Yoshida Taiji, Sakata Kenji, Nitta Yutaka, Taguchi Tomio, Kaku Bunji, Katsuda Shoji, Shimojima Masaya, Gamou Tadatsugu, Nakahashi Takuya, Konno Tetsuo, Kawashiri Masa-Aki, Yamagishi Masakazu, Hayashi Kenshi
Department of Cardiology, Toyama Red Cross Hospital, Toyama, Japan.
Division of Cardiovascular Medicine, Kanazawa University Graduate School of Medicine, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.
Heart Vessels. 2016 May;31(5):635-42. doi: 10.1007/s00380-015-0655-3. Epub 2015 Mar 11.
Although drug-eluting stents (DES) for percutaneous coronary intervention (PCI) have dramatically reduced the incidence of in-stent restenosis, their deployment for large-size coronary lesions is still controversial because of problems such as late in-stent thrombosis and late catch-up in DES. We aimed to evaluate the long-term outcome beyond 2 years of bare metal stents (BMS) as compared with DES in large vessels. Consecutive 228 patients who underwent PCI with large-size stents (>3.5 mm in diameter) in our hospital were enrolled in this study. The end points of this study are target lesion revascularization (TLR) and occurrence of major adverse cardiac events (MACE) for subject patients. We analyzed 183 patients (152 men, mean age 65.8 ± 10.5 years) whose outcome could be followed up for at least 2 years. At the first 8-month follow-up, clinically driven TLR rate was significantly higher in patients who received BMS than those who received DES (17.2 vs. 2.2 %, p < 0.05), although the rate of TLR was not different between the 2 groups beyond 8 months. Thus, overall rate of TLR was higher in BMS than in DES (22.7 vs. 5.4 %, p < 0.05). Under these conditions, the higher rate of TLR for BMS was observed in simple as well as complex lesions with or without diabetes, although there were no significant differences in MACE between BMS and DES. Multivariate analysis showed that BMS was an only independent factor of TLR at the 8 month follow-up period [p = 0.004, odds ratio 9.58, 95 % confidence interval (2.10-43.8)]. These results demonstrate that the rate of in-stent restenosis in large-size coronary lesions was transiently higher in the first 8 months for patients implanted with BMS compared with DES in which no in-stent thrombosis and TLR beyond 2 years were observed. We suggest using the DES even in large-size coronary lesions in terms of short- and long-term outcomes.
尽管用于经皮冠状动脉介入治疗（PCI）的药物洗脱支架（DES）显著降低了支架内再狭窄的发生率，但由于诸如晚期支架内血栓形成和DES晚期追赶等问题，其在大尺寸冠状动脉病变中的应用仍存在争议。我们旨在评估与DES相比，裸金属支架（BMS）在大血管中2年以上的长期预后。本研究纳入了我院连续228例行大尺寸支架（直径>3.5mm）PCI的患者。本研究的终点是目标病变血运重建（TLR）和受试者主要不良心脏事件（MACE）的发生情况。我们分析了183例患者（152例男性，平均年龄65.8±10.5岁），其预后至少随访了2年。在首次8个月随访时，接受BMS的患者临床驱动的TLR率显著高于接受DES的患者（17.2%对2.2%，p<0.05），尽管8个月后两组的TLR率没有差异。因此，BMS的总体TLR率高于DES（22.7%对5.4%，p<0.05）。在这些情况下，无论有无糖尿病，在简单和复杂病变中均观察到BMS的TLR率较高，尽管BMS和DES之间的MACE没有显著差异。多变量分析显示，在8个月随访期，BMS是TLR的唯一独立因素[p=0.004，优势比9.58，95%置信区间（2.10 - 43.8）]。这些结果表明，与DES相比，植入BMS的患者在大尺寸冠状动脉病变中，支架内再狭窄率在最初8个月内暂时较高，而DES未观察到2年以上的支架内血栓形成和TLR。就短期和长期预后而言，我们建议即使在大尺寸冠状动脉病变中也使用DES。
