Navigation Links
Investigators Report COSTAR II Pivotal Drug-Eluting Stent Trial,Results at EuroPCR 2007

BARCELONA, Spain, May 22, 2007 /PRNewswire/ -- Principal investigators for the COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial, the pivotal study for the CoStar(R) cobalt chromium paclitaxel-eluting coronary stent, presented today the clinical trial results of the study at EuroPCR 2007. The investigators confirmed that the study failed to meet its primary endpoint. Conor previously announced this conclusion in a press release on Monday, May 7, 2007.

The COSTAR II trial compared the CoStar(R) stent with the Taxus Express(2) paclitaxel drug-eluting stent, and was designed to demonstrate non-inferiority at eight-month follow-up with respect to major adverse cardiac events (MACE) in patients with multi-vessel or single-vessel disease. In this trial, MACE was defined as a composite of clinically driven target vessel revascularization (re-treatment), new myocardial infarction (heart attack or MI) related to the target vessel and cardiac death related to an intervened vessel.

At eight-month follow-up, the CoStar(R) stent had significantly higher MACE rate than the Taxus stent (11.0 percent vs. 6.9 percent; p=0.005). This difference was largely due to a significantly higher incidence of clinically driven target vessel revascularization (8.1 percent vs. 4.3 percent; p=0.002). No significant differences were found in terms of cardiac death (0.5 percent for the CoStar(R) stent vs. 0.7 percent for the Taxus stent; p=0.541) or new MI (3.4 percent vs. 2.4 percent; p=0.242).

The investigators also reported that the protocol-defined stent thrombosis rates at nine-month were similar between both arms of the study. The total stent thrombosis rate for the CoStar(R) stent was 0.6 percent vs. 0.1 percent for the Taxus stent (p=0.252).

"Comparably higher re-intervention rates are largely responsible for the outcome of this trial," said Mitchell W. Krucoff, M.D., from Duke Cli nical Research Institute in Durham, North Carolina, who presented the primary results of the study at the conference as a global co-principal investigator. "The safety data from this trial are consistent with other drug-eluting stent studies."

As a result of these outcomes, Conor Medsystems LLC recently terminated ongoing clinical trials with the CoStar(R) stent and halted the submission of its Pre-Market Approval application to the U.S. Food and Drug Administration for the product. Further, Conor Medsystems discontinued sale of the product through commercial partners in countries in Europe, Asia and Latin America where the CoStar stent was already approved.

The company cited potentially sub-optimal therapeutic dosing of paclitaxel as the potential reason why the COSTAR II Trial failed to meet its primary endpoint. Going forward, the company's clinical program will be heavily focused on the study of sirolimus on its platform, as well as on investigating the vast library of therapeutic agents accessible to its scientists through the research and development programs of pharmaceutical companies in the Johnson & Johnson family of companies.

"We remain optimistic about the ability of the novel Conor Medsystems reservoir platform to provide precise and controlled delivery of a therapeutic agent based on earlier proof of concept testing and trials," said Campbell Rogers, M.D., chief technology officer, Johnson & Johnson cardiovascular franchise. "We expect that the continued development of sirolimus on this platform will demonstrate promising outcomes because sirolimus has been shown to be a versatile and potent anti-restenosis agent with a wide therapeutic dosing range."

Sirolimus is the proven drug used with the CYPHER(R) Sirolimus-eluting Coronary Stent -- the most widely studied coronary stent in the world.

ABOUT CONOR MEDSYSTEMS

Conor Medsystems, LLC, a wholly-owned subsidiary of Johnson & Johnson, develops innova tive controlled vascular drug delivery technologies and has primarily focused on the development of drug-eluting stents to treat coronary artery disease. For further information about Conor Medsystems and controlled vascular delivery, visit http://www.conormed.com.

CONTACT: Christopher Allman, +1-305-586-6024, CAllman1@crdus.jnj.com

Web site: http://www.conormed.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
3. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
4. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
5. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
6. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
7. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
8. The International Myeloma Foundation Says Data Reported at a Global Medical Meeting in Greece Demonstrates Improved Survival for a Wide Range of Myeloma Patients
9. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
10. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
11. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... -- Clarifying Vision - Prospects and Developments ... Care What can be expected from the ... at the fastest rates? This visiongain report ... opportunities and prospects. ,Our 190-page report ... lucrative areas in the industry and the future market ...
(Date:5/23/2016)... Gamida Cell, a leader in cellular and ... genetic diseases, announced today it has been awarded a ... Innovation Authority (formerly the Office of the Chief Scientist) ... mission of the Israel Innovation Authority is to encourage ... technology, while stimulating economic growth. The non-dilutive ...
(Date:5/20/2016)... 20, 2016 ReportsnReports.com adds ... Medical Devices of its online business intelligence library. ... the current state of the Titrator industry. The ... like definitions, classifications, Specifications, applications and industry chain ... like Raw Material Suppliers, Equipment Suppliers, Manufacturing Cost ...
Breaking Medicine Technology:
(Date:5/24/2016)... ... May 24, 2016 , ... Educational opportunities, and ... with more advantaged communities providing richer opportunities. Recognizing the key role of housing ... improvement policies; (b) school choice policies; (c) school desegregation policies; (d) wealth-focused policies; ...
(Date:5/24/2016)... Freeport, Grand Bahama (PRWEB) , ... May 24, 2016 , ... ... rapid pace. Such breakthroughs in adult stem cell therapy technology, protocols and patient results ... for this emerging field to become a more accessible standard of care for patients ...
(Date:5/24/2016)... ... May 24, 2016 , ... Backed ... data logger for each job, ensuring the best suited solution to meet regulatory ... data loggers at their lab in Istanbul. , Metroloji Okulu specializes in MadgeTech’s ...
(Date:5/24/2016)... , ... May 24, 2016 , ... ... appointment of Jonathan (Jon) Otterstatter to its board of directors. Otterstatter ... proven leader in the development of technological innovations that lead to broad-based healthcare ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... WaterAid launched the #perioddrama campaign ... by more than 1 billion women around the world who do not have access to ... from across the US about their dread of #perioddrama. The (sometimes hilarious) results help shine ...
Breaking Medicine News(10 mins):