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Stents: Same Outcomes, Less Money Than Surgery for Many Heart Patients

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Drug-eluting stent and open heart coronary artery bypass grafting
Drug-eluting stent and open heart
coronary artery bypass grafting
   

March 28, 2009 -- Orlando, Florida -- For many patients with triple-vessel or left main disease, drug-eluting stents provide similar outcomes to bypass surgery -- and for less money, according to data from the SYNTAX trial, presented this morning to the i2 Summit at the American College of Cardiology’s 58th annual scientific session.

For patients with the most severe level of disease, coronary artery bypass graft (CABG) surgery remains the standard of care. But for those with straight-forward or intermediate disease, stenting provides equivalent outcomes at lower cost.

The SYNTAX Trial
The SYNTAX Trial (Synergy Between PCI With Taxus and Cardiac Surgery) was sponsored by the stent manufacturer Boston Scientific. SYNTAX enrolled 1,800 patients with multivessel and/or left main disease. Patients were randomized: half went to surgery (CABG); half were treated with Percutaneous Coronary Intervention, or PCI, using Taxus drug-eluting stents. Initial reports were made at the 2008 European Congress of Cardiology and TCT meetings, and SYNTAX was published on March 5, 2009 in the New England Journal of Medicine. The results, measured at one year, showed that bypass surgery had a lower rate of Major Adverse Cardiac Events (MACE) than stenting. MACE is defined as death, heart attack, stroke or revascularization -- a repeat procedure for opening up blocked vessels. In the case of stents, the higher MACE rates were driven primarily by the need for repeat procedures -- 13.5% for stents vs. 5.9% for surgery -- although the stroke rate during surgery was four times higher than for PCI (2.2% vs. 0.6%). Interestingly, when revascularization was excluded as part of the measure, there was no difference between the outcomes of stenting and surgery,

Comparative Effectiveness Research
Commenting on this aspect of the SYNTAX Trial, during a New England Journal of Medicine Roundtable, Dr. Elizabeth Nabel, Director of the National Heart, Lung, and Blood Institute (NHLBI) said:

"The trial design actually stacked the cards against PCI intervention by combining both the hard end points (death, MI and stroke) and the soft end point (the need for revascularization) into a combined primary endpoint. In other words, the device manufacturer in some ways stacked the cards against themselves.

"But the second important point is that this study is an example of Comparative Effectiveness Research which is receiving a lot of attention in Washington DC these days. Comparative Effectiveness Research is a rigorous evaluation of two different types of treatments...towards the same medical condition. And it evaluates the effectiveness of both those approaches. I think the industry is to be congratulated for conducting this type of heads-on comparison in the manner in which they did."

    Angioplasty.Org Image
Elizabeth Nabel, MD

Dr. Nabel continued: "It may be that what we're coming down to is a discussion between the patient and the medical and surgical team, really focusing on patient preferences, complexity of coronary anatomy and potential risks and benefits, depending upon their medical state and their co-morbidities."

Stents and Surgery: Similar Quality of Life
This morning's presentation at the ACC added quality of life and economic data to the original SYNTAX equation. Researchers found that both stenting and CABG improved the overall quality of life over one year of follow-up. Although chest pain (angina) relief was slightly better with CABG in some cases, the stented patients reported feeling better overall and, in the two month period following the procedure, stents patients recovered their quality of life far more quickly. In the end, at one-year, the results for both arms of the trial coincided with no significant difference.

Stents More Cost-Effective in Intermediate and Lower Risk Patients
One of the major contributions of the SYNTAX Trial has been the development of a sophisticated SYNTAX score for patients with multivessel disease, which measures their risk and therefore informs both patients and physicians as to whether stenting or surgery may be the better option. Dr. Cohen's presentation broke down the costs of the treatment according to low, medium and high risk patients and found that, for low risk patients, stenting initially cost about $6,000 less than surgery, which reflected the higher hospital costs and much higher physician fees for surgery. For medium risk patients, the difference was about $4,000. However, PCI added approximately $2,500 in follow-up costs over the next year, mostly because of additional heart procedures and the need for long-term anti-clotting medication. In the highest risk patients, those with the most complex anatomy and most diffuse disease, the costs between surgery and stenting were not statistically different.

No "One Size Fits All"
The presenter, Dr. David J. Cohen, director of cardiovascular research at Saint-Luke’s Mid America Heart Institute and a professor of medicine at the University of Missouri, stated:

“The data on quality of life will be helpful to physicians and patients as they consider an appropriate course of treatment. Long-term results will be essential to providing more definitive guidelines for treating these complex coronary patients, and five-year follow up is planned for all patients in the SYNTAX trial.

"The most important message is that there is no single answer. The relative cost-effectiveness of PCI and CABG for left main and three-vessel disease depends strongly on the complexity of underlying coronary disease."

Cost-Effectiveness A Moving Target
Dr. Cohen also pointed out that the cost-effectiveness data was based on the U.S. healthcare system and these conclusions may be different in other countries. Additionally, as the cost for long-term antiplatelet therapy is reduced (for example when Plavix, the brand-name of clopidogrel, goes out of patent protection) the cost-effectiveness of stenting will increase.

As with all trials, the results can be a moving target. While bypass surgery is a mature procedure and probably will not change appreciably, newer stents, such as the XIENCE/PROMUS have already come on the market since SYNTAX was done, and they may reduce the revascularization rate even further.

Realization of a 30 Year Dream
When Andreas Gruentzig first invented coronary angioplasty, using only balloons, he thought perhaps a modest 5-10% of patients could be helped by his procedure. He hoped for the day when angioplasty could compete with surgery, offering patients a less invasive treatment and, to that end, instituted rigorous registries and began the first angioplasty vs. surgery comparison trial in the mid-80's. The vast improvement both in equipment and the practice of interventional cardiology has now expanded non-surgical treatment of coronary artery disease further.

Dr. Ted Feldman, Past President of the SCAI and Director of the Cardiac Catheterization Laboratory at Evanston Hospital (Chicago, Ill.) summed it up:

"We were all excited to see the SYNTAX trial clinical results, demonstrating that many patients with left main and three-vessel coronary disease could be offered stents when their only option in the past was bypass surgery. The comparable death and heart attack rates for stents and surgery, and the lower stroke rate for stents, clearly demonstrate the safety of the less invasive alternative. To see now that this can be done with less cost and equivalent or better quality-of-life measures in many patients is a powerful finding."

    Ted Feldman, MD
Ted Feldman, MD

 

Reported by Burt Cohen, March 28, 2009