冠心病患者选用新一代药物释放支架更安全?

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楼主 2022-01-12 16:15:36
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医学路透社报道:


在美国,心血管疾病是死亡的第一位原因,而冠状动脉疾病则是心血管疾病中最常见的疾病。而在我国约有900万人患有冠状动脉疾病,每年大约有30万例病人死亡。对于这种疾病的治疗方法,有传统的冠脉搭桥手术,但对病人的侵人性、创伤性较大、成本较高、康复时间较长。药物释放支架是一种新型治疗手段,通过覆盖有一种可向动脉血管壁提供药物的聚合物载体,置入人体后控制式逐步释放药物,从而达到治疗效果。

随着科技的进步,药物释放支架技术也随之发展。新一代支架被认为是冠状动脉疾病患者经皮干预治疗的标准工具。然而,临床却鲜有数据证明新一代的支架在安全性和有效性方面是否胜于前一代。因此,最近刊登在美国心脏病学会杂志心血管介入治疗分刊上的一篇文章试图从冠状动脉疾病的解剖学复杂性角度,对这个问题进行临床数据的分析。

研究者从4个数据库中随机收取样本。试验的终点筛选指标包括心脏死亡、心肌梗塞或者缺血造成的靶血管再血管化。而对于安全性和有效性的判断标准则分别是再血管化以及明确的支架血栓形成。样本根据解剖学复杂度分为高低两组,研究者对其进行两年的调整风险比和95%置信区间的统计以及分析。

结果在接受随机分组的6081名患者中,使用新一代的药物释放支架的4554名患者较使用前代的1527名患者而言,试验意义上的生存率得到提高。而针对于解剖学上复杂度高的患者(SYNTAXscore >11),新一代的支架能明显改善再血管化(HR: 0.36 [95% CI: 0.26 to0.51]; p < 0.001)以及明确的支架血栓形成(HR: 0.28 [95% CI: 0.15to 0.55]; p < 0.001)。

这项研究表明,如果患者的冠状动脉解剖学复杂性已达高值(SYNTAX score>11)的话,在有效性和安全性方面新一代的药物释放支架将是更好的选择。

Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary ArteryDisease----A Patient-Level Pooled Analysis of 6,081 Patients


OBJECTIVES The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score.


BACKGROUND New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new-over early-generation DES according to the an atomic complexity of CAD.


METHODS Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, orischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score 11) and higher complexity (SYNTAX score >11).


RESULTS A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) comparedwith early-generation. DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI:0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p=0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR pint=0.059; ST pint= 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p =0.003) but not inpatients with SYNTAX score 11 (pint =0.042).


CONCLUSIONS New-generation DES improve clinical outcomes compared with early-generation DES, with a greatersafety and effectiveness in patients with SYNTAX score >11.




大医编原创翻译:

Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary Artery Disease: A Patient-Level Pooled Analysis of 6,081 Patients. JACCC ardiovasc Interv, 8(13), 1657-1666. doi: 10.1016/j.jcin.2015.08.013.






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