Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.

Less iodine injected for the same diagnostic performances: comparison of two low-osmolar contrast agents (iobitridol 350 and iopamidol 370) in coronary angiography and ventriculography: a randomized double-blind clinical study.

OBJECTIVE: Mild reductions in iodine concentration could reduce acute side effects after intraarterial contrast media administration without affecting the quality of coronary artery images. This study was designed to show the equivalence in terms of image quality of two nonionic low-osmolar monomers, iobitridol 350 and iopamidol 370, and to compare their clinical safety in coronary angiography and ventriculography. METHODS AND RESULTS: In this multicentre, double-blind clinical trial, 98 adult patients were randomized to receive either iobitridol 350 or iopamidol 370. The image quality (primary evaluation criterion) of the whole examination was assessed using a 5-point scale (poor, fair, moderate, good, excellent). Secondary endpoints were the image quality per territory, diagnostic efficacy, practical comfort (5-point scale: impossible to evaluate, not practical, moderately practical, practical, very practical to use) and clinical safety (adverse events and vital signs). The proportions of examinations presenting with good or excellent global image quality was similar with both contrast media: 87.8% with iobitridol 350 vs. 89.8% with iopamidol 370. Similar results were observed when considering the image quality specifically for each major coronary artery and left ventricle. No difference between groups was found with respect to other secondary criteria. Adverse events occurred in 7 patients with iobitridol 350 (14.3%) and in 10 patients with iopamidol 370 (20.4%). CONCLUSIONS: This study showed that, with regard to image quality and diagnostic efficacy and using a lower iodine concentration, iobitridol 350 was comparable to iopamidol 370 in adult patients requiring coronary angiography and ventriculography for diagnostic indications.

Seguridad a largo plazo de los stents recubiertos. El fenómeno de la trombosis tardía / Long-term safety of drug-eluting stents. The late thrombosis phenomenon

La aparición de los stents liberadores de fármacos ha supuesto uno de los grandes hitos en el intervencionismo percutáneo de la cardiopatía isquémica y ha logrado en muy poco tiempo una aceptación unánime en todo el mundo y un crecimiento exponencial en el número de unidades implantadas. Después de varios años de un entusiasmo excesivo en los que se ha constatado, sin ninguna duda, un beneficio claro sobre el talón de Aquiles de la angioplastia coronaria, como es el problema de la reestenosis, empiezan a surgir ciertas dudas acerca de la seguridad a largo plazo de estos dispositivos, fundamentadas en la aparición de casos tardíos de trombosis intra-stent, en ocasiones muy alejados en el tiempo, con consecuencias adversas para los pacientes (AU)

The introduction of drug-eluting stents is regarded as one of the landmarks of percutaneous coronary intervention for ischemic heart disease. In a very short time, they were universally accepted throughout the world and the number of units implanted grew exponentially. After several years of excessive enthusiasm, during which these stents demonstrated, without doubt, clear benefits for the Achilles’ heel of coronary angioplasty, namely the problem of restenosis, a number of doubts about the long-term safety of these devices began to arise. These stemmed from the appearance of cases of late intrastent thrombosis, sometimes occurring in a much later time period, which had adverse consequences for patients (AU)

[Importance of severe lesions left untreated in patients with acute coronary syndromes and angioplasty of the culprit lesion]. / Importancia de las lesiones severas no tratadas en pacientes con síndrome coronario agudo y angioplastia de la lesión causante.

INTRODUCTION AND OBJECTIVES: Patients with acute coronary syndromes may have significantly stenotic nonculprit lesions that do not show complex lesion morphology. We investigated whether these lesions were prone to become unstable since they exist within a prothrombotic and inflammatory systemic milieu. PATIENTS AND METHOD: We evaluated the clinical course of 150 patients after successful angioplasty of a culprit lesion: 75 patients with a severely stenotic but uncomplicated nonculprit lesion (group A) and 75 patients without these lesions (group B). RESULTS: In group A, 1 patient (1.3%) required angioplasty of an initially nonculprit lesion, and in group B, 2 patients (2.6%) died in cardiogenic shock. After 1 year of follow-up, in group A, 4 patients (5.3%) died (cardiac deaths), 1 patient (1.3%) had a myocardial infarction, and 10 patients (13.3%) underwent a repeat revascularization procedure, which in 6 cases (8%) was angioplasty of an initially nonculprit lesion. In all 6 patients with angioplasty of the initially nonculprit lesion, revascularization was done within the first 4 months and was indicated for unstable angina. In group B, 1 patient (1.3%) died (noncardiac death) and 2 patients (2.6%) underwent a repeat revascularization procedure because of restenosis. Survival curves were significantly different between both groups. Belonging to group A was the only independent predictor for events, and within this group location of the lesion in the left anterior descending artery was the main predictor. CONCLUSIONS: The presence of nonculprit lesions of uncomplicated morphology at the time of a percutaneous revascularization procedure for a culprit lesion in patients with acute coronary syndrome is a short- and middle-term predictor of a moderate rate of recurrent events when these initially innocuous lesions become unstable.

Importancia de las lesiones severas no tratadas en pacientes con síndrome coronario agudo y angioplastia de la lesión causante / Importance of severe lesions left untreated in patients with acute coronary syndromes and angioplasty of the culprit lesion

Introducción y objetivos. Los pacientes con síndrome coronario agudo pueden presentar lesiones coronarias no causantes que pueden ser severas y sin morfología compleja. Evaluamos si, a corto plazo, estas lesiones son proclives a la inestabilización al encontrarse en un entorno sistémico protrombótico e inflamatorio. Pacientes y método. Evaluamos la evolución clínica de 150 pacientes sometidos a angioplastia (ACTP) de la lesión causante, 75 pacientes (grupo A) con lesiones no causantes gravemente estenóticas no complicadas (LNC) y otros 75 pacientes (grupo B) con ausencia de estas lesiones. Resultados. En el grupo A, un paciente (1,3 por ciento) precisó ACTP de una LNC y en el grupo B, 2 pacientes (2,6 por ciento) fallecieron por shock cardiogénico. Al cabo de un año de seguimiento, en el grupo A, 4 pacientes (5,3 por ciento) murieron por causa cardíaca, uno (1,3 por ciento) sufrió un infarto y 10 (13,3 por ciento) precisaron revascularización, en 6 casos ACTP sobre LNC. Estos 6 procedimientos se efectuaron en los primeros 4 meses por angina inestable. En el grupo B, un paciente (1,3 por ciento) falleció de causa no cardíaca y 2 (2,6 por ciento) precisaron revascularización por reestenosis. Las curvas de supervivencia libre de acontecimientos fueron significativamente diferentes en ambos grupos. La pertenencia al grupo A fue la única variable predictora de acontecimientos y, dentro de este grupo, la localización de la lesión en descendente anterior (DA) fue el principal factor predictor de la necesidad de revascularización. Conclusiones. La presencia de LNC en pacientes con síndrome coronario agudo y ACTP de la lesión causante predice una moderada tasa de revascularización a cortomedio plazo por inestabilización (AU)