One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial.

BACKGROUND

Diffuse coronary artery disease may need multiple overlapping stents, associated with less favorable outcomes than those of a single stent. The availability of longer stents can circumvent the need for overlapping stents in long lesions. This prospective, single-arm, SPIRIT 48 trial evaluated the safety and effectiveness of Abbott's next-generation drug-eluting stent, XIENCE Skypoint 48, in patients with coronary artery disease with long de novo native coronary lesions.

METHODS

SPIRIT 48 enrolled 107 patients at 25 sites in 3 countries. Patients were required to have 1 target lesion treated with XIENCE Skypoint 48 (lesion length of >32.0 mm and ≤44.0 mm). The primary end point was target lesion failure (TLF; composite of cardiac death, target vessel-related myocardial infarction, or clinically indicated target lesion revascularization) at the 1-year compared with a prespecified performance goal of 20%, established through historical control data. This study recently completed its 1-year follow-up.

RESULTS

XIENCE Skypoint 48 was implanted in 105 patients with a device success rate of 97.2%. SPIRIT 48 met its primary end point, with a TLF rate of 5.7%, and the upper bound of 95% CI at 9.5% (<performance goal of 20%). This was associated with a low rate of 5.8% (6/104 patients) for cardiac death/all myocardial infarction at 1 year. Definite or probable device thrombosis at 1 year occurred in only 1 subject (1.0%).

CONCLUSIONS

Primary end point data obtained at the 1-year follow-up from the SPIRIT 48 trial present strong evidence supporting the deliverability, safety, and effectiveness of XIENCE Skypoint 48 mm drug-eluting stent in treating long de novo coronary lesions.