Chambers Jeffrey, Généreux Philippe, Lee Arthur, Lewin Jack, Young Christopher, Crittendon Janna, Mann Marita, Garrison Louis P
Metropolitan Heart and Vascular Institute, Mercy Hospital, Coon Rapids, MN, USA.
Cardiovascular Research Foundation, New York, NY, USA.
Ther Adv Cardiovasc Dis. 2016 Apr;10(2):74-85. doi: 10.1177/1753944715622145. Epub 2015 Dec 23.
Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective.
In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895.
Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions.
长期以来，人们已知因严重钙化冠状动脉病变接受经皮冠状动脉介入治疗（PCI）的患者，其临床和经济结局比无钙化或轻度钙化病变的患者更差。我们试图从卫生系统的角度评估使用钻石背360（®）轨道旋磨系统（OAS）治疗初发严重钙化病变的潜在成本效益。
在缺乏头对头试验和长期随访的情况下，成本效益基于临床和经济数据的模型合成。使用成本效益模型来预测可能的经济影响。为了估计净成本影响，将在患有初发严重钙化病变的老年（≥65岁）医疗保险患者中使用OAS技术的成本与成本抵消进行比较。使用观察数据将来自ORBIT II试验（评估OAS治疗严重钙化冠状动脉病变的安全性和有效性）[ClinicalTrials.gov标识符：NCT01092426]的老年OAS患者与类似患者进行间接比较。对于索引手术，与医疗保险数据进行比较；对于次年的血管重建和心源性死亡，与急性心肌梗死血管重建和支架置入统一结局（HORIZONS-AMI）/急性导管插入术和紧急干预分诊策略（ACUITY）试验的汇总分析进行比较。在调整年龄、性别和合并症差异后，ORBIT II平均索引手术成本低17%（P<0.001），约2700美元。在基础案例中，估计的平均血管重建成本低1240美元。第一年的这些成本抵消平均完全覆盖了设备成本，还额外节省了1.2%的成本。即使在低价值情景下，使用OAS也是具有成本效益的，每获得一个生命年的成本为11895美元。
基于经济模型，最近获批的冠状动脉OAS设备预计对于因严重钙化病变接受PCI的患者具有高度成本效益。
