番茄社区

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DENVER -- In lower surgical risk patients with left main coronary artery disease, stenting held an early quality of life advantage over coronary artery graft surgery (CABG), with some difference in depression even at 12 months, an EXCEL trial substudy showed.

At 1 month, summary SF-12 physical and mental component quality of life scores were significantly better for percutaneous coronary intervention (PCI) than with CABG (adjusted mean difference 8.2 and 2.0 points, respectively, both P<0.01).

At 1 month, 59.9% of patients in the PCI group were dyspnea-free as compared with 43.7% in the CABG group (p<0.01) based on Rose Dyspnea Scale scores, reported Suzanne Baron, MD, of Saint Luke's Mid America Heart Institute in Kansas City, Missouri, here at the Transcatheter Cardiovascular Therapeutics meeting and simultaneously .

Scores on each of the Seattle Angina Questionnaire subscales were significantly more improved at 1 month with PCI, with differences ranging from 1.5 points regarding angina frequency to 16.1 points related to physical limitations on scales where changes of 8 to 10 points are considered clinically meaningful.

The surgical group caught up by 12 and 36 months on those quality of life measures; the 2.3-point difference in depressive symptoms on the Patient Health Questionnaire-8 at 1 month narrowed by 12 months to a 0.4-points difference but remained significant at that point.

Dyspnea and angina are "very important for this population," Baron said at a press conference for the late-breaking clinical trial session. "Patients want to know 'Am I going to feel better? And if I'm feeling better faster, is there a price to pay down the road for that?' This data, although we know there's an increase in repeat revascularization, we can now tell them that it won't necessarily -- at least with the 3-year data we have -- won't affect their quality of life."

"We all talk about it in the clinic. This gives you extra oomph to be able to say this is a reasonable decision," she added.

The panel of interventional cardiologists at the press conference broadly saw the findings as a win for PCI.

Jonathan Hill, MD, of the London Bridge Hospital, said: "It legitimizes us asking the question and the patients asking the question about behavior which is avoiding sternotomy ... We need to apply these questions to all multivessel revascularization trials and not just with the left main population, but in patients who are choosing to have chronic total occlusions [treated], who are undergoing multivessel interventions. This really vindicates the decision making ... patients want to choose this option if it's available."

"We minimize the recovery period from CABG," said Cindy Grines, MD, of Hofstra Northwell School of Medicine in Manhasset, New York. "In my opinion, and in the patients' opinion, if you can have a more rapid recovery and be equally healthy at 3 years, I think there's a big role for PCI."

This study, coming on the 40th anniversary of Andreas Gruentzig performing the first human percutaneous transluminal coronary angioplasty, fulfills his vision of "comparable functional outcome" to CABG with "considerably less suffering" and earlier return to work and normal functioning, noted an by clinical cardiologist Daniel Mark, MD, MPH, and interventional cardiologist Manesh Patel, MD, both of Duke University Medical Center in Durham, North Carolina.

"Having achieved this milestone, some commentators presume, as Gruentzig did, that patients would uniformly prefer and their physicians would routinely recommend the path of 'considerably less suffering' and 'faster return to usual living,'" they wrote. "However, others are more cautious, suggesting some, particularly younger, lower-risk patients, might prefer the proven long-term durability of CABG."

That more cautious approach was voiced by cardiac surgeons contacted by 番茄社区.

Timothy Gardner, MD, a cardiac surgeon and medical director of the Christiana Care Health System's Center for Heart and Vascular Health in Newark, Delaware, called the early quality of life (QoL) advantage of PCI "hardly surprising."

However, "it is very notable that the 12 and 36 month QoL assessments by all patients were similar," he said. "In other words, after recovering from the CABG procedure, QoL was similar for both CABG and PCI patients.

"Although the EXCEL study itself is felt by some to suggest comparable selected clinical outcomes in the PCI and CABG patient groups, some sub-analyses favor CABG. The present study's finding of improved 30 day QoL in PCI compared to CABG patients should be weighed carefully against the long term benefit of CABG for many patients with left main disease."

Robert Michler, MD, surgeon-in-chief at Montefiore Medical Center in New York City, went further: "There is no more important quality of life than event-free survival and CABG remains superior for patients with three vessel disease. Surgery offers fewer events and fewer repeat procedures and longer life expectancy. These data are an attempt to confuse patients with respect to what truly matters."

The overall EXCEL trial, which randomized left main coronary artery disease patients with SYNTAX scores of 32 or less to everolimus-eluting stents or CABG, showed no difference in the primary composite of death, stroke, and myocardial infarction at 3 years (15.4% versus 14.7%, P=0.02 for noninferiority).

However, when the findings of that trial and the similar NOBLE trial with 5 year follow-up were reported at TCT in 2016, some pointed to trends in the wrong direction:

• All-cause mortality: HR 1.34, 95% CI 0.94-1.91 in EXCEL and 1.07, 95% CI 0.67-1.72 in NOBLE
• Spontaneous MI: HR 1.60, 95% CI 0.95-2.70 in EXCEL and 2.88, 95% CI 1.40-5.90 in NOBLE
• Total revascularizations: HR 1.72, 95% CI 1.27-2.33 in EXCEL and 1.50, 95% CI 1.04-2.17 in NOBLE

"The ideal approach would be to build models of outcomes -- QoL, death, stroke and need for repeat revascularization -- into tools that could be used with individual patients so that they have the data to choose what is most aligned with their goals and values," John Spertus, MD, director of Health Outcomes Research at St. Luke's told 番茄社区.

The Quality of Life substudy was limited to the first 1,800 patients enrolled in the EXCEL trial.