Mariasanta Napolitano, Giorgia Saccullo, Alessandra Malato, Delia Sprini, Lucio Lo Coco, Salvatrice Mancuso, Alessandra Casuccio, Giovam Battista Rini, and Sergio Siragusa, Università degli Studi di Palermo, Palermo; Walter Ageno, Università dell'Insubria, Varese; Davide Imberti, Ospedale di Piacenza, Piacenza; Doris Mascheroni, Istituto Clinico Villa Aprica, Como; Eugenio Bucherini, Ospedale di Faenza, Faenza Ravenna; Pina Gallucci, Centro Regionale Oncologico Basilicata, Rionero in Volture; Andrea D'Alessio, Policlinico San Marco, Zingonia; Tullia Prantera, Ospedale S. Giovanni di Dio, Crotone; Pietro Spadaro, Villa Salus, Messina; Stefano Rotondo, Centro Studi Neurolesi; Oreste Urbano, Ospedale Piemonte, Messina; Pierpaolo Di Micco, Ospedale Fatebenefratelli, Napoli; Vincenzo Oriana, Azienda Ospedaliera di Reggio Calabria, Reggio Calabria; Francesco Recchia, Ospedale di Avezzano, Avezzano; and Angelo Ghirarduzzi, Azienda Ospedaliera di Reggio Emilia Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
J Clin Oncol. 2014 Nov 10;32(32):3607-12. doi: 10.1200/JCO.2013.51.7433. Epub 2014 Sep 29.
We evaluated the role of residual vein thrombosis (RVT) to assess the optimal duration of anticoagulants in patients with cancer who have deep vein thrombosis (DVT) of the lower limbs.
Patients with active cancer and a first episode of DVT treated with low molecular weight heparin (LMWH) for 6 months were eligible. Patients were managed according to RVT findings: those with RVT were randomly assigned to continue LMWH for an additional 6 months (group A1) or to discontinue it (group A2), and patients without RVT stopped LMWH (group B). The primary end point was recurrent venous thromboembolism (VTE) during the 1 year after disconinuation of LMWH, and the secondary end point was major bleeding. Analyses are from the time of random assignment.
Between October 2005 and April 2010, 347 patients were enrolled. RVT was detected in 242 patients (69.7%); recurrence occurred in 22 of the 119 patients in group A1compared with 27 of 123 patients in group A2. The adjusted hazard ratio (HR) for group A2 versus A1 was 1.37 (95% CI, 0.7 to 2.5; P = .311). Three of the 105 patients in group B developed recurrent VTE; adjusted HR for group A1 versus B was 6.0 (95% CI, 1.7 to 21.2; P = .005). Three major bleeding events occurred in group A1, and two events each occurred in groups A2 and B. The HR for major bleeding in group A1 versus group A2 was 3.78 (95% CI, 0.77 to 18.58; P = .102). Overall, 42 patients (12.1%) died during follow-up as a result of cancer progression.
In patients with cancer with a first DVT, treated for 6 months with LMWH, absence of RVT identifies a population at low risk for recurrent thrombotic events. Continuation of LMWH in patients with RVT up to 1 year did not reduce recurrent VTE.
我们评估了下肢深静脉血栓形成（DVT）患者的残留静脉血栓（RVT）在评估癌症患者抗凝最佳持续时间中的作用。
符合条件的患者为患有活动性癌症且首次接受低分子肝素（LMWH）治疗 6 个月的 DVT 患者。根据 RVT 检查结果对患者进行管理：有 RVT 的患者被随机分配继续接受 LMWH 治疗 6 个月（A1 组）或停药（A2 组），无 RVT 的患者停止使用 LMWH（B 组）。主要终点是 LMWH 停药后 1 年内复发性静脉血栓栓塞（VTE），次要终点是大出血。分析基于随机分组时间。
2005 年 10 月至 2010 年 4 月期间，共纳入 347 例患者。242 例（69.7%）患者检测到 RVT；A1 组 119 例患者中有 22 例复发，A2 组 123 例患者中有 27 例复发。A2 组与 A1 组的调整后危险比（HR）为 1.37（95%CI，0.7 至 2.5；P=0.311）。B 组 105 例患者中有 3 例发生复发性 VTE；A1 组与 B 组的调整 HR 为 6.0（95%CI，1.7 至 21.2；P=0.005）。A1 组发生 3 例大出血事件，A2 组和 B 组各发生 2 例大出血事件。A1 组大出血的 HR 为 3.78（95%CI，0.77 至 18.58；P=0.102）。在随访期间，共有 42 例（12.1%）患者因癌症进展而死亡。
在首次接受 LMWH 治疗 6 个月的癌症合并首次 DVT 患者中，无 RVT 可识别出复发血栓事件风险较低的人群。在有 RVT 的患者中继续使用 LMWH 治疗 1 年并不能降低复发性 VTE 的风险。
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