TCT 2020丨DEFINE-PCI研究:PCI术后残余缺血患者的1年结局

2020-10-24 心关注 心关注

目前,心血管病死亡占我国城乡居民总死亡原因的首位。随着冠状动脉介入学的发展,PCI大大降低了急性冠脉综合征(ACS)患者死亡率,提高了患者的生活质量,已成为冠心病血运重建的主要手段。

目前,血管病死亡占我国城乡居民总死亡原因的首位。随着冠状动脉介入学的发展,PCI大大降低了急性冠脉综合征(ACS)患者死亡率,提高了患者的生活质量,已成为冠心病血运重建的主要手段。然而尽管造影显示成功的PCI术,但术后约四分之一的患者仍然会出现残余缺血。其原因大多是局灶性病变,并且与血管直径狭窄程度相关性较差,进一步行PCI有望治疗相关病变。此次研究证明在基线症状明显且术后无残余缺血(iFR≥0.95)的患者在一年内其心绞痛症状的改善明显优于有残余缺血的患者。同时其心源性死亡,自发心肌梗死或临床驱动的TVR发生都有所减少。充分的研究证明生物学指标(FFR/iFR)为选择血管血运重建的时机提供依据,接下来将在前瞻性随机DEFINE GPS试验中将研究iFR(目标iFR≥0.95)指导作为确定及消除PCI后缺血的临床有效性的生物学指标。总体而言,针对PCI手术患者术后心脏不良事件是亟待解决的问题,生理学指标iFR有一定指导意义。但对于PCI术后患者临床结局与iFR之间的联系,心脏不良事件的原因和机制需要心脏学专家、血管外科专家、放射科专家和病生理学家的通力合作,以更加优质的基础和临床数据为线索,得出更优的解决方案。

研究背景

约20%的患者PCI术后第一年内会复发心绞痛。既往DEFINE PCI研究表明血管造影提示的成功PCI后近25%的患者出现了残余缺血。并且在绝大多数情况下,术后残余缺血是局灶性病变,PCI术后血管造影所示狭窄程度与冠脉生理学评估结果相关性较差,进一步行PCI有望治疗相关病变。但该研究中对于PCI术后与残余缺血的临床和症状结果尚未见报道。此次DEFINE PCI将进一步研究PCI术后残余缺血患者的临床和症状相关结果,为iFR指导消除PCI后缺血提供依据。

研究设计

DEFINE PCI(PCI术后冠状动脉狭窄的生理学评估)是一项多中心、前瞻性、观察性研究,在500名患者经血管造影成功PCI后进行盲法iFR检测和回撤。主要终点是经手术血管造影评估PCI后的残余缺血发生率,其定义为iFR <0.90。次要终点包括一年内的临床事件(心源性死亡、心肌梗死和靶血管血运重建)和期间随访西雅图心绞痛问卷心绞痛频率(SAQ-AF)评分的变化。

既往研究结果

DEFINE PCI是一项多中心、前瞻性、观察性研究,其对500例患者中562条血管在造影成功后进行盲法iFR测定和iFR回撤。纳入标准是:稳定或不稳定的心绞痛、冠脉多支病变(CAD)、串联或长病变以及至少1个病变的基线iFR异常。该研究发现平均每位患者有1.1支血管出现异常的基线iFR,平均值为0.69±0.22,PCI术后改善为0.93±0.07,但有部分血管术后iFR有所下降(图1)。

图1. 患者PCI术前后血管iFR值

经血管造影成功PCI术后,24.0%的患者出现残余缺血(iFR<0.90),其中81.6%的患者未经治疗的局灶性狭窄在血管造影上不明显,18.4%的患者有弥漫性病变(图2.1)。在局灶性病变患者中,38.4%为支架处生理学丢失,支架近端及远端生理学丢失分别为31.5%、30.1%。

图2. 经皮冠状动脉治疗术后的冠状动脉生理学

造影显示的狭窄直径与PCI术后iFR相关性较差(图3.1)。多因素回归分析显示,参考血管直径(OR=0.32,95%CI 0.18~0.58,P=0.0002)、前降支病变(OR=5.65,95%CI 3.07~10.40,P<0.0001)是PCI术后iFR≤0.89的独立预测因素(图3.2)。

图3.1. 血管造影下狭窄直径与PCI术后iFR相关性

图3.2. 多变量分析PCI术后预测因子iFR≤0.89

此次研究结果

心源性死亡与自发性心肌梗死截断值为0.95 AUC(95%CI)=0.74(0.61,0.88)。

图4. PCI后iFR目标值的识别

基线SAQ-AF为73.3±22.8,12个月时PCI后 iFR<0.90的患者中63.1%评分增加≥10分,而iFR≥0.90的患者中71.0%评分增加≥10分(P=0.17)(图5)。

图5. 经贝叶斯分析与基线相比iFR<0.95及≥0.95的SAQ心绞痛评分差异分布

对于基线SAQ≤60的症状明显的患者,PCI后iFR≥0.95与iFR<0.95患者(100.0% vs. 88.5%,P=0.01)相比,SAQ-AF增加≥10分者更多见。PCI后iFR≥0.95与PCI后iFR<0.95(1.8% vs. 5.7%,P=0.04)相比,心源性死亡,自发性心肌梗死或临床驱动的TVR显着降低(图6)。

图6. PCI后心源性死亡、MI及临床驱动的TVR发生率

研究结论

1. 血管造影提示成功的PCI术后,在基线症状明显且术后无残余缺血(iFR≥0.95)的患者在一年内其心绞痛症状的改善明显优于有残余缺血的患者。

2. PCI术后iFR≥0.95与iFR<0.95者相比,其心源性死亡,自发心肌梗死或临床驱动的TVR发生均有所减少。

3. 在前瞻性随机DEFINE GPS试验中将研究iFR(目标iFR≥0.95)指导作为确定及消除PCI后缺血的临床有效性的生物学指标。

点评专家:郑红梅教授

天津医科大学总医院心内科副主任医师,医学博士。完成省级科研课题两项,获医学科技二等奖一项。擅长各种心律失常、心力衰竭及心内科危重症的诊治,尤其快速性心律失常电生理检查及射频消融术,缓慢性心律失常心脏起搏器植入术,具有丰富临床工作经验。

团队介绍

天津医科大学总医院是天津市医学中心,综合实力居国内前列。心血管病学专业历经石毓澍、周金台、石嘉玲、万征、孙跃民等几代科主任不懈努力,学术水平始终居国内前列。在现任科主任杨清领导下,目前学科亚专业完备,包括冠心病介入治疗、起搏与电生理、先心病与肺血管病学、高血压和心力衰竭等,各亚专业均在国内有较大学术影响。天津医科大学总医院心内科目前是卫健委心血管疾病心律失常和冠心病介入诊疗培训基地、国家级胸痛中心、国家高血压中心、中国房颤中心、房颤中心示范基地、心内科专科医师培训基地。

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    2021-07-03 zxl736
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    2020-10-27 Lexi

    在现任科主任杨清领导下,目前学科亚专业完备,包括冠心病介入治疗、起搏与电生理、先心病与肺血管病学、高血压和心力衰竭等,各亚专业均在国内有较大学术影响。

    0

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    2020-10-24 wxl882001

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