people like me," but that trial and meta-analysis data instead provide complex, disaggregated information for a hypothetical average patient.

Compounding the problem is that patients often arrive with preexisting preferences based on unrealistic beliefs about the benefits of revascularization that are not easily corrected.

"However, if we are really serious about moving to a patient-centric model of medicine, we need to meet patients where they are in understanding and answer the existential questions that matter most to them. Although much work on this has already been done, EXCELlence is still a long way off," Mark and Patel conclude.

EXCEL and the quality-of-life substudy were funded by a research grant from Abbott Vascular. Baron reported consulting income from Edwards Lifesciences and St Jude Medical. Disclosures for the coauthors are listed in the paper. Mark reported institutional grants from Eli Lilly, Gilead, AstraZeneca, Bristol Myers Squibb, Merck, and Oxygen Therapeutics. Patel reported institutional research grants from and serving as an advisory board member for Bayer, Jansen, and AstraZeneca. Capodanno reports receiving payments for consulting or honoraria from AstraZeneca, Bayer, Daiichi Sankyo, Eli Lilly, and the Medicines Company. Spertus founded Health Outcomes Sciences. Mehran previously reported grant support from/research contracts with Daiichi Sankyo/Eli Lilly, Bristol-Myers Squibb, AstraZeneca, the Medicines Company, OrbusNeich, Bayer, and CSL Behring; consultant fees/honoraria from or being on a speaker's bureau for Janssen Pharmaceuticals, Osprey Medical, Watermark Research Partners, and Medscape; equity in Claret Medical and Elixir Medical; and other financial support from Abbott Vascular.  

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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