LB-3
Clinical Outcomes of the XIENCE Skypoint 48mm Drug-Eluting Stent in Long Coronary Artery Lesions: Primary Endpoint Data from the SPIRIT 48 Trial
Presenter
Ki E Park, M.D., FSCAI, UF Health Shands Hospital, Gainesville, FL
Ki E Park, M.D., FSCAI, UF Health Shands Hospital, Gainesville, FL, Sandeep C Pingle, Abbott, Santa Clara, CA and Chi-Jen Chang, MD, Chang Gung Memorial Hospital, Taipei, Taipei, Taiwan
Keywords: Acute Coronary Syndromes (ACS), Coronary and Drug-eluting Stent (DES)
Background
:
PCI for long, diffuse lesions may often require multiple stents. Concerns remain with overlapping multiple stents, including geographic miss involving two stents, increase in procedural time, contrast use, radiation dose and procedural cost. The availability and use of longer stents can circumvent the need for overlapping stents and facilitate interventional management of patients with diffuse coronary artery lesions. The prospective, single-arm, open-label SPIRIT 48 trial evaluated the safety and efficacy of Abbott’s next-generation drug-eluting stent 48 mm everolimus-eluting coronary stent system (EECSS) (called "ABT NG DES 48") or XIENCE Skypoint 48 IDE, in subjects with coronary artery disease with long
de novo native coronary lesions.
Methods
:
SPIRIT 48 enrolled 107 patients at 25 sites in 3 countries. Patients enrolled were required to have one target lesion that would be treated with ABT NG DES 48. The primary endpoint of this study was target lesion failure (TLF; composite of cardiac death, target-vessel MI or clinically indicated TLR) at 1-year follow-up that was compared to a pre-specified performance goal (PG) of 20% and adjudicated by an independent Clinical Events Committee (CEC). This study recently completed its 1-year follow-up.
Results
:
SPIRIT 48 achieved a device success rate of 97.2%, which reflects the deliverability of ABT NG DES 48. In addition, a rate of 5.8% (6/104 subjects) for cardiac death/all MI at 1yr attests to the safety of this device. Importantly, SPIRIT 48 met its primary endpoint, with a TLF rate of 5.7%, and the upper bound of 95% CI at 9.5%, which was significantly lower than the pre-specified PG. In addition, definite/probable device thrombosis at 1 year occurred in only 1 subject treated with ABT NG DES 48 (1.0%).
Conclusions
:
This study obtained robust data collected through the peak of the COVID-19 pandemic. The primary endpoint data obtained at 1-year follow-up from the SPIRIT 48 trial presents strong evidence supporting the deliverability, effectiveness, and safety of XIENCE Skypoint 48mm drug-eluting stent in treating long
de novo coronary lesions.