Tag: clinical guidelines

‘Every Guideline We Write Is Out of Date’ Quips ESC as New Data Emerges

Image by Marcelo Leal on Unsplash

Just as the European Society of Cardiology (ESC) unveiled their new guidelines for the treatment of heart failure, along came some data that the guideline’s authors hint will cause the work to be revised.

The guidelines, which appear in the European Heart Journal, state that so far, there is no treatment shown to reduce mortality and morbidity in patients with heart failure with preserved ejection fraction, however there are positive results from the EMPEROR-Preserved study showing that treatment with empagliflozin robustly reduced hospitalisation risk.

“Every guideline we write is out of date a few days after it’s published. I’m, of course, exaggerating a little bit, but guidelines are dynamic documents. They represent what we know at the time that they’re written and then new information comes out and they have to be updated, and that takes time,” Milton Packer, MD, of Baylor University Medical Center in Dallas, told MedPage Today.

“It’s a process, and we all understand that process; there is no real concept of finality here. We do the best we can with the data we have. And so these guidelines coming won’t represent the results of the EMPEROR-Preserved trial, but the next one will,” Dr Packer added.

Carlos Aguiar, MD, of Hospital Santa Cruz in Lisbon, agreed: “We also know that these new indications do need to go through the regulatory authorities, so it does take some time for the whole process to be concluded.”

“We do need to wait for those approvals also from the regulatory agencies in their reviews for physicians to be able to implement this in clinical practice,” he told MedPage Today.

However, the writers of the 2021 guideline did tweak the comprehensive algorithm for the treatment of heart failure, the highlights of which include:

  • Right heart catheterisation should be considered in patients in whom heart failure is thought to be due to constrictive pericarditis, restrictive cardiomyopathy, congenital heart disease, and high-output states. It may be considered in selected patients with heart failure with preserved left ventricular ejection fraction (LVEF) to confirm the diagnosis.
  • In patients with chronic heart failure with reduced LVEF, dapagliflozin (Farxiga) or empagliflozin are recommended to reduce hospitalisation and mortality risk. As a Class I recommendation, it is based on evidence gleaned from randomised clinical trials.
  • Vericiguat (Verquvo) may be considered in patients with New York Heart Association (NYHA) class II to IV heart failure after worsening with treatment with an angiotensin inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist, to reduce the risks of cardiovascular mortality or heart failure hospitalisation.
  • For treatment of heart failure with midrange LVEF — a change in term from “mildly reduced” ejection fraction — to reduce hospitalisation and mortality risk, the guidelines suggest a number of treatments including angiotensin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and the combination agent sacubitril/valsartan but none have strong clinical trial evidence (Class IIb)  .
  • For patients with heart failure with preserved ejection fraction, the current guidelines recommend (Class I evidence) screening for and treatment of aetiologies, as well as cardiovascular and non-cardiovascular comorbidities.
  • After hospitalisation for heart failure, the guidelines recommend (Class I evidence) that patients be carefully evaluated to exclude persistent signs of congestion before discharge and to optimise oral treatment, and that evidence-based oral medical treatment be administered before discharge. An early follow-up visit is recommended at 1 to 2 weeks after discharge to assess signs of congestion and drug tolerance, and to start and/or uptitrate evidence-based therapy.
  • The SGLT2 inhibitors canagliflozin (Invokana), dapagliflozin, empagliflozin, ertugliflozin (Steglatro), and sotagliflozin are recommended in patients with heart failure and type 2 diabetes at risk of cardiovascular events to reduce hospitalisations for heart failure, major cardiovascular events, end-stage renal dysfunction, and cardiovascular death. The SGLT2 inhibitors dapagliflozin, empagliflozin, and sotagliflozin are recommended in patients with type 2 diabetes and heart failure with reduced ejection fraction (Class I evidence). The DPP-4 inhibitor saxagliptin (Onglyza) is not recommended in patients with heart failure (Class III evidence).

Source: MedPage Today

New Guidelines for Venous Thromboembolism Released

Source: Marcelo Leal on Unsplash

The American College of Chest Physicians (CHEST) have released new clinical guidelines for venous thromboembolism (VTE) management, which provide 29 recommendations on 17 Patients, Interventions, Comparators, Outcomes (PICO) questions, four of which have not been addressed previously.

The last full edition of the guideline, “Antithrombotic Therapy and Prevention of Thrombosis 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines,” was published in 2012, with an update in 2016. This guideline is the first addressing this topic, which will have regular updates as new evidence emerges according to the Living Guidelines Model of the American College of Chest Physicians.

Within the updated recommendations, the panel generated 29 guidance statements, 13 of which are graded as strong recommendations. These include:

  • In patients with acute isolated distal deep vein thrombosis (DVT) of the leg who are managed with anticoagulation, we recommend using the same anticoagulant regimen as for patients with acute proximal DVT.
  • In patients with cerebral venous sinus thrombosis, we recommend anticoagulation therapy for at least the treatment phase (first 3 months) over no anticoagulant therapy.
  • In patients with acute DVT of the leg, we recommend against the use of an inferior vena cava (IVC) filter in addition to anticoagulants.
  • In patients with thrombosis and antiphospholipid syndrome being treated with anticoagulant therapy, we suggest adjusted-dose vitamin K antagonists over direct oral anticoagulant therapy.

“These guidelines help to clarify for providers the intricacies of managing patients with VTE,” said expert panel member, Scott C Woller, MD, FCCP. “Serving as a comprehensive reference for any stage, the recommendations cover aspects from initial management through secondary prevention and risk reduction of post-thrombotic syndrome.”

The order in which PICOs and guidance statements are presented in the manuscript is intended to follow the chronology of VTE management:

  • Whether to treat
  • Interventional and adjunctive treatments
  • Initiation phase
  • Treatment phase
  • Extended phase
  • Complications of VTE

The guidance statements are mainly intended for clinicians who manage patients with VTE but could also inform researchers selecting topics for future studies. Patients and policy makers may also be informed by the guideline content.

Source: EurekAlert!