雅培公布TECTONIC试验30天结果：SonicForce冠脉碎石系统手术成功率97%
总部位于伊利诺伊州 Lake County 雅培公园（Abbott Park）的雅培公司（Abbott）11月1日宣布，其关键性临床试验 TECTONIC 冠状动脉疾病血管内碎石（IVL）研究达到预设的主要安全性与有效性终点：受试的 SonicForce 冠状动脉血管内碎石系统在治疗严重钙化冠状动脉病变时，30天靶病变失败率仅为0.3%，手术成功率达97%。
该试验在全美40家医疗中心共招募335名严重钙化冠状动脉疾病患者，评估这一研究性系统在支架植入前处理钙化斑块的表现。血管内碎石术是一种微创技术，利用与治疗肾结石原理相近的声压波震裂血管壁内的钙质沉积；SonicForce 系统通过球囊导管以每秒2次的频率递送最多160次脉冲。
研究的主要安全性终点为30天靶病变失败率，结果为0.3%；主要有效性终点手术成功率达97%；主要不良心血管事件（心源性死亡、心肌梗死与靶血管血运重建的复合终点）在按治疗分析人群中为0.3%。一项预设的106人光学相干断层成像（OCT）子研究显示，治疗后病变内出现钙质断裂，支架植入后的扩张效果得到改善。
研究结果在10月31日至11月3日于圣迭戈举行的经导管心血管治疗大会（TCT）上公布，并同步发表于《美国心脏病学会杂志：心血管介入》（JACC: Cardiovascular Interventions）。试验共同主要研究者、波士顿 Beth Israel Deaconess 医疗中心血管介入主任 Eric A. Secemsky 表示，严重钙化病变是冠脉介入治疗中最具挑战的情形之一，此次数据为该类患者的处理提供了新的证据。
雅培表示，SonicForce 系统目前仍属研究性器械，尚未获得美国食品药品管理局（FDA）批准，在美国仅限研究用途；公司尚未公布递交审批的时间表。
Abbott Reports TECTONIC Trial 30-Day Results: SonicForce Coronary IVL System Achieves 97% Procedural Success
Abbott, headquartered in Abbott Park in Lake County, Illinois, announced on November 1 that its pivotal TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) study met its prespecified primary safety and effectiveness endpoints: the investigational SonicForce Coronary IVL System recorded a 30-day target lesion failure rate of just 0.3% and a procedural success rate of 97% in patients with severely calcified coronary lesions.
The study enrolled 335 patients with severely calcified coronary artery disease at 40 U.S. sites, evaluating the system for modifying calcium buildup in narrowed coronary arteries before stent placement. Intravascular lithotripsy is a minimally invasive technique that uses acoustic pressure waves, similar to the technology used to break up kidney stones, to crack hardened plaque; the SonicForce system delivers up to 160 pulses at two pulses per second through a balloon-mounted catheter.
The primary safety endpoint, 30-day target lesion failure, was 0.3%, and the primary effectiveness endpoint, procedural success, was 97%. Major adverse cardiovascular events, a composite of cardiac death, myocardial infarction and target vessel revascularization, were 0.3% in the as-treated population. A prespecified optical coherence tomography (OCT) imaging substudy of 106 patients identified calcium fractures within lesions after treatment and showed improved post-stent expansion.
The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego from October 31 to November 3 and published simultaneously in JACC: Cardiovascular Interventions. Eric A. Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston and a co-principal investigator of the trial, said severely calcified lesions remain among the most challenging scenarios in coronary intervention and that the data add new evidence for managing such patients.
Abbott said the SonicForce system remains investigational and has not been approved by the U.S. Food and Drug Administration; its use in the United States is limited to investigational settings, and the company has not disclosed a regulatory submission timeline.
发布：GSM·美国（发布链接）
图片来源：冠状动脉粥样硬化示意图。美国国家心肺血液研究所（NHLBI）绘制，公共领域，经 Wikimedia Commons。 / Diagram of coronary artery atherosclerosis. Drawn by the National Heart, Lung, and Blood Institute (NHLBI), public domain, via Wikimedia Commons.
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