News | March 31, 2008

Registry Unveils “Real-World” Data on Novel Excel Stent

April 1, 2008 - “Real-world” use of a novel drug-eluting stent coated with a biodegradable polymer is associated with good clinical outcomes, according to one-year data from a large international registry.

Results of the CREATE study, which focused on the sirolimus-eluting Excel Stent were reported yesterday in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

For the study, Yaling Han, M.D., Shenyang Northern Hospital, Shenyang, China, and colleagues recruited a total of 2,077 patients from 59 medical centers in four countries. All had stenting with the Excel stent, a novel device with a biodegradable polymer coating. Of these, 369 (17.8 percent) underwent primary stenting within 24 hours of having a heart attack.

After stenting, all patients were prescribed both clopidogrel and aspirin for six months to inhibit the action of platelets in the blood. Anti-platelet medications prevent the development of unwanted blood clots within the stent, or stent thrombosis, a serious complication that can cause heart attack or even death. On average, patients continued to take clopidogrel for 199 days.

Twelve-month follow-up data were available for 2,060 patients (99.2 percent). After 12 months, the overall rate of major cardiovascular complications was 2.77 percent, including cardiac death in 23 patients (1.12 percent), heart attack in 8 patients (0.39 percent), and repeat coronary procedure in 32 patients (1.55 percent). Death from any cause occurred in 34 patients (1.64 percent), including 11 noncardiac deaths. Overall, thrombotic complications occurred in 16 patients (0.78 percent), including six definite cases, five probable cases and five possible cases. Of these, three thrombotic complications (0.15 percent) occurred after discontinuation of clopidogrel.

The researchers concluded that the Excel stent is associated with a low incidence of cardiovascular complications, and that six months of dual-antiplatelet therapy appears to be feasible and safe.

For more information: www.scai-acci2.org

Related Content

FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Gore Tigris Vascular Stent, Health Canada approval, PAD, peripheral artery disease
News | Stents Peripheral| March 16, 2017
W. L. Gore & Associates Inc. recently announced the Health Canada approval of the Gore Tigris Vascular Stent, a...
Sponsored Content | Videos | Stents Bifurcation| March 06, 2017
This video, provided by Tryton, demonstrates the implantation of the Tryton Side Branch Stent.
Overlay Init