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Abbott's XIENCE V(R) Demonstrates Impressive Low Rates of Repeat Procedure, Stent Thrombosis and Major Adverse Cardiac Events in Complex, 'Real World' Patients in SPIRIT V Study
Date:5/21/2009

participating in the study, ensuring a patient population composed of multiple ethnic groups. The patient and lesion types studied in SPIRIT V include patients 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 (greater than or equal to 20 mm; 28 percent of lesions; 911 patients) that need treatment, and patients with smaller vessels (reference vessel diameter less than or equal to 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 measu
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SOURCE Abbott
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