Navigation Links
Patient Enrollment Complete in First Trial to Compare Physiologic Guidance vs. Angiographic Guidance of Stent Deployment in Patients with Multivessel Disease
Date:10/22/2007

WASHINGTON, Oct. 22 /PRNewswire/ -- Patient enrollment is complete in the first randomized, prospective, multicenter trial that will compare the clinical outcomes and cost-effectiveness of a physiologic-guided percutaneous coronary intervention (PCI) strategy to an angiographic-guided one in patients with multivessel coronary artery disease (CAD). Bernard De Bruyne, M.D., Ph.D., presented the study update today at the Transcatheter Cardiovascular Therapeutics symposium (TCT 2007) in Washington.

One thousand patients at 20 centers worldwide are participating in the FAME (Fractional flow reserve vs. Angiography for Multivessel Evaluation) study. Participants enrolled in the study meet the following criteria:

-- Coronary lesions in at least two of the three major cardiac vessels

have narrowings of greater than or equal to 50 percent by visual

assessment.

-- The lesions require stenting, according to the investigator.

-- The vessels are large enough to accommodate drug-eluting stents.

After an investigator's visual assessment of an angiogram and notation of which lesions appear to require stenting, patients will be assigned randomly to one of the two PCI strategies. Patients assigned to angiographic guidance will undergo stenting as planned, while patients assigned to physiologic guidance will have fractional flow reserve (FFR) measured in diseased vessels with a coronary pressure wire using a system provided by Radi Medical Systems AB. If FFR is less than or equal to 0.80, meaning the coronary pressure or flow beyond the narrowing is less than or equal to 80% of what it should be, the lesion will be stented.

The study's primary endpoint is a composite of major adverse cardiac events (MACE), including death, myocardial infarction and repeat coronary revascularization at one year. Secondary endpoints include global cost effectiveness after one year, cardiac death and myocardial infarction rate at one year, functional class at one year, number of anti-anginal drugs after one year, overall MACE rate at one month post-procedure and at six months, two, three and five years.

"With drug-eluting stents (DES) and lower restenosis rates, interventional cardiologists are performing PCI more often in patients with increasingly complex CAD, including multivessel disease," said Dr. De Bruyne. "Furthermore, some physicians are stenting all intermediate lesions with DES regardless of the physiologic significance of those lesions. DES are expensive and have been associated with potential late complications. Therefore, the objective of FAME is to help us identify an approach to PCI that will improve overall clinical outcomes and reduce healthcare expenditure."

In addition to Dr. De Bruyne, the FAME study's investigators are represented by Nico H. J. Pijls, M.D., Ph.D.; Pim Tonino, M.D.; Uwe Siebert, M.D., M.Sc., M.P.H., Sc.D.; and William Fearon, M.D. A paper outlining the rationale and design of the trial is published in the October issue of American Heart Journal (American Heart Journal Vol.154, No. 4, pp.632-636). For more information about the FAME study, visit http://clinicaltrials.gov/ct/gui/show/NCT00267774?order=17 .

Media Contacts:

David Schull or Benjamin Carmichael

Russo Partners

+1 212-845-4271

+1 858-717-2310 (during TCT 2007)

david.schull@russopartnersllc.com

benjamin.carmichael@russopartnersllc.com


'/>"/>
SOURCE Radi Medical Systems AB
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Monitoring Patient Glucose Levels: New Advances in software make it easier
2. Managing Preanalytical Processes for Patient Safety
3. Hematology Analyzers Simple, Sophisticated Technology Serving All Patients
4. Near-Patient Testing: The Advantages of C-Reactive Protein in Hematological Testing
5. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
6. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
7. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
10. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , Feb. 23, 2017 Report analyzes the ... provides separate comprehensive analytics for the US, Canada ... , Asia-Pacific , Latin ... forecasts are provided for the period 2015 through 2022. Also, ... data and analytics are derived from primary and secondary research. ...
(Date:2/24/2017)... Feb. 23, 2017 Non-alcoholic steatohepataitis ... the various drugs being developed for the ... the drugs that are in various phases ... pipeline focuses on novel pharmacologic drugs & ... cell therapies, recombinant proteins and RNA-based therapeutics, ...
(Date:2/23/2017)... BOSTON , Feb. 23, 2017 ... devices and services since 1997, is changing the ... modern technology providing patients with pro-active, custom-made solutions. ... desire for instant and affordable healthcare without walls, ... of high-level devices developed with healthcare professionals that ...
Breaking Medicine Technology:
(Date:2/27/2017)... , ... February 27, 2017 , ... New Jersey ranks ... among all types and genders. And the need for advanced services is growing. ... its top-rated cancer care program, in collaboration with their non-profit partners in their fight ...
(Date:2/26/2017)... ... February 26, 2017 , ... LatitudeC Baby Products, ... today announced it would be offering some it’s exclusive product line to the ... quality and unique baby clothing/feeding products, will team up with AMAZON to distribute ...
(Date:2/26/2017)... ... February 26, 2017 , ... ... in persons with a specific LRRK2 mutation, according to a study released today ... have provided evidence of a link between pesticides and incidence of sporadic PD ...
(Date:2/24/2017)... ... 2017 , ... WHAT: , The New Jersey Tech Council, ... as advocacy for the state and region‘s technology businesses, hosted their 2017 Innovation ... Innovation Forecast event highlights innovation throughout the region from small to large companies. ...
(Date:2/24/2017)... ... 2017 , ... With millions of Americans and people worldwide ... all are aware of our options and are empowered with strength and information ... of its newest edition of "Vision and Hearing" in USA Today, that will ...
Breaking Medicine News(10 mins):