Elsevier

International Journal of Cardiology

Volume 202, 1 January 2016, Pages 265-272
International Journal of Cardiology

Review
Clinical follow-up of atrial-fibrillation patients treated with novel oral anti-coagulants: A multi-disciplinary consensus from the Apulia section of the Italian Association of Hospital Cardiologists (ANMCO)

https://doi.org/10.1016/j.ijcard.2015.08.205Get rights and content

Highlights

  • NOACs should be preferably prescribed by specialists.

  • Follow-up could be managed by a GP, by hematologist in the case of complications.

  • Periodical clinical re-assessment should be held by a cardiologist.

  • Patients with NOACs should be followed by a dedicated out-patient hospital service.

Abstract

The clinical use of novel oral anti-coagulant (NOAC) drugs is actually regulated in Italy by bureaucratic restrictions; clinical prescription of NOACs preliminarily requires an online prescription plan which should be compiled on the Italian Drug Agency website. The prescription plan has 1-year validity and clinical condition of the patient treated with NOACs should be reassessed at 1-year prescription renewal. Only few specialists are presently allowed to prescribe NOACs: cardiologists, geriatricians, neurologists, hematologists and internists; general practitioners (GPs) are not currently allowed to prescribe NOACs, although they are the most in proximity with the patient.

An even more complex issue is the pertinence of clinical follow-up of patients prescribed with NOACs (control of possible interactions with any new drug, periodical assessment of renal function, management of dose assumption mistakes or drug suspension for occurring surgery before hospitalization for any planned intervention).

International statements partially indicate when and how periodical laboratory and clinical follow-up should be performed, but such statements do not often comply with local regulations and do not always take in due consideration the local criticalities and prescription limitations.

In May 2015, the regional section of the Italian Association of Hospital Cardiologists of Apulia (ANMCO) therefore convened local representative champions of medical professionals potentially involved in prescription of NOACs, clinical management and follow-up of patients prescribed with NOACs. A final consensus conference formulated a possible shared diagnostic and therapeutic pathway for the clinical management and follow-up of patients assuming NOACs for atrial fibrillation.

Introduction

The clinical use of novel oral anti-coagulant (NOAC) drugs was firstly authorized in Italy in 2013 [1]. So far, the market share owned by NOACs does not exceed 10% [2], [3]. The large clinical implementation of NOAC is actually constrained in Italy by several bureaucratic limitations; clinical prescription of NOACs preliminarily requires an online prescription plan which should be compiled on the Italian Drug Agency (AIFA Agenzia Italiana FArmaco) website [4]. Clinical and demographic data of the patient, CHA2DS2-VASc and HAS-BLED score must be reported and NOAC prescription is allowed just under limited conditions of overt clinical superiority over vitamin-K antagonists (VKA). The prescription plan has 1-year validity and clinical condition of the patient treated with NOACs should be reassessed at 1-year prescription renewal.

Only few specialists are presently allowed to prescribe NOACs in Italy: cardiologists, geriatricians, neurologists, hematologists and internists; general practitioners (GPs) are not currently allowed to prescribe NOACs, although they are the most in proximity with the patient.

An even more complex issue is clinical follow-up of patients prescribed with NOACs: who should control possible interactions with any new drugs that the patient could be prescribed after initiation of therapy with NOACs? Who should periodically assess renal function as recommended by guidelines [5]? Who should manage any case of dose assumption mistake or drug suspension for occurring surgery before hospitalization for any planned intervention?

International statements partially indicate when and how periodical laboratory and clinical follow-up should be performed, but such statements do not often comply with local regulations and do not always take in due consideration the local criticalities and prescription limitations.

In May 2015, the regional section of the Italian Association of Hospital Cardiologists (ANMCO, Associazione Nazionale Medici Cardiologi Ospedalieri) of Apulia convened local representative champions of medical professionals potentially involved in prescription of NOACs, clinical management and follow up of patients prescribed with NOACs (cardiologists, geriatricians, neurologists, hematologist, internists, general practitioners, surgeons).

After preliminary meetings and document preparation, a final consensus conference took place on May 30th to formulate a possible shared diagnostic and therapeutic pathway for the clinical management and follow up of patients assuming NOACs for atrial fibrillation (AF).

The consensus conference had 20 participants who had a vast clinical experience on AF, who represented main medical stakeholders involved in clinical management of subjects with AF treated with anti-coagulants in Apulia, most of them Chiefs of Department. All subjects involved in the consensus conference were divided into 4 working groups, which dealt with a particular aspect of the problem (role of the prescriber, role of the GP, role of the center for hemostasis and thrombosis control (CHT), supporting tools).

Before the conference an online survey was used to obtain thoughts on management of patients with AF treated with NOACs from all participants invited. Results of this survey are summarized as follows.

  • Thrombo-embolic and hemorrhagic risk assessment could be performed by all medical profiles encountering subjects affected by AF.

  • After careful thombo-embolic risk assessment, NOACs should be preferably prescribed by specialists.

  • Clinical and laboratory follow-up could be managed by GP or hematologist in the case of complications.

  • Periodical clinical re-assessment should be held by a cardiologist.

  • Patients treated with NOACs should be followed by a dedicated out-patient service, possibly in a hospital setting with facilities able to manage main complications of NOAC therapy (major bleedings).

  • A NOAC patient's card should report all clinical follow-up, clinical indication, dose changes, complications and side-effects; the card should be presented by the patients treated with NOACs in every clinical or laboratory control.

In a series of workshops, each working group has outlined its elaborate offering it to the group discussion for the preparation of the final document.

Section snippets

Clinical background

International guidelines recommend the use of NOACs for the prevention of thrombo-embolism in patients with AF and CHA2DS2-VASc score > 0. Evidence from RE-LY [6], ROCKET-AF [7] and ARISTOTLE [8] studies showed excellent efficacy and safety profile of NOACs when compared to VKA. The incidence of bleeding complications, either minor or intra-cranial hemorrhage, is lower is subjects treated with NOACs. In the ARISTOTLE study, the incidence of major hemorrhage was 30% lower in subjects treated with

The role of the “prescriber”

It is defined as the “prescriber” any licensed doctor allowed to prescribe NOAC therapy according to Italian legislation, presently cardiologists, neurologists, internists, geriatricians and hematologists, either working for the National Health Care Service (NHS), or accredited with the NHS, licensed by the regional authorities.

The prescriber establishes or verifies the indication for anticoagulation with NOACs, evaluates laboratory parameters (blood count, creatinine clearance, liver function)

Support tools

Support tools, shared and standardized for all professionals involved in the management and follow-up of patients treated with NOACs, may be extremely useful. Possible instruments aimed at this purpose may be the following:

  • 1.

    Referral letter to first prescriber (Fig. 3): the GP reports patient's demographics, CHA2DS2-VASc and HAS-BLED score, possible current therapy with VKA, regional GP code (required for online prescription plan) and contact information.

  • 2.

    Patient's card (Fig. 4): the card contains

Limitations

This consensus is aimed to start-up a possible shared pathway for the follow-up of patients with AF treated with NOACs: the working flow-chart is supposed to be applied for an initial phase with a relatively limited number of patients. It has also been conceived as an ideal benchmark, regardless of possible costs (which, however, are not expected to increase after a possible implementation of the proposed diagnostic and therapeutic pathway).

In case of larger number of patients to be followed up

Conflict of interest statements

None of the other authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

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