Why is this study important? 

Percutaneous coronary intervention for diffuse or long lesions can be challenging. Such interventions often require the use of multiple and often overlapping stents.

Multiple overlapping stents used in such interventions are associated with a higher rate of geographic miss at the site of stent overlap, increase procedural time, contrast use, radiation dose and procedural cost. Use of multiple stents for diffuse coronary lesions have been shown to be associated with higher rates of target lesion failure and stent thrombosis.

The availability and use of longer coronary stents provides a viable alternative to overlapping stents in treating diffuse de-novo coronary lesions.

Key Takeaway

• The study demonstrates safety and efficiency of treating diffuse de-novo coronary artery lesions with the Xience Skypoint 48 mm stent at 1 year after intervention.
• The Xience Skypoint 48 mm stent also demonstrated excellent deliverability and low rates of target lesion failure, stent thrombosis, cardiac death and myocardial infarction.
• The study aims to provide a viable alternative to the Synergy XD 48 mm stent.

What question was this study supposed to answer? 

The prospective, single-arm, open-label SPIRIT 48 trial sought to evaluate the efficiency and safety of the Xience Skypoint 48mm everolimus-eluting coronary stent system in long or diffuse de novo native coronary artery lesions.

The trial enrolled 107 patients at 25 sites in 3 countries. Patients enrolled were required to have one target lesion treated with Xience Skypoint 48mm stent.

The primary endpoint was target lesion failure (composite of cardiac death, target-vessel MI or clinically indicated target lesion revascularization) at 1-year follow-up compared to a pre-specified performance goal of 20% and adjudicated by an independent clinical events committee. This study recently completed its 1-year follow-up.

What did the study show? 

• The trial achieved a high device success rate of 97.2%, demonstrating excellent deliverability of the Xience Skypoint 48mm stent.
• The cardiac death/all MI at one year was 5.8% (6/104 participants).
• The SPIRIT 48 trial met its primary endpoint, with a target lesion failure rate of 5.7%. The upper bound of 95% CI at 9.5%, which was significantly lower than the pre-specified PG.
• Definite/probable device thrombosis at one year occurred in 1 subject treated with the XIENCE Skypoint 48mm stent (1%).