DES Efficacy Expands Beyond Current Labeling

　　2007年TCT会议报告的美国Guthrie研究是一项单中心、前瞻性、目前仍在进行中的临床注册研究。从2001年7月至2005年12月，共入选3044例PCI患者，排除409例未置入支架者、443例曾行PCI者、69位同时置入DES和BMS者以及769位非DES适应证患者，通过病案回顾分析、电话问卷以及检索社会保险死亡登记等方法随访。

　　结果显示：置入BMS组和DES组全因死亡率分别为11.5%比5.2% (P = 0.052)。其它终点事件，DES组也明显优于BMS组。置入DES，服用抗血小板药物>12个月和<12个月各组死亡及心肌梗死总体发生率分别为7.6%和11%。置入BMS，服用抗血小板药物>12个月和<12个月各组死亡及心肌梗死总体发生率分别为13%和16%。

　　Guthrie 医学中心Harjai博士指出，由于BMS组随访时间为800天，而DES组仅随访500天，同时由于入组患者病情较重（平均LVEF仅为45%，21%有心肌梗死病史，21%曾行CABG，近一半病例需紧急介入治疗），可能增加DES组评估有效性。

　　（哈尔滨医科大学附属第一医院　李悦　耿建强　编译　李为民　审校）

DES Efficacy Expands Beyond Current Labeling

Drug-eluting stents reduced TVR without a detrimental effect on stent thrombosis.

DES implantation and prolonged dual-antiplatelet therapy in patients who are not indicated for newer stents appears to be superior to bare-metal stents or use of DES and short-duration dualantiplatelet therapy, according to results of the Guthrie PCI registry.

When comparing DES with baremetal stents all-cause mortality was 11.5% for patients treated with baremetal stents vs. 5.2% for patients treated with DES (P = .052). Kishore J. Harjai, MD, a cardiologist atGuthrie Hospital System in Sayre, Pa., said this difference may be exaggerated because follow-up was 800 days for bare-metal stents and 500 days for DES. Other outcomes also favored DES (Table).

 
Patients treated with DES who had antiplatelet therapy for more than 12 months had a 7.6% rate of death or MI. Patients treated with DES and antiplatelet therapy for 12 months or less had an 11% rate of death or MI.

Among patients treated with BMS, the rate of MI or death was 13% if antiplatelet therapy lasted longer than 12 months and 16% if antiplatelet therapy was 12 months or less.

Sicker patients

The Guthrie PCI registry is a single-center, prospective, ongoing observational PCI registry. It began in July 2001. Guthrie researchers monitor clinical outcomes for all PCIs using medical record review, telephone questionnaire, and Social Security Death Index.

Researchers had originally screened 3,044 patients between July 2001 and December 2005 but excluded 409 who did not receive a stent, 443 who had a previous PCI during the study period, 69 who had been given both a DES and a baremetal stent, and a final 769 patients who were not indicated for DES under current labeling.

Harjai said the patients (n=1,354) in the Guthrie registry were sicker than the general PCI population, with
21% having a prior MI and 21% having prior CABG. Nearly half of the patients needed an urgent procedure, and mean LVEF was 45% (Figure).