SYNTAX Analysis: PCI, CABG Offer Substantial Symptom Relief But Timing Differs

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Among patients with left main or 3-vessel disease who are candidates for either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery, both strategies offer substantial angina relief and improve overall health. However, each treatment appears superior at different time points, with PCI holding the lead for quality of life (QoL) during the recovery period and CABG making gains by 6- and 12-month follow-up.

Results from the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) QoL subanalysis appear in the March 17, 2011, issue of the New England Journal of Medicine and were previously presented at the American College of Cardiology Scientific Session/i2 Summit 2009 in Orlando, FL.

SYNTAX employed an all-comers design that involved 3,075 consecutive patients with triple-vessel or left main disease at 85 sites in 17 countries. Each patient was evaluated by a local interventional cardiologist and cardiac surgeon; those eligible for either treatment were randomized to receive CABG (n = 897) or PCI with paclitaxel-eluting Taxus stents (n = 903; Boston Scientific, Natick, MA). In the main results, CABG patients experienced fewer major adverse events at 1 year than did PCI patients, a difference driven largely by reduced need for repeat revascularization (Serruys PW. N Engl J Med. 360;961-972).

In Search of Angina Relief

For the prespecified subanalysis, David J. Cohen, MD, of Saint Luke’s Mid America Heart and Vascular Institute (Kansas City, MO), and colleagues evaluated health-related QoL using the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months post-treatment. The overall response rate exceeded 90% at all 4 time points.

At baseline, the PCI and CABG groups had similar angina frequency and SAQ scores. Approximately 12% reported daily angina symptoms in the month prior to randomization and 20% reported no angina.

The primary endpoint of SAQ angina-frequency score remained similar for the 2 treatment groups at 1 month, but over longer follow-up CABG patients showed superior outcomes. They also were more likely to report freedom from angina by 12 months. However, both patient groups showed substantial improvement, defined as an increase of at least 20 points over baseline SAQ angina-frequency score (table 1).

Table 1. Angina Relief

Two measures of general health status—the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the European Quality of Life-5 Dimensions (EQ-5D)—also showed an early advantage for PCI that tapered off by 6 and 12 months.

Additional calculations found a relationship between baseline angina frequency and the benefits of PCI or CABG. Among patients with daily or weekly angina at baseline, CABG provided better relief from angina at 6 months compared with PCI (mean adjusted difference in SAQ score, 4.4 points). Patients with daily or weekly angina also were more likely to be free from angina after CABG than after PCI at 6 months (65.4% vs. 56.9%; P = 0.02) and 12 months (70.3% vs. 60.0%; P = 0.02).

But patients who reported little or no angina prior to the study showed a different pattern; those with monthly symptoms fared marginally better with CABG and those with no symptoms had slightly better outcomes with PCI (P for interaction = 0.03).

“Our study shows that despite inclusion of patients with more complex coronary artery disease than those in previous trials, the continued evolution of PCI techniques, including the use of drug-eluting stents, has narrowed the gap in health-related quality of life between patients who undergo PCI and those who undergo CABG,” the investigators conclude, adding that the “symptomatic benefits of CABG were counterbalanced by the more rapid recovery and improved short-term health status achieved with PCI.”

No Easy Decisions

In a telephone interview with TCTMD, Dr. Cohen said the goal of the analysis was to obtain objective, high-quality information that physicians could then provide to their patients so they could make choices based on the strengths and weaknesses of both treatments. “The message here is that clinicians need to communicate the differences and the expectations for these 2 procedures so that the patients can make the best decision for themselves,” he advised. “I don’t think clinicians should be deciding without the patient.”

“What we are learning as we study bypass surgery and PCI more carefully in these very complicated patients is that it’s a very multidimensional problem and there are many different nuances to the outcomes,” he said. One example is the interaction between baseline angina frequency and treatment, Dr. Cohen noted, pointing out that even in that case the difference in outcomes was “not enormous,” such that “some patients may still prefer the more rapid recovery of PCI.”

Asked whether the choice of DES matters, Dr. Cohen said the choice would not likely matter in terms of angina. “What we know about the newer stents as compared with Taxus is that they do have somewhat lower rates of restenosis and repeat procedures. That’s obviously a good thing. They do seem to be somewhat safer in terms of stent thrombosis, at least in the first year or so. Those things do need to be factored in,” he said. “Whether they would differ on angina, that’s another matter, because even restenosis has a transient effect on angina. . . . That’s harder to know.”

Many recent trials have not addressed angina relief, which is “somewhat of a disappointment,” said Dr. Cohen, because it is the principal benefit of PCI in patients undergoing elective procedures and should be studied more often.

“There are many, many factors. It’s going to be very challenging, probably impossible to capture them all in 1 or 2 sound bytes or easy decision rules,” he said. Rather, clinicians should seek to understand what is driving the procedure, whether prognostic benefit, symptom relief, or both, and discuss all the relevant information with patients.

Dr. Cohen said that 3- and 5-year QoL analyses from SYNTAX are forthcoming. “We have some speculation that things will stay similar or, if anything, get even closer together, but that’s extrapolation from previous trials and certainly by no means guaranteed,” he noted.

Analysis Offers Lessons for Practice

In a telephone interview with TCTMD, Sorin J. Brener, MD, of Weill Cornell Medical College (New York, NY), praised the study’s methodology and highlighted the importance of measuring not only hard clinical endpoints but also how patients “feel about themselves and how their lives are going” following revascularization.

The gains from either PCI or CABG over baseline are “huge” and fairly comparable, Dr. Brener noted. “So it’s okay to tell people that it’s very likely that whatever we do to you, you’ll feel much better.”

Despite this overall equivalence, differences in recovery within the first 6 months may influence treatment decisions, he said. “I think that’s important particularly when you advise very old people about what to do, because they recover less quickly and are less likely to derive the potential benefit in survival that might happen with bypass surgery,” Dr. Brener explained. “If you’re 90 years old, which would you prefer, to maybe live 1 week less or be disabled for 6 months?”

However, the current follow-up of only 1 year is not sufficient to truly weigh the long-term effects of CABG and PCI on quality of life, he noted. 

But Does It Go Far Enough?

Speaking in a telephone interview, Christopher J. White, MD, of Ochsner Clinic Foundation (New Orleans, LA), expressed surprise that the authors’ tone was so ‘low key.’

“My concern is that a lot of interventionalists who read this may not read between the lines and understand how important this paper really is,” he said.

The big news, Dr. White stressed, is that even in patients with left main and 3-vessel disease, “the highest-risk, biggest bang for your buck revascularization group that’s ever been looked at,” PCI held up so well against CABG.

“Today, what I think we know is that surgery is not better than stenting. There is a marginal benefit in terms of angina alone, but in terms of survival and the other important things that people worry about and are the reason they get surgery, there really isn’t any reason to prefer surgery over stenting,” Dr. White commented. “Stenting has finally grown up and is a mature therapy that can be reasonably offered as an option to [the types of] patients who qualified for this trial.”

 

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Source:
Cohen DJ, Van Hout B, Serruys PW, et al. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011;364:1016-1026.

 

 

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• SYNTAX Published: CABG Remains Standard for Severe CAD