接受利伐沙班两种治疗策略或剂量调整口服维生素K拮抗剂治疗策略的冠状动脉内支架置入术房颤患者的再住院情况

Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.

作者信息

Gibson C Michael, Pinto Duane S, Chi Gerald, Arbetter Douglas, Yee Megan, Mehran Roxana, Bode Christoph, Halperin Jonathan, Verheugt Freek W A, Wildgoose Peter, Burton Paul, van Eickels Martin, Korjian Serge, Daaboul Yazan, Jain Purva, Lip Gregory Y H, Cohen Marc, Peterson Eric D, Fox Keith A A

机构信息

From Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.M.G., D.S.P., G.C., D.A., M.Y., S.K., Y.D., P.J.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany (C.B.); Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (F.W.A.V.); Janssen Pharmaceuticals, Inc, Beerse, Belgium (P.W., P.B.); Bayer Pharmaceuticals, Inc, Berlin, Germany (M.v.E.); University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (G.Y.H.L.); Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.); Duke Clinical Research Institute, Durham, NC (E.D.P.); and Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom (K.A.A.F.).

出版信息

Circulation. 2017 Jan 24;135(4):323-333. doi: 10.1161/CIRCULATIONAHA.116.025783. Epub 2016 Nov 14.

DOI:10.1161/CIRCULATIONAHA.116.025783

PMID:27881555

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5266420/

Abstract

BACKGROUND

Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization.

METHODS

Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment.

RESULTS

The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not.

CONCLUSIONS

Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.

摘要

背景

接受冠状动脉内支架置入术的房颤患者传统上采用维生素K拮抗剂（VKA）加双联抗血小板治疗（DAPT），但这种治疗会导致高出血风险。我们假设利伐沙班联合P2Y抑制剂单药治疗方案或利伐沙班联合DAPT方案可减少出血，从而对全因死亡率和再次住院需求产生有利影响。

方法

将2124例接受支架置入术的非瓣膜性房颤患者按1:1:1随机分组，分别给予每日15 mg低剂量利伐沙班联合P2Y抑制剂治疗12个月（第1组）；每日两次2.5 mg利伐沙班，并分层为1、6或12个月的预设DAPT疗程（第2组）；或每日剂量调整的VKA联合类似DAPT分层的参照组（第3组）。本次事后分析评估全因死亡率或因不良事件再次住院的终点，该终点进一步分为出血、心血管原因或与治疗分配无关的其他原因导致的结果。

结果

第1组全因死亡率或再次住院风险为34.9%（风险比=0.79；95%置信区间，0.66 - 0.94；与第3组相比，P = 0.008；需治疗人数=15），第2组为31.9%（风险比=0.75；95%置信区间，0.62 - 0.90；与第3组相比，P = 0.002；需治疗人数=10），第3组（VKA + DAPT）为41.9%。与VKA组相比，利伐沙班组因出血导致的全因死亡加住院（第1组=8.6% [与第3组相比，P = 0.032]，第2组=8.0% [与第3组相比，P = 0.012]，第3组=12.4%）以及因心血管原因导致的全因死亡加再次住院（第1组=21.4% [与第3组相比，P = 0.001]，第2组=21.7% [与第3组相比，P = 0.011]，第3组=29.3%）均有所降低，但其他形式的再次住院情况未降低。