JACC Identifies DEFER With 5 Year Outcomes As Landmark Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices;  Clinical Trials / Drug Trials
Article Date: 09 Mar 2008 - 0:00 PDT

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The Journal of the American College of Cardiology has recognized the five year follow up results of the DEFER (Deferral Versus Performance of PTCA in Patients Without Documented Ischemia) as one of the studies that had the greatest impact on cardiology in 2007, according to an article entitled "Highlights of the Year in JACC" by Anthony N. DeMaria, MD, et al. (JACC Vol. 51, No. 4, 2008 January 29, 2008:490-512)

Initially published in the May 29, 2007, issue of the peer-reviewed journal, DEFER concluded that patients treated based on fractional flow reserve (FFR) results had achieved long-term outcomes equal, or superior, to patients who underwent stenting solely based on angiographic evidence. The study's investigators measured FFR using PressureWire(R), a diagnostic tool developed by Radi Medical Systems AB.

Dr. Nico Pijls, the study's principal investigator, said, "From the DEFER study and other recent publications, it has become clear that the key issue in deciding which lesions should be stented is knowledge about whether a stenosis is responsible for ischemia. We are glad that JACC has recognized this study that demonstrates the importance of FFR and its role in interventional cardiology."

FFR expresses maximum achievable blood flow in a coronary artery with abnormal stenosis as a fraction of maximum blood flow in the absence of a stenosis. FFR is 100% specific in identifying which lesions are actually causing the flow restriction and may be treated.

"The DEFER data was, and continues to be, an important topic of discussion among cardiologists," said Jim Archetto, Chief Operating Officer of Radi Medical Systems, Inc. "There is a lot of uncertainty in interventional cardiology when it comes to determining whether or not a stent is necessary. Measuring FFR is the only way physicians can determine with precision that a suspect lesion requires treatment."

As an adjunct to DEFER, authors have designed a new 1000 patient study, Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) (American Heart Journal Volume 154, Number 4). The objective of this groundbreaking, multicenter, randomized clinical trial is to compare angiographic guidance versus fractional flow reserve (FFR) to determine which coronary lesions to stent in patients with multivessel coronary disease.

The primary end point of the study is a composite of major adverse cardiac events, including death, myocardial infarction, and repeat coronary revascularization, at 1 year.

About Radi Medical Systems AB

Radi Medical Systems AB (Radi) develops, manufactures and sells medical devices designed to improve patient care. The company's pioneering work in the field of interventional cardiology has resulted in market-leading intravascular sensors and hemostasis management and radiology devices. Radi works closely with medical practitioners to develop solutions that address clinical needs, as well as provide clinical education support. Founded in 1988, Radi employs more than 350 people globally and has representation in more than 40 countries. The company is based in Uppsala, Sweden, and maintains a U.S. headquarters in Wilmington, Mass. For more information, visit http://www.radi.se.

Radi Medical Systems AB
http://www.radi.se