No Benefit of Thienopyridines Beyond 1 Year in Analysis of TAXUS Data

　　根据对三份研究5年随访结果的综合分析，学者们认为thienopyridine对裸支架或药物释放支架置入者没有明显帮助。

　　CRF主席Gregg W. Stone在宣讲中指出，来自Taxus II和Taxue IV的5年随访结果，以及Taxus V研究的两年随访结果证实了这一点。他说：“目前的结果并不支持在原发单支病变中将thienopyridine的常规使用延长到药物释放支架或裸支架术后一年之后。”

　　现在继续研究的重点应该集中在为何两家研究机构得出了不同的结论。两家机构分别是杜克大学和来自米兰的研究所。研究共囊括了2171名PCI术后一年的患者，这些患者均未发生过心梗，靶血管血运重建和支架血栓。

　　未观察到差异

　　根据患者接受支架的类型对其进行了分组，其中裸支架1030例，Taxus支架1141例，并再次细分为服用thienopyridine组和未服用组。其中56.6%的裸支架患者和54.7%的药物释放支架患者未接受thienopyridine治疗。

　　四组中都未显示thienopyridine有何更多益处，考察的因素包括死亡，心梗和支架血栓，时程为2年和5年。基线水平的差异通过多因分析进行了消除，四组在消除了基线差异后没有显著性不同。

　　Stone指出支架血栓出现在12名药物释放支架患者中，8名在1年时未坚持采用thienopyridine，4名接受了thienopyridine治疗。这一差异未达到显著性指标。

　　那些未坚持药物治疗的患者，血栓最早出现在410天时，此时药物治疗已经中止。在接受thienopyridine治疗的药物释放支架组人群中，一年时有两名出现了支架血栓。

　　Stone指出，在一年时接受和不接受thienopyridine治疗的人群间存在着一个显著的基线差异。在DES组，接受thienopyridine治疗的患者中糖尿病人较多。另外，无论DES组还是裸支架组，病变长度，支架个数和总支架长度在thienopyridine组中都比未接受thienopyridine治疗组严重。

　　有些在一年期时接受thienopyridine的患者在5年时放弃了治疗，而有些则坚持了下来。这些差异都通过多因分析进行了消除，因此结果应该是准确的。

　　（北京协和医院　鲁勖　编译）

No Benefit of Thienopyridines Beyond 1 Year in Analysis of TAXUS Data

Five-year follow-up from 3 trials: no event ratedifference between bare-metal stents and DES.

There was no significant benefit from extended thienopyridine use in patients with DES or bare-metal stents with up to 5 years’ follow-up, according to a retrospective analysis of pooled data from three clinical trials.

Gregg W. Stone, MD, chairman of the Cardiovascular Research Foundation, presented the analysis of combined data from 5-year results of the TAXUS II and TAXUS IV trials and 2-year results of the TAXUS V trial.

“The current analysis does not provide support for routinely extending thienopyridine treatment beyond 1 year in patients event-free at this time after either DES or bare metal stents in single de novo lesions in native coronary arteries,” Stone said.

The impetus for the landmark analysis, he said, was the conflicting results reached by researchers from Duke University and Milan, Italy. The two groups reached opposite conclusions concerning the risk of adverse events in patients receiving DES.

The trials included 2,171 patients who were free of death, MI, TVR or ARC-defined stent thrombosis at 1
year after PCI.

No differences seen

Patients were divided according to whether they received a bare-metal stent (n = 1,030) or a Taxus (Boston Scientific) stent (n= 1,141), and subdivided into those taking or not taking a thienopyridine at 1 year (56.6% of those with bare-metal stents and 54.7% of those with DES were not taking a thienopyridine).

No statistically significant benefits of thienopyridine use were seen among the 4 groups (patients receiving DES or bare-metal stents with or without thienopyridines) at 2 or 5 years in terms of all-cause death; death or MI; stent thrombosis; or death, MI or stent thrombosis (P = NS for all).

Multivariate analysis was performed to compensate for baseline differences. No statistically significant differences were seen among the four groups.

Stone pointed out that stent thrombosis occurred in 12 patients with DES – 8 who were noncompliant with thienopyridines at 1 year and 4 who were compliant. This difference was not statistically significant (P = .43).

In those who were noncompliant with drug therapy, thrombosis occurred within at least 410 days and up to 1,334days after drug therapy was stopped. In the DES patients who were compliant with thienopyridine use at 1 year, 2 of the stent thromboses occurred while the patient was still taking the drugs.

There were some significant baseline differences between those taking and not taking a thienopyridine at 1 year, Stone said. In patients with DES, among those taking the drug there were more diabetic patients (29.4% vs. 19.9%, P = .0002). In addition, in both DES and bare-metal stent patients, lesion length was longer, number of stents was greater, and total stent length was greater in those taking a thienopyridine (P , .05 for all).

Some patients who were compliant with thienopyridine at 1 year were noncompliant by 5 years, and some who were noncompliant at 1 year had become compliant during the remaining follow-up. These differences were compensated for with multivariate analysis, Stone said.