DES联合DCB治疗原位冠脉弥漫病变的初步疗效、炎症反应及优化策略探讨

Preliminary Investigation of Drug-Eluting Stent Combined with Drug-Coated Balloon Therapy for In-Situ Diffuse Coronary Disease: Efficacy, Inflammatory Response, and Optimization Strategies

摘要: 背景：原位冠状动脉弥漫病变属于冠状动脉粥样硬化性心脏病的复杂类型，传统治疗手段效果有限。药物洗脱支架(drug-eluting stents, DES)和药物涂层球囊(drug-coated balloon, DCB)已被广泛应用于介入治疗，但二者联合应用及其对炎症反应的影响尚缺乏系统研究。目的：评估DES联合DCB治疗原位冠状动脉弥漫病变的疗效，并分析其对炎症标志物高敏C反应蛋白(high-sensitivity C-reactive protein, hs-CRP)、白细胞介素-6 (interleukin-6, IL-6)、肿瘤坏死因子-α (tumor necrosis factor-α, TNF-α)的影响。方法：本研究为单中心、前瞻性、随机对照试验，选取2024年2月至2025年2月收治的70例原位冠状动脉弥漫病变患者，按照随机数字表法分为DES组(n = 35)和DES + DCB联合组(n = 35)，均接受经皮冠状动脉介入治疗(PCI)。比较两组患者在术前、术后即刻及术后12个月的冠状动脉最小管腔直径(MLD)、狭窄率及炎症标志物水平，并评估主要不良心血管事件(MACE)发生率。结果：两组患者的一般基线资料和冠脉病变情况差异无统计学意义(P > 0.05)。术后，两组患者的最小管腔直径均显著增加(P < 0.01)，且DES + DCB组在术后即刻及12个月时均明显优于DES组(P < 0.05)。与术前相比，术后即刻及12个月时，两组MLD均显著升高(P < 0.01)，且DES + DCB组始终高于DES组，差异具有统计学意义(P < 0.01)。术后即刻及12个月时，两组患者的靶血管管腔狭窄率均较术前显著降低(P < 0.01)，其中DES + DCB组的狭窄率明显低于DES组(P < 0.05)。在术前及术后即刻，两组炎症指标(hs-CRP, IL-6, TNF-α)未表现出统计学上的显著差异(P > 0.05)。然而，术后12个月复查时，DES + DCB组的炎症指标明显低于DES组(P < 0.01)，且该差异具有统计学意义(P < 0.05)。此外，12个月随访期间，两组MACE发生率无统计学上的显著区别(P > 0.05)。结论：DES联合DCB治疗可显著改善冠状动脉弥漫病变患者的血管通畅性，提高术后即刻及12个月随访时的MLD，降低靶血管狭窄率，同时减少hs-CRP、IL-6和TNF-α水平，抑制炎症反应，是治疗原位冠状动脉弥漫病变的潜在有效方法，为该类病变的治疗提供了新的临床选择。

Abstract: Background: In-situ diffuse coronary disease (IDCD) is a complex subtype of coronary atherosclerotic heart disease (CHD), with limited efficacy of conventional treatment strategies. Drug-eluting stents (DES) and drug-coated balloons (DCB) have been widely used in percutaneous coronary intervention (PCI); however, the combined application of these two approaches and their impact on the inflammatory response remain insufficiently studied. Objective: To evaluate the efficacy of DES combined with DCB in the treatment of in-situ diffuse coronary disease and to analyze its effects on inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α). Methods: This study is a single-center, prospective, randomized controlled trial. A total of 70 patients with IDCD, admitted between February 2024 and February 2025, were randomly assigned to either the DES group (n = 35) or the DES + DCB combination group (n = 35) using a random number table method. All patients underwent PCI. The minimal lumen diameter (MLD), lumen stenosis rate, and inflammatory biomarker levels were compared between the two groups at baseline (pre-procedure), immediately post-procedure, and at the 12-month follow-up. Additionally, the incidence of major adverse cardiovascular events (MACE) was recorded. Results: There were no significant differences in baseline clinical characteristics and coronary lesion profiles between the two groups (P > 0.05). After PCI, the MLD significantly increased in both groups (P < 0.01), with the DES + DCB group demonstrating superior outcomes both immediately post-procedure and at the 12-month follow-up compared to the DES group (P < 0.05). Compared with pre-procedure values, MLD significantly increased immediately post-procedure and at 12 months in both groups (P < 0.01), and the DES + DCB group consistently showed higher values than the DES group (P < 0.01). Similarly, the target vessel stenosis rate significantly decreased in both groups immediately post-procedure and at 12 months (P < 0.01), with a significantly lower stenosis rate observed in the DES + DCB group compared to the DES group (P < 0.05). Pre-procedure and immediately post-procedure, there were no significant differences in inflammatory markers (hs-CRP, IL-6, and TNF-α) between the two groups (P > 0.05). However, at the 12-month follow-up, the inflammatory marker levels in the DES + DCB group were significantly lower than those in the DES group (P < 0.01), with statistically significant differences between the groups (P < 0.05). The incidence of MACE during the 12-month follow-up showed no statistically significant difference between the two groups (P > 0.05). Conclusion: DES combined with DCB therapy can significantly improve vascular patency in patients with diffuse coronary artery disease, increase MLD immediately after surgery and at the 12-month follow-up, and reduce target vessel stenosis. Additionally, this strategy lowers hs-CRP, IL-6, and TNF-α levels, suppresses inflammatory responses. It is a potentially effective approach for treating de novo diffuse coronary artery disease, providing a new clinical option for managing this condition.