新一代药物洗脱支架的复杂与非复杂经皮冠状动脉介入治疗：来自随机 BIOFLOW 试验的分析。
Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.
机构信息
Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Department of Cardiology, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum, Bochum, Germany.
出版信息
Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.
BACKGROUND
Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents.
AIM
We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES).
METHODS
Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years.
RESULTS
Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16).
CONCLUSION
Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES).
CLINICAL TRIAL REGISTRATION
Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .
背景
接受复杂经皮冠状动脉介入治疗（PCI）的患者发生不良结局的风险更高，但在新一代冠状动脉支架时代，相关数据较为匮乏。
目的
我们旨在比较生物可吸收聚合物西罗莫司洗脱支架（BP-SES）与持久聚合物依维莫司洗脱支架（DP-EES）治疗复杂 PCI 患者的临床结局。
方法
BIOFLOW-II、-IV 和 -V 随机试验的患者（n=2350）分为非复杂 PCI 与复杂 PCI。复杂 PCI 至少符合以下标准之一：多血管 PCI、治疗病变≥3 个、植入支架≥3 个、总支架长度≥60 mm。终点为靶病变失败（TLF：心源性死亡、靶血管心肌梗死[TV-MI]或靶病变血运重建[TLR]）和三年时可能/确定的支架血栓形成（ST）。
结果
与非复杂 PCI 患者（n=2002）相比，行复杂 PCI 的患者（n=348）年龄更大，更常出现急性冠状动脉综合征。复杂 PCI 病变多为 B2/C 型和分叉病变，需要更多的预扩张和后扩张。复杂 PCI 患者的 TLF 发生率更高（14.6% vs. 8.1%；aHR 1.89，95%CI[1.31-2.73]，p=0.001）、TV-MI 发生率更高（10.2% vs. 4.4%，aHR 2.17，95%CI[1.40-3.37]，p=0.001）和 ST 发生率更高（1.5% vs. 0.4%，p=0.025）。与非复杂 PCI 相比，复杂 PCI 患者中 BP-SES 组的 TLF 并不低于 DP-EES 组（12.6% vs. 18.2%，p=0.16）。
结论
与非复杂 PCI 相比，接受新一代 DES 治疗的复杂 PCI 患者的 TLF、TV-MI 和支架血栓形成风险仍然较高。支架平台（BP-SES 与 DP-EES）并不能显著改变这一不良结局。
临床试验注册
Clinicaltrial.gov NCT01356888、NCT01939249、NCT02389946，https://clinicaltrials.gov/show/NCT01356888；https://clinicaltrials.gov/show/NCT01939249；https://clinicaltrials.gov/show/NCT02389946。
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