• SCAI Statement and Quotes – Health-Related Quality of Life and U.S. Economic Outcomes of PCI with Drug-Eluting Stents vs. Bypass Surgery: One-Year Results from the SYNTAX Trial

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    The one-year findings on health-related quality of life and U.S. economic indicators from the SYNTAX (SYNergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) trial found that,at one year, percutaneous coronary intervention (PCI) cost significantly less than open-heart surgery and delivered equivalent or greater improvement in quality-of-life indices for many patients with left main and multi-vessel disease.

    This new information reinforces the clinical value and the cost-effectiveness of angioplasty with drug-eluting stents as an option for patients with left main and multi-vessel cardiovascular disease, and will help guide treatment decisions for complex heart disease.

    Before drug-eluting stents became available, open-heart surgery was generally considered the best option for most patients with left main and multi-vessel cardiac disease. SYNTAX, the first large randomized comparison of PCI with drug-eluting stents vs. bypass surgery in patients with left main stenosis and multi-vessel disease, has yielded evidence indicating that PCI is a good option for many patients for multiple reasons:

    • PCI was found to be safe and effective for SYNTAX patients one year after their initial procedure. PCI patients were no more likely than bypass patients to die or suffer a heart attack, and they were significantly less likely to suffer stroke. PCI did result in a greater number of repeat revascularization procedures compared to bypass surgery. (NEJM, Feb. 18, 2009)
    • PCI delivered the same or greater improvement in most quality-of-life measures as bypass surgery for many patients studied to 12 months. At one year, bypass patients had slightly less angina than PCI patients. (Presentation at the American College of Cardiology i2 Summit, March 28, 2009)
    • On average, PCI cost less than bypass surgery for U.S. patients enrolled in SYNTAX. Average cost savings was as high as $3590 for many of the patients and $467 for patients with the most complex and severe disease. The severity of disease was assessed on angiographic criteria resulting in a scoring system known as SYNTAX score. Patients were grouped in three tertile groups of low, moderate, or high scores, with the highest score for the most complex patients. Cost calculations accounted for the initial procedure through one-year follow-up, including initial hospitalization, repeat procedures, physician fees, rehabilitation, and medications. The cost savings with PCI occurred despite the fact that patients enrolled in SYNTAX required an average of 4.6 stents per case to treat severe and often diffuse disease. (Presentation at the American College of Cardiology i2 Summit, March 28, 2009

    The take-home message for patients: Angioplasty with stenting is a safe, effective, and less invasive treatment option for many who have left main or multi-vessel heart disease. For many patients, PCI delivers equal or better quality of life at various time points studied and at less cost compared to bypass surgery, as assessed by SYNTAX through one year. As with every medical treatment, there are both benefits and risks to consider with both options. Patients should discuss both the risks and benefits of all of their treatment options with their doctor, and treatment should be individualized to each patient.

    The Society for Cardiovascular Angiography and Interventions also seeks to make physicians aware of the SYNTAX score as a new tool to help guide treatment recommendations for patients who are candidates for either PCI or bypass surgery. Each patient’s angiogram and SYNTAX score should be fully evaluated to decide if blockages are of low, moderate, or high complexity. As the complexity increased, the cost savings of PCI declined but were still present.

    Patients with SYNTAX scores, as assessed by angiography, in the low (0-22) to mid-range (23-32) can be more cost-effectively treated with PCI, while patients with high SYNTAX scores (33 and up) are typically better candidates for bypass surgery. PCI’s impact on quality of life was greater in patients with low- to mid-range SYNTAX scores, while bypass surgery yielded slightly greater quality-of-life outcomes for patients with high SYNTAX scores.

    The Society for Cardiovascular Angiography and Interventions emphasizes that, despite the cost-effectiveness analysis reflected in the SYNTAX score, the individual patient’s safety, health, and quality of life should always be the first priorities in decision making about healthcare options.

    Quotes from SCAI:

    The following quotes are from SCAI leaders, who are available for interview. Please call 717-422-1181 or email: kbdavid@scai.org

    “The data from SYNTAX are important because they help us examine the clinical effectiveness and cost effectiveness that PCI can deliver for patients who are at the greatest risk and who suffer the worst symptoms from their underlying heart disease. This trial offers a strong indication that PCI is an excellent option for patients with left main or multi-vessel coronary disease, although we need to make sure the results continue beyond one year,” said Mark Turco, MD, FSCAI, an SCAI Trustee and Director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Md.

    “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,” said Ted Feldman, MD, FSCAI, SCAI Past President, Director of the Cardiac Catheterization Laboratory at Evanston Hospital (Chicago, Ill.), and SYNTAX Steering Committee member.

    “Given the financial strain on the healthcare system, it is good to be able to closely examine where the dollars are adding up so we can make improvements. For example, as innovation continues and stents continue to improve, we may see a decreasing need for repeat procedures and a reduction in the need for medications after PCI. That would help us to reduce PCI costs even further,” said Mark Turco, MD, FSCAI, an SCAI Trustee and Director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Md.

    “SYNTAX is an example of comparative effectiveness research that is on the right track. The patients who are enrolled could be an appropriate match for either therapy, the clinical outcomes are carefully defined and able to be examined individually or as composites, and the findings, if replicated in the longer term, give us more information to guide our treatment decisions,” said Mark Turco, MD, FSCAI, an SCAI Trustee and Director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Md. “Cardiac intervention requires looking at improved health and safety as well as cost. Individual endpoints must be applied to each patient. Ultimately, that’s what SCAI and the Interventional Cardiology community are looking for from comparative effectiveness research.”

    About SCAI

    SCAI is a professional medical society representing invasive and interventional cardiologists whose mission is to promote excellence in this specialty through physician education and advancement of quality standards to enhance patient care. For more information:  www.scai.org or www.seconds-count.org


    Kathy Boyd David
    717-422-1181 or kbdavid@scai.org