• Prasugrel vs Ticagrelor: qué dice la evidencia en largos registros y meta-análisis

    On: 27 abril, 2018
    In: Cardiología Intervencionista, Investigación
    Views: 52
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    Recientes estudios relacionados al uso de thyenopiridinas, clopidogrel, prasugrel y ticagrelor, muestran resultados consistentes a favor del prasugrel en pacientes con STEMI tratados con angioplastia.

    Una reciente revisión de mçultiples registros que incluyen extensos meta-análisis demuestran que tanto el prasugrel como ticagrelor tienen beneficios sobre el clopidogrel a expensas de un mayor sangrado, pero el prasugrel parece ser superior al ticagrelor en pacientes con STEMI.

    Este hallazgo fue consistente en todos los registros y meta-análisis observados por estos investigadores en esta revisión:

    https://www.eurekalert.org/pub_re…/2018-02/bsp-acs020718.php
    https://benthamscience.com/recent-trends/RT-20182302-004/

    El beneficio de prasugrel sobre ticagrelor y clopidogrel en pacientes con STEMI tambien fue reportado en un extenso registro de 89000 pacientes realizado en Gran Bretaña:

    https://www.ncbi.nlm.nih.gov/pubmed/29437885

    ¿Son todas estas evidencias suficientes para cambiar las guÍas de tratamiento a favor de prasugrel en pacientes con STEMI?

    Dado que estudios randomizados extensos con suficiente poder es muy probable que no se puedan realizar nunca, como se vio en el trial PRAGUE, los resultados de estos largos estudios observacionales y meta-análisis deberían ser tomados en cuenta debido a la enorme cantidad de datos todos a favor del prasugrel.

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  • Caso en Vivo desde el Congreso CIT 2018

    On: 4 abril, 2018
    In: Cardiología Intervencionista, Investigación, Novedades
    Views: 90
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    En el meeting llevado a cabo en Suzhou, con motivo del China International Therapeutics (CIT 2018), en conjunto con TCT, un caso realizado por el Dr Alfredo E. Rodriguez fue transmitido en vivo desde el First Hospital de Nanjing, China.
    Se trató de una lesión en bifurcación de Tronco de Coronaria Izquierda no protegido. En esta ocasión, luego de una evaluación con IVUS y preparación con “cutting balloon”, se implantó un stent farmacológico Firehawk con polímero bioabsorbible y técnica final de POT en el tronco y ostium de la arteria DA.

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  • Reciente meta-análisis muestra prevalencia de la cirugía convencional(SAVR) sobre el implante percutáneo de válvula aórtica(TAVI)

    Este estudio, que incluyó dos estudios randomizados y 4 estudios observacionales en pacientes con estenosis aórtica y bajo riesgo clínico, mostró similar mortalidad en el período hospitalario entre TAVI y SAVR, pero una mayor sobrevida a los 3 años con SAVR.
    Se incluyeron 3487 pacientes de 6 estudios, 4 de ellos observacionales y 2 randomizados. El TAVI se acompañó de menor insuficiencia renal y riesgo de sangrado pero mayores complicaciones vasculares e indicación de marcapaso definitivo.

    Abstract/Summary

    Background
    Although transcatheter aortic valve replacement (TAVR) is officially indicated for high risk aortic stenosis (AS) patients, the procedure is increasingly being performed in patients who are not at high surgical risk, including a substantial number of low risk patients. However, data on the benefit of TAVR in this patient population is limited.

    Methods
    We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) of TAVR versus surgical aortic valve replacement (SAVR) in patients who are at low surgical risk. The primary outcome was all-cause mortality. The secondary outcomes included stroke, myocardial infarction, bleeding, and various procedural complications.

    Results
    Six studies (2 RCTs and 4 PSM studies) totaling 3,484 patients were included. Follow-up ranged from 3 months to 3 years (median 2 years). The short-term mortality was similar with either TAVR or SAVR (2.2% for TAVR and 2.6% for SAVR, RR 0.89, 95% CI 0.56–1.41, P = 0.62), however, TAVR was associated with increased risk for intermediate-term mortality (17.2% for TAVR and 12.7% for SAVR, RR 1.45, 95% CI 1.11–1.89, P = 0.006). In terms of periprocedural complications, TAVR was associated with reduced risk for bleeding and renal failure and an increase in vascular complications and Pacemaker implantation.

