Waters D, Craven T E, Lespérance J
Department of Medicine, Montreal Heart Institute.
Circulation. 1993 Apr;87(4):1067-75. doi: 10.1161/01.cir.87.4.1067.
Angiographic progression of coronary atherosclerosis is frequently observed in clinical practice and is used as an end point in clinical trials; however, its prognostic significance is unclear.
Progression defined as an increase in diameter stenosis by > or = 15% of at least one coronary lesion was seen in 141 (42%) of 335 patients who underwent repeat coronary arteriography after a 2-year interval as part of clinical trial. Coronary lesions were measured quantitatively from comparable end-diastolic frames selected by a radiologist viewing each pair of films together. During a mean follow-up of 44 +/- 10 months after the second arteriogram, cardiac death occurred in 19 patients (5.7%), cardiac death or nonfatal infarction was seen in 40 cases (11.9%), and 90 patients (26.9%) underwent coronary revascularization. At least one end point event occurred in 112 of the 335 patients. Sixteen of the 19 cardiac deaths were in progressors, a relative risk of 7.3 (95% CI, 2.2-24.7; p < 0.001). The relative risk of cardiac death or nonfatal infarction for progressors was 2.3 (1.3-4.2, p = 0.009) and of any cardiac event was 1.7 (1.3-2.3, p < 0.001). A stepwise multivariable Cox regression model of time to event was used to assess the relative contribution of progression as a predictor of coronary events. Low ejection fraction (p = 0.001), progression (p = 0.001), and hypertension (p = 0.011) were retained as predictors of cardiac death. Angina and the number of diseased vessels were the strongest predictors of revascularization.
Coronary progression is a strong, independent predictor of future coronary events, particularly cardiac death, and its use as a surrogate end point in clinical trials is justified.
在临床实践中经常观察到冠状动脉粥样硬化的血管造影进展情况,并且它被用作临床试验的一个终点;然而,其预后意义尚不清楚。
作为一项临床试验的一部分,335例患者在间隔2年后接受了重复冠状动脉造影,其中141例(42%)出现进展,定义为至少一处冠状动脉病变的直径狭窄增加≥15%。冠状动脉病变由放射科医生一起查看每对造影剂充盈末期图像时从可比的舒张末期图像中进行定量测量。在第二次血管造影后的平均随访44±10个月期间,19例患者(5.7%)发生心源性死亡,40例(11.9%)出现心源性死亡或非致死性心肌梗死,90例患者(26.9%)接受了冠状动脉血运重建。335例患者中有112例至少发生了一项终点事件。19例心源性死亡中有16例发生在病变进展者中,相对风险为7.3(95%可信区间,2.2 - 24.7;p<0.001)。病变进展者发生心源性死亡或非致死性心肌梗死的相对风险为2.3(1.3 - 4.2,p = 0.009),发生任何心脏事件的相对风险为1.7(1.3 - 2.3,p<0.001)。使用事件发生时间的逐步多变量Cox回归模型来评估进展作为冠状动脉事件预测指标的相对贡献。低射血分数(p = 0.001)、病变进展(p = 0.001)和高血压(p = 0.011)被保留为心源性死亡的预测指标。心绞痛和病变血管数量是血运重建的最强预测指标。
冠状动脉病变进展是未来冠状动脉事件尤其是心源性死亡的一个强有力的独立预测指标,将其用作临床试验的替代终点是合理的。