Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
J Am Heart Assoc. 2018 Jun 30;7(13):e008718. doi: 10.1161/JAHA.118.008718.
Previous intravascular ultrasound studies suggested the association of stent underexpansion with increased risk of stent thrombosis and restenosis. However, no previous study has addressed the association of the suboptimal angiographic result with target-lesion revascularization (TLR) in patients receiving new-generation drug-eluting stents (DES).
RESET (Randomized evaluation of sirolimus-eluting versus everolimus-eluting stent trial) and NEXT (NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent trial) are prospective, multicenter, randomized "DES versus DES" trials; 3196 patients and 3235 patients were enrolled in the RESET and NEXT, respectively. Using the pooled individual patient-level data, the current study population consisted of 3679 patients who received single-lesion treatment using new-generation DES such as everolimus-eluting stent and biolimus-eluting stent. The study population was divided into 3 groups according to the residual in-stent % diameter stenosis (%DS) after stent implantation by offline quantitative coronary angiography assessed in a core angiographic laboratory (optimal group: %DS <10%, intermediate group: %DS=10% to 20%, suboptimal group: %DS ≧20%). The cumulative 3-year incidence of TLR was significantly higher in the suboptimal group than in the intermediate and optimal groups (9.8% versus 5.8% versus 5.7%, log-rank =0.004). Even after adjusting for the clinical, angiographic, and procedural characteristics, the excess TLR risk of the suboptimal group relative to the optimal group remained significant (hazard ratio: 1.65, 95% confidence interval, 1.14-2.41, =0.009). The excess TLR risk of the suboptimal group relative to the optimal group was consistently seen across all the subgroups including heavy calcification.
The residual angiographic in-stent %DS ≥20% was associated with increased risk for TLR in patients treated with the new-generation DES.
先前的血管内超声研究表明支架扩张不足与支架血栓形成和再狭窄的风险增加有关。然而，以前没有研究探讨接受新一代药物洗脱支架（DES）治疗的患者中，造影结果不理想与靶病变血运重建（TLR）的关系。
RESET（西罗莫司洗脱支架与依维莫司洗脱支架的随机评估试验）和 NEXT（NOBORI 生物可降解涂层依维莫司洗脱支架与 XIENCE/PROMUS 依维莫司洗脱支架试验）是前瞻性、多中心、随机的“DES 与 DES”试验；RESET 和 NEXT 分别纳入了 3196 例和 3235 例患者。利用汇总的个体患者水平数据，当前的研究人群包括 3679 例接受新一代 DES（如依维莫司洗脱支架和生物可降解涂层依维莫司洗脱支架）单病灶治疗的患者。根据核心血管造影实验室离线定量冠状动脉造影评估的支架内残余狭窄百分比（%DS），将研究人群分为 3 组（最佳组：%DS＜10%，中间组：%DS=10%至 20%，不理想组：%DS≥20%）。不理想组的 3 年累积 TLR 发生率明显高于中间组和最佳组（9.8%比 5.8%比 5.7%，log-rank=0.004）。即使调整了临床、血管造影和手术特征，不理想组相对于最佳组的 TLR 风险仍然显著增加（风险比：1.65，95%置信区间，1.14-2.41，=0.009）。在包括重度钙化在内的所有亚组中，不理想组相对于最佳组的 TLR 风险均较高。
接受新一代 DES 治疗的患者，支架内残余造影狭窄百分比≥20%与 TLR 风险增加相关。
