Chan Chi Yuen, Vlachos Helen, Selzer Faith, Mulukutla Suresh R, Marroquin Oscar C, Abbott Dawn J, Holper Elizabeth M, Williams David O
Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Catheter Cardiovasc Interv. 2014 Jul 1;84(1):24-9. doi: 10.1002/ccd.25339. Epub 2014 Jan 6.
This study sought to evaluate the safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels.
Randomized trials have demonstrated that DES reduce the risk of target vessel revascularization (TVR) compared to BMS. This benefit is less pronounced as artery diameter increases. Whether DES are superior to BMS for larger coronary arteries in the setting of routine clinical practice is unknown.
We analyzed data from 869 patients undergoing de novo lesion PCI with reference vessel diameter greater than or equal to 3.5 mm in the NHLBI Dynamic Registry according to whether they were treated with DES or BMS. Patients were followed for 3 years for the occurrence of cardiovascular events.
At 3-year follow-up, rates of TVR at 3 years were similar and low in both groups (4.4% vs. 3.7%, P = 0.62). After adjustment for differences in baseline characteristics, the adjusted hazard ratio for 3-year MI for DES was 1.85 (95% CI 0.93-3.7, P = 0.08), for TVR at 3 years 1.14 (95% CI 0.52-2.49, P = 0.75) and for mortality 0.89 (95%CI 0.49-1.62, P = 0.71).
In our study of the unrestricted use of DES for patients with lesions in larger diameter coronary arteries, first generation DES did not reduce 3-year risk of TVR. Our findings do not support the preferred use of DES over BMS for patients with lesions located in arteries >3.5 mm. It is unknown whether secondary generation DES can offer better outcome compared to BMS in large coronary vessels. Further study on this issue is warranted.
本研究旨在评估药物洗脱支架（DES）与裸金属支架（BMS）相比，用于大冠状动脉患者的安全性和有效性。
随机试验表明，与BMS相比，DES可降低靶血管重建（TVR）风险。随着动脉直径增加，这种益处不太明显。在常规临床实践中，DES对于较大冠状动脉是否优于BMS尚不清楚。
我们根据患者接受DES或BMS治疗情况，分析了美国国立心肺血液研究所动态注册研究中869例首次病变经皮冠状动脉介入治疗（PCI）且参考血管直径大于或等于3.5mm患者的数据。对患者进行3年随访，观察心血管事件的发生情况。
在3年随访时，两组3年TVR发生率相似且较低（4.4%对3.7%，P = 0.62）。在对基线特征差异进行调整后，DES组3年心肌梗死（MI）的调整后风险比为1.85（95%置信区间0.93 - 3.7，P = 0.08），3年TVR为1.14（95%置信区间0.52 - 2.49，P = 0.75），死亡率为0.89（95%置信区间0.49 - 1.62，P = 0.71）。
在我们对大直径冠状动脉病变患者 unrestricted 使用DES的研究中，第一代DES并未降低3年TVR风险。我们的研究结果不支持对于动脉直径>3. mm病变患者优先使用DES而非BMS。与BMS相比，第二代DES在大冠状动脉中是否能提供更好的结果尚不清楚。对此问题有必要进一步研究。
