提示: 手机请竖屏浏览!

急诊PCI是否结合常规手工血栓抽吸术的随机试验
Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy


Sanjit S. Jolly ... 心脑血管疾病 • 2015.04.09

摘要


背景

急诊经皮冠状动脉介入治疗(PCI)中行手工血栓抽吸可减少远端栓塞的发生,从而改善心肌微循环灌注。尽管一些小规模临床试验提示血栓抽吸能够改善替代指标和临床结局,但一项大规模临床试验却报告了相反的结论。

 

方法

本研究将10,732例拟行急诊PCI的ST段抬高型心肌梗死(STEMI)患者随机分入单纯PCI组或PCI结合手工血栓抽吸组。主要复合结局为心血管原因死亡、再发心肌梗死、心源性休克,或术后180天内出现纽约心脏学会(New York Heart Association;NYHA)定义的Ⅳ级心力衰竭。关键安全性结局设为术后30天内的卒中发生。

 

结果

主要复合终点事件发生率在血栓抽吸组为6.9%(347/5033患者),与单纯PCI组的7.0%发生率(351/5030患者)无显著性差异(血栓抽吸组风险比0.99;95%可信区间[CI],0.85~1.15;P=0.86)。同时,心血管性死亡(血栓抽吸组3.1%对单纯PCI组3.5%;风险比0.90;95% CI,0.73~1.12;P=0.34)与主要复合结局加上支架内血栓形成或靶血管血运重建的发生率亦相似(9.9% 对9.8%;风险比1.00;95% CI,0.89~1.14;P=0.95)。但是,血栓抽吸组30天内卒中的0.7%发生率(33例)较单纯PCI组的0.3%(16例)显著升高(风险比2.06;95% CI,1.13~3.75;P=0.02)。

 

结论

与单纯PCI相比,PCI术前接受常规手工血栓抽吸并不能降低STEMI患者术后180天内心血管性死亡、再发心肌梗死、心源性休克或NYHA Ⅳ级心力衰竭等不良事件的发生率,但与PCI术后30天内卒中发生风险的增加相关(试验由美敦力公司[Medtronic]和加拿大卫生研究院[Canadian Institutes of Health Research]赞助,TOTAL ClinicalTrials.gov注册号为NCT01149044)。





作者信息

Sanjit S. Jolly, M.D., John A. Cairns, M.D., Salim Yusuf, M.D., D.Phil., Brandi Meeks, M.Eng., Janice Pogue, Ph.D., Michael J. Rokoss, M.D., Sasko Kedev, M.D., Ph.D., Lehana Thabane, Ph.D., Goran Stankovic, M.D., Raul Moreno, M.D., Ph.D., Anthony Gershlick, M.B., B.S., Saqib Chowdhary, M.D., Ph.D., Shahar Lavi, M.D., Ph.D., Kari Niemelä, M.D., Philippe Gabriel Steg, M.D., Ivo Bernat, M.D., Ph.D., Yawei Xu, M.D., Ph.D., Warren J. Cantor, M.D., Christopher B. Overgaard, M.D., Christoph K. Naber, M.D., Ph.D., Asim N. Cheema, M.D., Ph.D., Robert C. Welsh, M.D., Olivier F. Bertrand, M.D., Ph.D., Alvaro Avezum, M.D., Ph.D., Ravinay Bhindi, M.B.B.S., Ph.D., Samir Pancholy, M.D., Sunil V. Rao, M.D., Madhu K. Natarajan, M.D., Jurriën M. ten Berg, M.D., Ph.D., Olga Shestakovska, M.Sc., Peggy Gao, M.Sc., Petr Widimsky, M.D., D.Sc., and Vladimír Džavík, M.D., for the TOTAL Investigators *
The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Address reprint requests to Dr. Jolly at Rm. C3-118, DBCVSRI Bldg., Hamilton General Hospital, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada, or at sanjit.jolly@phri.ca. * A complete list of investigators in the Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet 2003;361:13-20

2. Buller CE, Fu Y, Mahaffey KW, et al. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation 2008;118:1335-1346

3. Stone GW, Peterson MA, Lansky AJ, Dangas G, Mehran R, Leon MB. Impact of normalized myocardial perfusion after successful angioplasty in acute myocardial infarction. J Am Coll Cardiol 2002;39:591-597

4. De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J 2008;29:3002-3010

5. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med 2008;358:557-567

6. Vlaar PJ, Svilaas T, van der Horst IC, et al. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet 2008;371:1915-1920

7. Kushner FG, Hand M, Smith SC Jr, et al. 2009 Focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2009;54:2205-2241[Erratum, J Am Coll Cardiol 2009;54:2464.]

8. Steg PG, James SK, Atar D, et al. ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012;33:2569-2619

9. Tamhane UU, Chetcuti S, Hameed I, Grossman PM, Moscucci M, Gurm HS. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for acute ST elevation MI: a meta-analysis of randomized controlled trials. BMC Cardiovasc Disord 2010;10:10-10

10. Frobert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013;369:1587-1597[Erratum, N Engl J Med 2014;371:786.]

11. Lagerqvist B, Frobert O, Olivecrona GK, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med 2014;371:1111-1120

12. Kumbhani DJ, Bavry AA, Desai MY, et al. Aspiration thrombectomy in patients undergoing primary angioplasty: totality of data to 2013. Catheter Cardiovasc Interv 2014;84:973-977

13. Jolly SS, Cairns J, Yusuf S, et al. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration: ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J 2014;167:315-321

14. Stone GW, Maehara A, Witzenbichler B, et al. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA 2012;307:1817-1826

15. Guptill JT, Mehta RH, Armstrong PW, et al. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv 2013;6:176-183

16. Budaj A, Flasinska K, Gore JM, et al. Magnitude of and risk factors for in-hospital and postdischarge stroke in patients with acute coronary syndromes: findings from a Global Registry of Acute Coronary Events. Circulation 2005;111:3242-3247

服务条款 | 隐私政策 | 联系我们