在抢救PCI的初期使用GP IIb/IIIa 抑制剂会增加非颅内性出血


  2003 年3月31 日(芝加哥) - 11个再灌流试验的统合分析(meta-analysis) 结果显示,在经皮冠状动脉介入性治疗期间(PCIs)的初期,使用糖蛋白(GP)IIb/IIIa 抑制剂,会增加出血的风险,但不会增加颅内出血的比率(ICH)。
  
  北卡罗来纳州Duke临床研究机构的医学助教,也是本研究的领导作者Matthew T. Roe博士表示,胃肠道出血和生殖泌尿道出血是最常报告的并发症。GP IIb/IIIa 治疗的患者,其中度对重度的出血比率为17.1%,相较于未进行治疗的患者为11.6%。
  
  Roe补充,有一个较低ICH的趋势,但是并未达到统计意义。在GP IIb/IIIa 组中,ICH比率是0.48%,相较于未接受GP IIb/IIIa 抑制剂的患者则为0.75%。GP IIb/IIIa 治疗的患者,其30天死亡率较低 (3.7% 对4.9%)。Roe于美国心脏病学会第52届年度科学会议中提出这项研究结果。
  
  Roe表示,年长、体重轻的女性与相关糖蛋白IIb/IIIa 抑制剂相关的增加出血风险较大。但是这些为棘手的患者,并没有清楚的证据建议如何治疗这个族群的患者。
  
  马萨诸塞州波士顿哈佛医学院的医学教授Elliott Antman指出,一项重要的因素是病势渐退的时间,如果是12个到24 小时以外,出血的并发症较不可能发生。Antman博士并未参与研究,但是他主持提出这项研究结果的会议。
  
  另外,Antman博士认为,GP IIb/IIIa 抑制剂在减少剂量的病势渐退以后,也许是安全的。这份资料来自于完整剂量病势渐退的试验中。
  
  统合分析包括11项试验的资料,评估ST段压高心肌梗塞的再灌流新疗法。包括的试验为ASSENT1、2和3;GUSTO III和V;TIMI 10B和14;In-TIME2;FASTER,及INTEGRITI。
  
  Roe博士分析了3,342 名以完整剂量的纤维溶解疗法治疗的患者资料,他们在PCI初期的24 小时内接受治疗。评估患者并用GP IIb/IIIa抑制剂的第一个24 小时之内,其GUSTO等级之中度/重度出血风险、ICH及30 天死亡率的差异。
  
  大约三分之一的患者 (n = 1,038) 接受了GP IIb/IIIa 抑制剂。通常,以GP IIb/IIIa 抑制剂治疗的患者更加年轻(平均年龄,57.3 对58.3岁) 体重也更重(平均重量为84.8 公斤对81.6公斤)。接受GP IIb/IIIa 抑制剂治疗的男性(20.6%) 也比女性多(18.5%)。治疗的患者是较不可能发生前梗塞(40.9% 对42.4%),但是和更可能罹患糖尿病(17.0% 对14.7%)。
  
  根据结果,Roe博士认为还需要一项预期性、随机化的试验,以描绘出GP IIb/IIIa抑制剂在PTCA治疗期间的风险和优点。
  ACC第52届科学年会:1025MP-163。于2003 年3月30 日提出。

Early GP IIb/IIIa Blockade Dur

By Peggy Peck
Medscape Medical News

March 31, 2003 (Chicago) — Results of a meta-analysis of 11 reperfusion trials indicate that early use of glycoprotein (GP) IIb/IIIa blockade during rescue percutaneous coronary interventions (PCIs) increases the risk for bleeding, but does not increase the rate of intracranial hemorrhage (ICH).

"GI bleeds and genitourinary bleeding were the most common reported complications," said lead author Matthew T. Roe, MD, assistant professor of medicine at Duke Clinical Research Institute in Durham, North Carolina. The moderate to severe bleed rate was 17.1% in the GP IIb/IIIa-treated patients compared with 11.6% in the nontreated patients, he said.

There was a "trend toward lower ICH but this did not reach statistical significance," added Dr. Roe. In the GP IIb/IIIa group, the ICH rate was 0.48% compared with 0.75% in patients who didn't receive GP IIb/IIIa blockade.

Thirty-day mortality was lower in the GP IIb/IIIa-treated patients (3.7% vs. 4.9%). Dr. Roe presented the results here yesterday at the American College of Cardiology 52nd Annual Scientific Session.

"Elderly, light-weight females had the greatest risk for increased bleeding" associated with glycoprotein IIb/IIIa blockade, Dr. Roe said. "But these are tough patients and there is no clear evidence to suggest how to treat this group."

"An important factor is time out from lysis," Elliott Antman, MD, professor of medicine at Harvard Medical School in Boston, Massachusetts, told Medscape. "I think if one is 12 to 24 hours out, bleeding complications are less likely." Dr. Antman was not involved in the study, but he chaired the session at which the results were presented.

Additionally, Dr. Antman said that GP IIb/IIIa blockade may be safer after "reduced-dose lysis. These data come from trials that looked at full-dose lysis."

The meta-analysis included data from 11 trials that evaluated new reperfusion regimens for ST-elevation myocardial infarction. The included trials were ASSENT 1, 2, and 3; GUSTO III and V; TIMI 10B and 14; In-TIME-2; SPEED; FASTER; and INTEGRITI.

Dr. Roe analyzed data from 3,342 patients who were treated with full-dose fibrinolytic therapy who then underwent early PCI within 24 hours. The risks of moderate/severe bleeding by the GUSTO scale, ICH, and 30-day mortality were evaluated stratified by the adjunctive use of GP IIb/IIIa inhibitors within the first 24 hours.

About a third of these patients (n = 1,038) underwent GP IIb/IIIa blockade, he said. Generally, patients treated with GP IIb/IIIa inhibitors were younger (mean age, 57.3 vs. 58.3 years) and heavier (mean weight, 84.8 kg vs. 81.6 kg). Also more men (20.6%) than women (18.5%) received GP IIb/IIIa inhibitors. The treated patients were less likely to have anterior infarct (40.9% vs. 42.4%) and more likely to have diabetes (17.0% vs. 14.7%).

Based on the results, Dr. Roe said that a prospective, randomized trial is needed to "delineate the risks and benefits of GP IIb/IIIa blockade during rescue PTCA."

ACC 52nd Annual Scientific Session: 1025MP-163. Presented March 30, 2003.

Reviewed by Gary D. Vogin, MD

    
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