Abstract 18405: Low Clinical Event Rates in Real-World Patients with Bifurcation Lesions Receiving XIENCE V® Everolimus-Eluting Stents: One-Year Results from the XIENCE V USA Study
Objectives: The safety and efficacy of the XIENCE V® everolimus-eluting stent (XIENCE V) have been demonstrated by low clinical outcome rates in the SPIRIT trials. However, only limited data exists regarding the high-risk population with bifurcation lesions (BIF). The objective of this analysis is to evaluate the safety and efficacy of XIENCE V in patients with and without BIF from XIENCE V USA.
Methods: This was a large, prospective, multicenter, FDA-required, post-approval study designed to evaluate the safety and effectiveness of XIENCE V in an unrestricted, real-world population. Patients (n=5054) were consecutively enrolled with no eligibility criteria except for the receiving of only XIENCE V during the index procedure. Baseline data and clinical outcomes such as TLF (cardiac death, TV-MI and clinically indicated TLR) and TLR at 1 year in patients with (n=509) and without BIF (n=4278) were compared; these outcomes were also adjudicated by an independent CEC.
Results: Of 5054 enrolled patients, 10.6% (509) were patients with BIF and 89.4% (4278) were patients without BIF. Mean age, gender distribution, diabetic, presence of ACS, and mean lesion length were similar in the two groups. Compared to patients without BIF, patients with BIF more often had Class III&IV angina status (21.0% vs. 17.1%), B2/C lesions (66.5% vs. 45.3%), 2 or more lesions treated (48.9% vs. 27.6%), and post dilatation (65.5% vs. 52.0%); less often they had prior stenting (33.3% vs. 38.7%) and direct stenting (29.2% vs. 40.8%). More bifurcation lesions were located in the left coronary artery (LAD: 50.3% vs. 35.7%, LCX: 27.1% vs. 23.0%, LM: 2.8% vs. 1.5%). Despite the complexity of treating BIF, similar rates of procedure success (97.6% vs. 98.2%) and device success (99.9% vs. 99.9%) were observed in both groups. The 1-year rates of TLF (9.9% vs. 8.1%, p=NS) and TLR (5.3% vs. 4.2%, p=NS) were also comparable between the two groups.
Conclusions: The results from this large, multicenter, real-world study suggest that the XIENCE V benefits observed in the SPIRIT trials continue to be seen in this complex, high-risk, BIF population. Although rates of TLF and TLR were expectedly higher compared to patients without BIF, the overall clinical outcome rates for those with BIF remain low at 1 year.
- © 2010 by American Heart Association, Inc.