冠状动脉迂曲对新一代药物洗脱支架置入术后结局的影响。随机BIOFLOW试验分析。
Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials.
作者信息
Mankerious Nader, Toelg Ralph, Abdelghani Mohammad, Garcia-Garcia Hector M, Farhan Serdar, Allali Abdelhakim, Windecker Stephan, Lefèvre Thierry, Saito Shigeru, Kandzari David E, Waksman Ron, Richardt Gert, Hemetsberger Rayyan
机构信息
Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany; Cardiology Department, Zagazig University, Sharkia, Egypt. Electronic address: https://twitter.com/@MankeriousNader.
Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany; Center for Cardiovascular and Diabetes Medicine, Asklepios Clinic, Bad Oldesloe, Germany; Medical Faculty of the Christian-Albrechts University of Kiel, Kiel, Germany.
出版信息
Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):682-691. doi: 10.1016/j.rec.2024.12.009. Epub 2025 Jan 4.
INTRODUCTION AND OBJECTIVES
Patients undergoing percutaneous coronary intervention in vessels with moderate-to-severe tortuosity are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation stents. We compared outcomes following percutaneous coronary intervention in vessels with moderate-to-severe tortuosity using a bioresorbable-polymer sirolimus-eluting stent (BP-SES) vs a durable-polymer everolimus-eluting stent (DP-EES).
METHODS
A total of 2350 patients from the BIOFLOW II, IV, and V randomized trials were stratified into 2 groups based on target-vessel tortuosity: none-to-mild and moderate-to-severe. The primary endpoints included target lesion failure (TLF)-a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (TLR)-and probable/definite stent thrombosis at 3 years.
RESULTS
Patients with moderate-to-severe tortuosity (n=903) had more comorbidities than those with none-to-mild tortuosity (n=1447). Rates of TLF (P=.354), cardiac death (P=.690), TLR (P=.447), and stent thrombosis (P=.084) were similar between the 2 groups, whereas TV-MI occurred more frequently in the moderate-to-severe tortuosity group (P=.031). However, on multivariate analysis, moderate-to-severe tortuosity was not an independent predictor of TV-MI (adjusted HR, 1.06; 95% CI, 0.72-1.55; P=.772). Among patients with moderate-to-severe tortuosity, the use of BP-SES was associated with significantly lower rates of TLF compared with the DP-EES (7.8% vs 13.4%; HR, 0.57; 95% CI, 0.37-0.87; P=.009), driven by reductions in TV-MI (5.0% vs 9.2%; HR, 0.54; 95% CI, 0.32-0.90; P=.018) and TLR (2.7% vs 6.1%; HR, 0.45; 95% CI, 0.23-0.90; P=.021).
CONCLUSIONS
This pooled analysis of the randomized BIOFLOW trials demonstrates that patients with none-to-mild and moderate-to-severe tortuosity have comparable long-term adverse event rates. However, the use of BP-SES in patients with moderate-to-severe tortuosity may help mitigate potential ischemic risks.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov NCT01356888, NCT01939249, NCT02389946.
引言与目的
在中度至重度迂曲血管中接受经皮冠状动脉介入治疗的患者发生不良结局的风险较高，但在新一代支架时代相关数据较少。我们比较了使用生物可吸收聚合物西罗莫司洗脱支架（BP-SES）与耐用聚合物依维莫司洗脱支架（DP-EES）在中度至重度迂曲血管中进行经皮冠状动脉介入治疗后的结局。
方法
来自BIOFLOW II、IV和V随机试验的2350例患者根据靶血管迂曲程度分为两组：无至轻度和中度至重度。主要终点包括靶病变失败（TLF）——心脏死亡、靶血管心肌梗死（TV-MI）或缺血驱动的靶病变血运重建（TLR）的复合终点——以及3年时可能/确定的支架血栓形成。
结果
中度至重度迂曲患者（n=903）比无至轻度迂曲患者（n=1447）有更多合并症。两组之间的TLF（P=0.354）、心脏死亡（P=0.690）、TLR（P=0.447）和支架血栓形成（P=0.084）发生率相似，而TV-MI在中度至重度迂曲组中更频繁发生（P=0.031）。然而，多变量分析显示，中度至重度迂曲不是TV-MI的独立预测因素（校正HR，1.06；95%CI，0.72-1.55；P=0.772）。在中度至重度迂曲患者中，与DP-EES相比，使用BP-SES与显著更低的TLF发生率相关（7.8%对13.4%；HR，0.57；95%CI，0.37-0.87；P=0.009），这是由于TV-MI（5.0%对9.2%；HR，0.54；95%CI，0.32-0.90；P=0.018）和TLR（2.7%对6.1%；HR，0.45；95%CI，0.23-0.90；P=0.021）的降低。
结论
这项对随机BIOFLOW试验的汇总分析表明，无至轻度和中度至重度迂曲患者的长期不良事件发生率相当。然而，在中度至重度迂曲患者中使用BP-SES可能有助于减轻潜在的缺血风险。
临床试验注册
Clinicaltrials.gov NCT01356888、NCT01939249、NCT02389946。
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