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Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT–FFR Trial
Circulation: Cardiovascular Interventions ( IF 5.6 ) Pub Date : 2022-04-29 , DOI: 10.1161/circinterventions.121.011728
Enrico Fabris 1 , Balasz Berta 2, 3 , Tomasz Roleder 4 , Renicus S Hermanides 3 , Alexander J J IJsselmuiden 5 , Floris Kauer 6 , Fernando Alfonso 7 , Clemens von Birgelen 8, 9 , Javier Escaned 10 , Cyril Camaro 11 , Mark W Kennedy 12 , Bruno Pereira 13 , Michael Magro 14 , Holger Nef 15 , Sebastian Reith 16 , Magda Roleder-Dylewska 17 , Pawel Gasior 17 , Krzysztof Malinowski 18 , Giuseppe De Luca 19 , Hector M Garcia-Garcia 20 , Juan F Granada 21, 22 , Wojciech Wojakowski 17 , Elvin Kedhi 17, 23
Affiliation  

Background:Autopsy studies have established that thin-cap fibroatheromas (TCFAs) are the most frequent cause of fatal coronary events. In living patients, optical coherence tomography (OCT) has sufficient resolution to accurately differentiate TCFA from thick-cap fibroatheroma (ThCFA) and not lipid rich plaque (non-LRP). However, the impact of OCT-detected plaque phenotype of nonischemic lesions on future adverse events remains unknown. Therefore, we studied the natural history of OCT-detected TCFA, ThCFA, and non-LRP in patients enrolled in the prospective multicenter COMBINE FFR-OCT trial (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients).Methods:In the COMBINE FFR-OCT trial, patients with diabetes and ≥1 lesion with a fractional flow reserve >0.80 underwent OCT evaluation and were clinically followed for 18 months. A composite primary end point of cardiac death, target vessel-related myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina was evaluated in relation to OCT-based plaque morphology.Results:A total of 390 patients (age 67.5±9 years; 63% male) with ≥1 nonischemic lesions underwent OCT evaluation: 284 (73%) had ≥1 LRP and 106 (27%) non-LRP lesions. Among LRP patients, 98 (34.5%) had ≥1 TCFA. The primary end point occurred in 7% of LRP patients compared with 1.9% of non-LRP patients (7.0% versus 1.9%; hazard ratio [HR], 3.9 [95% CI, 0.9–16.5]; P=0.068; log rank-P=0.049). However, within LRP patients, TCFA patients had a much higher risk for primary end point compared with ThCFA (13.3% versus 3.8%; HR, 3.8 [95% CI, 1.5–9.5]; P<0.01), and to non-LRP patients (13.3% versus 1.9%; HR, 7.7 [95% CI, 1.7–33.9]; P<0.01), whereas ThCFA patients had risk similar to non-LRP patients (3.8% versus 1.9%; HR, 2.0 [95% CI, 0.42–9.7]; P=0.38). Multivariable analyses identified TCFA as the strongest independent predictor of primary end point (HR, 6.79 [95% CI, 1.50–30.72]; P=0.013).Conclusions:Among diabetes patients with fractional flow reserve-negative lesions, patients carrying TCFA lesions represent only one-third of LRP patients and are associated with a high risk of future events while patients carrying LRP-ThCFA and non-LRP lesions portend benign outcomes.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02989740.

中文翻译:

