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[稳定型冠状动脉疾病患者的上消化道出血(抗栓治疗注册研究“REGATТA”结果)]

[Upper gastrointestinal bleeding in patients with stable coronary artery disease (registry of antithrombotic therapy "REGATТA" results)].

作者信息

Shakhmatova O O, Komarov A L, Korobkova V V, Yarovaya E B, Andreevskaya M V, Shuleshova A G, Panchenko E P

机构信息

National Medical Research Center of Cardiology.

Lomonosov Moscow State University.

出版信息

Ter Arkh. 2020 Oct 14;92(9):30-38. doi: 10.26442/00403660.2020.09.000699.

Abstract

INTRODUCTION

Upper gastrointestinal (UGI) bleeding is a common complication of antiplatelet therapy. Data from real clinical practice that characterize the range of risk factors for UGI bleeding, prophylactic proton pump inhibitors (PPIs) therapy, bleeding frequency and their long-term effects in patients with stable coronary artery disease (CAD) are limited.

AIM

To identify predictors of UGI bleeding in patients with stable CAD, to assess the role of PPI in the prevention of bleeding and the long-term prognosis of patients after bleeding.

MATERIALS AND METHODS

934 patients with stable CAD (median age 61 [5368] years, 78.6% men) were included in the single institution prospective REGistry of Long-term AnTithrombotic TherApy (REGATTA). Atherosclerosis of peripheral arteries (APA) and abdominal aortic aneurysm (AAA) screening was performed by doctor decision, as well as esophagogastroduodenoscopy. 76% of patients received dual antiplatelet therapy for 612 months after elective PCI. PPIs were prescribed in 28.3% of cases.

RESULTS

The median follow-up was 2.5 [1.15.1] years. The frequency of overt UGI bleeding was 1.9 per 100 patients per year. Anamnesis of peptic ulcer disease (OR 4.7; 95% CI 1.911.8;p=0.001), erosion of the upper gastrointestinal tract (OR 6.7; 2.716.6;p=0.00004 ), as well as concomitant diseases associated with a decrease in blood supply to the mucosa, such as heart failure HF (OR 6.1; 2.316.0;p=0.0002), AAA (OR 9.3; 2.534.2;p=0.0008) and APA (OR 2.3; 0.985.5;p=0.05) turned out to be independent predictors of UGI bleeding. The frequency of AAA among those who underwent UGI bleeding was 19.6% (in patients without bleeding 1.4%;p0.001). 90.2% of patients with UGI bleeding received PPI; the frequency of UGI bleeding in patients receiving pantoprazole and omeprazole did not differ significantly. After UGI bleeding, rebleeding rate was 7.8%, thrombotic events (TE) rate 31.4%, mortality rate 17.7% for 30 days, 19.4% for 1 year and 35.3% for the entire observation period. The predictors of deaths were AAA (OR 92.5; 7.7107.9;p0.0001), APA (OR 4.2; 1.0317.2;p=0.045) and HF (OR 34.5; 8.5140.6;p0.0001). The worst prognosis was expected for patients who underwent UGI bleeding and thrombotic events: 2/3 of these patients died.

CONCLUSION

In a prospective analysis of patients with stable CAD, we identified UGI bleeding was a significant risk factor for late thromboembolism and death, compared with patients without bleeding. Predictors of UGI bleeding and poor prognosis are factors that indicate atherothrombotic burden abdominal aortic aneurysm, peripheral atherosclerosis and HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04347200.

摘要

引言

上消化道(UGI)出血是抗血小板治疗的常见并发症。关于稳定型冠状动脉疾病(CAD)患者中UGI出血的危险因素范围、预防性质子泵抑制剂(PPI)治疗、出血频率及其长期影响的真实临床实践数据有限。

目的

确定稳定型CAD患者UGI出血的预测因素,评估PPI在预防出血中的作用以及出血后患者的长期预后。

材料与方法

934例稳定型CAD患者(中位年龄61[53 - 68]岁,78.6%为男性)被纳入单机构前瞻性长期抗栓治疗注册研究(REGATTA)。根据医生的判断进行外周动脉粥样硬化(APA)和腹主动脉瘤(AAA)筛查,以及食管胃十二指肠镜检查。76%的患者在择期PCI术后接受双联抗血小板治疗6 - 12个月。28.3%的病例使用了PPI。

结果

中位随访时间为2.5[1.1 - 5.1]年。显性UGI出血的发生率为每年每100例患者1.9例。消化性溃疡病史(OR 4.7;95%CI 1.9 - 11.8;p = 0.001)、上消化道糜烂(OR 6.7;2.7 - 16.6;p = 0.00004),以及与黏膜血供减少相关的伴随疾病,如心力衰竭(HF)(OR 6.1;2.3 - 16.0;p = 0.0002)、AAA(OR 9.3;2.5 - 34.2;p = 0.0008)和APA(OR 2.3;0.98 - 5.5;p = 0.05)被证明是UGI出血的独立预测因素。发生UGI出血的患者中AAA的发生率为19.6%(无出血患者中为1.4%;p < 0.001)。90.2%的UGI出血患者接受了PPI;接受泮托拉唑和奥美拉唑的患者UGI出血频率无显著差异。UGI出血后,再出血率为7.8%,血栓形成事件(TE)率为31.4%,30天死亡率为17.7%,1年死亡率为19.4%,整个观察期死亡率为35.3%。死亡的预测因素为AAA(OR 92.5;7.7 - 107.9;p < 0.0001)、APA(OR 4.2;1.03 - 17.2;p = 0.045)和HF(OR 34.5;8.5 - 140.6;p < 0.0001)。发生UGI出血和血栓形成事件的患者预后最差:这些患者中有2/3死亡。

结论

在对稳定型CAD患者的前瞻性分析中,我们发现与未出血患者相比,UGI出血是晚期血栓栓塞和死亡的重要危险因素。UGI出血和预后不良的预测因素是表明动脉粥样硬化血栓形成负担的因素,如腹主动脉瘤、外周动脉粥样硬化和HF。注册信息:网址:https://www.clinicaltrials.gov;唯一标识符:NCT04347200。

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