New data presented at EuroPCR from an international, post-approval, single-arm study show that Abbott's XIENCE V Everolimus Eluting Coronary Stent System demonstrated low rates of repeat procedure (target lesion revascularization), stent thrombosis and major adverse cardiac events (MACE) in a complex patient population. In the SPIRIT V (five) study, XIENCE V (vee) demonstrated a very low 1.8 percent rate of target lesion revascularization (TLR), a 0.7 percent rate of stent thrombosis and a 5.1 percent rate of MACE at one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction attributed to the target vessel), and TLR driven by lack of blood supply. The SPIRIT V study evaluated XIENCE V in a diverse, "real world" population of patients and lesion types, including diabetics, patients with multi-vessel disease and patients with highly complex lesions.
The data from real-world studies are valuable because they reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice, said Eberhard Grube, M.D., chief, Department of Cardiology and Angiology, Heart Center Sieburg in Germany and principal investigator of the SPIRIT V study. The one-year results from SPIRIT V indicate that even in a patient population with a high percentage of complex lesions, XIENCE V exhibits remarkably low event rates, similar to what was seen when XIENCE V was studied in controlled, randomized SPIRIT studies.
SPIRIT V is an international, post-approval study of 2,663 patients. Approximately 100 clinical sites throughout Europe, Asia-Pacific and Canada are participating in the study, ensuring a patient population composed of multiple ethnic groups. The patient and lesion types studied in SPIRIT V includepatients with diabetes (30 percent of patients; 794 patients), patients with multi-vessel disease (42 percent of patients; 1,107 patients), patients with highly complex lesions (lesion type B2 or C; 82 percent of lesions; 2,307 patients), patients with moderately or severely calcified lesions (29 percent of lesions; 809 patients), patients with longer lesions (= 20 mm; 28 percent of lesions; 911 patients) that need treatment, and patients with smaller vessels (reference vessel diameter = 2.75 mm, 35 percent of lesions, 1,068 patients). The safety and efficacy of XIENCE V has not been established in the United States for patients with multi-vessel disease, patients with highly complex lesions (lesion type B2 or C), or patients with severely calcified lesions.
The primary endpoint of the study is a composite rate of all death, heart attack (myocardial infarction) and target vessel revascularization at 30 days, in which XIENCE V had a rate of 2.7 percent. At one year, the SPIRIT V study demonstrated the following positive results for XIENCE V:
•A 1.8 percent rate of repeat procedure to the treated lesion (TLR)
•A 0.7 percent cumulative rate of definite/probable stent thrombosis (to one year) and a low 0.2 percent rate of definite/probable late stent thrombosis (between 30 days and one year)
•A 5.1 percent rate of MACE
•A 1.1 percent rate of cardiac death
All events were adjudicated according to the Academic Research Consortium (ARC) definitions by an independent Clinical Events Committee. The ARC definitions were developed to eliminate variability in definitions across various drug eluting stent trials; using ARC definitions to measure events sets a new standard in real-world studies.
The low occurrence of repeat procedure and stent thrombosis is noteworthy given that the SPIRIT V study includes high-risk patient groups, including diabetics, patients with multi-vessel disease and patients with highly complex or calcified lesions, said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. The outstanding data from SPIRIT V and consistently strong performance of XIENCE V across all clinical trials reinforce why physicians throughout the world have embraced this technology.
Abbott also presented five-year results from the SPIRIT FIRST trial, which was a 60-patient, first-in-man study comparing XIENCE V to the MULTI-LINK VISION Coronary Stent System. XIENCE V continued to demonstrate an excellent long-term safety profile with no MACE or stent thrombosis events between one and five years.
As part of the company’s commitment to advancing the treatment of coronary artery disease, Abbott’s robust post-approval and continued access program is projected to study more than 20,000 XIENCE V patients across several clinical trials. In addition to SPIRIT V, ongoing studies include:
•SPIRIT IV, a continued-access trial looking at a more complex patient population in the United States;
• XIENCE V SPIRIT WOMEN, the world’s first drug eluting stent trial to study only female