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- Medscape

01/28/2008 - More patients with multivessel disease will die within 18 months if treated with drug-eluting stents (DES) than they will if they undergo coronary artery bypass grafting (CABG) surgery — that's the upshot of an analysis of all patients undergoing those procedures in the State of New York between October 1, 2003 and December 31, 2004 [1]. The study is the first large-scale, multicenter comparison of the two modern-day revascularization strategies and should cause physicians to rethink the information and advice they give to patients choosing between the two procedures, experts say.

In the study, patients with either two- or three-vessel disease were 20% to 29% less likely to die and 25% to 29% less likely to die or have a myocardial infarction (MI) if treated with CABG instead of DES; rates of repeat revascularizations were also significantly lower. Results are published in the January 24, 2008 issue of the New England Journal of Medicine.

"Certainly, physicians and patients need to be aware of this study," lead author Dr Edward L Hannan (University at Albany, NY) told heartwire. "There are other studies, confined to single hospital settings, that concluded the same thing: that even in the era of DES, the longer-term outcomes favor CABG surgery."

Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA), commenting on the study for heartwire and who was uninvolved in the study, was more blunt about the results.

"Bottom line: these data underscore the fact that CABG remains the gold standard for patients with multivessel CAD [coronary artery disease] and for left main stenosis, because of its survival advantage, freedom from repeat intervention, and relief of angina," he told heartwire. "Until the results of the ongoing clinical trials such as FREEDOM [Future Revascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease], SYNTAX [SYNergy between PCI with TAXUS and Cardiac Surgery], and VA CARDS [Veterans Administration Coronary Artery Revascularization in Diabetes] come out, clinicians would be well-advised that CABG remains the 'winning strategy' in patients with multivessel and left main disease."

Others, however, warn against making too much of registry results. In this particular study, there are no data on whether patients who got percutaneous coronary intervention (PCI) did so because they were too sick to undergo CABG, and there are no data on "completeness" of revascularization in stented patients. Moreover, an important subgroup, patients with left main disease, were not included in the study.

"Overall, the data are the data: they're probably right," Dr Ron Waksman (Washington Hospital, DC) commented, noting that a recent paper from his group showed similar findings. "The problem is that most people will generalize from these conclusions after publication, and there is three-vessel disease and there is three-vessel disease. Not all three-vessel disease is the same. You can have diffuse long lesions, total occlusions, etc, etc, and you can have three focal lesions in three vessels. This is where randomization is very important, and I would suggest that we wait for the results of the SYNTAX trial before jumping to conclusions. It's going to give us a much more accurate answer to this question."

Surgeons, however, point out that they have been warning patients and their peers about the inferiority of DES for multivessel disease for some time. "These results favoring CABG over DES are consistent with earlier studies comparing CABG with bare-metal stents," Dr Robert Guyton, chief of cardiothoracic surgery at Emory University, Atlanta, GA, reminded heartwire. "And it has been shown before that there is no survival benefit or MI benefit of DES over bare-metal stents."

Event rate lower in CABG-treated patients

The study compared death and death/MI in 7437 patients treated with CABG and 9963 treated with DES. After 18 months, the adjusted hazard ratio (HR) for death was 0.80 among CABG-treated patients with three-vessel disease and 0.71 for CABG-treated patients with two-vessel disease. Adjusted hazard ratios for the end point of death/MI were similarly reduced for CABG-treated patients as compared with DES-treated patients. Revascularization rates were also dramatically and significantly lower in CABG-treated patients.

Adjusted survival rates for patients with three- and two-vessel disease

Patients 80 years and older and patients with ejection fractions less than 40% were also significantly more likely to survive 18 months or survive free of MI if they received CABG. By contrast, there were no significant differences in outcomes between CABG- and DES-treated diabetics, although the results trended in favor of CABG for this subgroup.

Hannan singled out the diabetics as one group that warranted special attention in further studies, given that other reports have more clearly favored CABG over stenting for this group. "We need to explore this in more detail and try to identify precisely which groups either benefit more from stenting or at least for which there is no significant difference between CABG and stenting, because if there is no significant difference in outcomes, patients might opt for stenting because it's a much less invasive procedure."

Waksman views the diabetic data differently, pointing out that it is a "bizarre" finding that serves as an example of the "deficiencies" of registry-derived data and the potential pitfalls they produce. "You need to look for things that seem to contradict prior literature, and in this case, the diabetes results are very disturbing."

Kaul had other observations about the results, noting that the absolute risk differences between the two groups are relatively modest, ranging from 1.3% for death to 2.4% for death/MI in the patients with three-vessel disease and from 1.4% for death to 2.0% for death/MI in patients with two-vessel disease. That said, "it is quite likely that larger differences would be evident at longer follow-up, because treatment benefits with CABG take longer to materialize and the risk of late stent thrombosis associated with DES begins to emerge after one to two years," Kaul points out.

Another point to keep in mind is the lack of data regarding the completeness of revascularization for both CABG, in terms of grafts, and PCI, in terms of number of stents used, Kaul noted, and the lack of information on use of dual antiplatelet therapy. An accompanying editorial by Dr Joseph P Carrozza (Harvard Medical School, Boston, MA) points out that Hannan et al's study preceded awareness of the need for extended duration of dual antiplatelet therapy: shorter-term antiplatelet drug use might have driven up deaths in the DES-treated patients, Carrozza notes [2].

"That's something we don't have information for, and something that needs to be investigated," Hannan conceded. As to the issue of complete vs incomplete revascularization, Hannan said that this is an issue his group is actively investigating, and a paper addressing this topic is currently under review for publication. Patients with multivessel disease who receive only one stent will have worse results than patients who receive stents for all occluded segments, he explained: DES results would likely be stronger if only patients with "complete revascularization" are compared with CABG-treated patients.

Everyone who spoke with heartwire agreed that the best answers will come from randomized controlled trials, although Hannan pointed out that registries will always play a role, given that randomized trials can never enroll enough patients to provide insights into specific subgroups. Hannan also believes the information is relevant now in the ongoing debate over how to restructure current hospitals, whereby patients who undergo diagnostic catheterizations and are diagnosed with significant occlusions are treated in the same session by PCI. Increasingly, surgeons and noninterventional cardiologists have been calling for the need to "stop the train."

Guyton could not agree more. "These results bring home again the need for full discussion with the patient of outcomes and options prior to coronary revascularization," he told heartwire. "In the case of multivessel disease, the patient should not have a cath and then proceed to PCI while sedated on the cath table. Some patients would choose PCI despite the 22% to 35% relative higher mortality with DES compared with CABG in 18 months shown in this study, but many would not. The patient needs to make the choice with as much information as we can provide."

The New York State Department of Health supported this study. One of the study authors has received consulting fees from Sanofi-Aventis and Astellas Pharma and receiving lecture fees from Sanofi-Aventis. The other study authors have disclosed no relevant financial relationships. Dr. Carrozza has disclosed no relevant financial relationships.

Sources

1. Hannan EL, Chuntao W, Walford G, et al. Drug-eluting stents vs coronary artery bypass grafting in multivessel coronary disease. N Engl J Med. 2008;358:331-341.
2. Carrozza JP. Drug-eluting stents: Pushing the envelope beyond the labels? N Engl J Med. 2008;358:405-407.

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