Late-breaking data from the SPIRIT IV trial, one of the largest randomized clinical trials between two drug eluting stents, continued to demonstrate outstanding clinical results of Abbott’s market-leading XIENCE V Everolimus Eluting Coronary Stent System versus the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS) in key areas of safety and efficacy through two years. The impressive two-year results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center and NewYork-Presbyterian Hospital, during the Cardiovascular Research Foundation’s 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
In the trial’s composite endpoint, XIENCE V demonstrated a clinically significant 30 percent risk reduction in TLF (target lesion failure) compared to TAXUS (6.9 percent for XIENCE V vs. 9.9 percent for TAXUS, p-value=0.003). TLF is a composite measure of important efficacy and safety outcomes for patients and is defined as cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (ID-TLR). XIENCE V also demonstrated a clinically significant 34 percent risk reduction in ID-TLR (repeat procedure) compared to TAXUS (4.5 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.004). ID-TLR is one of the major secondary endpoints of the SPIRIT IV trial2.
“The two-year results from SPIRIT IV show that XIENCE V significantly reduces a patient’s risk of experiencing a heart attack, stent thrombosis and the need for a repeat procedure,” said Dr. Stone, principal investigator of the SPIRIT IV trial. “These are important measures of safety that have a major impact on the lives of the millions of patients who receive a drug eluting stent every year. The positive SPIRIT IV data at two years continue to demonstrate superior safety and efficacy of the XIENCE V stent platform.”
In addition to demonstrating clinically significant results for TLF and ID-TLR, XIENCE V had an impressive low rate of stent thrombosis through two years. Per protocol definition, XIENCE V demonstrated a 70 percent risk reduction in stent thrombosis compared to TAXUS (0.33 percent for XIENCE V vs. 1.25 percent for TAXUS, p-value=0.002) through two years. Per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis, XIENCE V demonstrated a 64 percent risk reduction through two years (0.42 percent for XIENCE V and 1.23 percent for TAXUS, p-value=0.008). The ARC definitions of stent thrombosis were developed to harmonize the definition of stent thrombosis across various drug eluting stent trials.
Key Results from the SPIRIT IV Trial
In the SPIRIT IV trial of 3,690 patients, XIENCE V demonstrated the following key results at two years:
- A 30 percent risk reduction in TLF compared to TAXUS (6.9 percent for XIENCE V vs. 9.9 percent for TAXUS, p-value=0.003).
- A 29 percent risk reduction in major adverse cardiac events (MACE) compared to TAXUS (7.1 percent for XIENCE V vs. 10.1 percent for TAXUS, p-value=0.003). MACE is a composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ID-TLR driven by lack of blood supply.
- A 34 percent risk reduction in ID-TLR compared to TAXUS (4.5 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.004).
- A 25 percent risk reduction in cardiac death or target vessel MI compared to TAXUS (3.1 percent for XIENCE V vs. 4.2 percent for TAXUS, p-value=0.11).
- A 34 percent risk reduction in heart attacks attributed to the target vessel compared to TAXUS (2.3 percent for XIENCE V vs. 3.5 percent for TAXUS, p-value=0.04).
- Comparable rates in cardiac death compared to TAXUS (0.9 percent for XIENCE V vs. 1.3 percent for TAXUS, p-value=0.34).
- A 70 percent risk reduction in stent thrombosis per protocol definition compared to TAXUS (0.33 percent for XIENCE V vs. 1.25 percent for TAXUS, p-value=0.002).
- A 64 percent risk reduction in stent thrombosis per ARC definition of definite/probable stent thrombosis compared to TAXUS (0.42 percent for XIENCE V and 1.23 percent for TAXUS, p-value=0.008).
“The latest results from SPIRIT IV confirm the durable and outstanding performance of XIENCE V and demonstrate why physicians continue to embrace it for the treatment of their patients with coronary artery disease,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “In addition to strong efficacy results, the SPIRIT IV two-year data show a substantial safety advantage for XIENCE V compared to TAXUS, with very low rates of stent thrombosis.”
“The two-year results for SPIRIT IV provide convincing longer-term data for XIENCE V’s exceptional performance,” said Robert Hance, senior vice president, vascular, Abbott. “In trial after trial, the consistently strong safety and efficacy results we see in large, simple and complex patient populations continue to confirm why XIENCE V has become the leading drug eluting stent around the world.”
Event Rates in Complex Patients
The SPIRIT IV trial included multiple complex patient subgroups, including more than 1,100 patients with diabetes, who typically are sicker and have more challenging coronary artery disease. In patients with diabetes, XIENCE V demonstrated numerically lower TLF rates compared to TAXUS through two years (9.2 percent for XIENCE V vs. 10.4 percent for TAXUS, p-value=0.69). In patients without diabetes, XIENCE V demonstrated a 41 percent risk reduction in TLF compared to TAXUS through two years (5.9 percent for XIENCE V vs. 9.7 percent for TAXUS, p-value=0.0005). In the endpoint of ARC definite/probable stent thrombosis, XIENCE V demonstrated a 9 percent risk reduction compared to TAXUS in patients with diabetes (1.05 percent for XIENCE V vs. 1.28 percent for TAXUS, p-value=0.86), and a 90 percent risk reduction compared to TAXUS in patients without diabetes (0.12 percent for XIENCE V vs. 1.22 percent for TAXUS, p-value=0.0002).
In addition, XIENCE V demonstrated low event rates in analyses of multiple subgroups3 that are frequently treated in routine clinical practice, such as patients with smaller vessels (reference vessel diameter less than or equal to 2.75 mm), patients with longer lesions (lesion length greater than 13.3 mm) and patients with multiple lesions. In patients with smaller vessels, XIENCE V demonstrated a 33 percent reduction in TLF compared to TAXUS at two years (7.3 percent for XIENCE V vs. 10.9 percent for TAXUS). In patients with longer lesions, XIENCE V demonstrated a 36 percent reduction in TLF compared to TAXUS at two years (7.2 percent for XIENCE V vs. 11.3 percent for TAXUS). In patients with two or more lesions treated, XIENCE V demonstrated a 25 percent reduction in TLF compared to TAXUS at two years (9.6 percent for XIENCE V vs. 12.8 percent for TAXUS).
About XIENCE V
Abbott’s market-leading XIENCE V drug eluting stent is marketed in the United States, Europe, Japan and other international markets.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available online at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.
Abbott (NYSE:ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
1 Complex patient groups include patients with diabetes, small vessels, long lesions and multiple lesions.
2 Unless otherwise noted, all event rates based on Kaplan-Meier estimates; p-values are for descriptive purposes only.
3 Binary event rates are presented for the subgroups