RESUMO
BACKGROUND: The appropriate duration of treatment with beta-blocker drugs after a myocardial infarction is unknown. Data are needed on the safety and efficacy of the interruption of long-term beta-blocker treatment to reduce side effects and improve quality of life in patients with a history of uncomplicated myocardial infarction. METHODS: In a multicenter, open label, randomized, noninferiority trial conducted at 49 sites in France, we randomly assigned patients with a history of myocardial infarction, in a 1:1 ratio, to interruption or continuation of beta-blocker treatment. All the patients had a left ventricular ejection fraction of at least 40% while receiving long-term beta-blocker treatment and had no history of a cardiovascular event in the previous 6 months. The primary end point was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of <3 percentage points for the upper boundary of the two-sided 95% confidence interval). The main secondary end point was the change in quality of life as measured by the European Quality of Life-5 Dimensions questionnaire. RESULTS: A total of 3698 patients underwent randomization: 1846 to the interruption group and 1852 to the continuation group. The median time between the last myocardial infarction and randomization was 2.9 years (interquartile range, 1.2 to 6.4), and the median follow-up was 3.0 years (interquartile range, 2.0 to 4.0). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P = 0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients' quality of life. CONCLUSIONS: In patients with a history of myocardial infarction, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation. (Funded by the French Ministry of Health and ACTION Study Group; ABYSS ClinicalTrials.gov number, NCT03498066; EudraCT number, 2017-003903-23.).
RESUMO
BACKGROUND: Patients with renal failure (RF) have been systematically excluded from clinical trials; consequently their outcomes have not been well studied in the setting of percutaneous coronary intervention (PCI). AIMS: To compare cardiovascular outcomes after contemporary PCI in patients with versus without RF, according to clinical presentation (ST-segment elevation myocardial infarction [STEMI], acute coronary syndrome [ACS] or stable coronary artery disease [sCAD]). METHODS: Consecutive patients undergoing PCI with stent were prospectively included from 2007 to 2012. RF was defined as creatinine clearance<60mL/min. The primary endpoint was all-cause mortality; secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE: composite of cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and Academic Research Consortium definite/probable stent thrombosis (ST) at 1 year. RESULTS: Among 5337 patients, 23% had PCI for STEMI, 34% for ACS and 43% for sCAD, while 27% had RF. RF patients had a higher unadjusted death rate than those with preserved renal function (nRF) in all PCI indication groups (STEMI, 41% vs. 7.5%; ACS, 19% vs. 6%; sCAD, 10% vs. 3%; P<0.0001 for all). The rate of MACCE was also higher in RF patients whatever the PCI indication (STEMI, 45% vs. 15%; ACS, 23% vs. 14%; sCAD, 14% vs. 9%; P<0.05 for all). Rates of TLR (5.5-7.4%) and ST (<2.5%) were similar (P>0.05 for both). sCAD-RF and STEMI-nRF patients had similar rates of mortality (P=0.209) and MACCE (P=0.658). RF was independently associated with mortality, with a doubled relative risk in STEMI versus ACS and sCAD groups (odds ratio 5.3, 95% confidence interval 3.627-7.821 vs. 2.1, 1.465-3.140 and 2.3, 1.507-3.469, respectively; P<0.0001). CONCLUSION: RF is a stronger independent predictor of death after PCI in STEMI than in ACS or sCAD patients. sCAD-RF and STEMI-nRF patients had similar prognoses.