    Conclusions
    In patients who are at low surgical risk, TAVR seems to be associated with increased mortality risk. Until more data in this population is available, SAVR should remain the treatment of choice for these patients.

     http://onlinelibrary.wiley.com/doi/10.1002/ccd.27518/abstract

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  • Primer metaanálisis sobre mortalidad entre CABG y Stents arroja como favorable a la Cirugía

    On: 23 febrero, 2018
    In: Cardiología Intervencionista, Investigación
    Views: 105
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    La revista The Lancet publicó un extenso metaanálisis de 11 estudios randomizados entre stents(bare metal o farmacológicos) y cirugía de revascularización miocárdica, para pacientes con enfermedad de múltiples vasos y tronco no protegido de CI. Se basó en la base de datos individuales de todos esos estudios randomizados.

    La conclusión es que los pacientes tratados con cirugía tienen una significativa mejor sobrevida que los tratados con stents, en relación con la complejidad de las lesiones y la presencia de diabetes. No hubo interacción entre el uso de stents convencionales o farmacológicos.

    Los resultados de este importante estudio sobre métodos de revascularización en enfermedad coronaria, el primero que analiza mortalidad, será motivo seguramente de mucha discusión y análisis de subgrupos.

    Summary
    Background
    Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies.

    Methods
    We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics.

    Findings
    We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06–1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09–1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19–1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86–1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87–1·33; p=0·52), regardless of diabetes status and SYNTAX score.

    Interpretation
    CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies.

    Funding
    None.

    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30423-9/fulltext

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  • Más datos a favor del Prasugrel en síndromes coronarios agudos

    Un extenso registro de Gran Bretaña muestra nuevamente los beneficios del Prasugrel sobre Ticagrelor y Clopidogrel en pacientes con infarto agudo del miocardio supra ST y tratados con angioplastia primaria.
    Ante la ausencia casi definitiva de datos randomizados válidos, ¿deberán incorporarse todas estas evidencias de registros observacionales prospectivos en las guías de tratamiento?

    Abstract
    OBJECTIVES:
    Prasugrel and ticagrelor both reduce ischaemic endpoints in high-risk acute coronary syndromes, compared with clopidogrel. However, comparative outcomes of these two newer drugs in the context of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) remains unclear. We sought to examine this question using the British Cardiovascular Interventional Society national database in patients undergoing primary PCI for STEMI.

    METHODS:
    Data from January 2007 to December 2014 were used to compare use of P2Y12 antiplatelet drugs in primary PCI in >89 000 patients. Statistical modelling, involving propensity matching, multivariate logistic regression (MLR) and proportional hazards modelling, was used to study the association of different antiplatelet drug use with all-cause mortality.

    RESULTS:
    In our main MLR analysis, prasugrel was associated with significantly lower mortality than clopidogrel at both 30 days (OR 0.87, 95% CI 0.78 to 0.97, P=0.014) and 1 year (OR 0.89, 95% CI 0.82 to 0.97, P=0.011) post PCI. Ticagrelor was not associated with any significant differences in mortality compared with clopidogrel at either 30 days (OR 1.07, 95% CI 0.95 to 1.21, P=0.237) or 1 year (OR 1.058, 95% CI 0.96 to 1.16, P=0.247). Finally, ticagrelor was associated with significantly higher mortality than prasugrel at both time points (30 days OR 1.22, 95% CI 1.03 to 1.44, P=0.020; 1 year OR 1.19 95% CI 1.04 to 1.35, P=0.01).

    CONCLUSIONS:
    In a cohort of over 89 000 patients undergoing primary PCI for STEMI in the UK, prasugrel is associated with a lower 30-day and 1-year mortality than clopidogrel and ticagrelor. Given that an adequately powered comparative randomised trial is unlikely to be performed, these data may have implications for routine care.

    https://www.ncbi.nlm.nih.gov/pubmed/29437885

     

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  • Asociación entre la oclusión del apéndice auricular izquierdo y la readmisión por tromboembolismo en pacientes con fibrilación auricular sometidos a cirugía cardíaca concomitante

    On: 25 enero, 2018
    In: Cardiología Intervencionista, Investigación
    Views: 90
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    Un artículo publicado recientemente en el JAMA (Journal of the American Medical Association) destaca los beneficios de la oclusión quirúrgica del auricular izquierdo para prevenir eventos tromboembólicos en pacientes mayores con fibrilación auricular sometidos a cirugía cardíaca.

    Asociación entre la oclusión del apéndice auricular izquierdo y la readmisión por tromboembolismo en pacientes con fibrilación auricular sometidos a cirugía cardíaca concomitante.

