Routine Manual Thrombus Aspiration in ST Elevation Myocardial Infarction: End of the TASTE after TOTALity of Data

Abstract

Introduction: We aimed to update our meta-analysis that investigated the effects of routine manual thrombus aspiration (TA) on clinical outcomes in patients with ST elevation myocardial infarction by publishing an additional large randomized clinical trial.

Patients and Metods: Sixteen studies in which primary percutaneous coronary intervention [(PPCI) (n= 10.440) vs. TA + PPCI (n= 10.434)] was performed were included to this meta-analysis. We calculated the risk ratio (RR) for clinical outcome, such as all cause death, recurrent infarction (Re-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), stent thrombosis (ST), and stroke. In addition, we performed trial sequential analysis (TSA) to differentiate conclusive vs inconclusive results and to demonstrate the presence or absence of futility. Our assumptions for TSA included two-sided testing were type 1 error= 5%, power= 80%, and 20% relative risk reduction (RRR).

Results: There were no significant differences between TA + PPCI and PPCI alone arms in terms of all cause mortality [4.9% vs. 5.5%, RR= 0.895, 95% confidence interval (CI): 0.797-1.005, p= 0.060], Re-MI (2.1% vs. 2.2%, RR= 0.958, 95% CI: 0.797–1.151, p= 0.647), TVR/TLR (6.3% vs. 6.1%, RR= 1.030, 95% CI: 0.926-1.146, p= 0.586), and ST (1.2% vs. 1.4%, RR= 0.911, 95% CI: 0.712-1.166, p= 0.459). However, TA slightly increased the risk of stroke (0.8% vs. 0.5%, RR= 1.535, 95% CI: 1.003-2.351, p= 0.049). TSA indicates that sufficient evidence exists to draw a firm conclusion regarding death, re-MI, and TVR/TLR. However, TSA showed a lack of sufficient evidence that TA resulted in a reduction in the incidence of ST or increased the risk of stroke.

Conclusion: This updated meta-analysis including over 20.000 patients showed that routine manual TA did not reduce the incidence of all cause mortality, re-MI, TVR/TLR, and ST. The risk of stroke might be increased in TA.

Keywords

• Aspiration thrombectomy,ST segment elevation myocardial infarction,primary percutaneous coronary intervention,meta-analysis

ST Elevasyonlu Miyokart İnfarktüsünde Rutin Trombüs Aspirasyonunun Yeri

Abstract

Giriş: Bu çalışmada, büyük bir randomize kontrollü klinik çalışma yayınlanması nedeniyle, daha önce yayınladığımız ST elevasyonlu miyokart infarktüsü olan hastalarda rutin trombüs aspirasyonunun (TA) etkilerini inceleyen meta-analizimizi güncellemeyi amaçladık.

Hastalar ve Yöntem: Bu meta-analize primer perkütan koroner girişim (PPKG) uygulanmış hastaların alındığı çalışmalar dahil edildi. Tüm nedenlere bağlı ölüm, tekrarlayan infarktüs (Re-MI), hedef damar/lezyon revaskülarizasyon (TVR/TLR), stent trombozu (ST) ve inme  gibi klinik sonuçlar için risk oranı (RR) hesaplandı. Ayrıca  klinik sıralı analiz uygulandı. Klinik sıralı analiz için varsayımlarımız: tip 1 hata = %5, güç = %80 ve relatif risk azalması %20 idi.

Bulgular: TA + PPKG ve PPKG kolları arasında tüm nedenlere bağlı ölüm (%4.9 vs. %5.5, RR= 0.895, %95 CI: 0.797-1.005, p= 0.060), Re-MI (%2.1 vs. %2.2, RR= 0.958, %95 CI: 0.797-1.151, p= 0.647), TVR/TLR (%6.3 vs. %6.1, RR= 1.030, %95 CI: 0.926-1.146, p= 0.586) ve ST (%1.2 vs. %1.4, RR= 0.911, %95 CI: 0.712-1.166, p= 0.459) bakımından anlamlı fark yoktu. Bununla beraber TA’nın inme riskini bir miktar artırdığı gözlendi (%0.8 vs. %0.5, RR= 1.535, %95 CI: 1.003-2.351, p= 0.049).

