Abstract 20347: Low Clinical Event Rates in Real-World Patients with Acute Myocardial Infarction Receiving XIENCE V® Everolimus-Eluting Stents: One-Year Results from the XIENCE V USA Study
Objectives: The XIENCE V® everolimus-eluting stent (XIENCE V) was superior to the TAXUS® paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT randomized controlled trials. However, AMI patients were excluded in these earlier trials. The objective of this analysis was to evaluate the safety and efficacy of XIENCE V in real-world AMI patients.
Methods: XIENCE V USA is a large, prospective, multicenter, all-inclusive, real-world study required by the FDA as post-market surveillance. A total of 5054 patients undergoing PCI with XIENCE V were consecutively enrolled between July and December 2008. In this analysis, clinical outcomes in patients with (n=761) and without AMI (n=3455) were compared at 1 year. AMI was diagnosed based on clinical assessment including ECG and/or cardiac enzymes. Clinical outcomes were adjudicated by an independent Clinical Event Committee.
Results: Age, gender distribution, lesion length, number of lesions and vessels treated, number of implanted stents, maximum balloon pressures, and device success rates were similar between the two groups. The AMI group had fewer diabetics compared to the non-AMI group (29.4% vs. 37.0%, p<0.0001). At 1 year, 77.1% of patients in the AMI group remained on DAPT vs. 80.3% in the non-AMI group, p=0.055. Overall ARC-defined definite and probable stent thrombosis (ST) rates were 1.1% in the AMI group vs. 0.9% in the non-AMI group (p=NS). Rates of clinically indicated (CI) TLR were 3.9% vs. 4.4% (AMI vs. non-AMI), p=NS, and rates of target lesion failure (TLF: composite of cardiac death, ARC-defined MI attributed to target vessel, and CI-TLR) were 9.1% vs. 8.5%, (AMI vs. non-AMI), p=NS. Within the AMI group, rates of CI-TLR and TLF were similar between STEMI vs. non-STEMI patients (3.3% vs. 4.8% for CI-TLR, p=NS; 9.1 % vs. 10.6% for TLF, p=NS).
Conclusions: In this large, multicenter, real-world study, AMI patients treated with XIENCE V had low rates of ST, CI-TLR, and TLF that were similar to non-AMI patients at 1 year. The event rates in the STEMI subgroup were consistently low as the overall AMI population. These results suggest the safety and efficacy of XIENCE V in this high-risk real-world patient population.
- Drug eluting stents
- Myocardial infarction
- Myocardial infarction, STEMI
- Interventional cardiology
- Percutaneous coronary intervention
- © 2010 by American Heart Association, Inc.