Healthcare Industry News: drug-eluting stent
News Release - September 1, 2008
SCAI: SYNTAX Data Show PCI Is a Good Option for Patients With Complex Coronary Artery DiseaseOne-Year Data Find Angioplasty and Stenting Safe and Effective in Patients for Whom Standard Therapy Has Been Open-Heart Surgery
WASHINGTON, September 1 (HSMN NewsFeed) -- Data announced today from the landmark SYNTAX trial indicate that patients with very complex coronary artery disease can safely choose to be treated with angioplasty and drug-eluting stents rather than open-heart surgery, says The Society for Cardiovascular Angiography and Interventions (SCAI). The one-year results of SYNTAX also show that most patients with left main and multi-vessel disease who undergo angioplasty and stenting will not need a second revascularization procedure in the first year.
Until this morning's announcement at the European Society of Cardiology Congress (Munich, Germany), patients with advanced and anatomically complex coronary artery disease were advised to undergo open-heart bypass surgery. The SYNTAX (SYNergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) study found that the less-invasive option of percutaneous coronary intervention (PCI) with drug-eluting stents had rates of heart attack and death no different from bypass surgery after one year.
"Starting today, I can tell my patients with left main and multi-vessel disease that angioplasty and drug-eluting stents are just as safe for them as surgery in terms of death or heart attack," says Dr. Ted Feldman, SCAI Past President, Professor of Medicine at Northwestern University School of Medicine, Director of the Cardiac Catheterization Laboratory at Evanston Hospital (Chicago, IL), and SYNTAX Steering Committee member. "The SYNTAX results are good news for patients and physicians because we now have another treatment option for the most complex patients. PCI is less invasive than surgery, and it takes days, not weeks, to recover from."
The results of SYNTAX have been eagerly anticipated because the study is the first randomized comparison of PCI with drug-eluting stents vs. bypass surgery in patients with the most complex coronary artery disease -- left main stenosis and three-vessel disease. Today's presentation revealed findings for the primary endpoint, focusing on the safety and effectiveness of the two therapies and whether either group experienced more heart attack, stroke, or death, or was more likely to require repeat revascularization procedures (either a second PCI or bypass surgery) by the end of the first year.
In its head-to-head comparison of PCI vs. bypass surgery, SYNTAX found no statistically significant difference in risk of death (4.3% vs. 3.5%, respectively; p=0.37) or heart attack (4.8% vs. 3.2%, respectively, p=0.11). The risk of stroke was significantly greater for bypass surgery (0.6% for PCI vs. 2.2% for bypass; p=0.003). Taken together as a composite, these three data points (death, heart attack, and stroke) show that PCI and bypass surgery stack up overall as equally safe options for patients with left main and multi-vessel coronary artery disease.
Less than 8% more PCI than bypass patients underwent either a second angioplasty procedure or bypass surgery by the end of the year following their procedure. "Historically speaking, this is remarkable," says Dr. Feldman. "It means that more than 85% of patients can choose the less-invasive angioplasty / stenting option and won't need another procedure a year later. On the revascularization question, we've never seen such a small difference between PCI and bypass surgery, even in less complex patients."
SCAI urges all patients and their physicians to consider the broad spectrum of care for treatment of cardiovascular disease, stressing that no single therapy is best for every patient. "All patients need to talk with their doctors about the best options for them as individuals, considering the status of their health and their desired outcomes for quality of life," says Dr. Ziyad M. Hijazi, SCAI President, Director of the Rush Center for Congenital & Structural Heart Disease, Section Chief of Pediatric Cardiology, and Professor of Pediatrics & Internal Medicine at Rush University Medical Center (Chicago, IL).
"The take-away message is that SYNTAX has extended the spectrum of care for a large number of patients with very complex coronary artery disease. For some, bypass surgery will still be the most appropriate option, but many more patients now have another choice," says Dr. Feldman.
Headquartered in Washington, D.C., The Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in more than 60 countries. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty. SCAI's new patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.seconds-count.org.
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