Lp(a)HORIZON试验：pelacarsen使脂蛋白(a)平均降78%，主要心血管事件12.3%对12.1%无差异
伊利诺伊州库克县芝加哥市消息—11月7日在芝加哥举行的美国心脏协会2026年科学年会（Scientific Sessions 2026）上公布的 III 期 Lp(a)HORIZON 试验结果显示，新型药物 pelacarsen 使已有心血管疾病且脂蛋白(a)［Lp(a)］升高者的 Lp(a) 水平平均下降78%，但未能改变主要不良心血管事件的发生时间。主要分析结果同日在《新英格兰医学杂志》发表，扩展分析发表于《NEJM Evidence》。
据美国心脏协会发布，该试验在42个国家的797个中心随机入组8350名成年人，其中8322人纳入疗效分析，受试者基线 Lp(a) 至少为70毫克/分升；12个月时，pelacarsen 组 Lp(a) 较基线下降78.4%，安慰剂组下降3.2%，两组差为77.7个百分点。中位随访4.7年，主要复合终点（心血管死亡、非致死性心肌梗死、非致死性卒中或紧急冠脉血运重建）在 pelacarsen 组发生率为12.3%（511/4157），安慰剂组为12.1%（503/4165），风险比1.02，差异无统计学意义；包括基线 Lp(a) 最高（90毫克/分升及以上）的亚组在内，各亚组均未见获益。
研究资深作者、克利夫兰诊所米勒家族心脏、血管与胸科研究所首席学术官史蒂文·尼森（Steven E. Nissen）表示，pelacarsen 使 Lp(a) 指标显著改善、降低78%，但心血管结局未变，这一阴性结果出乎意料、令医学界意外；研究团队同时表示，仍建议人们检测 Lp(a) 水平以评估心血管风险。本稿仅报道上述已公布的试验数据与研究方表态，不构成对任何个体的诊疗建议。
（来源：美国心脏协会）
Lp(a)HORIZON Trial: Pelacarsen Lowered Lipoprotein(a) by an Average of 78%, With Major Cardiovascular Events at 12.3% Versus 12.1%
CHICAGO, Cook County, Illinois — Results of the phase III Lp(a)HORIZON trial, presented on November 7 at the American Heart Association's Scientific Sessions 2026 in Chicago, showed that the novel medication pelacarsen lowered lipoprotein(a) [Lp(a)] levels by a mean of 78% in adults with elevated Lp(a) and established cardiovascular disease, but did not change the time to a major adverse cardiovascular event. The primary analysis was published simultaneously in the New England Journal of Medicine, with extended analyses in NEJM Evidence.
According to the American Heart Association's release, the trial randomized 8,350 adults at 797 sites in 42 countries, with 8,322 included in the efficacy analysis; participants had baseline Lp(a) of at least 70 mg/dL. At 12 months, Lp(a) had fallen by 78.4% with pelacarsen and 3.2% with placebo, a difference of 77.7 percentage points. Over a median follow-up of 4.7 years, the primary composite endpoint — cardiovascular death, nonfatal heart attack, nonfatal stroke or urgent coronary revascularization — occurred in 12.3% of the pelacarsen group (511 of 4,157) and 12.1% of the placebo group (503 of 4,165), a hazard ratio of 1.02 that was not statistically significant; no subgroup benefited, including patients with the highest baseline Lp(a), at or above 90 mg/dL.
Senior author Steven E. Nissen, M.D., FAHA, chief academic officer of the Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic, said pelacarsen improved Lp(a) measures significantly — 78% lower — while cardiovascular outcomes were unchanged, calling the neutral finding unexpected and surprising to the medical community; the researchers also urge everyone to have their Lp(a) levels measured to help estimate cardiovascular risk. This report presents only the published trial data and the investigators' statements and does not constitute medical advice for any individual.
(Source: American Heart Association)
来源：美国心脏协会
发布：GSM·美国（发布链接）
图片来源：图：冠状动脉 CT 成像（资料图）。Goleisureintl 摄，CC BY 4.0，经 Wikimedia Commons。 / Photo: CT coronary artery imaging (file photo). Photo by Goleisureintl, CC BY 4.0, via Wikimedia Commons.
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