Three-Year Outcomes of the RESILIENT Trial: Are They Enough to Support a Primary Stenting Policy?
Three-Year Outcomes of the RESILIENT Trial: Are They Enough to Support a Primary Stenting Policy?
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RESILIENT 试验的三年结果：是否足以支持主要支架置入政策？
DOI：
10.1583/11-3627c.1
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发表时间：
2012
影响因子：
2.6
通讯作者：
M. Davies
中科院分区：
文献类型：
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作者：
M. Davies
Laird等人在本期JEVT中的报告描述了RESILIENT试验中患者的晚期临床结局，该试验比较了SFA和近端腘动脉中长度达15 cm的病变的初次镍钛合金支架植入术与球囊血管成形术。本试验的第一份报告表明，支架组12个月无靶病变血运重建（TLR）和一期通畅率（通过超声评估）显著优于血管成形术组。然而，当在二次分析中检查球囊血管成形术加临时支架植入术时，差异幅度减小。目前的研究扩展了这些观察结果，但不能使用前12个月的严格随访策略。在本报告中，对于SFA和近端腘动脉中的中等长度病变，初次支架植入术与球囊血管成形术之间的临床驱动TLR差异维持在3年。支架断裂率仍然较低，支架断裂很少伴有任何不良临床后遗症。重要的是，初次支架植入术和球囊血管成形术加临时支架植入术在后期时间点的结局没有差异：初次支架植入术组36个月时无TLR的比例为75.5%，而血管成形术加临时支架植入术组为70.1%。这项研究回答了它提出的狭义问题。初次支架植入术优于无紧急支架植入术的血管成形术。然而，目前的临床实践是基于初次支架植入术或血管成形术和补救性支架植入术，本研究也证明了这些策略没有差异。这样的发现是重要的，因为成本效益和成本控制现在是大多数介入套件的焦点。支架断裂的低发生率证明了当前的技术，并且确实消除了需要支架植入术的患者对支架断裂的担忧。虽然解剖通畅性和血流动力学成功很重要，但进行任何经皮介入的主要原因是症状缓解、生活质量改善和长期临床成功。临床驱动的TLR和生活质量在初次支架植入术组和血管成形术组之间没有差异，这提出了该患者人群中解剖结局和以患者为中心的结局之间存在差异的问题。总之，虽然该研究是积极的，并满足其假设和目标，所采取的策略的临床效用和令人失望的缺乏差异的生活质量在2至3年必须提出的问题，是否这个数据集本身就应该强制要求改变的做法和供应成本急剧增加与主要支架植入政策。
The report by Laird et al. in this issue of JEVT describes the late clinical outcomes for patients in the RESILIENT trial, which compared primary nitinol stent implantation with balloon angioplasty for lesions up to 15 cm in length in the SFA and proximal popliteal artery. The first report from this trial demonstrated that 12-month freedom from target lesion revascularization (TLR) and primary patency as assessed by ultrasound were significantly better for the stent group compared to the angioplasty group. However, the magnitude of the difference was diminished when balloon angioplasty plus provisional stenting was examined in secondary analyses. The current study extends these observations, but could not use the rigorous follow-up strategy of the first 12 months. In the current report, the difference in clinically-driven TLR between primary stenting over balloon angioplasty for moderate-length lesions in the SFA and proximal popliteal artery was maintained at 3 years. The rate of stent fracture remained low, and stent fracture was infrequently associated with any adverse clinical sequelae. Importantly, there was no difference in the outcomes of primary stenting and balloon angioplasty plus provisional stenting at the later time points: freedom from TLR at 36 months was 75.5% for the primary stent group compared to 70.1% for the angioplasty plus provisional stent group. This study has answered the narrow question it posed. Primary stenting is better than angioplasty without bailout stenting. However, current clinical practice is based on primary stenting or angioplasty with bailout stenting, and this study has also demonstrated that there is no difference in these strategies. Such findings are important as cost effectiveness and cost containment are now a focal point in most interventional suites. The low rate of stent fractures is a testament to the current technology and does ally fears of stent fracture in patients requiring stenting. While anatomical patency and hemodynamic success are important, the primary reason to perform any percutaneous intervention is symptom relief, improved quality of life, and long-term clinical success. Clinically-driven TLR and quality of life were not different between the primary stenting and angioplasty groups, which raised the question of the discrepancy between anatomical outcomes and the patientcentered outcomes in this patient population. In conclusion, while the study is positive and satisfies its hypothesis and goal, the clinical utility of the strategy adopted and the disappointing lack of difference in quality of life at 2 to 3 years must raise the question whether this dataset alone should mandate a change in practice and the dramatic increase in supply costs associated with a primary stenting policy.