Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials

Abstract

Objectives: We evaluated outcomes following XIENCE V everolimus-eluting stent (EES) compared with the Taxus Express(2) paclitaxel-eluting stent (PES) in patients undergoing multilesion and multivessel intervention.

Background: The optimal revascularization strategy for patients with multivessel disease is unknown.

Methods: The SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) (n = 1,002) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) (n = 3,690) trials enrolled patients with de novo lesions ≤ 28 mm in length and reference vessel diameter of 2.5 to 3.75 mm. The SPIRIT III trial enrolled patients with a single lesion in 1 or 2 coronary arteries, and the SPIRIT IV trial enrolled patients with up to 2 lesions in 3 different vessels (maximum 2 lesions per vessel). In both trials, patients were randomized 2:1 to EES vs. PES. Clinical outcomes to 1 year were analyzed in patients with single (n = 3,823) versus multiple (n = 765) treated vessels, and in those with single (n = 3,536) versus multiple (n = 1,052) treated lesions.

Results: Among patients with multivessel disease, EES compared with PES resulted in reduced rates of target vessel myocardial infarction (2.2% vs. 6.1%, p = 0.007) and ischemia-driven target lesion revascularization (4.2% vs. 8.0%, p = 0.04). Among patients undergoing multilesion stenting, EES compared with PES resulted in reduced rates of target vessel myocardial infarction (2.1% vs. 5.4%, p = 0.008) and ischemia-driven target lesion revascularization (3.7% vs. 7.4%, p = 0.01). The absolute benefits of EES versus PES in patients undergoing multivessel or multilesion intervention were greater than in those undergoing single-lesion, single-vessel intervention.

Conclusions: The EES compared with PES provided significant improvements in clinical safety and efficacy outcomes. The absolute benefit provided by EES versus PES appears to be proportional to the complexity of coronary disease.

Trial registration: ClinicalTrials.gov NCT00180479 NCT00307047.