Subject(s)
Cardiology/standards , Guideline Adherence/standards , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/standards , Practice Guidelines as Topic/standards , Societies, Medical/standards , Time-to-Treatment/standards , Consensus , Cooperative Behavior , Evidence-Based Medicine/standards , Humans , International Cooperation , Myocardial Infarction/diagnosis , Patient Safety , Percutaneous Coronary Intervention/adverse effects , Risk Factors , Terminology as Topic , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used. RESULTS: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67). CONCLUSIONS: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.
Subject(s)
Coronary Thrombosis/epidemiology , Myocardial Infarction/epidemiology , Stents/adverse effects , Stents/statistics & numerical data , Aged , Causality , Cause of Death , Comorbidity , Denmark/epidemiology , Drug Delivery Systems/adverse effects , Drug Delivery Systems/statistics & numerical data , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Outcome and Process Assessment, Health Care , Prospective Studies , Registries , Risk AssessmentABSTRACT
BACKGROUND: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction may result in reduced myocardial perfusion, infarct extension, and impaired prognosis. METHODS AND RESULTS: In a prospective randomized trial, we studied the effect of routine thrombectomy in 215 patients with ST-segment-elevation myocardial infarction lasting <12 hours undergoing primary PCI. Patients were randomized to thrombectomy pretreatment or standard PCI. The primary end point was myocardial salvage measured by sestamibi SPECT, calculated as the difference between area at risk and final infarct size determined after 30 days (percent). Secondary end points included final infarct size, ST-segment resolution, and troponin T release. Baseline variables, including ST-segment elevation and area at risk, were similar. Salvage was not statistically different in the thrombectomy and control groups (median, 13% [interquartile range, 9% to 21%] and 18% [interquartile range, 7% to 25%]; P=0.12), but 24 patients in the thrombectomy group and 12 patients in the control group did not have an early SPECT scan, mainly because of poor general or cardiac condition (P=0.04). In the thrombectomy group, final infarct size was increased (median, 15%; [interquartile range, 4% to 25%] versus 8% [interquartile range, 2% to 18%]; P=0.004). CONCLUSIONS: Thrombectomy performed as routine therapy in primary PCI for ST-elevation myocardial infarction does not increase myocardial salvage. The study suggests a possible deleterious effect of thrombectomy, resulting in an increased final infarct size, and does not support the use of thrombectomy in unselected primary PCI patients.
