ESC 2009:中風之後使用壓迫彈性襪對預防DVT沒有幫助


  May 29, 2009(瑞典斯德哥爾摩) — 一篇新的隨機試驗顯示,中風之後無法行動的病患使用大腿長度的漸進性壓迫彈性襪(GCS)來預防近端深部靜脈栓塞(deep vein thrombosis,DVT)並無幫助。
  
  「Clots in Legs or Stockings After Stroke (CLOTS-1)」試驗結果顯示,使用這種襪子,對於此類病患的膝後窩、股骨靜脈發生有症狀或無症狀之DVT並無顯著幫助,反而常常在使用襪子處發生破皮、潰瘍、水泡、以及皮膚壞死。
  
  主要研究者、蘇格萊西方綜合醫院、愛丁堡大學的Martin Dennis醫師向與會聽眾表示,總結來說,對於急性中風,我們相信大腿長度的漸進性壓迫彈性襪並無法降低3%的絕對風險;許多國家的指引必須因為這個新證據而改版。
  
  Dennis醫師表示,有另外兩個試驗正在探討減少此類病患DVT的其他方法,比較大腿長與小腿長襪子的相對結果的CLOTS-2試驗,根據CLOTS-1試驗結果停止招募病患,這個試驗的結果預計在今年12月發表。評估間歇氣壓治療的CLOTS-3試驗正在進行中。
  
  這些結果線上發表於5月27日的Lancet期刊,與於此間舉辦的第18屆歐洲中風研討會(XVIII European Stroke Conference)中。
  
  【中風之後常見DVT】
  Dennis醫師表示,在中風之後常見DVT與肺栓塞。一些小型試驗認為,漸進性壓迫彈性襪可減少這些事件的風險;彙整使用這類襪子的17篇試驗結果顯示,減少DVT的勝算比有63%。
  
  Dennis醫師指出,不過,這17篇試驗之中有15篇是手術試驗,在臥床癱瘓之前就已經開始使用這種襪子;使用天數只有幾天;在第7到14天測量結果。只有1個小型試驗著眼於中風病患的使用。因此,目前的指引都是根據其他類型病患推測而來。
  
  CLOTS-1試驗的目標在解答這類襪子用於急性中風人口的實際幫助。總共有英國、義大利與澳洲、64家醫學中心急性中風住院且臥床的2,518名病患,隨機分派接受常規照護加上大腿長的彈性襪,或者常規照護但不使用這些襪子。Dennis醫師指出,常規照護包括早期活動、水合、預防性使用肝素。
  
  由不知情的技術員在第7到10天對病患雙腳進行壓迫性都卜勒超音波,如果有效,則在試驗後第25到30天再度進行一次超音波。他指出,同時也進行6個月的追蹤,將在往後的會議中提出報告。
  
  Dennis醫師表示,兩組之間的初步結果,膝後窩、股骨靜脈發生有症狀或無症狀之DVT並無顯著差異。
  
  【CLOTS-1:發生有症狀或無症狀之DVT】

終點

漸進性壓迫彈性襪, n (%)

無漸進性壓迫彈性襪, n (%)

風險降低絕對百分比 (95% CI)

有症狀或無症狀之 DVT

126 (10.0)

133 (10.5)

0.5 (-1.9 to 2.9)


  
  各組有症狀的DVT也沒有差異,均各有約5%的發生率。
  
  不過,分派使用彈性襪之中風病患的破皮、潰瘍、水泡、以及皮膚壞死顯著較多。他警告,這可能是觀察者的偏見所致,因為回顧者並非不知情。
  
  【CLOTS-1:治療組之破皮、潰瘍、水泡、以及皮膚壞死】

終點

漸進性壓迫彈性襪,n (%)

無漸進性壓迫彈性襪, n (%)

勝算比 (95% CI)

事件

64 (5)

16 (1)

4.18 (2.40 – 7.27)


