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

ABSTRACT: 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.).

SUBMITTER: Jolly SS

PROVIDER: S-EPMC4995102 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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

Jolly Sanjit S SS Cairns John A JA Yusuf Salim S Meeks Brandi B Pogue Janice J Rokoss Michael J MJ Kedev Sasko S Thabane Lehana L Stankovic Goran G Moreno Raul R Gershlick Anthony A Chowdhary Saqib S Lavi Shahar S Niemelä Kari K Steg Philippe Gabriel PG Bernat Ivo I Xu Yawei Y Cantor Warren J WJ Overgaard Christopher B CB Naber Christoph K CK Cheema Asim N AN Welsh Robert C RC Bertrand Olivier F OF Avezum Alvaro A Bhindi Ravinay R Pancholy Samir S Rao Sunil V SV Natarajan Madhu K MK ten Berg Jurriën M JM Shestakovska Olga O Gao Peggy P Widimsky Petr P Džavík Vladimír V

The New England journal of medicine 20150316 15

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 25853743

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

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

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