Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial

Diego Fernández-Rodríguez; Ander Regueiro; Salvatore Brugaletta; Victoria Martín-Yuste; Mónica Masotti; Angel Cequier; Andrés Iñíguez; Antonio Serra; Rosana Hernández-Antolín; Vicente Mainar; Marco Valgimigli; Maurizio Tespili; Pieter den Heijer; Armando Bethencourt; Nicolás Vázquez; Patrick W Serruys; Manel Sabaté; EXAMINATION investigators

doi:10.1161/CIRCINTERVENTIONS.113.000964

Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial

Circ Cardiovasc Interv. 2014 Jun;7(3):294-300. doi: 10.1161/CIRCINTERVENTIONS.113.000964. Epub 2014 May 27.

Authors

Diego Fernández-Rodríguez¹, Ander Regueiro¹, Salvatore Brugaletta¹, Victoria Martín-Yuste¹, Mónica Masotti¹, Angel Cequier¹, Andrés Iñíguez¹, Antonio Serra¹, Rosana Hernández-Antolín¹, Vicente Mainar¹, Marco Valgimigli¹, Maurizio Tespili¹, Pieter den Heijer¹, Armando Bethencourt¹, Nicolás Vázquez¹, Patrick W Serruys¹, Manel Sabaté²; EXAMINATION investigators

Affiliations

¹ From the Cardiology Department, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain (D.F.-R., A.R., S.B., V.M.-Y., M.M., M.S.); Cardiology Department, University Hospital of Bellvitge, Barcelona, Spain (A.C.); Cardiology Department, Hospital do Meixoeiro, Vigo, Spain (A.I.); Cardiology Department, University Hospital of Sant Pau, Barcelona, Spain (A.S.); Cardiology Department, University Hospital San Carlos, Madrid, Spain (R.H.-A.); Cardiology Department, Hospital General of Alicante, Alicante, Spain (V.M.); Cardiology Department, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands (M.V., P.W.S.); Cardiology Department, University Hospital Bolognini Seriate, Bergamo, Italy (M.T.); Cardiology Department, Amphia Ziekenhuis, Breda, The Netherlands (P.d.H.); Cardiology Department, Hospital Son Dureta, Palma de Mallorca, Spain (A.B.); and Cardiology Department, Hospital Juan Canalejo, A Coruña, Spain (N.V.).
² From the Cardiology Department, University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain (D.F.-R., A.R., S.B., V.M.-Y., M.M., M.S.); Cardiology Department, University Hospital of Bellvitge, Barcelona, Spain (A.C.); Cardiology Department, Hospital do Meixoeiro, Vigo, Spain (A.I.); Cardiology Department, University Hospital of Sant Pau, Barcelona, Spain (A.S.); Cardiology Department, University Hospital San Carlos, Madrid, Spain (R.H.-A.); Cardiology Department, Hospital General of Alicante, Alicante, Spain (V.M.); Cardiology Department, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands (M.V., P.W.S.); Cardiology Department, University Hospital Bolognini Seriate, Bergamo, Italy (M.T.); Cardiology Department, Amphia Ziekenhuis, Breda, The Netherlands (P.d.H.); Cardiology Department, Hospital Son Dureta, Palma de Mallorca, Spain (A.B.); and Cardiology Department, Hospital Juan Canalejo, A Coruña, Spain (N.V.). masabate@clinic.ub.es.

PMID: 24867891
DOI: 10.1161/CIRCINTERVENTIONS.113.000964

Abstract

Background: Manual thrombus aspiration (TA) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction. The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention.

Methods and results: Population of the EXAMINATION trial (n=1498) was divided into 2 groups according to the use of TA. Immediate angiographic results, primary patient-oriented end point (combination of all-cause death, myocardial infarction, and any revascularization) and secondary device-oriented end point (combination of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization), definite/probable stent thrombosis, and major/minor bleeding were evaluated at 2 years. A total of 976 (65.2%) patients were classified into TA group and 522 (34.8%) patients into nonthrombus aspiration group. Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow. The TA group received less number of stents implanted (1.35 ± 0.62 versus 1.45 ± 0.71, P = 0.005) with bigger size (3.25 ± 0.44 versus 3.11 ± 0.46 mm, P < 0.001) compared with the nonthrombus aspiration group. A higher rate of direct stenting (69.2% versus 43.3%, P < 0.001) with lower rate of postdilatation (13.0% versus 18.0%, P < 0.009) was also present in the TA group compared with the nonthrombus aspiration group. At 2-year follow-up, no differences in clinical end point were observed between groups.

Conclusions: Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting, a lower rate of postdilatation, and larger and less stents in comparison with conventional primary percutaneous coronary intervention. Conversely, manual TA had no apparent impact on clinical outcomes at long-term follow-up.

Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Keywords: drug-eluting stent; myocardial infarction; percutaneous coronary intervention; stent; thrombectomy.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Aged
Combined Modality Therapy
Coronary Angiography
Drug-Eluting Stents*
Electrocardiography*
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction / mortality
Myocardial Infarction / therapy*
Percutaneous Coronary Intervention / methods*
Prospective Studies
Suction / methods
Thrombectomy / methods*
Thrombosis / surgery*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT00828087