The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of the efficacy of pharmacoinvasive management for ST-segment elevation myocardial infarction in smokers versus non-smokers (from the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction).
Compared with non-smokers, cigarette smokers with ST-segment elevation myocardial infarctions derive greater benefit from fibrinolytic therapy. However, it is not known whether the optimal treatment strategy after fibrinolysis differs on the basis of smoking status. The Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) randomized patients with ST-segment elevation myocardial infarctions to a routine early invasive (pharmacoinvasive) versus a standard (early transfer only for rescue percutaneous coronary intervention or delayed angiography) strategy after fibrinolysis. ⋯ Smoking status did not modify treatment effect on any measured outcomes (p>0.10 for all). In conclusion, compared with non-smokers, current smokers receiving either standard or early invasive management of ST-segment elevation myocardial infarction after fibrinolysis have more favorable outcomes, which is likely attributable to their better baseline risk profile. The beneficial treatment effect of a pharmacoinvasive strategy is consistent in smokers and non-smokers.
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Randomized Controlled Trial Multicenter Study
Impact of pre-procedural cardiopulmonary instability in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial).
Rapid reperfusion with primary percutaneous coronary intervention improves survival in patients with ST-segment elevation myocardial infarction. Preprocedural cardiopulmonary instability and adverse events (IAE) may delay reperfusion time and worsen prognosis. The aim of this study was to evaluate the relation between preprocedural cardiopulmonary IAE, door-to-balloon time (DBT), and outcomes in the Harmonizing Outcomes With Revascularization and Stents in AMI (HORIZONS-AMI) trial. ⋯ Mortality at 3 years was significantly higher in patients with versus those without IAE (17.0% vs 6.3%, p<0.0001), and IAE was an independent predictor of mortality, whereas DBT was not. However, a significant interaction was present such that 3-year mortality was reduced in patients with DBT<99 minutes (the median) versus ≥99 minutes to a greater extent in patients with IAE (9.9% vs 20.7%, hazard ratio 0.43, 95% confidence interval 0.16 to 1.16) compared with those without IAE (5.0% vs 7.2%, hazard ratio 0.69, 95% confidence interval 0.50 to 0.95) (p for interaction=0.004). In conclusion, IAE before PCI is an independent predictor of death and identifies a high-risk group in whom faster reperfusion may be particularly important to improve survival.
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Randomized Controlled Trial Multicenter Study
Outcomes of a pharmacoinvasive strategy for successful versus failed fibrinolysis and primary percutaneous intervention in acute myocardial infarction (from the STrategic Reperfusion Early After Myocardial Infarction [STREAM] study).
Although a fibrinolytic pharmacoinvasive strategy is recommended for patients with ST elevation myocardial infarction (STEMI) unable to undergo timely primary percutaneous coronary intervention (PCI), there are limited data addressing outcomes specific to those with successful or unsuccessful pharmacologic reperfusions. Accordingly, we evaluated a contemporary pharmacoinvasive strategy for failed and successful reperfusions within the STrategic Reperfusion Early After Myocardial infarction study. Of 1,823 per-protocol-treated patients with STEMI, we examined clinical outcomes and angiographic and electrocardiographic metrics in 3 groups as follows: fibrinolysis requiring rescue (rescue, n = 348), fibrinolysis with scheduled angiography (scheduled, n = 516), and primary PCI (n = 927). ⋯ Compared with successfully reperfused patients undergoing scheduled angiography, the adjusted relative risk of the primary outcome was 2.92 (95% confidence interval 1.92 to 4.45) in rescue patients. In conclusion, pharmacoinvasive-treated patients requiring rescue angiography had greater baseline risk with more co-morbidities and worse 30-day outcomes compared with successful fibrinolytic-treated patients. Residual ST elevation after reperfusion assists in defining prognosis.
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Randomized Controlled Trial
Effect of alirocumab, a monoclonal proprotein convertase subtilisin/kexin 9 antibody, on lipoprotein(a) concentrations (a pooled analysis of 150 mg every two weeks dosing from phase 2 trials).
Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular disease, with limited treatment options. This analysis evaluated the effect of a monoclonal antibody to proprotein convertase subtilisin/kexin 9, alirocumab 150 mg every 2 weeks (Q2W), on Lp(a) levels in pooled data from 3 double-blind, randomized, placebo-controlled, phase 2 studies of 8 or 12 weeks' duration conducted in patients with hypercholesterolemia on background lipid-lowering therapy (NCT01266876, NCT01288469, and NCT01288443). Data were available for 102 of 108 patients who received alirocumab 150 mg Q2W and 74 of 77 patients who received placebo. ⋯ Regression analysis indicated that <5% of the variance in the reduction of Lp(a) was explained by the effect of alirocumab on low-density lipoprotein cholesterol. In conclusion, pooled data from 3 phase 2 trials demonstrate substantive reduction in Lp(a) with alirocumab 150 mg Q2W, including patients with baseline Lp(a) >50 mg/dl. Reductions in Lp(a) only weakly correlated with the magnitude of low-density lipoprotein cholesterol lowering.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of one- and 12-month outcomes of transcatheter aortic valve replacement in patients with severely stenotic bicuspid versus tricuspid aortic valves (results from a multicenter registry).
The aim of the study was to evaluate the transcatheter aortic valve replacement (TAVR) in high-risk patients with severe bicuspid aortic valve (BAV) stenosis and to compare the outcomes with a matched group of patients with tricuspid aortic valve. TAVR became an alternative treatment method in high-risk patients with symptomatic aortic stenosis; however, BAV stenosis is regarded as a relative contraindication to TAVR. The study population comprised 28 patients with BAV who underwent TAVR. ⋯ The postprocedural mean pressure gradient (11.5 ± 6.4 vs 10.4 ± 4.5 mm Hg, p = 0.33), aortic regurgitation grade ≥2 of 4 (32% vs 23%, p = 0.45), 30-day mortality (4% vs 7%, p = 0.68), and 1-year all-cause mortality (19% vs 18%, p = 1.00) did not differ between the groups. Echocardiography showed well-functioning valve prosthesis with a mean prosthetic valve area of 1.6 ± 0.4 cm(2) versus 1.7 ± 0.3 cm(2) (p = 0.73), a mean pressure gradient of 10.3 ± 5.4 versus 9.8 ± 2.8 mm Hg (p = 0.64), and aortic regurgitation grade ≥2 of 4 (22% vs 22%, p = 1.00) for the 2 groups. In conclusion, selected high-risk patients with BAV can be successfully treated with TAVR, and their outcomes are similar to those reported in patients without BAV.