論文No695
Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry
アメリカからの報告．
＜背景＞
急性肺塞栓（ＰＥ）に対する全身血栓溶解療法は最大２０％の大出血リスク，２－５％の脳出血性梗塞のリスクがある．
我々は急性ＰＥの代替治療としてカテーテル療法（ＣＤＴ）の安全性，有効性について評価した．
＜方法＞
急性ＰＥに対してＣＤＴを多施設で行った連続１０１名を前向きに調査した．
広範なＰＥ（２８名），小さなＰＥ（７３名）はただちにカテーテル下に機械的にあるいは薬物使用にて血栓除去あるいはtPAあるいはウロキナーゼを低用量で持続投与する方法で治療された．
臨床的成功は以下がすべて達成されたこととした：
血行動態の安定，肺高血圧の改善，右心不全の改善，軽快退院．
主要な安全アウトカムは手技に関連した合併症，大出血イベントである．
＜結果＞
５３名が男性，４８名が女性（平均６０歳，平均ＢＭＩ ３１．０３）であった．
平均血栓溶解薬使用量はｔＰＡが２８±１１ｍｇ（７６名），ウロキナーゼが２６９７１０１±９３６２８７国際単位（２３名）であった．
臨床的成功は広範なＰＥで２８名中２４名（８５．７％）で達成された．
小さなＰＥでは７３名中７１名（９７．３％）で達成された．
平均肺動脈圧は５１．１７から３７．２３に改善した（ｐ＜０．０００１）．
心エコーフォローされた群では６４名中５７名（８９．１％）で右心機能が改善した．
手技に関連した合併症，大出血，脳出血はなかった．
＜感想＞
ＰＥに対して全身性に薬物投与するよりも，
カテーテルで病変に選択的に薬物を到達させることで治療効果は大きく，合併症は少ないという報告でした．
BACKGROUND: Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% rsk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE.
METHODS: One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n = 28) and submassive PE (n = 73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events.
RESULTS: Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes.
CONCLUSIONS: CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE.