Zbinden Rainer, von Felten Stefanie, Wein Bastian, Tueller David, Kurz David J, Reho Ivano, Galatius Soren, Alber Hannes, Conen David, Pfisterer Matthias, Kaiser Christoph, Eberli Franz R
Department of Cardiology, Triemlispital Zurich, Zurich, Switzerland.
Department of Cardiology, University Hospital Basel, Basel, Switzerland.
Cardiovasc Ther. 2017 Feb;35(1):19-25. doi: 10.1111/1755-5922.12229.
The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS.
METHODS/RESULTS: The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001). The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective.
In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length.
英国国家临床优化研究所(NICE)指南建议,仅在病变长度大于15毫米或血管直径小于3毫米的情况下使用药物洗脱支架(DES)而非裸金属支架(BMS)。我们在BASKET - PROVE研究人群中分析了支架长度和支架直径对支架内再狭窄(ISR)的影响,并评估了DES与BMS相比的成本效益。
方法/结果:BASKET - PROVE试验在大冠状动脉(≥3毫米)中比较了DES与BMS。我们计算了关于获得的质量调整生命年(QALY)和避免的靶病变血运重建(TLR)的增量成本效益比(ICER)和成本效益可接受性曲线。分析共纳入2278例患者。观察到63例患者发生74例ISR。与DES治疗的节段相比,BMS治疗的节段中支架内再狭窄明显更频繁(5.4%对0.76%;P<0.001)。DES与BMS相比在ISR方面的益处分别在支架长度>15毫米和≤15毫米的亚组中是一致的。在短病变中使用DES时,QALY仅获得了极小的增加,增加量为0.005。在每避免一次TLR的阈值为10000瑞士法郎时,DES具有较高的成本效益概率。
在BASKET - PROVE研究人群中,ISR的最强预测因素是使用BMS,即使在需要支架的病变长度≥3.0毫米且≤15毫米的患者中,DES也具有成本效益。这应促使NICE重新评估其仅在血管<3.0毫米和病变长度>15毫米时使用DES而非BMS的建议。