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Randomized trial of primary PCI with or without routine manual thrombectomy.

Publication ,  Journal Article
Jolly, SS; Cairns, JA; Yusuf, S; Meeks, B; Pogue, J; Rokoss, MJ; Kedev, S; Thabane, L; Stankovic, G; Moreno, R; Gershlick, A; Chowdhary, S ...
Published in: N Engl J Med
April 9, 2015

BACKGROUND: During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results. METHODS: We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days. RESULTS: The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02). CONCLUSIONS: In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 9, 2015

Volume

372

Issue

15

Start / End Page

1389 / 1398

Location

United States

Related Subject Headings

  • Thrombectomy
  • Stroke
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged
  • Microvessels
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Heart Failure
 

Citation

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Jolly, S. S., Cairns, J. A., Yusuf, S., Meeks, B., Pogue, J., Rokoss, M. J., … TOTAL Investigators, . (2015). Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med, 372(15), 1389–1398. https://doi.org/10.1056/NEJMoa1415098
Jolly, Sanjit S., John A. Cairns, Salim Yusuf, Brandi Meeks, Janice Pogue, Michael J. Rokoss, Sasko Kedev, et al. “Randomized trial of primary PCI with or without routine manual thrombectomy.N Engl J Med 372, no. 15 (April 9, 2015): 1389–98. https://doi.org/10.1056/NEJMoa1415098.
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 Apr 9;372(15):1389–98.
Jolly, Sanjit S., et al. “Randomized trial of primary PCI with or without routine manual thrombectomy.N Engl J Med, vol. 372, no. 15, Apr. 2015, pp. 1389–98. Pubmed, doi:10.1056/NEJMoa1415098.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemelä K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Džavík V, TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389–1398.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 9, 2015

Volume

372

Issue

15

Start / End Page

1389 / 1398

Location

United States

Related Subject Headings

  • Thrombectomy
  • Stroke
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged
  • Microvessels
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Heart Failure