使用Clopidogrel可降低PCI前、後的心血管事件發生率


  Sept. 6, 2005 (斯德哥爾摩) — 根據研究者於2005歐洲心臟醫學會年會中的報告,接受經皮冠狀動脈介入(PCI)的ST段上升心肌梗塞(STEMI)的病患,使用clopidogrel(Plavix)可以降低隨機分派30天後的心臟血管事件死亡、心肌梗塞(MI)、或是中風機率達41%。
  
  麻州波士頓哈佛醫學院及布萊根婦女醫院的Marc S. Sabatine醫師表示,以臨床的角度來看,每對100位接受PCI的病患,於PCI前使用clopidogrel治療,可以降低4件重大心血管事件的發生;在PCI之前大約可以避免2件MI的發生,而在PCI之後30天內可以額外避免2件心血管死亡、MI、或是中風的發生。
  
  他向Medscape表示,並沒有發生重大安全性問題的考量;早期治療是較好且安全的。
  
  PCI-Clopidogrel as Adjunctive Reperfusion Therapy(PCI-CLARITY)臨床試驗是CLARITY的分組分析結果,包含了1,863位於PCI之前隨機分派接受clopidogrel的病患,以及930位接受安慰劑治療的病患。
  
  Clopidogrel的劑量第一次時為300毫克,之後每天投予75毫克;所有病患同時接受由醫師決定的血栓溶解治療以及aspirin;接受血栓解治療的病患同時也使用48小時的heparin。
  
  這項臨床試驗的結果同時發表於JAMA上,顯示在PCI之前以clopidogrel治療可以降低MI或是中風的風險(4.0%相較於6.2%;P=.03)。
  
  以臨床試驗的綜合終點來看,使用clopidogrel在PCI之後30天可以降低心臟血管死亡、MI與中風的風險;相較於安慰劑,使用clopidogrel在PCI之後30天可以降低心臟血管死亡、MI與中風的風險達46%(3.6%相較於6.2%;P=.008)。
  
  整體而言,以clopidogrel治療的病患,發生綜合試驗終點的機率為7.5%,相較於接受安慰劑病患的12%,轉換為勝算比為0.59(95%信賴區間為0.42-0.81;P=.001)。
  
  接受clopidogrel治療的病患發生出血、重大安全性考量的機率為2.0%,相較於接受安慰劑病患的1.9%,這在統計上是沒有顯著意義的。
  
  明尼蘇達羅徹斯特梅約診所醫學教授Raymond Gibbons醫師向Medscape表示,這項試驗發現增加更多支持於PCI之前使用clopidogrel的證據。
  
  他表示,過去的臨床試驗已經證實使用clopidogrel對其他病患族群是有益的,這些病患族群包括非穩定性心絞痛、與非ST段上升MI,現在這試驗結果證實ST段上升MI的病患也會受益。
  
  Gibbons醫師表示,雖然某些醫師不願意使用clopidogrel,除非病患已經透過冠狀動脈血管攝影排除需要進行手術的可能性;但是事實證明,這群病患中幾乎所有病患都需要接受PCI,因為時間是最重要的。
  
  Sabatine醫師同意這樣的說法,並且附帶表示,因為使用clopidogrel而使手術需要延後5至7天的壞處遠低於其所帶來的好處。
  
  Sabatine醫師表示,相較於目前在PCI前對病患投予速效劑量,以及之後的維持劑量,每對23位病患進行這樣的治療就可以避免1位病患發生心血管死亡、MI與中風的事件。
  
  這項臨床試驗由美國國家心臟、肺臟與血液機構、Sanofi-Aventis與Bristol-Myers Squibb贊助。

Pretreatment With Clopidogrel<

By
Medscape Medical News

Sept. 6, 2005 (Stockholm) — In patients with recent ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI), pretreatment with clopidogrel (Plavix) reduced the risk of cardiovascular death, myocardial infarction (MI), or stroke in the first 30 days after randomization by 41%, researchers reported here at the European Society of Cardiology 2005 Congress.

"From a clinical perspective, approximately four major cardiovascular events would be prevented for every 100 patients undergoing PCI in whom a strategy of clopidogrel pretreatment is adopted," said Marc S. Sabatine, MD, MPH, from Brigham and Women's Hospital and Harvard Medical School in Boston, Massachusetts. "Approximately two MIs would be prevented before PCI and an additional two cardiovascular deaths, MIs, or strokes would be prevented in the 30 days after PCI."

Noting that there were no major safety concerns, he told Medscape, "Earlier treatment is better and safe."

The PCI-Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study, a prespecified subgroup analysis of CLARITY, included 1,863 STEMI patients randomized to clopidogrel and 930 patients randomized to placebo prior to PCI.

Clopidogrel was given as a 300-mg loading dose, followed by 75 mg once daily. All patients were also given a physician-selected fibrinolytic and aspirin; those receiving a fibrin-specific lytic were also given heparin for 48 hours.

The study, which was simultaneously published online in JAMA, showed that pretreatment with clopidogrel reduced the risk of MI or stroke prior to PCI by 38% (4.0% vs 6.2%, respectively; P = .03).

The benefit of pretreatment with clopidogrel remained consistent when assessing the trial's composite end point — cardiovascular death, MI, and stroke — at 30 days after PCI. Pretreatment with clopidogrel reduced the risk of cardiovascular death, MI, and stroke at 30 days by 46% compared with placebo (3.6% vs 6.2%, respectively; P = .008).

Overall, the composite end point occurred in 7.5% of patients pretreated with clopidogrel compared with 12% of those receiving placebo, translating to an adjusted odds ratio of 0.59 (95% confidence interval, 0.42 - 0.81; P = .001).

Bleeding, a major safety concern, occurred in 2.0% of patients receiving clopidogrel vs 1.9% receiving placebo, a nonsignificant difference.

Raymond Gibbons, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, and president-elect of the American Heart Association, told Medscape that the "findings add to the growing body of evidence supporting the use of clopidogrel prior to PCI.

"While previous studies have shown that clopidogrel pretreatment is beneficial for other patient subgroups — those with nonstable angina and non-ST elevation MI — this adds ST-elevation MI to the list," he said.

Although some physicians have been reluctant to pretreat patients until coronary angiography has excluded their need for surgical revascularization, Dr. Gibbons said that "the reality is that nearly everyone in this patient group will get PCI because time is of the essence."

Dr. Sabatine agreed, adding that the small risk of having to potentially postpone surgery for five to seven days is outweighed by the benefits of pretreatment.

"Compared with the current practice of giving patients a loading dose of clopidogrel at the time of PCI and a maintenance dose thereafter, only 23 patients would have to be pretreated with clopidogrel to prevent one cardiovascular death, MI, or stroke," Dr. Sabatine said.

The study was funded by the National Heart, Lung, and Blood Institute, Sanofi-Aventis, and Bristol-Myers Squibb.

ESC 2005 Congress: Abstract 755. Presented Sept. 4, 2005

JAMA. 2005;294:1224-1232

Reviewed by Gary D. Vogin, MD

    
相關報導
移除卵巢不能降低糖尿病女性的CVD風險
2015/11/11 上午 09:31:25
甲狀腺功能過高與失智症有關
2015/11/4 上午 10:18:09
心電圖測量可預測慢性腎病患者的心血管原因死亡
2015/7/22 上午 09:57:51

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