Department of Cardiology, Poznan University of Medical Sciences, Poznan, 61-701, Poland.
DCB Academy, Milano, Italy.
Catheter Cardiovasc Interv. 2024 Nov;104(6):1168-1177. doi: 10.1002/ccd.31225. Epub 2024 Oct 9.
Percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or drug-eluting stents (DES) are well-established treatments for in-stent restenosis, however little is known about the impact of vessel size on the outcomes. The study aimed to evaluate the efficacy and safety profile of DCB versus DES in DES in-stent restenosis depending on the vessel size.
Consecutive patients with DES in-stent restenosis who underwent PCI between January 2010 and February 2018 entered the registry with a long-term follow-up. Patients who received DCB at the index procedure were compared with those who received DES in three subgroups depending on the vessel size (≤2.5 mm; 2.5-3.5 mm; >3.5 mm). Data were analyzed using propensity score matching and Kaplan-Meier estimator plots.
Among 1,374 patients with DES in-stent restenosis, 615 were treated with DES and 759 with DCB. After propensity score matching, we analyzed 752 patients in the DES and DCB groups at a long-term follow-up. The risk of DOCE did not differ significantly between the DES and DCB groups, both in the overall population (HR 0.85; 95%CI [0.58; 1.26], log-rank p = 0.41) and when divided into small (HR 0.84; 95%CI [0.36; 1.95], log-rank p = 0.70), medium-sized (HR 0.90; 95%CI [0.49; 1.65], log-rank p = 0.73), and large-sized (HR 0.81; 95%CI [0.42; 1.53], log-rank p = 0.50) coronary arteries. The incidence of all-cause death was significantly higher in the overall DES population (HR 4.03; 95%CI [2.40; 6.79], log-rank p < 0.001) and subgroup of small (HR 5.54; 95%CI [1.80; 17.02], log-rank p = 0.003), medium-sized (HR 4.37; 95%CI [1.92; 9.94], log-rank p = 0.009) and large-sized coronary arteries (HR 3.26; 95%CI [1.35; 7.86], log-rank p = 0.02).
DES and DCB strategies are comparable methods of treating ISR regardless of the diameter of the treated vessel in a long-term follow-up.
经皮冠状动脉介入治疗(PCI)中使用药物涂层球囊(DCB)或药物洗脱支架(DES)是治疗支架内再狭窄的成熟治疗方法,但对于血管大小对结果的影响知之甚少。本研究旨在评估 DCB 与 DES 在 DES 支架内再狭窄患者中的疗效和安全性,根据血管大小进行分组。
2010 年 1 月至 2018 年 2 月期间接受 PCI 治疗的连续 DES 支架内再狭窄患者进入登记处进行长期随访。根据血管大小(≤2.5mm;2.5-3.5mm;>3.5mm),将接受指数手术中 DCB 治疗的患者与接受 DES 治疗的患者分为三组进行比较。数据采用倾向评分匹配和 Kaplan-Meier 估计图进行分析。
在 1374 例 DES 支架内再狭窄患者中,615 例接受 DES 治疗,759 例接受 DCB 治疗。在进行倾向评分匹配后,我们对长期随访的 752 例 DES 和 DCB 组患者进行了分析。DES 和 DCB 组之间的 DOCE 风险无显著差异,在总体人群中(HR 0.85;95%CI [0.58;1.26],log-rank p=0.41)和分为小血管(HR 0.84;95%CI [0.36;1.95],log-rank p=0.70)、中等大小血管(HR 0.90;95%CI [0.49;1.65],log-rank p=0.73)和大血管(HR 0.81;95%CI [0.42;1.53],log-rank p=0.50)时,差异均无统计学意义。DES 总体人群(HR 4.03;95%CI [2.40;6.79],log-rank p<0.001)和小血管亚组(HR 5.54;95%CI [1.80;17.02],log-rank p=0.003)、中等大小血管亚组(HR 4.37;95%CI [1.92;9.94],log-rank p=0.009)和大血管亚组(HR 3.26;95%CI [1.35;7.86],log-rank p=0.02)中,全因死亡率均显著升高。
在长期随访中,DES 和 DCB 策略是治疗 ISR 的等效方法,与治疗血管直径无关。