White Harvey D, O'Brien Sean M, Boden William E, Fremes Stephen E, Bangalore Sripal, Reynolds Harmony R, Stone Gregg W, Ali Ziad A, Parakh Neeraj, Lopez-Sendon Jose Luis, Wang Yixin, Chen Ying Qing, Mark Daniel B, Chaitman Bernard R, Spertus John A, Maron David J, Hochman Judith S
Health New Zealand - Te Whatu Ora, Te Toka Tumai, Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Am Heart J. 2025 Nov;289:78-94. doi: 10.1016/j.ahj.2025.05.009. Epub 2025 May 20.
In the ISCHEMIA Trial, 5,179 patients with stable coronary disease were randomized to initial invasive or conservative management.
PCI was recommended with a SYNTAX score 0 to 22 (low) and CABG with a SYNTAX score ≥33 (high). Either could be recommended for intermediate scores. The composite primary outcome was cardiovascular death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. There were 2 cohorts in this analysis. The descriptive cohort included patients who underwent CABG or PCI within 180 days of randomization and had no primary outcome before revascularization. The comparative cohort excluded patients with prior CABG, single vessel disease, SYNTAX score ≥ 45, and without core laboratory assessment. We focused on the intermediate (23-32) SYNTAX comparative group for which either CABG or PCI could be recommended.
For 1,935 patients in the descriptive cohort (485 CABG, 1,450 PCI), the SYNTAX score was 27.3 ± 11.0 in the CABG group and 15.3 ± 8.6 in the PCI group, P < .0001. Most patients with low SYNTAX scores underwent PCI (87.1%), while most with high SYNTAX scores underwent CABG (72.6%). For the 1,203 patients (385 CABG, 818 PCI) in the comparative cohort, the adjusted 4-year primary event rate was 14.5% for CABG and 13.2% for PCI (difference 1.3%, 95% CI, -4.9% to 7.7%). For the 346 patients (163 CABG, 183 PCI) in the intermediate SYNTAX group, the adjusted 4-year primary event rate was 10.6% for CABG and 18.3% for PCI (difference -7.6%, 95% CI, -16.1% to 0.9%).
Selection of revascularization method resulted in more PCI in the low SYNTAX group and more CABG in the high SYNTAX group. There was no statistical evidence of a difference between PCI and CABG in the intermediate SYNTAX group but the CIs are broad, reflecting uncertainty.
NCT01471522; https://clinicaltrials.gov/ct2/show/NCT01471522.
在缺血性心脏病（ISCHEMIA）试验中，5179例稳定型冠心病患者被随机分配至初始侵入性或保守治疗组。
推荐对SYNTAX评分0至22（低）的患者进行经皮冠状动脉介入治疗（PCI），对SYNTAX评分≥33（高）的患者进行冠状动脉旁路移植术（CABG）。对于中等评分的患者，两种治疗方法均可推荐。复合主要结局为心血管死亡、心肌梗死（MI）或因不稳定型心绞痛、心力衰竭或心脏骤停复苏而住院。本分析中有两个队列。描述性队列包括在随机分组后180天内接受CABG或PCI且在血运重建前无主要结局的患者。比较性队列排除了既往接受过CABG、单支血管病变、SYNTAX评分≥45且未进行核心实验室评估的患者。我们重点关注SYNTAX评分中等（23 - 32）的比较组，该组患者CABG或PCI均可推荐。
对于描述性队列中的1935例患者（485例CABG，1450例PCI），CABG组的SYNTAX评分为27.3±11.0，PCI组为15.3±8.6，P <.0001。大多数SYNTAX评分低的患者接受了PCI（87.1%），而大多数SYNTAX评分高的患者接受了CABG（72.6%）。对于比较性队列中的1203例患者（385例CABG，818例PCI），CABG的调整后4年主要事件发生率为14.5%，PCI为13.2%（差异1.3%，95%CI， - 4.9%至7.7%）。对于SYNTAX评分中等组的346例患者（163例CABG，183例PCI），CABG的调整后4年主要事件发生率为10.6%，PCI为18.3%（差异 - 7.6%，95%CI， - 16.1%至0.9%）。
血运重建方法的选择导致SYNTAX评分低的组中PCI更多，SYNTAX评分高的组中CABG更多。在SYNTAX评分中等组中，PCI和CABG之间没有统计学上的差异证据，但置信区间较宽，反映了不确定性。
NCT01471522；https://clinicaltrials.gov/ct2/show/NCT01471522 。
