Park Ki E, Wu Chiung-Jen, Chehab Bassem, Maksoud Aziz, Bertolet Barry, Ying Shih-Wa, Simoes Tiessa, Pingle Sandeep C, Chang Chi-Jen
Division of Cardiovascular Medicine, Malcom Randall VA Medical Center, University of Florida, Gainesville, Florida.
Department of Cardiology, Chung-Gung Memorial Hospital, Kaohsiung, Taiwan.
J Soc Cardiovasc Angiogr Interv. 2023 May 18;2(4):101001. doi: 10.1016/j.jscai.2023.101001. eCollection 2023 Jul-Aug.
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.
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.
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%).
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.
弥漫性冠状动脉疾病可能需要多个重叠支架，与单个支架相比，其预后较差。更长支架的出现可以避免在长病变中使用重叠支架。这项前瞻性、单臂、SPIRIT 48试验评估了雅培新一代药物洗脱支架XIENCE Skypoint 48在患有长的原发性冠状动脉病变的冠心病患者中的安全性和有效性。
SPIRIT 48在3个国家的25个地点招募了107名患者。患者需有1个用XIENCE Skypoint 48治疗的靶病变（病变长度>32.0 mm且≤44.0 mm）。主要终点是1年时的靶病变失败（TLF；包括心源性死亡、靶血管相关心肌梗死或临床指征的靶病变血运重建的复合终点），并与通过历史对照数据确定的预设性能目标20%进行比较。本研究最近完成了1年随访。
105例患者植入了XIENCE Skypoint 48，器械成功率为97.2%。SPIRIT 48达到了其主要终点，TLF率为5.7%，95%CI的上限为9.5%（<性能目标20%）。这与1年时5.8%（6/104例患者）的心源性死亡/所有心肌梗死发生率较低相关。1年时明确或可能的器械血栓形成仅发生在1例受试者（1.0%）。
SPIRIT 48试验1年随访获得的主要终点数据提供了有力证据，支持XIENCE Skypoint 48 mm药物洗脱支架在治疗原发性长冠状动脉病变中的可输送性、安全性和有效性。
