Cardiovascular Business - January/February 2009 - (Page 19)

Diabetics Do Well with Surgery vs. Balloon Angioplasty CABG Percentage of Patients 100– 75– 50– 25– 0– 82.7 84.4 PCI Percentage of Patients 100– 75– 50– 25– 0– 84 86.4 86.8 CABG PCI 79.3 80.9 82.6 EAST BARI EAST BARI Long-term survival (at least five years follow-up) of diabetics with multivessel disease (left chart) shows they fared better with bypass surgery than balloon angioplasty in the emory angioplasty vs. surgery trial (east) and the Bypass angioplasty Revascularization investigation (BaRi). in the nondiabetic group, the difference between the two treatment strategies was negligible. studies are underway to compare drug-eluting stents with bypass surgery in this patient population. source: Journal of invasive Cardiology for an answer on the long-term clinical outcomes and cost-effectiveness of stenting diabetic patients with multivessel disease. “We perhaps have enough evidence to know that stenting is associated with more overall revascularization,” says Mehran. “Yet, we are confident that death and MI—those hard endpoints—are equivalent between DES and surgery.” As a result, patients might initially prefer a percutaneous approach to surgery, but “we can’t make that recommendation without concrete clinical evidence, which we will not have until we get the results from the FREEDOM trial.” quality-of-life metrics and cost-effectiveness at three years. The researchers have examined previous trials to assess the proper approach for FREEDOM. In the SYNTAX trial, for example, investigators looked at revascularization rates in the small diabetic subpopulation,” but this is not a hard outcome,” Farkouh says. SYNTAX also evaluated patients up to 12 months, and “death in this diabetic population usually occurs later, which is why FREEDOM is following its patients out to five years,” he notes. FREEDOM Trial The NIH-sponsored FREEDOM trial is an international, multicenter, open-label prospective randomized superiority trial of PCI versus CABG in approximately 2,000 diabetic patients in whom revascularization is indicated. Diabetic patients with multivessel disease will be randomized on a one-to-one basis to either CABG or multivessel stenting (two or more vessels) using DES and observed at 30 days, one year and annually for up to five years. The trial is currently 75 percent enrolled. “This trial also is testing very aggressive medical therapy in both arms of the study,” says Michael Farkouh, MD, a cardiologist at Mount Sinai School of Medicine in New York City, and co-principal investigator of FREEDOM. Based on the AHA/American Diabetes Association recommendations, the researchers are seeking to achieve a hemoglobin A1c level of less than 7 percent, blood pressure control of 130 over 80 and LDL cholesterol of less than 70 mg/dL. The primary endpoints are death, non-fatal MI and non-fatal stroke at three years. The secondary endpoints will involve Interim clinical practice While awaiting the outcome of FREEDOM and other more definitive trials, “it will be important for physicians to carefully weigh the previous evidence favoring bypass surgery for patients with diabetes and extensive multivessel disease before concluding that drug-eluting stenting has completely altered the prudent choice,” Spencer B. King, III, MD, Columbia University Medical Center, Center for Interventional Vascular Therapy in New York City, wrote in a Circulation editorial (2005;112:1500-1515). Williams concurs that while current and previous clinical evidence supports stenting diabetic patients with multivessel disease with DES, it is best to judge each case on an individual basis. Farkouh agrees with Williams, but adds that in patients with three-vessel disease and aggressive diabetes, the evidence points to CABG as the preferred method of revascularization. “If a diabetic patient with multivessel disease is elective, we should spend the four to six weeks to get their medical risk factors under better control through medical management. If a physician doesn’t have that time because the patient’s risk factors are out of control, I don’t see how PCI is the preferred route—in this CardiovascularBusiness.com Cardiovascular Business 19 http://www.CardiovascularBusiness.com

Table of Contents Feed for the Digital Edition of Cardiovascular Business - January/February 2009

Cardiovascular Business - January/February 2009 Contents First Word Electrophysiology Roundtable Forum: A Candid Conversation about Profits, Procedures and Patients Heart Failure Care Gets Boost from Technology Emerging Technologies in Peripheral Vascular Interventions Stent vs. Graft: Choosing the Best Path for the Diabetic Patient with Multivessel Disease Cardiology Groups and Hospitals Strive to ‘Connect’ Seamlessly CT Beyond 64 Slices Clinical Study Digest: Kidney Disease & PCI; Women and Valve Disease Compact Echo Systems Come Up Big in Cardiac Care News & Views Reader Resources The ACC Corner

Cardiovascular Business - January/February 2009

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