Phoenix, AZ - Findings from the SPIRIT 48 Trial were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions. The study demonstrated the safety and efficacy of a newly designed longer length stent designed to perform percutaneous coronary interventions (PCI) for patients with diffuse coronary artery disease (CAD). The study was simultaneously published in JSCAI, the official journal of SCAI. 

Diffuse coronary artery disease is common and can be more challenging to treat due to multiple or long, continuous plaques within the arteries supplying blood to the heart. The current standard treatment includes PCI, which can require the use of multiple stents during procedures, increasing the risk of stent failure and adverse outcomes in addition to longer procedure times, increased costs and larger radiation doses. The availability and use of longer stents have the potential to eliminate the need for overlapping stents. The study sought to evaluate the use of a novel, 48 mm stent to perform PCI.  

The prospective, single-arm, open-label SPIRIT 48 trial evaluated the safety and efficacy of the XIENCE Skypoint 48mm drug-eluting stent in subjects with coronary artery disease with long de novo native coronary lesions. The trial enrolled 107 patients at 25 sites in three countries. Patients enrolled were required to have one target lesion treated with XIENCE Skypoint 48mm stent. The primary endpoint was target lesion failure (TLF; composite of cardiac death, target-vessel MI or clinically indicated TLR) at 1-year follow-up 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. 

The trial achieved an exceptionally high device success rate of 97.2%, which reflects the deliverability of XIENCE Skypoint 48mm stent. In addition, there was a very low rate of cardiac death/all MI at one year (5.8%). Importantly, the SPIRIT 48 trial 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 one year occurred in only one subject treated with the XIENCE Skypoint 48mm stent (1%). 

“Currently, there is only one other drug eluting stent available on the market to treat complex coronary artery disease patients,” said Ki Park, MD, MS, FACC, FSCAI Associate Professor of Medicine in the Division of Cardiovascular Medicine at the University of Florida, lead researcher of the SPIRIT 48 Trial. “The results of this study are encouraging and offer a safe and efficient alternative option for patients with diffuse CAD in need of stenting.” 

Session Details: 

“Clinical Outcomes of the XIENCE Skypoint 48mm Drug-Eluting Stent in Long Coronary Artery Lesions: Primary Endpoint Data from the SPIRIT 48 Trial” [Thursday, May 18, 2023, 4:30 – 5:30 PM MST, West 103, First Floor, Phoenix Convention Center]