BACKGROUNDA polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODSIn this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTSA total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondaryoutcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONSTreatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015 -002868 -17.
In STEMI patients, pre-treatment with a 600-mg clopidogrel loading dose before primary PCI was associated with a reduction of the infarct size compared with a 300-mg loading dose, as well as with improvement of angiographic results, residual cardiac function, and 30-day major adverse cardiovascular events; further studies are warranted to evaluate impact of such strategy on survival.
ObjectiveWe assessed the diagnostic and prognostic implications of early cardiac magnetic resonance (CMR), CMR-based deformation imaging and conventional risk factors in patients with troponin-positive acute chest pain and non-obstructed coronary arteries.MethodsIn total, 255 patients presenting between 2009 and 2019 with troponin-positive acute chest pain and non-obstructed coronary arteries who underwent CMR in ≤7 days were followed for a clinical endpoint of all-cause mortality. Cine movies, T2-weighted and late gadolinium-enhanced images were evaluated to establish a diagnosis of the underlying heart disease. Further CMR analysis, including left ventricular strain, was carried out.ResultsCMR (performed at a mean of 2.7 days) provided the diagnosis in 86% of patients (54% myocarditis, 22% myocardial infarction (MI) and 10% Takotsubo syndrome and myocardial contusion (n=1)). The 4-year mortality for a diagnosis of MI, myocarditis, Takotsubo and normal CMR patients was 10.2%, 1.6%, 27.3% and 0%, respectively. We found a strong association between CMR diagnosis and mortality (log-rank: 24, p<0.0001). Takotsubo and MI as the diagnosis, age, hypertension, diabetes, female sex, ejection fraction, stroke volume index and most of the investigated strain parameters were univariate predictors of mortality; however, in the multivariate analysis, only hypertension and circumferential mechanical dispersion measured by strain analysis were independent predictors of mortality.ConclusionsCMR performed in the early phase establishes the proper diagnosis in patients with troponin-positive acute chest pain and non-obstructed coronary arteries and provides additional prognostic factors. This may indicate that CMR could play an additional role in risk stratification in this patient population.
AimTo analyze the efficacy of a regionally organized primary percutaneous coronary intervention (PCI) network at the Heart Center, Semmelweis University Budapest, part of the "Budapest model, " and the factors that influence it.Methods In order to investigate the differences between regular and off-hours patient care in a 24-hour myocardial infarction primary care system, we included 1890 consecutive, unselected patients with ST-segment elevation myocardial infarction and followed them until at least one year. The follow-up was complete for all participants. ResultsThe difference between regular hours and offhours mortality was not significant either after 30 days (8.6% vs 8.8%, respectively) or after 1 year (15.3% vs 14.7%, respectively). The rate of patients with re-infarction, frequency of re-intervention, and major adverse cardiac events, including death, re-infarction, re-intervention, and coronary artery bypass graft surgery, were similar in both patient groups. The time delay between the onset of chest pain and arrival to the clinic was 5.9 ± 5.8 hours (mean ± standard deviation) during regular hours and 5.2 ± 4.6 hours during off-hours (P = 0.235). Direct transport caused significant decrease in the 30-day and 1-year mortality independent of duty time (7.2% vs 9.9%, P = 0.027; 12.6% vs 16.7%, P = 0.028; respectively). ConclusionCentralized primary PCI network of the "Budapest model" achieved the same level of patient care during both off-hours and regular hours. The generally accepted treatment of acute ST elevation myocardial infarction (STEMI) within 12 hours is primary percutaneous coronary intervention (PCI). However, the outcome of PCI may be influenced by several factors, like annual number of procedures (1-4), experience of the operating physician, time delay to treatment (5-8), and organization level of myocardial infarction care (9-16). In case of organized primary PCI network, the most important factor that influences the clinical outcome is the time of the arrival to the PCI center. Patients treated during off-hours can have a higher incidence of failed operation procedure and consequently a worse prognosis than patients treated during regular hours (17-22).Assali et al (18) reported that the unadjusted mortality at 1 month was significantly higher in patients treated during the night than in those treated during the day (9.7% vs 3.1%) (18). Henriques et al (19) demonstrated that the admittance of patients between 8:00 am and 6:00 pm was associated with an angioplasty failure rate of 3.8%, compared with 6.9% between 6:00 pm and 08:00 am Thirty-day mortality was 1.9% in patients with hospital admission between 8:00 am and 6:00 pm, compared with 4.2% in patients with hospital admission between 6:00 pm and 8:00 am (19). A related study of 231 164 STEMI patients (20) showed that the 30-day mortality was significantly higher for patients admitted on weekends (12.9% vs 12.0%). A cohort study of 68 439 patients with STE-MI (21) showed that these patients had substantially longer door-to-balloon ti...
BackgroundDistal radial access (DRA) was recently introduced in the hopes of improving patient comfort by allowing the hand to rest in a more ergonomic position throughout percutaneous coronary interventions (PCI), and potentially to further reduce the rate of complications (mainly radial artery occlusion, [RAO]). Its safety and feasibility in chronic total occlusion (CTO) PCI have not been thoroughly explored, although the role of DRA could be even more valuable in these procedures.MethodsFrom 2016 to 2021, all patients who underwent CTO PCI in 3 Hungarian centers were included, divided into 2 groups: one receiving proximal radial access (PRA) and another DRA. The primary endpoints were the procedural and clinical success and vascular access-related complications. The secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) and procedural characteristics (volume of contrast, fluoroscopy time, radiation dose, procedure time, hospitalization time).ResultsA total of 337 consecutive patients (mean age 64.6 ± 9.92 years, 72.4% male) were enrolled (PRA = 257, DRA = 80). When compared with DRA, the PRA group had a higher prevalence of smoking (53.8% vs. 25.7%, SMD = 0.643), family history of cardiovascular disease (35.0% vs. 15.2%, SMD = 0.553), and dyslipidemia (95.0% vs. 72.8%, SMD = 0.500). The complexity of the CTOs was slightly higher in the DRA group, with higher degrees of calcification and tortuosity (both SMD >0.250), more bifurcation lesions (45.0% vs. 13.2%, SMD = 0.938), more blunt entries (67.5% vs. 47.1%, SMD = 0.409). Contrast volumes (median 120 ml vs. 146 ml, p = 0.045) and dose area product (median 928 mGy×cm2 vs. 1,300 mGy×cm2, p < 0.001) were lower in the DRA group. Numerically, local vascular complications were more common in the PRA group, although these did not meet statistical significance (RAO: 2.72% vs. 1.25%, p = 0.450; large hematoma: 0.72% vs. 0%, p = 1.000). Hospitalization duration was similar (2.5 vs. 3.0 days, p = 0.4). The procedural and clinical success rates were comparable through DRA vs. PRA (p = 0.6), moreover, the 12-months rate of MACCE was similar across the 2 groups (9.09% vs. 18.2%, p = 0.35).ConclusionUsing DRA for complex CTO interventions is safe, feasible, lowers radiation dose and makes dual radial access more achievable. At the same time, there was no signal of increased risk of periprocedural or long-term adverse outcomes.
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