ESC 2009:中风之后使用压迫弹性袜对预防DVT没有帮助


  May 29, 2009(瑞典斯德哥尔摩) — 一篇新的随机试验显示,中风之后无法行动的病患使用大腿长度的渐进性压迫弹性袜(GCS)来预防近端深部静脉栓塞(deep vein thrombosis,DVT)并无帮助。
  
  「Clots in Legs or Stockings After Stroke (CLOTS-1)」试验结果显示,使用这种袜子,对于此类病患的膝后窝、股骨静脉发生有症状或无症状之DVT并无显著帮助,反而常常在使用袜子处发生破皮、溃疡、水泡、以及皮肤坏死。
  
  主要研究者、苏格莱西方综合医院、爱丁堡大学的Martin Dennis医师向与会听众表示,总结来说,对于急性中风,我们相信大腿长度的渐进性压迫弹性袜并无法降低3%的绝对风险;许多国家的指引必须因为这个新证据而改版。
  
  Dennis医师表示,有另外两个试验正在探讨减少此类病患DVT的其它方法,比较大腿长与小腿长袜子的相对结果的CLOTS-2试验,根据CLOTS-1试验结果停止招募病患,这个试验的结果预计在今年12月发表。评估间歇气压治疗的CLOTS-3试验正在进行中。
  
  这些结果在线发表于5月27日的Lancet期刊,与于此间举办的第18届欧洲中风研讨会(XVIII European Stroke Conference)中。
  
  【中风之后常见DVT】
  Dennis医师表示,在中风之后常见DVT与肺栓塞。一些小型试验认为,渐进性压迫弹性袜可减少这些事件的风险;汇整使用这类袜子的17篇试验结果显示,减少DVT的胜算比有63%。
  
  Dennis医师指出,不过,这17篇试验之中有15篇是手术试验,在卧床瘫痪之前就已经开始使用这种袜子;使用天数只有几天;在第7到14天测量结果。只有1个小型试验着眼于中风病患的使用。因此,目前的指引都是根据其它类型病患推测而来。
  
  CLOTS-1试验的目标在解答这类袜子用于急性中风人口的实际帮助。总共有英国、意大利与澳洲、64家医学中心急性中风住院且卧床的2,518名病患,随机分派接受常规照护加上大腿长的弹性袜,或者常规照护但不使用这些袜子。Dennis医师指出,常规照护包括早期活动、水合、预防性使用肝素。
  
  由不知情的技术员在第7到10天对病患双脚进行压迫性都卜勒超音波,如果有效,则在试验后第25到30天再度进行一次超音波。他指出,同时也进行6个月的追踪,将在往后的会议中提出报告。
  
  Dennis医师表示,两组之间的初步结果,膝后窝、股骨静脉发生有症状或无症状之DVT并无显著差异。
  
  【CLOTS-1:发生有症状或无症状之DVT】

终点

渐进性压迫弹性袜, n (%)

无渐进性压迫弹性袜, n (%)

风险降低绝对百分比 (95% CI)

有症状或无症状之 DVT

126 (10.0)

133 (10.5)

0.5 (-1.9 to 2.9)


  
  各组有症状的DVT也没有差异,均各有约5%的发生率。
  
  不过,分派使用弹性袜之中风病患的破皮、溃疡、水泡、以及皮肤坏死显著较多。他警告,这可能是观察者的偏见所致,因为回顾者并非不知情。
  
  【CLOTS-1:治疗组之破皮、溃疡、水泡、以及皮肤坏死】

终点

渐进性压迫弹性袜,n (%)

无渐进性压迫弹性袜, n (%)

胜算比 (95% CI)

事件

64 (5)

16 (1)

4.18 (2.40 – 7.27)


  他指出,截肢方面并无显著差异,弹性袜组有7名病患、非弹性袜组有2名病患进行下肢截肢。回顾时认为,这些都与使用这类袜子无关。
  
  在发表后的讨论中,Dennis医师指出,弹性袜会增加中风患者的护理负担,因为这些病患无法自己穿袜子。我们估计,在英国,若不使用这些袜子可以节省大约220,000护理工时,因为这种袜子的穿著与维持很耗时。
  
  【评论】
  Lancet期刊文章的评论中,英国诺丁罕大学神经科学研究中心中风试验小组的Phillip M. W. Bath医师以及Timothy J. England医师结论表示,这些结果显示,弹性袜并未减少最近中风患者之DVT或者整体的静脉栓塞(venous thromboembolism,VTE),他们写道,实际上,这类袜子伤害了皮肤且可能造成肢体缺血。
  
  他们写道,中风之后不应使用GCS,现有的指引必须有所补救。没有哪里一种预防方式是必须的,然而,早期再水合、走动与阿斯匹灵是良好中风照护的关键。预防性肝素只可用于VTE高风险病患;目前指引中建议的常规使用并不适当,因为会增加颅内出血风险。
  
  最后,他们断言,须在其它类型对象,包括一般病患,进行使用此类袜子的评估,他们也可能缺乏效果。
  
  【等待CLOTS-3试验】
  美国心脏协会(AHA)主席候选人、迈阿密大学Miller医学院Ralph Sacco的医师受邀对这些发现发表评论时指出,在美国,这类指引并未实际要求使用这种袜子。
  
  他表示,我们在美国几乎不使用这种袜子,然而,他指出,他们并非根据证据而不使用。美国心脏协会指引实际上建议使用气体压迫策略而非渐进性压迫弹性袜。
  
  他指出,对于可以使用肝素来预防DVT与肺栓塞的病患,我们的指引也倾向提倡多使用皮下肝素。然而,对于有出血性中风或者刚以tPA治疗后的病患,低分子量肝素则是禁忌。
  
  他指出,在此你必须使用气压性弹性袜,但是我认为,我们都必须等著看那些试验结果。
  
  英国医学研究委员会、苏格兰政府科学办公室、苏格兰胸腔心脏与中风、美国Tyco Healthcare (Covidien) (赞助弹性袜)以及英国中风研究网络支持本研究。 CLOTS撰写委员会宣称无利益冲突。
  
  Lancet 2009;在线发表于2009年5月27日。
  
  2009年第18届欧洲中风研讨会:大型临床试验组,摘要6。发表于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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