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Latest DES Analysis Stresses Importance of Physicians Well-Trained in Implantation Technique and Patient Follow-Up

Monday, September 3, 2007 General News
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WASHINGTON, Sept. 2 New data about the safety of drug-eluting stents (DES) translates into excellent news for thousands of patientswith cardiovascular disease, according to The Society for CardiovascularAngiography and Interventions (SCAI). These new findings also underscore thecrucial importance of training physicians in the proper selection of patients,proper implantation technique, and in prescribing a strict regimen ofmedications that prevent blood clots in the first one to two years after DESimplantation.

Findings announced this morning from the European Society of CardiologyCongress indicate that patients treated with DES benefit from a 50 percentreduction in restenosis, the re-clogging of arteries that has plagued baremetal stents, with no increased long-term risk. This is in direct contrast tolast year's findings based on shorter-term observation of patients from thesame registry, which led to widespread concern about whether the devices causedangerous blood clots and may have dissuaded some patients and their doctorsfrom treatment with DES.

Describing the findings as "reassuring news for patients withcardiovascular disease," SCAI President Bonnie H. Weiner, M.D., FSCAI,Professor of Medicine and Interim Chair of Cardiovascular Medicine at St.Vincent Hospital at Worcester Medical Center in Worcester, MA said, "Patientsand physicians have been confused about stents, and we have been concernedthat last year's headlines may have prevented some patients from getting thebest therapy. This report is consistent with all other data on the benefits ofDES and reaffirms the value of drug-eluting stents as a highly effective toolto open blocked arteries and stop regrowth of plaque and scar tissue in thosevessels."

After tracking over 13,000 patients for up to 4 years after implantationof stents, Swedish Coronary Angiography and Angiolasty Registry (SCAAR) leadinvestigator Dr. Stefan James stated that "drug-eluting stents are notdangerous," but he pointed out that in a very small percentage of patients(0.5 percent per year) blood clots may form in these stents. This is in starkcontrast to the 50 percent decrease in repeat artery narrowing in DES comparedto in that in bare metal stents.

"The SCAAR data represent 'real-world' outcomes that show how Swedishdoctors' technique improved over time because of more experience implantingdrug-eluting stents resulting in improved outcomes for patients," says SCAISecretary Steven R. Bailey, M.D., FSCAI, Interim Chief of the Division ofCardiology, Professor of Medicine and Radiology, and Janey BriscoeDistinguished Chair at the University of Texas Health Sciences Center at SanAntonio. "Our patients can be reassured by these findings. If theirinterventional cardiologist chooses to implant a drug-eluting stent, they arereceiving a safe and effective treatment."

To explain the new findings, Dr. Weiner points to indications thatphysicians' technique with the stents has improved and stent patients are nowmore likely to be on strict regimens of anti-clotting medications for a longerperiod. SCAI reemphasizes the need for high-quality education and trainingthat will guide physicians in evaluating the benefits and risks of DES foreach patient, depending on his or her age, gender, co-morbid conditions, andcomplexity of disease.

In addition, both physicians and patients need further education on theimportance of a strict regimen of both clopidogrel and aspirin, two drugs thathelp prevent the formation of blood clots. SCAI, a leader in physicianeducation, urges doctors to review the Clinical Alert the Society issued inearly 2007(http://www.scai.org/pdf/DES%20clinical%20alert%20in%20CCI%20Feb07.pdf), whichstresses that physicians must take care to use DES in the right patients andthe right blood vessels, and only if the patient is willing and able to complyto a long-term regimen of clopidogrel and a


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