IJCS | Volume 32, Nº2, March/April 2019

126 Machado et al. Care changes in primary PCI Int J Cardiovasc Sci. 2019;32(2)125-133 Original Article intervention (PCI) performed via radial access is associated with a significant reduction in mortality rate and a lower incidence of adverse cardiac events in patients with a STEMI diagnosis. Moreover, it has been shown that performing routine aspiration thrombectomy shows no benefit in terms of reduction of mortality and major adverse cardiac and cerebrovascular events. 3-6 There have been few registries documenting clinical practice in Brazilian patients treated through the Brazilian national health system, Sistema Único de Saúde (SUS). Despite its many accomplishments, the Brazilian health systemfaces serious financial andorganizational challenges and, thus, high-end treatments are not always available, leading to different results from those seen in clinical trials in developed countries. Therefore, the aim of the current analysis was to assess the care changes in primary PCI, in addition to its mortality, in a tertiary university hospital in southern Brazil over a six-year period. Methods Patients This was a prospective single-center cohort study, which included consecutive patients with STEMI who underwent primary PCI in a tertiary university hospital with 24-hour primary PCI service in southern Brazil, between March 2011 and February 2017. Patients were stratified according to the year of admission. Each 1-year period was considered from March to February of the next year. Temporal trends in baseline characteristics, in-hospital treatment, and clinical events in the follow-up period were assessed. STEMI was defined as typical chest pain at rest associated with ST-segment elevation of at least 1 mm in two contiguous leads in the frontal plane or 2 mm in the horizontal plane, or typical pain at rest in patients with a new, or presumably new, left bundle-branch block. This study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki, as reflected in a previous approval by the Institutional Research and Ethics Committee and written informed consent was obtained from all individual participants included in the study. Study protocol Data from medical records were transferred into standardized case report forms (CRFs). Data collected included: baseline clinical characteristics, medical history, procedure characteristics, reperfusion strategy, initial and final thrombolysis in myocardial infarction (TIMI) flow grade, and discharge therapies. In-hospital and 30-day mortality rates were also recorded in the CRF. Thirty-day and 1-year follow-up were ascertained by clinical visit or telephone contact with patients or their families. When follow-up was conducted by telephone contact, a standardized questionnaire was used to guide the conversation with the patients or their families. Blood samples were collected by venipuncture before the procedure as part of routine patient care. Blood parameters were analyzed with the XE 5000 system (Sysmex ® , Norderstedt, Germany). All patients were pre-treated with a loading dose of acetylsalicylic acid (300 mg) and clopidogrel (600 mg), and unfractionated heparin was used during the procedure (70-100 UI/kg). Use of IIb/IIIa glycoprotein, aspiration thrombectomy and PCI technical strategies (i.e. pre-dilation, direct stenting , post-dilation) were performed according to the operator`s choice. Coronary epicardial blood flow before and after the procedure was assessed and described according to TIMI criteria. Anticoagulants were suspended after the end of the procedure, and dual antiplatelet therapy was recommended for 12 months after the event. Creatinine was measured at baseline and 48-72 hours post-procedure. Clinical definitions Major adverse cardiac and cerebrovascular events (MACCE) were defined as death from any cause, new myocardial infarction (MI), stroke, Canadian Cardiovascular Society (CCS) class III/IV angina or re- hospitalization for heart failure 30 days after primary PCI. New MI was defined as recurrent chest pain with ST-segment elevation or new Q waves and increase in serum biomarkers after their initial decrease. Stroke was defined as a new, sudden-onset focal neurological deficit, of presumably cerebrovascular cause, irreversible (or resulting in death) and not caused by other readily identifiable causes. Cardiogenic shock at admission was defined as a systolic BP < 90 mmHg for ≥ 30 minutes, clinical signs of pulmonary congestion, and end-organ hypoperfusion (cool extremities, alteredmental status, or urine output < 30mL/h). Contrast-induced nephropathy (CIN) was considered when there was an increase of 0.3mg/dL or 50.0% in post-procedure (24-72 h) creatinine compared to baseline, as proposed by the Acute Kidney Injury Network (AKIN) as a standardized definition of acute kidney injury.