Abbott’s Xience Skypoint 48-mm DES Studied in SPIRIT 48 Trial

May 18, 2023—The Society for Cardiovascular Angiography & Interventions (SCAI) announced that findings from the SPIRIT 48 trial demonstrated the safety and efficacy of the newly designed, longer length Xience Skypoint 48-mm drug-eluting stent (DES; Abbott) for percutaneous coronary intervention (PCI) in patients with diffuse coronary artery disease (CAD).

As noted in the SCAI press release, the availability and use of longer stents can potentially eliminate the need for overlapping stents; this study sought to evaluate the use of the novel 48-mm stent to perform PCI.

The findings were presented as late-breaking clinical research at the SCAI 2023 Scientific Sessions held May 18-20 in Phoenix, Arizona. The study was simultaneously published online by Ki E. Park, MD, et al in JSCAI.

According to SCAI, the prospective, single-arm, open-label SPIRIT 48 trial evaluated the safety and efficacy of the Xience Skypoint 48-mm DES in patients with CAD with long de novo native coronary lesions. The trial enrolled 107 patients at 25 sites in three countries. The enrolled patients were required to have one target lesion treated with the Xience Skypoint 48-mm DES.

The SPIRIT 48 study’s primary endpoint was target lesion failure (TLF; composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularization) at 1-year follow-up compared to a prespecified performance goal (PG) of 20% and adjudicated by an independent Clinical Events Committee (CEC). The study recently completed its 1-year follow-up, noted SCAI.

As summarized in the SCAI press release, the trial achieved a device success rate of 97.2%, which reflects the deliverability of Xience Skypoint 48-mm DES. The rate of cardiac death/all MI at 1 year was 5.8%.

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%, significantly lower than the prespecified PG. Definite/probable device thrombosis at 1 year occurred in only one patient treated with the Xience Skypoint 48-mm stent (1%).

“Currently, there is only one other DES available on the market to treat complex coronary artery disease patients,” commented Dr. Park in the SCAI press release. “The results of this study are encouraging and offer a safe and efficient alternative option for patients with diffuse CAD in need of stenting.” Dr. Park, who serves as the lead investigator of the SPIRIT 48 trial, is Associate Professor of Medicine in the Division of Cardiovascular Medicine at the University of Florida in Gainesville, Florida.