Effect of Coronary Thrombus Aspiration During Primary Percutaneous Coronary Intervention on One-Year Survival (from the FAST-MI 2010 Registry) Etienne Puymirat, MD, PhDa,b,*, Nadia Aissaoui, MD, PhDa, Yves Cottin, MD, PhDc, Gérald Vanzetto, MD, PhDd, Didier Carrié, MD, PhDe, Karl Isaaz, MD, PhDf, Yann Valy, MDg, Didier Tchetche, MDh, François Schiele, MD, PhDi, Philippe Gabriel Steg, MD, PhDj,k,l, Tabassome Simon, MD, PhDl,m,n, and Nicolas Danchin, MDa Results from randomized trials evaluating thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) are conflicting. We assessed 1-year survival in STEMI patients participating in the French Registry of Acute ST-Elevation and noneSTElevation Myocardial Infarction (FAST-MI) 2010 according to the use of TA during primary percutaneous coronary intervention (PCI). FAST-MI 2010 is a nationwide French registry that included 4,169 patients with acute myocardial infarction at the end of 2010 in 213 centers. Of those, 2,087 patients had STEMI, of whom 1,538 had primary PCI, with TA used in 671 (44%). Patients with TA were younger (61 – 13.5 vs 63 – 14 years), with a similar risk score of the Global Registry of Acute Coronary Events (140 – 31 vs 143 – 34) and a shorter median time from symptom onset (245 vs 285 minutes); location of acute myocardial infarction, history of myocardial infarction, PCI, or coronary artery bypass surgery did not differ significantly. Thirty-day mortality was 2.1% versus 2.1% (adjusted p [ 0.18), and the rate of 1-year survival was 95.5% versus 94.8%. Using fully adjusted Cox multivariate analysis, hazard ratio for 1-year death was 1.13 (95% confidence interval 0.66 to 1.94). After propensity score matching (480 patients per group), 1-year survival was also similar with both strategies. In a real-world setting of patients admitted with STEMI, the use of TA during primary PCI was not associated with improved 1-year survival. Ó 2014 Elsevier Inc. All rights reserved. (Am J Cardiol 2014;114:1651e1657) Primary percutaneous coronary intervention (PCI) is the preferred reperfusion therapy in patients with ST-elevation myocardial infarction (STEMI).1,2 When there is an evident thrombus on angiography, thrombus aspiration (TA) is commonly used with the intent to reduce distal embolization a Departement of Cardiology, European Hospital of Georges Pompidou, Assistance Publique des Hôpitaux de Paris (AP-HP), University Paris Descartes, Paris, France; bINSERM U-970, Paris, France; cDepartment of Cardiology, Dijon University Hospital, Dijon, France; dDepartment of Cardiology, Grenoble University Hospital, Grenoble, France; eDepartment of Cardiology, Toulouse University Hospital, Toulouse, France; fDepartment of Cardiology, Saint-Etienne University Hospital, Saint-Etienne, France; g Department of Cardiology, CH Saint-Louis, LaRochelle, France; hDepartment of Cardiology, Clinique Pasteur, Toulouse, France; iDepartment of Cardiology, University Hospital Jean Minjoz, Besançon, France; jHôpital Bichat, Department of Cardiology and mClinical Research Unit (URC-EST), Hospital Saint Antoine, Assistance Publique des Hôpitaux de Paris, Paris, France; kUniversité Paris-Diderot, Sorbonne Paris-Cité, Paris, France; l INSERM U-698, Paris, France; and nUniversité Pierre et Marie Curie, Paris, France. Manuscript received July 19, 2014; revised manuscript received and accepted August 28, 2014. The FAST-MI 2010 registry is a registry of the French Society of Cardiology, supported by unrestricted grants from: Merck, the Eli-LillyDaiichi-Sankyo alliance, AstraZeneca, sanofi-aventis, GSK, and Novartis. See page 1656 for disclosure information. *Corresponding author: Tel: þ 00-33-(0)1-56-09-2851; fax: þ 00-33(0)1-56-09-3810. E-mail address: [email protected] (E. Puymirat).

0002-9149/14/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2014.08.039

and to restore optimal myocardial reperfusion. However, several randomized trials have reported conflicting results, and even meta-analyses cannot agree on whether clinical outcomes with aspiration thrombectomy are improved (higher survival), neutral, or even worsened (increased stroke).3e13 Extremely limited data are available from registries that collect data on its real-world utilization.14e16 The aim of this study was to assess 1-year outcome in patients participating in the French Registry of Acute ST-elevation or noneST-Elevation Myocardial Infarction (FAST-MI) 2010 treated with primary PCI for STEMI, according to the use of TA. Methods FAST-MI 2010 is a national, prospective multicenter registry including consecutive adult patients hospitalized for acute STEMI and non-STEMI (with symptom onset
48 hours) for a period of 1 month (from October 2010), with a possible extension of recruitment up to 1 additional month. Patients with acute myocardial infarction (AMI) after cardiovascular procedures were excluded. Participation in the study was offered to all French institutions with intensive care units in the capacity to receive ACS emergencies.17 A total of 4,169 patients in 213 centers (76% of active centers in France) were included in this registry, and patients with STEMI were selected for the present study. The registry was conducted in compliance with Good Clinical Practice guidelines, the www.ajconline.org

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The American Journal of Cardiology (www.ajconline.org)

