Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
Department of Cardiology, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum, Bochum, Germany.
Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.
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.
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).
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.
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).
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).
Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .
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。
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。
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）。
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）。
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。
Clinicaltrial.gov NCT01356888、NCT01939249、NCT02389946，https://clinicaltrials.gov/show/NCT01356888；https://clinicaltrials.gov/show/NCT01939249；https://clinicaltrials.gov/show/NCT02389946。