    Friedman DJ, Piccini JP, Wang T, Zheng J, Malaisrie SC, Holmes DR, Suri RM, Mack MJ, Badhwar V, Jacobs JP, Gaca JG, Chow SC, Peterson ED, Brennan JM.

    Key Points
    Question Is surgical left atrial appendage occlusion associated with a reduction in long-term thromboembolic events?

    Findings In this retrospective cohort study of 10 524 Medicare recipients with atrial fibrillation undergoing cardiac surgery, surgical left atrial appendage occlusion, compared with no surgical left atrial appendage occlusion, was significantly associated with lower risk of readmission for thromboembolism at 3 years (unadjusted, 4.2% vs 6.2%; adjusted hazard ratio, 0.67).

    Meaning Surgical left atrial appendage occlusion may be of benefit in preventing thromboembolic events in older patients with atrial fibrillation undergoing cardiac surgery, although randomized trials would be necessary to provide definitive evidence.

     

    https://www.ncbi.nlm.nih.gov/pubmed/29362794

     

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  • Redefiniendo la presión arterial: riesgos y beneficios

    On: 22 enero, 2018
    In: Cardiología Clínica, Investigación
    Views: 139
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    La nueva guía de diagnóstico, prevención, detección, evaluación y manejo en EEUU de hipertensión arterial cambiaría drásticamente el número de pacientes en EEUU considerados como hipertensos y necesitados de medicación. Las nuevas directrices fueron emitidas por la American College of Cardiology (ACC) y la American Heart Association (AHA).

    Los autores de esta revisión, sin embargo, le hacen una crítica, ya que muchos pacientes tendrían además efectos secundarios adversos, por la medicación que deben tomar, que no se compensarían con la disminución del riesgo cardíaco.

     

    Redefining Hypertension — Assessing the New Blood-Pressure Guidelines
    George Bakris, M.D., and Matthew Sorrentino, M.D.

    http://www.nejm.org/doi/full/10.1056/NEJMp1716193?query=featured_home

     

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  • Rivaroxaban con o sin aspirina en enfermedades cardiovasculares estables: lo que dejó el COMPASS Trial

    On: 18 enero, 2018
    In: Cardiología Intervencionista, Investigación
    Views: 112
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    Uno de los highlights de la investigación científica cardiológica en 2017 fue el COMPASS trial presentado por John W. Eikelboom en el New England Journal of Medicine, que demostró que el rivaroxaban con aspirina mejora los resultados en pacientes con enfermedad cardiovascular estable. Dejamos la descripción del abstract del paper y sus autores para más detalles:

    Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease.
    Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O’Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators.

    Abstract
    BACKGROUND:
    We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention.

    METHODS:
    In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.

    RESULTS:
    The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.

    CONCLUSIONS:
    Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).

    https://www.ncbi.nlm.nih.gov/pubmed/28844192

     

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  • ¿Cuál es el inhibidor ideal para tratar a los pacientes con síndromes coronarios agudos incluyendo infarto con supra ST: clopidogrel, ticagrelos o prasugrel ? ¿Qué nos dice la evidencia clínica? ¿Cuánto tiempo deben tomar esta droga los pacientes y cuáles son los potenciales riesgos?

    On: 9 enero, 2018
    In: Cardiología Intervencionista, Investigación
    Views: 135
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    Dos artículos recientemente publicados tratan de responder estos interrogantes, uno de ellos publicado por el grupo del Centro CECI.

    Estos son los dos artículos:

    1- Wilson SJ , Newby D, Dawson D, Irving J and Berry C Duration of DAPT in acute coronary syndrome Heart. 2017 Apr;103(8):573-580. doi: 10.1136/heartjnl-2016-309871. Epub 2017 Mar 1.
    2- Rodriguez AE, Rodriguez-Granillo AM, Azcarrunz SD, Peralta-Bazan F, Cho MY. Did Prasugrel and Ticagrelor Offer the Same Benefit in Patients with Acute Coronary Syndromes after Percutaneous Coronary Interventions Compared to Clopidogrel? Insights from Randomized Clinical Trials, Registries and Meta-analysis. Curr Pharm Des. 2018 Jan 8. doi: 10.2174/1381612824666180108121834.

