Koertke H, Minami K, Boethig D, Breymann Th, Seifert D, Wagner O, Atmacha N, Krian A, Ennker J, Taborski U, Klövekorn W P, Moosdorf R, Saggau W, Koerfer R
Heart and Diabetes Center North Rhine-Westphalia Bad Oeynhausen, Germany, Clinic of the Ruhr University of Bochum, Bochum, Germany.
Circulation. 2003 Sep 9;108 Suppl 1:II75-8. doi: 10.1161/01.cir.0000089185.80318.3f.
The Early Self Controlled Anticoagulation Trial (ESCAT I) showed that anticoagulation self-management after mechanical heart valve replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio (INR) home doctor management. The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic valves. ESCAT II should find out whether lowering the target range for INR self-management would further reduce complication rates.
ESCAT II is a prospective controlled randomized (valves: St. Jude Medical Standard or Medtronic Hall, treatment: conventional/low-dose) multicenter study with 3,300 patients. We present interim results of 1,818 patients. 908 were categorized as having a low-dose target range, which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or in combined valve replacement. The control group (conventional group) with 910 patients aimed at an INR of 2.5 to 4.5 for all valve positions.
In the conventional group, 74% of INR values measured were within the therapeutic range. In the low-dose group, 72% of the values were within that range. The linearized thromboembolism rate (% per patient year) was 0.21% for both groups. The bleeding complication rate was 0.56% in the low-dose regimen group versus 0.91% in the conventional group.
Early onset INR self-management under oral anticoagulation after mechanical heart valve replacement enables patients to keep within a lower and smaller INR target range. The reduced anticoagulation level resulted in fewer grade III bleeding complications without increasing thromboembolic event rates.
早期自我控制抗凝试验（ESCAT I）表明，机械心脏瓣膜置换术后的抗凝自我管理通过使国际标准化比值（INR）水平比家庭医生管理更接近目标范围，降低了并发症发生率。在该研究中，所有位置的人工瓣膜INR治疗范围为2.5至4.5。ESCAT II旨在确定降低INR自我管理的目标范围是否会进一步降低并发症发生率。
ESCAT II是一项前瞻性对照随机（瓣膜：圣犹达医疗标准型或美敦力霍尔型，治疗：传统/低剂量）多中心研究，有3300名患者。我们展示了1818名患者的中期结果。908名患者被归类为低剂量目标范围组，主动脉位置的人工瓣膜INR为1.8至2.8，二尖瓣位置或联合瓣膜置换的人工瓣膜INR为2.5至3.5。对照组（传统组）有910名患者，所有瓣膜位置的INR目标为2.5至4.5。
在传统组中，74%的测量INR值在治疗范围内。在低剂量组中，72%的值在该范围内。两组的线性化血栓栓塞率（每年每位患者的百分比）均为0.21%。低剂量方案组的出血并发症发生率为0.56%，而传统组为0.91%。
机械心脏瓣膜置换术后口服抗凝治疗下的早期INR自我管理使患者能够保持在更低且更窄的INR目标范围内。抗凝水平的降低导致III级出血并发症减少，而血栓栓塞事件发生率没有增加。