薄帽纤维粥样斑块而不是任何脂质斑块会增加糖尿病患者心血管事件的风险:来自 COMBINE OCT-FFR 试验的见解

背景:尸检研究表明,薄帽纤维粥样硬化瘤 (TCFAs) 是致死性冠状动脉事件的最常见原因。在活体患者中,光学相干断层扫描 (OCT) 具有足够的分辨率来准确区分 TCFA 和厚帽纤维粥样斑块 (ThCFA),而不是富含脂质的斑块(非 LRP)。然而,OCT 检测到的非缺血性病变斑块表型对未来不良事件的影响仍然未知。因此,我们研究了参加前瞻性多中心 COMBINE FFR-OCT 试验的患者 OCT 检测到的 TCFA、ThCFA 和非 LRP 的自然病程预测糖尿病患者的不良事件结果)。方法:在 COMBINE FFR-OCT 试验中,患有糖尿病和≥1 个病灶且血流储备分数 >0.80 的患者接受了 OCT 评估,并进行了 18 个月的临床随访。心脏死亡、靶血管相关性心肌梗死、靶病变血运重建和不稳定型心绞痛住院的复合主要终点与基于 OCT 的斑块形态相关。结果:共有 390 名患者(年龄 67.5±9 岁) ; 63% 男性) 有≥1 个非缺血性病变接受 OCT 评估:284 (73%) 有 ≥1 LRP 和 106 (27%) 非 LRP 病变。在 LRP 患者中,98 人(34.5%)的 TCFA ≥1。主要终点发生在 7% 的 LRP 患者和 1.9% 的非 LRP 患者(7.0% 对 1.9%;风险比 [HR],3.9 [95% CI,0.9–16.5];心脏死亡、靶血管相关性心肌梗死、靶病变血运重建和不稳定型心绞痛住院的复合主要终点与基于 OCT 的斑块形态相关。结果:共有 390 名患者(年龄 67.5±9 岁) ; 63% 男性) 有≥1 个非缺血性病变接受 OCT 评估:284 (73%) 有 ≥1 LRP 和 106 (27%) 非 LRP 病变。在 LRP 患者中,98 人(34.5%)的 TCFA ≥1。主要终点发生在 7% 的 LRP 患者和 1.9% 的非 LRP 患者(7.0% 对 1.9%;风险比 [HR],3.9 [95% CI,0.9–16.5];心脏死亡、靶血管相关性心肌梗死、靶病变血运重建和不稳定型心绞痛住院的复合主要终点与基于 OCT 的斑块形态相关。结果:共有 390 名患者(年龄 67.5±9 岁) ; 63% 男性) 有≥1 个非缺血性病变接受 OCT 评估:284 (73%) 有 ≥1 LRP 和 106 (27%) 非 LRP 病变。在 LRP 患者中,98 人(34.5%)的 TCFA ≥1。主要终点发生在 7% 的 LRP 患者和 1.9% 的非 LRP 患者(7.0% 对 1.9%;风险比 [HR],3.9 [95% CI,0.9–16.5];63% 男性)有 ≥1 个非缺血性病变接受 OCT 评估:284 个(73%)有 ≥1 个 LRP 和 106 个(27%)个非 LRP 病变。在 LRP 患者中,98 人(34.5%)的 TCFA ≥1。主要终点发生在 7% 的 LRP 患者和 1.9% 的非 LRP 患者(7.0% 对 1.9%;风险比 [HR],3.9 [95% CI,0.9–16.5];63% 男性)有 ≥1 个非缺血性病变接受 OCT 评估:284 个(73%)有 ≥1 个 LRP 和 106 个(27%)个非 LRP 病变。在 LRP 患者中,98 人(34.5%)的 TCFA ≥1。主要终点发生在 7% 的 LRP 患者和 1.9% 的非 LRP 患者(7.0% 对 1.9%;风险比 [HR],3.9 [95% CI,0.9–16.5];P = 0.068;对数秩- P = 0.049)。然而,在 LRP 患者中,与 ThCFA 相比,TCFA 患者的主要终点风险更高(13.3% 对 3.8%;HR,3.8 [95% CI,1.5-9.5];P <0.01)和非 LRP患者(13.3% 对 1.9%;HR,7.7 [95% CI,1.7–33.9];P <0.01),而 ThCFA 患者的风险与非 LRP 患者相似(3.8% 对 1.9%;HR,2.0 [95% CI,0.42–9.7];P = 0.38)。多变量分析确定 TCFA 是主要终点的最强独立预测因子(HR,6.79 [95% CI,1.50–30.72];P=0.013).结论:在部分血流储备阴性病变的糖尿病患者中,携带 TCFA 病变的患者仅占 LRP 患者的三分之一,并且与携带 LRP-ThCFA 和非 LRP 病变的患者未来事件的高风险相关预示良性结果。注册:URL:https://www.clinicaltrials.gov;唯一标识符:NCT02989740。
更新日期:2022-04-29
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