Percutaneous coronary intervention or medical therapy in patients with severe aortic stenosis and coronary artery disease undergoing transcatheter aortic valve implantation: a real-world analysis using data from an international network.

Patients undergoing transcatheter aortic valve implantation (TAVI) due to severe aortic stenosis have a high prevalence of coronary artery disease (CAD). As many of them have high surgical risk, CAD treatment in this group has typically been carried out with optimal medical treatment or paired with percutaneous coronary intervention (PCI). However, the best approach in this scenario is not well established. We aimed to evaluate 5-year cardiovascular outcomes in patients with aortic stenosis and chronic CAD treated with medical treatment alone compared to PCI coupled with medical therapy before or during TAVI. We used data from a large multinational electronic health record network (TriNetX). Patients aged 18 years or older with severe aortic stenosis and CAD who underwent TAVI in the last 10 years before the analysis were considered eligible. Five-year Kaplan-Meier curves and hazard ratios were calculated. We identified 19 058 patients undergoing isolated TAVI and 2277 patients undergoing TAVI and PCI. Using propensity matching scores, 2277 patients in each group were compared. The 5-year cumulative incidence of MACE was 22.92% in the isolated TAVI group, vs. 25.91% in the PCI-TAVI group. The probability of the composite primary outcome was not significantly different between the isolated TAVI group vs. the PCI-TAVI group [53.1 vs. 47.6%, adjusted hazard ratio (HR) 0.92, 95% confidence interval (CI), 0.80-1.05]. In a real-world study of patients with CAD and severe aortic stenosis, the 5-year probability of death, acute coronary syndrome and ischemic stroke did not differ between patients undergoing isolated TAVI compared to patients undergoing PCI before or during TAVI.

Stem-cell therapy in ST-segment elevation myocardial infarction with reduced ejection fraction: A multicenter, double-blind randomized trial.

BACKGROUND: Left ventricular ejection fraction (LVEF) is a major determinant of long-term prognosis after ST-segment elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have a poor prognosis, despite successful reperfusion and the use of renin-angiotensin-aldosterone inhibitors. HYPOTHESIS: Intracoronary infusion of bone marrow-derived mononuclear cells (BMMC) may improve LVEF in STEMI patients successfully reperfused. METHODS: The main inclusion criteria for this double-blind, randomized, multicenter study were patient age 30 to 80 years, LVEF ≤50%, successful angioplasty of infarct-related artery, and regional dysfunction in the infarct-related area analyzed before cell injection. Cardiac magnetic resonance imaging was used to assess LVEF, left ventricular volumes, and infarct size at 7 to 9 days and 6 months post-myocardial infarction. RESULTS: One hundred and twenty-one patients were included (66 patients in the BMMC group and 55 patients in the placebo group). The primary endpoint, mean LVEF, was similar between both groups at baseline (44.63% ± 10.74% vs 42.23% ± 10.33%; P = 0.21) and at 6 months (44.74% ± 12.95 % vs 43.50 ± 12.43%; P = 0.59). The groups were also similar regarding the difference between baseline and 6 months (0.11% ± 8.5% vs 1.27% ± 8.93%; P = 0.46). Other parameters of left ventricular remodeling, such as systolic and diastolic volumes, as well as infarct size, were also similar between groups. CONCLUSIONS: In this randomized, multicenter, double-blind trial, BMMC intracoronary infusion did not improve left ventricular remodeling or decrease infarct size.

Riscos da Radiação X e a Importância da Proteção Radiológica na Cardiologia Intervencionista: Uma Revisão Sistemática / Radiation Risks and the Importance of Radiological Protection in Interventional Cardiology: A Systematic Review

Discutimos aqui aspectos vinculados ao enquadramento legal, a recomendações internacionais e a programas de formação em proteção radiológica; ao angiógrafo e à qualidade da imagem; aos efeitos biológicos e aos riscos das radiações ionizantes; às lesões em operadores e pacientes; aos níveis de referência do paciente; ao limite de dose ocupacional e a suas medidas de prevenção. O uso das radiações ionizantes acarreta riscos, que, contudo, justificam-se em procedimentos diagnósticos e terapêuticos. A consciência e o conhecimento desses riscos minimizam o dano, otimizando a qualidade da imagens e o uso seguro das radiações ionizantes. Tem-se demonstrado a ocorrência de cataratas radioinduzidas em trabalhadores de laboratórios de cateterismo. Diversos estudos sugerem que pode haver um risco significativo de opacidade do cristalino, caso não se utilizem adequadamente os dispositivos de proteção radiológica. Adicionalmente, esses tipos de procedimentos intervencionistas são realizados na América Latina, geralmente por médicos especialistas, com a colaboração de enfermeiros, tecnólogos e técnicos, que, muitas vezes, não têm formação adequada em proteção radiológica.

We discuss some aspects related to the legal framework, international recommendations and training programs on radiological protection; image quality and equipment; the biological effects and risks of ionizing radiation; lesions in patients and operators; patient's reference levels; occupational dose limit and preventive actions. The use of ionizing radiation involves risks that are justified in diagnostic and therapeutic procedures. The awareness and knowledge of these risks minimizes the damage, optimizing the quality of images and safe use of ionizing radiation. There is evidence of radiation-induced cataracts in individuals who work in catheterization laboratories. Several studies suggest there may be a significant risk of lens opacity, if radiological protection devices are not properly used. Additionally, these interventional procedures are performed in Latin America, usually by medical specialists in collaboration with nurses, technologists and technicians, who often do not have adequate training in radiological protection.

Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.

IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.

Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study.

BACKGROUND: Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS: The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS: The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings.

Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.