Sirolimus-releasing stents more effective than VBT for treating restenosis within a stent

March 12, 2006

David R. Holmes, Jr., M.D., of Mayo Clinic, Rochester, Minn., and colleagues with the SISR trial compared the use of vascular brachytherapy (VBT - intra-coronary radiation therapy) with implantation of the sirolimus-eluting stent for the treatment of restenosis occurring within a previously placed bare-metal stent, in a study appearing in the March 15 issue of JAMA. Data on the relative merits of each approach are limited. The study is being released early online to coincide its release with the American College of Cardiology annual conference.

The multicenter trial included 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community centers. Follow-up continued until June 2005. Patients were randomized to VBT (n = 125) or the sirolimus-eluting stent (n = 259).

Major adverse cardiac events in or out of the hospital were markedly different at 270 days (19.2 percent for the VBT group vs. 10.0 percent for the sirolimus-eluting stent group). The difference in the rate of target lesion revascularization was 19.2 percent in the VBT group vs. 8.5 percent in the sirolimus-eluting stent group. There also was a significant difference in the primary trial end point of target vessel failure (21.6 percent in the VBT group vs. 12.4 percent in the sirolimus-eluting stent group). The angiographic restenosis rate was 29.5 percent for the VBT group vs. 19.8 percent for the sirolimus-eluting stent group. Compared with the VBT group, minimal lumen diameter (size of the opening inside the vessel through which the blood flows) was larger in the sirolimus-eluting stent group at 6-month follow-up.

"In conclusion, in-stent restenosis following bare-metal stent placement remains a significant clinical problem. While vascular brachytherapy remains the only approved therapy for this condition, the results of this study indicate that the sirolimus-eluting stent is superior to vascular brachytherapy at 9 months. Angiographic measurements indicate that while both methods are effective at suppressing neointimal hyperplasia [abnormal increase in cells on vessel wall], the sirolimus-eluting stent yields greater benefits from acute gain due to the stent component of the device and from the absence of edge restenosis. This study suggests that the sirolimus-eluting stent is a safe and effective treatment for in-stent restenosis occurring within bare-metal stents," the authors write.
(JAMA. 2006;295:1264-1273. Available pre-embargo to the media at

Editor's Note: Funding for this study was provided by the Cordis Corporation (Warren, N.J.), a Johnson & Johnson Company. For the financial disclosures of the authors, please see the JAMA article.

The JAMA Network Journals

Related Mayo Clinic Articles from Brightsurf:

Mayo Clinic-led study links obesity with pancreatitis
A study by researchers at Mayo Clinic in Arizona published in the The Journal of Clinical Investigation has found that obesity is not only implicated in chronic diseases such as diabetes, but also in sudden-onset diseases such as pancreatitis.

Mayo Clinic researchers clarify how cells defend themselves from viruses
A protein known to help cells defend against infection also regulates the form and function of mitochondria, according to a new paper in Nature Communications.

Mayo Clinic study looks at changes in outcomes for coronary revascularization
The most common type of heart disease -- coronary artery disease -- affects 6.7% of adults and accounts for 20% of 2 in 10 deaths of adults under age 65.

Mayo Clinic researchers review modern cases of leprosy
Leprosy has a history that has spanned centuries and societies across the globe.

Kidney stones on the rise, Mayo Clinic study finds
Kidney stones are a painful health condition, often requiring multiple procedures at great discomfort to the patient.

Mayo Clinic researchers demonstrate value of second opinions
Many patients come to Mayo Clinic for a second opinion or diagnosis confirmation before treatment for a complex condition.

Mayo Clinic researchers clarify chemo resistance, and perhaps a new therapy
Mayo Clinic scientists have identified a specific protein implicated in drug resistance, as well as a possible therapeutic tool.

Mayo Clinic researchers identify therapy
Mayo Clinic researchers have found that an experimental drug, LCL161, stimulates the immune system, leading to tumor shrinkage in patients affected by multiple myeloma.

Mayo Clinic researchers uncover new agents
Mayo Clinic researchers have uncovered three new agents to add to the emerging repertoire of drugs that aim to delay the onset of aging by targeting senescent cells -- cells that contribute to frailty and other age-related conditions.

Mayo Clinic: Reversing physician burnout, using nine strategies to promote well-being
Researchers at Mayo Clinic have been documenting the rise and costs of physician burnout for more than a decade.

Read More: Mayo Clinic News and Mayo Clinic Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to