Moreno Raúl, Fernandez Cristina, Sanchez-Recalde Angel, Galeote Guillermo, Calvo Luis, Alfonso Fernando, Hernandez Rosana, Sánchez-Aquino Rosa, Angiolillo Dominick J, Villarreal Sergio, Macaya Carlos, Lopez-Sendon Jose L
Department of Interventional Cardiology, University Hospital La Paz, Paseo La Castellana, 261, 28046 Madrid, Spain.
Eur Heart J. 2007 Jul;28(13):1583-91. doi: 10.1093/eurheartj/ehl423. Epub 2007 Feb 8.
Controversy exists about the clinical significance of in-stent late loss (ISLL) after drug-eluting stent (DES) implantation. We sought to clarify whether ISLL after DES implantation is related to a potential clinical impact.
We included in a meta-regression analysis 21 trials (8641 patients) that randomly compared DES with bare-metal stents (BMS). We evaluated the relationship between angiographic behaviour of DES and the clinical impact of using DES instead of BMS in each trial using meta-regression techniques, weighting by the number of patients included in each trial. Mean ISLL in patients allocated to DES and DeltaISLL (difference in ISLL in patients allocated to BMS and DES) were used as angiographic parameters of efficacy of DES. The number of patients needed to be treated (NNT) to prevent one target lesion revascularization (TLR) was used to quantify the clinical impact of using DES instead of BMS. There was a significant relationship between mean ISLL in patients allocated to DES and the clinical benefit of using DES instead of BMS, as measured with the NNT for TLR: NNT for TLR = 6.2 + 18.4 [ISLL-DES] (R = 0.62; P = 0.007). Therefore, a 0.1 mm increase in mean ISLL-DES was associated with a 1.8 increase in NNT for TLR. There was also a significant association between the degree of inhibition of neointimal hyperplasia of DES in comparison with BMS with the NNT for TLR: NNT for TLR = 17.1-11.8 [DeltaISLL] (R = 0.61; P = 0.008). Therefore, a 0.1 mm reduction in ISLL by using DES instead of BMS was associated with a 1.2 decrease in mean NNT for TLR.
There is a strong and significant association between the degree of inhibition of neointimal formation with the use of DES and the clinical impact of using DES instead of BMS.
药物洗脱支架(DES)植入术后支架内晚期管腔丢失(ISLL)的临床意义存在争议。我们试图阐明DES植入术后的ISLL是否与潜在的临床影响相关。
我们纳入了21项试验(8641例患者)进行Meta回归分析,这些试验将DES与裸金属支架(BMS)进行了随机对照比较。我们使用Meta回归技术,根据每个试验纳入的患者数量进行加权,评估了DES的血管造影表现与在每个试验中使用DES而非BMS的临床影响之间的关系。分配至DES组患者的平均ISLL以及DeltaISLL(分配至BMS组和DES组患者的ISLL差值)被用作DES疗效的血管造影参数。预防一次靶病变血管重建(TLR)所需治疗的患者数量(NNT)用于量化使用DES而非BMS的临床影响。分配至DES组患者的平均ISLL与使用DES而非BMS的临床获益之间存在显著关系,以预防TLR的NNT衡量:预防TLR的NNT = 6.2 + 18.4 [DES组的ISLL](R = 0.62;P = 0.007)。因此,DES组平均ISLL每增加0.1 mm,预防TLR的NNT增加1.8。与BMS相比,DES对内膜增生的抑制程度与预防TLR的NNT之间也存在显著关联:预防TLR的NNT = 17.1 - 11.8 [DeltaISLL](R = 0.61;P = 0.008)。因此,使用DES而非BMS使ISLL降低0.1 mm,平均预防TLR的NNT降低1.2。
使用DES对内膜形成的抑制程度与使用DES而非BMS的临床影响之间存在强烈且显著的关联。