    • “Duration of dual antiplatelet therapy in acute coronary syndrome”

    Abstract: Despite a large volume of evidence supporting the use of dual antiplatelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Clinical trials have varied markedly in the duration of therapy, both across and within trials. Recent systematic reviews and meta-analyses suggest that shorter durations of dual antiplatelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. These findings did not show significant heterogeneity according to whether patients had stable or unstable coronary heart disease. Moreover, the potential hazards and benefits may differ when applied to the general broad population of patients encountered in everyday clinical practice who have markedly higher bleeding and atherothrombotic event rates. Clinicians lack definitive information regarding the duration of therapy in patients with acute coronary syndrome and risk scores do not appear to be sufficiently robust to address these concerns. We believe that there is a pressing need to undertake a broad inclusive safety trial of shorter durations of therapy in real world populations of patients with acute coronary syndrome. The clinical evidence would further inform future research into strategies for personalised medicine.

    • “Did Prasugrel and Ticagrelor Offer the Same Benefit in Patients with Acute Coronary Syndromes after Percutaneous Coronary Interventions Compared to Clopidogrel? Insights from Randomized Clinical Trials, Registries and Meta-analysis.”

    Abstract: 

    BACKGROUND:
    According to ACC/ AHA guidelines, a minimum of 1 year of dual anti- platelet therapy (DAPT) consisting of aspirin and a platelet ADP-receptor antagonist (P2Y12 inhibitor) is recommended for patients presenting acute coronary syndromes (ACS), regardless of which type of revascularization is performed during the acute event.

    METHODS:
    The purpose of this presentation was to review the present data either from a direct randomized comparison among the three compounds and also large prospective observational registries and meta-analysis were analyzed in detail. With this aim, we performed an extensive large search from PubMed/Medline Journals identifying studies comparing fashion the new P2Y12 inhibitors in patients with ACS including ST elevation myocardial infarction (STEMI)in direct and indirect manner.

    RESULTS:
    Pivotal large randomized clinical trials (RCT) in patients with ACS including STEMI, comparing clopidogrel, a first generation P2Y12 inhibitor against the newer prasugrel and ticagrelor showed major efficacy advantages of the latters although both drugs had more bleeding risk than clopidogrel. Direct comparisons of prasugrel and ticagrelor from large RCT are not yet available, however, several observational registries and meta-analysis reported results from an indirect comparison between both compounds. Major findings and limitations of each of these studies were identified, highlighted and discussed.

    CONCLUSION:
    Prasugrel and ticagrelor are both more effective than clopidogrel to prevent adverse cardiac events in patients with ACS. Compared to ticagrelor, prasugrel appears to be more effective in patients with STEMI , although lack of randomized data didn’t allow to draw definitive conclusions.

    https://www.ncbi.nlm.nih.gov/pubmed/28249994

    https://www.ncbi.nlm.nih.gov/pubmed/29308737

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  • Relaciones de la Industria Farmacéutica y de Dispositivos con los Editores de Revistas Científicas de Alto Impacto

    On: 9 enero, 2018
    In: Investigación
    Views: 154
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    Acaba de salir publicado un estudio sobre las relaciones de la Industria con los Editores y Editores Asociados de las más importantes revistas científicas médicas en sus distintas especialidades de EEUU.
    En ella se analizan los estrechos vínculos financieros que tendrían algunos Editores con la Industria farmacéutica, que serían mucho más frecuentes e importantes que lo deseado y que indudablemente afecta la independencia y transparencia de la información médica publicada en las mismas.
    Los autores identificaron 52 Journals con alto impacto científico en su área y la mayoría de los Editores tenían fuertes relaciones con la Industria farmacéutica y/o de “devices” médicos, algunos de ellos con cifras millonarias.
    Sólo Editores de EEUU fueron seleccionados, ya que los pagos de la Industria están en un registro nacional, no pudiendo los autores conocer el de aquellos de otras nacionalidades ya que la respuesta espontánea dada por los propios involucrados tiene obviamente muchas limitaciones.
    Cuando los autores quisieron corroborar estos datos con los Editores en Jefe de cada Journal solo el 23% respondió a la encuesta.
    La relación de Editores en Jefe/Asociados o aquellos con fuerte decisión en la posible aceptación de trabajos científicos (Deputy Editor) debería ser factor de exclusión de los mismos para actuar como tales y afecta en grado severo la credibilidad de las publicaciones científicas especialmente en Revistas de alto impacto.
    Este excelente artículo publicado en BMJ open habla una vez más de la transparencia Editorial de esta revista inglesa.

    Abstract:

    Objective: To estimate financial payments from industry to US journal editors.

    Design: Retrospective observational study.

    Setting: 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014.

    Participants: 713 editors at the associate level and above identified from each journal’s online masthead.

    Main outcome measures: All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible.

    Results: Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals.

    Conclusions: Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research.

    http://www.bmj.com/content/359/bmj.j4619

    BMJ 2017;359:j4619

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