Magnoni Marco, Gallone Guglielmo, Ceriotti Ferruccio, Vergani Vittoria, Giorgio Daniela, Angeloni Giulia, Maseri Attilio, Cianflone Domenico
IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Department of Heart and Vessels, Careggi Hospital, University of Florence, Florence, Italy.
Int J Cardiol Heart Vasc. 2018 Jun 19;20:14-19. doi: 10.1016/j.ijcha.2018.06.004. eCollection 2018 Sep.
High-sensitivity cardiac troponin T (hsTnT) was recently approved for clinical use by the Food and Drug Administration. The transition from contemporary to hsTnT assays requires a thorough understanding of the clinical differences between these assays.
HsTnT may provide a more accurate prognostic stratification than contemporary cardiac troponin I (cTnI) in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
HsTnT and cTnI were measured in 644 patients with CK-MB negative NSTE-ACS who were enrolled in the prospective multicenter SPAI (Stratificazione Prognostica dell'Angina Instabile) study. Patients were stratified at the 99th percentile reference limit for each assay. The primary endpoint was cardiovascular death (CVD) or non-fatal myocardial infarction (MI); the secondary endpoint was the occurrence of unstable angina (UA). Follow-up lasted 180 days.
Patients with hsTnT ≥99th percentile were at higher risk of CVD/MI (30-day: 5.9% vs 0.8%, = 0.001; 180-day: 11.1% vs 4.7%, = 0.004), also after adjusting for TIMI Risk Score. No significant difference in CVD/MI at 180-day was found between hsTnT-positive/cTnI-negative and hsTnT-negative/cTnI-negative patients (adjHR 1.61, 95% CI 0.74-3.49, = 0.232). Occurrence of UA was not differently distributed between hsTnT groups dichotomized at the 99th percentile (12.4% vs 12.5% = 0.54).
Our investigation on a real-world NSTE-ACS population showed good prognostic performance of hsTnT in the risk stratification of the hard endpoint, but did not demonstrate the improved prognostic ability of hsTnT over contemporary cTn. Neither troponin assay predicted the recurrence of UA, suggesting the acute rise of cardiac troponin as a marker of severity, but not the occurrence of future coronary instability.
高敏心肌肌钙蛋白T(hsTnT)最近获得美国食品药品监督管理局批准可用于临床。从当代心肌肌钙蛋白检测方法过渡到hsTnT检测方法需要全面了解这些检测方法之间的临床差异。
在非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者中,hsTnT可能比当代心肌肌钙蛋白I(cTnI)提供更准确的预后分层。
在纳入前瞻性多中心SPAI(不稳定型心绞痛预后分层)研究的644例CK-MB阴性的NSTE-ACS患者中检测hsTnT和cTnI。根据每种检测方法的第99百分位数参考限值对患者进行分层。主要终点是心血管死亡(CVD)或非致命性心肌梗死(MI);次要终点是不稳定型心绞痛(UA)的发生。随访持续180天。
hsTnT≥第99百分位数的患者发生CVD/MI的风险更高(30天:5.9%对0.8%,P = 0.001;180天:11.1%对4.7%,P = 0.004),在调整TIMI风险评分后也是如此。hsTnT阳性/cTnI阴性患者与hsTnT阴性/cTnI阴性患者在180天时的CVD/MI无显著差异(校正风险比1.61,95%置信区间0.74 - 3.49,P = 0.232)。在按第99百分位数二分的hsTnT组之间,UA的发生分布没有差异(12.4%对12.5%,P = 0.54)。
我们对真实世界NSTE-ACS人群的研究表明,hsTnT在硬终点风险分层中具有良好的预后性能,但未证明hsTnT比当代cTn具有更好的预后能力。两种肌钙蛋白检测方法均未预测UA的复发,提示心肌肌钙蛋白的急性升高是严重程度的标志物,但不是未来冠状动脉不稳定发生的标志物。