於進行血管修復術前服用溶解血栓劑會導致較高死亡率


  Sept. 6, 2004(斯德哥薾摩) - 比利時的研究學者指出,病患在進行經皮冠狀動脈介入性治療(PCIs)前,不應事先服用溶解血栓劑。
  
  一項急性心肌梗塞新療程試驗之安全與有效評估(ASSENT IV)的初步結果顯示,那些在事前服用溶解血栓劑的病患,相較於僅接受PCI治療的病患,在接下來30天內,會增加2%嚴重的致死風險。
  
  在歐盟心臟學會年度代表大會上,調查研究學者指出,接受tenecteplase(TNKase)加上PCI治療之829名病患,30天之致死率達6%,而僅接受PCI單一療法的836名病患,致死率達3.8%;這些患者皆在症狀發生後一到三小時之內進行血管修復手術。
  
  在隨機分配下,接受tenecteplase加上血管修復術治療的患者,因為產生令人震驚的超高致死率,這項試驗於是提前終止;在比利時魯汶蓋斯堡教學醫院心臟病學部的院長Frans Van de Werf醫學博士向Medscape表示,原先預期的試驗參與者有4千名,只有不到不到一半願意接受這項試驗;溶解血栓劑組有著偏高的大量出血與中風現象,但這並無法解釋這一組患者的高死亡率;Van de Werf表示,我們無法確定到底發生了什麼事,難道另外一組的醫師與臨床中心較有經驗?
  
  Van de Werf博士表示,希望最後90天死的亡率的結果能夠好轉;預定在11月份在美國心臟學會年會發表該階段的結果數據。
  
  參與研究討論的比利時阿斯特城列肯赫斯區心血管疾病研究中心副主任William Wijns醫學博士警告同業,不要斷然放棄溶解血栓劑的使用;他表示,必須使用PCI卻無法即時獲取此項療法時,就必須要使用溶血劑作再灌注治療,這種治療方式本身不曾造成危害。
  
  明尼蘇達州羅契斯特梅約醫學中心教授,暨美國心臟學會準會長Raymond Gibbons醫學博士同意此說法,因為許多鄉村醫院並沒有PCI的設備,他表示,細胞溶解方法仍舊扮演個重要的角色,目前有25%的病患不是使用溶血劑,就是使用非PCI的治療方式。
  
  Gibbons博士補充,患者在進行PCI治療手術前的一到三個小時,醫師應停止提供溶解血栓劑。
  
  Wijns博士表示,這項研究並非最後定論,在未來的研究中,其他纖維蛋白溶解劑或抗血小板的聯合治療方法,可能改善這些結果。

Thrombolytics Before Angioplas

By
Medscape Medical News

Sept. 6, 2004 (Stockholm) — Patients who are scheduled for percutaneous coronary interventions (PCIs) should not be administered thrombolytics beforehand, Belgian researchers report.

Preliminary results of Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction (ASSENT IV) trial show that patients who are pretreated with thrombolytics face an absolute and significant 2.2% increased risk of dying in the next 30 days compared with those who undergo PCI alone.

At the annual congress of the European Society of Cardiology here, investigators reported a 30-day mortality rate of 6% among the 829 patients who received tenecteplase (TNKase) plus PCI compared with 3.8% among the 836 patients who had PCI alone (P = .04). The patients underwent angioplasty within one to three hours of symptoms.

The surprising excess death rate in patients randomized to tenecteplase plus angioplasty led to premature termination of the trial; less than half of the planned 4,000 patients were enrolled, said Frans Van de Werf, MD, chairman of the cardiology department of the University Hospital Gasthuisberg in Leuven, Belgium. Dr. Van de Werf told Medscape that an increased rate of major bleeding and strokes in the thrombolytics group cannot fully explain the difference in mortality. "We're not sure what is going on," he said. "Had we selected more experienced cardiologists or more experienced centers for one group?"

Dr. Van de Werf said he hopes that final 90-day mortality results, scheduled to be released in November at the annual meeting of the American Heart Association, will help shed more light on the issue.

Study discussant William Wijns, MD, codirector of the Cardiovascular Center at OLV Ziekenhuis in Aalst, Belgium, cautioned colleagues not to abandon thrombolytics altogether. "While PCI is the treatment of choice, reperfusion therapy using lytic agents is indicated when PCI is not available. This has not been jeopardized," he said.

Raymond Gibbons, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, and president-elect of the American Heat Association, agreed. Noting that many rural hospitals do not have PCI facilities, Dr. Gibbons said that "lytics still play an important role. Right now, 25% of patients who are candidates for treatment with either lytic therapy or PCI get neither."

But physicians who are now giving thrombolytics to patients who will be transferred for PCI within one to three hours should stop using the drugs, Dr. Gibbons added.

Dr. Wijns said that the study is not the final word. Future study may show that other fibrinolytics or antiplatelet cotreatment might improve outcomes, he added.

ESC 2005 Congress: Abstract 2578. Presented Sept. 6, 2005.

Reviewed by Gary D. Vogin, MD

    
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