Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.
In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.
Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.
In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.).
稳定型冠状动脉疾病患者的首选初始治疗是最佳的可用药物治疗。我们假设，对于通过测量血流储备分数（FFR）确定存在功能性狭窄的患者，经皮冠状动脉介入治疗（PCI）加最佳的可用药物治疗将优于单纯最佳的可用药物治疗。
对于正在考虑进行 PCI 的稳定型冠状动脉疾病患者，我们通过测量 FFR 评估所有狭窄。至少存在一处狭窄的患者存在功能性狭窄（FFR≤0.80），被随机分配至 FFR 指导下的 PCI 加最佳的可用药物治疗（PCI 组）或单纯最佳的可用药物治疗（药物治疗组）。所有狭窄的 FFR 均大于 0.80 的患者被纳入登记处并接受最佳的可用药物治疗。主要终点是死亡、心肌梗死或紧急血运重建的复合终点。
在招募了 1220 名患者（888 名接受随机分组，332 名进入登记处）后，因组间主要终点事件发生率存在显著差异，提前终止了入组（PCI 组为 4.3%，药物治疗组为 12.7%；PCI 组的风险比为 0.32；95%置信区间[CI]为 0.19 至 0.53；P<0.001）。这一差异是由于 PCI 组较药物治疗组紧急血运重建率较低（1.6%比 11.1%；风险比为 0.13；95%CI 为 0.06 至 0.30；P<0.001）所致，尤其是 PCI 组中，因心肌梗死或心电图提示缺血而触发的紧急血运重建较少（风险比为 0.13；95%CI 为 0.04 至 0.43；P<0.001）。登记处中的患者有 3.0%发生了主要终点事件。
对于存在功能性狭窄的稳定型冠状动脉疾病患者，与单纯最佳的可用药物治疗相比，FFR 指导下的 PCI 加最佳的可用药物治疗可减少紧急血运重建的需求。对于不存在缺血的患者，单纯应用最佳的可用药物治疗似乎也有较好的效果。（由圣犹达医疗公司资助；ClinicalTrials.gov 注册号：NCT01132495）。