Sonuç: Yirmi binden fazla hastanın dahil edildiği güncellenmiş bu meta-analiz rutin manual trombüs aspirasyonunun tüm nedenlere bağlı ölüm, tekrarlayan infarktüs (Re-MI), hedef damar/lezyon revaskülarizasyonu ve stent trombozunu azaltmadığını gösterdi. Fakat trombüs aspirasyonu ile inme riski artıyor olabilir.

Keywords

• Aspirasyon trombektomi,ST elevasyonlu miyokart infarktüsü,primer perkütan koroner girişim,meta-analiz

References

1. 1. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, 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;371:1915-20.
2. 2. Lagerqvist B, Frobert O, Olivecrona GK, Gudnason T, Maeng M, Alstrom P, et al. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med 2014;371:1111-20.
3. 3. Tanboga IH, Topcu S, Aksakal E, Kurt M, Kaya A, Oduncu V, et al. Thrombus aspiration in patients with ST elevation myocardial infarction: meta-analysis of 16 randomized trials. Anatol J Cardiol 2015;15:175-87.
4. 4. Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, et al. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med 2015;372:1389-98.
5. 5. Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive--Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. Int J Epidemiol 2009;38:287-98.
6. 6. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008;61:64-75.
7. 7. Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, et al. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses? Int J Epidemiol 2009;38:276-86.
8. 8. Lipiecki J, Monzy S, Durel N, Cachin F, Chabrot P, Muliez A, et al. Effect of thrombus aspiration on infarct size and left ventricular function in high-risk patients with acute myocardial infarction treated by percutaneous coronary intervention. Results of a prospective controlled pilot study. Am Heart J 2009;157:583 e1-7.

9. 9. Stone GW, Witzenbichler B, Godlewski J, Dambrink JH, Ochala A, Chowdhary S, et al. Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial. Circ Cardiovasc Interv 2013;6:527-34.
10. 10. Kumbhani DJ, Bavry AA, Desai MY, Bangalore S, Byrne RA, Jneid H, et al. Aspiration thrombectomy in patients undergoing primary angioplasty: totality of data to 2013. Catheter Cardiovasc Interv 2014;84:973-7.
11. 11. De Luca G, Navarese EP, Suryapranata H. A meta-analytic overview of thrombectomy during primary angioplasty. Int J Cardiol 2013;166:606-12.
12. 12. Costopoulos C, Gorog DA, Di Mario C, Kukreja N. Use of thrombectomy devices in primary percutaneous coronary intervention: a systematic review and meta-analysis. Int J Cardiol2013;163:229-41.
13. 13. Bavry AA, Kumbhani DJ, Bhatt DL. Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction: a comprehensive meta-analysis of randomized trials. Eur Heart J2008;29:2989-3001.
14. 14. Mongeon FP, Belisle P, Joseph L, Eisenberg MJ, Rinfret S. Adjunctive thrombectomy for acute myocardial infarction: A bayesian metaanalysis.Circ Cardiovasc Interv 2010;3:6-16.
15. 15. 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.
16. 16. Barkagan M, Steinvil A, Berchenko Y, Finkelstein A, Keren G, Banai S, et al. Impact of routine manual aspiration thrombectomy on outcomes ofpatients undergoing primary percutaneous coronary intervention foracute myocardial infarction: A meta-analysis. Int J Cardiol2016;204:189-95.
17. 17. Spitzer E, Heg D, Stefanini G, Stortecky S, Rutjes A, Raber L, et al. Rev aspiration thrombectomy for treatment of ST-segment elevation myocardial infarction: a meta-analysis of 26 randomized trialsin 11 943 patients. Esp Cardiol 2015;68:74652.
18. 18. Elgendy IY, Huo T, Bhatt DL, Bavry AA. Is aspiration thrombectomy beneficial in patients undergoing primary percutaneous coronary intervention? Meta-Analysis of randomized trials. Circ Cardiovasc Interv 2015;8:e002258.