Table 1 Baseline characteristics: demographics, risk factors and clinical parameters on admission according to use of thrombus aspiration Variable Age (years) Women Body mass index (kg/m2) Hypertension Diabetes mellitus Current smoker Dyslipidemia* Previous myocardial infarction Previous percutaneous coronary intervention Previous coronary artery bypass grafting Previous heart failure Previous stroke Peripheral artery disease Chronic renal failure History of cancer GRACE score Left ventricle ejection fraction Anterior myocardial infarction Admission Killip class 1 Aspirin before admission Clopidogrel before admission Beta-blockers before admission Statins before admission Angiotensin-converting enzyme-inhibitors before admission Diuretics before admission Calcium channel blockers before admission

Stand-alone pPCI (n¼867)

Thrombus aspiration (n¼671)

P value

62.9  14.1 223 (26%) 26.7  4.5 409 (47%) 133 (15%) 375 (43%) 353 (41%) 85 (10%) 78 (9%) 41 (5%) 19 (2%) 19 (2%) 41 (5%) 16 (2%) 68 (8%) 143  34 51  10.9 349 (40%) 733 (86%) 129 (15%) 49 (6%) 163 (19%) 193 (22%) 106 (12%) 158 (18%) 121 (14%)

61.1  13.5 131 (19.5%) 26.9  4.4 277 (41%) 88 (13%) 305 (45.5%) 256 (38%) 64 (9.5%) 75 (11%) 36 (5%) 8 (1%) 19 (3%) 26 (4%) 10 (1.5%) 50 (7.5%) 140  31 49  10.0 292 (43.5%) 584 (89%) 97 (14.5%) 40 (6%) 106 (16%) 125 (19%) 68 (10%) 95 (14%) 84 (12.5%)

0.01 0.004 0.59 0.02 0.22 0.39 0.31 0.09 0.16 0.57 0.14 0.42 0.42 0.59 0.78 0.10 0.003 0.20 0.24 0.82 0.80 0.12 0.08 0.20 0.03 0.41

Values are expressed as mean (SD) or number (percentage). GRACE ¼ Global Registry of Acute Coronary Events. * Included patients with previously documented diagnosis of hypercholesterolemia be treated with diet or medication or new diagnosis made during this hospitalization with elevated total cholesterol >160 mg/dl; did not include elevated triglycerides.

French data protection law, and approved by the Committee for the Protection of Human Subjects in Biomedical Research of Saint-Louis University Hospital (Clinicaltrials.gov identifier: NCT01237418). STEMI was diagnosed when ST elevation 1 mm was seen in at least 2 contiguous leads in any location on the index or qualifying electrocardiogram or when presumed new left bundle branch block (LBBB) or new Q waves were observed. In this registry, manual TA devices were used as per current practice in the centers and decision of whether to use them depended on operators. Baseline characteristics were collected prospectively on computerized case record forms by dedicated research technicians sent in each of the centers at least once a week. The degree of coronary flow was classified by Thrombolysis In Myocardial Infarction (TIMI) grade flow as assessed by the investigators.18 The presence of a “significant amount of thrombus” was reported by the physicians, but it was not precisely quantified. In-hospital complications (recurrent myocardial infarction [MI], stent thrombosis, ventricular fibrillation, atrial fibrillation, bleed, or transfusion) were collected. Stent thrombosis was defined as definite or probable according to the Academic Research Consortium definition.19 In addition, 30-day and 1-year mortality were also collected. One-year follow-up was 99% complete.

Statistical analysis was performed using SPSS 20.0 software (SPSS Inc., Chicago, IL). For quantitative variables, means and SDs were calculated. Medians with interquartile ranges were calculated when appropriate. Discrete variables are presented as number of events and percentages. Comparisons were made with chi-square or Fisher’s exact tests for discrete variables and by unpaired t tests, Wilcoxon sign-rank tests, or 1-way analyses of variance for continuous variables. Survival curves were estimated using the Kaplan-Meier estimators and compared using log-rank tests. In addition, a propensity score (PS) for getting TA rather than stand-alone primary PCI was calculated using multiple logistic regressions and used to build 2 cohorts of patients (480 patients each) matched on the PS. The variables used were those listed in Table 1, antithrombotic medications used at the acute stage, and baseline TIMI flow. Correlates of 1-year survival were determined using a multivariate backward stepwise Cox analysis. Cumulative hazard functions were computed to assess proportionality. Three models were used: model 1, adjusted on the risk score of the Global Registry of Acute Coronary Events (GRACE); model 2, adjusted on the PS for getting TA; and model 3, adjusted on the most important preprocedural variables (sex, GRACE score, time from onset to angiography, baseline TIMI score, admission to a community hospital, risk factors, history of heart failure,

Coronary Artery Disease/Effect of Coronary Thrombus Aspiration During Primary PCI on 1-Year Survival

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Table 2 Procedural characteristics and early management according to use of thrombus aspiration Variable Time to first call (minutes) Median (IQR) No. of patients Admission to community hospital Time to primary PCI (minutes) Median (IQR) No. of patients Radial approach No. of patients Culprit coronary vessel - Left anterior descending - Left circumflex - Right - Left main - Bypass graft - Undetermined TIMI flow before -0/1 -2 -3 No. of patients High thrombus burden No. of patients DES BMS TIMI flow after -0/1 -2 -3 No. of patients Clopidogrel first Prasugrel first Glycoprotein IIb-IIIa inhibitors Fondaparinux before/during angiography Bivalirudine before/during angiography LMWH before/during angiography UFH before/during angiography Statins in first 24 hours Beta-blockers in first 24 hours ACE-inhibitors in first 24 hours

Stand-alone pPCI (n¼867)

Thrombus aspiration (n¼671)

P value

75 [30;201] [n¼849] 354 (41%)

70 [30;240] [n¼643] 206 (31%)

0.99

285 [180;640] [n¼789] 596 (69%) [n¼862]

245 [165;500] [n¼629] 490 (73%) [n¼670]