Feature | April 06, 2011

Trial Results Show Positive Performance for Everolimus-Eluting Stent

April 6, 2011 – A pooled analysis of the SPIRIT II, III, IV and COMPARE trials further reinforces the positive clinical performance of an everolimus eluting coronary stent system. As part of the analysis, two-year results on the safety and efficacy of Abbott’s Xience V was compared to Taxus Liberte and Taxus Express2 paclitaxel-eluting coronary stent systems were presented at the American College of Cardiology's (ACC) Scientific Session in New Orleans.

In a presentation given by Dean J. Kereiakes, M.D., medical director of The Christ Hospital Heart and Vascular Center in Cincinnati, Ohio, predictors of artery re-blockage, cardiac death or heart attack were evaluated out to two years in nearly 7,000 patients from the SPIRIT II, III, IV and COMPARE clinical trials.

The data demonstrated that use of Xience V resulted in significantly lower clinical event rates following a stent procedure. In the pooled analysis, it demonstrated a 36 percent reduction in the risk of major adverse cardiac events (MACE) compared to Taxus (7.3 percent for Xience V versus 11.1 percent for Taxus, p-value

"Xience V consistently demonstrated low adverse cardiac event rates in trial after trial," said Kereiakes. "The SPIRIT II, III, IV, and COMPARE pooled analysis suggests that Xience V reduced the occurrence of adverse events compared to patients treated with the Taxus stent. The low event rates demonstrated by Xience V in these trials are especially impressive given the complexity of patients in the SPIRIT IV and COMPARE trials and confirm that the results seen with Xience V in earlier randomized clinical trials are consistent with clinical practice."

In addition to the 36 percent reduction in the risk of overall MACE, data also were presented at ACC from the pooled analysis that demonstrated the following for Xience V:

• A 47 percent reduction in the risk of heart attack (2.9 percent for Xience V versus 5.5 percent for Taxus, p-value

• A 40 percent reduction in the risk of cardiac death or heart attack (4.0 percent for Xience V versus 6.6 percent for Taxus, p-value

• A 36 percent reduction in the risk of ID-TLR (4.1 percent for Xience versus 6.6 percent for Taxus, p-value

• A 70 percent reduction in the risk of stent thrombosis, defined as definite or probable according to ARC (Academic Research Consortium) (0.7 percent for Xience V vs. 2.3 percent for Taxus, p-value

"The pooled analysis of the SPIRIT II, III, IV and COMPARE trials further supports the strong body of clinical evidence that has made Xience V a leading drug eluting stent technology for patients and physicians," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "Xience V's long-term clinical performance is backed by clinical data from more than 30,000 patients worldwide."

The SPIRIT trials were sponsored and conducted by Abbott. SPIRIT IV included 3,690 patients, many of whom presented with multiple medical complexities, including more than 1,100 patients with diabetes, and patients with small vessels, long lesions, and multiple lesions. The COMPARE study was a physician-initiated trial involving 1,800 patients with complex vascular disease. This pooled analysis was performed independently of Abbott. Taxus Liberte was the control in COMPARE and Taxus Express2 was the control in SPIRIT II, SPIRIT III and SPIRIT IV.

For more information: www.abbott.com, www.xiencev.com

Related Content

common adult CT examinations, computed tomography, diagnostic reference levels, DRLs, radiation dose, achievable dose, AD
News | Radiation Dose Management| February 23, 2017
Using data from the world’s largest computed tomography (CT) dose index registry, researchers have established national...
News | Cardiac Diagnostics| February 17, 2017
Levels of a protein in the blood associated with heart disease are also linked to early-stage brain damage, according...
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Arterial Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Medtronic, IDE approval, IN.PACT Admiral drug-coated balloon, DCB, end-stage renal disease
News | Drug-Eluting Balloons| February 08, 2017
Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices| February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Penn Medicine, heart failure causes, YAP and TAZ proteins, Journal of Clinical Investigation study
News | Heart Failure| February 07, 2017
February 7, 2017 — Of the more than 700,000 Americans who suffer a heart attack each year, about a quarter go on to d
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices| February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Texas Heart Institute, ischemic heart failure, adult stem cell therapy, CONCERT-HF clinical trial
News | Stem Cell Therapies| February 03, 2017
Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to...
Ohio State, Wexner Medical Center, keeping human hearts alive, track abnormal beats, reanimate, Vadim Fedorov

Part of a donated human heart is reanimated and recorded with four high-definition optic cameras in a laboratory at The Ohio State University Wexner Medical Center. Researchers keep the heart tissue alive to look for the causes of irregular heartbeats in cases of persistent atrial fibrillation. Image courtesy of The Ohio State University Wexner Medical Center.

News | EP Lab| February 01, 2017
Researchers have developed a technique that allows them to revive parts of human hearts in the laboratory for up to 12...
CT, computed tomography, IV contrast media, acute kidney injury risk, Annals of Emergency Medicine study

A new study in Annals of Emergency Medicine finds no association between intravenous contrast media used in computed tomography (CT) and kidney damage. Roughly 80 million doses of IV contrast media are given every year. Credit: American College of Emergency Physicians

News | Contrast Media| January 30, 2017
Intravenous contrast media (typically iohexol or iodixanol) used in computed tomography (CT) does not appear to be...
Overlay Init