  他指出,截肢方面並無顯著差異,彈性襪組有7名病患、非彈性襪組有2名病患進行下肢截肢。回顧時認為,這些都與使用這類襪子無關。
  
  在發表後的討論中,Dennis醫師指出,彈性襪會增加中風患者的護理負擔,因為這些病患無法自己穿襪子。我們估計,在英國,若不使用這些襪子可以節省大約220,000護理工時,因為這種襪子的穿著與維持很耗時。
  
  【評論】
  Lancet期刊文章的評論中,英國諾丁罕大學神經科學研究中心中風試驗小組的Phillip M. W. Bath醫師以及Timothy J. England醫師結論表示,這些結果顯示,彈性襪並未減少最近中風患者之DVT或者整體的靜脈栓塞(venous thromboembolism,VTE),他們寫道,實際上,這類襪子傷害了皮膚且可能造成肢體缺血。
  
  他們寫道,中風之後不應使用GCS,現有的指引必須有所補救。沒有哪一種預防方式是必須的,然而,早期再水合、走動與阿斯匹靈是良好中風照護的關鍵。預防性肝素只可用於VTE高風險病患;目前指引中建議的常規使用並不適當,因為會增加顱內出血風險。
  
  最後,他們斷言,須在其他類型對象,包括一般病患,進行使用此類襪子的評估,他們也可能缺乏效果。
  
  【等待CLOTS-3試驗】
  美國心臟協會(AHA)主席候選人、邁阿密大學Miller醫學院Ralph Sacco的醫師受邀對這些發現發表評論時指出,在美國,這類指引並未實際要求使用這種襪子。
  
  他表示,我們在美國幾乎不使用這種襪子,然而,他指出,他們並非根據證據而不使用。美國心臟協會指引實際上建議使用氣體壓迫策略而非漸進性壓迫彈性襪。
  
  他指出,對於可以使用肝素來預防DVT與肺栓塞的病患,我們的指引也傾向提倡多使用皮下肝素。然而,對於有出血性中風或者剛以tPA治療後的病患,低分子量肝素則是禁忌。
  
  他指出,在此你必須使用氣壓性彈性襪,但是我認為,我們都必須等著看那些試驗結果。
  
  英國醫學研究委員會、蘇格蘭政府科學辦公室、蘇格蘭胸腔心臟與中風、美國Tyco Healthcare (Covidien) (贊助彈性襪)以及英國中風研究網絡支持本研究。 CLOTS撰寫委員會宣稱無利益衝突。
  
  Lancet 2009;線上發表於2009年5月27日。
  
  2009年第18屆歐洲中風研討會:大型臨床試驗組,摘要6。發表於2009年5月27日。
  
  

ESC 2009: No Benefit of Compression Stockings in DVT Prevention After Stroke

By Susan Jeffrey
Medscape Medical News

May 29, 2009 (Stockholm, Sweden) — A new randomized trial shows no benefit from the use of thigh-length graduated compression stockings (GCS) to prevent proximal deep vein thrombosis (DVT) in patients immobilized by stroke.

Results of the Clots in Legs or Stockings After Stroke (CLOTS-1) trial show no significant benefit from use of the stockings on the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral vein among these patients, but skin breaks, ulcers, blisters, and skin necrosis were more common in those allocated to use of the stockings.

"In conclusion, we've reliably excluded a 3% absolute risk reduction from thigh-length graduated compression stockings in acute stroke," principal investigator Martin Dennis, MD, from the University of Edinburgh, Western General Hospital, in Scotland, told conference attendees here. "Many national guidelines may now need to be revised to take account of this new evidence."

Two ongoing trials are looking at other methods of DVT reduction in these patients, Dr. Dennis noted. CLOTS-2, comparing the relative effects of thigh-length and below-knee stockings, stopped enrollment on the basis of the CLOTS-1 results, and the findings from that trial are expected to be reported in December of this year. CLOTS-3, evaluating the use of intermittent pneumatic compression in this same indication, is ongoing.

The results are published online May 27 in the Lancet, to coincide with their presentation here at the XVIII European Stroke Conference.

DVT Common After Stroke

DVT and pulmonary embolism are common after stroke, Dr. Dennis said. Small trials of patients undergoing surgery have suggested that graduated compression stockings reduce the risk for these events; a pooled analysis of 17 trials using these stockings showed a 63% odds reduction of DVT.

However, 15 of these 17 trials were surgical trials, where the stockings could be applied before immobilization paralysis; they were applied for just a few days; and outcomes were measured at 7 to 14 days, Dr. Dennis pointed out. Only 1 small trial has looked at their use in stroke patients, he added. "So all of the guidelines we currently have are based on extrapolation from basically another population of patients."

The CLOTS-1 trial, then, aimed to answer the question of the real benefit of these stockings in an acute-stroke population. A total of 2518 patients admitted to the hospital with an acute stroke who were immobile were enrolled from 64 centers in the United Kingdom, Italy, and Australia and randomized to receive routine care plus thigh-length stockings or routine care avoiding use of the stockings. Routine care could include early mobilization, hydration, or background prophylactic heparin, Dr. Dennis noted.

A technician blinded to treatment allocation carried out compression Doppler ultrasound of both legs at 7 to 10 days, when it was practical, and again at 25 to 30 days after enrollment. A 6-month follow-up was also done and will be reported at a later meeting, he added.

The primary outcome, the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins, was not significantly different between the groups, Dr. Dennis said.

CLOTS-1: Occurrence of Symptomatic or Asymptomatic DVT
End Point Graduated Compression Stockings, n (%) No Graduated Compression Stockings, n (%) Absolute Percent Risk Reduction (95% CI)
Symptomatic or asymptomatic DVT 126 (10.0) 133 (10.5) 0.5 (-1.9 to 2.9)

There also was no difference in symptomatic DVT, which occurred in about 5% of each group.

However skin breaks, ulcers, blisters, and skin necrosis were significantly more common among stroke patients allocated to use of the compression stockings. He cautioned that this finding was open to observer bias, since reviewers were not blinded to allocation.

CLOTS-1: Skin Breaks, Ulcers, Blisters, and Necrosis by Treatment Group
End Point Graduated Compression Stockings, n (%) No Graduated Compression Stockings, n (%) Odds Ratio (95% CI)
Events 64 (5) 16 (1) 4.18 (2.40 – 7.27)

There was a nonsignificant excess of amputations, with 7 patients in the stocking group and 2 in the nonstocking group having lower-limb amputations, he noted. "None of these, on review, seemed to be related to stocking use."

During the discussion after his presentation, Dr. Dennis pointed out that the stockings add to the nursing burden for stroke patients because patients cannot manage them on their own. "We've estimated that in the UK, we'll save about 220,000 hours of nursing time by not using these stockings, because they take time to fit and to maintain."

Urgent Assessment

In an editorial accompanying the Lancet paper, Phillip M. W. Bath, MD, and Timothy J. England, MD, from the Stroke Trials Unit of the Institute of Neuroscience at the University of Nottingham, in the United Kingdom, conclude that these results show that stockings do not reduce DVT or overall venous thromboembolism (VTE) in patients with recent stroke: "Indeed, they damage the skin and might promote limb ischemia," they write.

"GCS should not be used after stroke, and current guidelines will need to be amended," they write. "No specific prophylaxis appears to be necessary, although early rehydration, mobilization, and aspirin are key cornerstones of good stroke care," they add. "Prophylactic heparin should be used only in patients at very high risk of VTE; routine use, as currently recommended in guidelines, is not appropriate, because of the increased risk of intracerebral hemorrhage."

Finally, they assert that use of the stockings must "be assessed urgently in other settings where they might also lack efficacy, including in general medical patients."

Waiting for CLOTS-3

Asked for comment on these findings, Ralph Sacco, MD, from the Miller School of Medicine at the University of Miami, in Florida, and president-elect of the American Heart Association (AHA), pointed out that in the United States the guidelines do not actually call for use of the stockings.

"We hardly use those stockings in the United States

    
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