Secondary prevention of acute coronary syndrome: comparative effectiveness of recommended vs. less intensive drug combination using Clinical Practice Research Datalink (CPRD). The SCARFACE-CPRD study.

Study type
Protocol
Date of Approval
Study reference ID
15_197
Lay Summary

After the occurrence of a first acute coronary syndrome, the therapeutic objective is to reduce in patients the risk of recurrence of the event, to prevent the occurrence of other serious cardiovascular events and to reduce the risk of overall death from cardiovascular cause. To obtain this reduction, societies of cardiology have established recommendations that advocates to use, in patients who recently presented with an acute coronary syndrome, a treatment based on the association of four drug classes: betablockers, antiplatelet agents, statins and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. The therapeutic success of these drugs highly depends on their goodness of use (duration, daily intake). However, the impact of not using properly one of these on the effectiveness of the complete association, constituting the treatment recommended after an acute coronary syndrome, is unknown. Therefore, this project aims to evaluate the impact of lack of adherence to the recommended post-acute coronary syndrome treatment on morbi-mortality. Its results could have a major impact by providing useful information for the establishment of health policy decisions and therapeutic guidelines aiming to improve the management and prognosis of patients after they presented with an acute coronary syndrome.

Technical Summary

This study is aimed to compare the morbidity and mortality in patients treated for secondary prevention after incident acute coronary syndrome with the recommended combination of four therapeutic classes (betablockers, antiplatelet agents, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) to that of incomplete combinations associating only three, two, one or none of the four recommended classes. A retrospective cohort analysis will be conducted in the United Kingdom Clinical Practice Research Database. The cohort will be constituted of adult patients who presented an incident acute coronary syndrome between 01/01/2005 and 31/12/2009 and survived at least three months after its occurrence. For each patient of the cohort, the exposure to the four therapeutic classes, to the recommended combination of the four therapeutic classes and to all possible incomplete combinations will be evaluated. The effectiveness of these therapeutic classes and combinations will be assessed considering the recurrence of acute coronary syndrome, incidence of ischemic stroke or all-cause death during follow-up. The incidence of the outcomes of interest will be determined for each therapeutic class and combinations according to a Cox model adjusted on potential time-fixed and time-dependent confounders and a marginal structural model using the inverse probability of treatment weighting approach.

Collaborators

Olaf Klungel - Chief Investigator - Utrecht University
Julien Bezin - Corresponding Applicant - University of Bordeaux
Anthonius de Boer - Collaborator - Utrecht University
Antoine Pariente - Collaborator - University of Bordeaux
Bernard Begaud - Collaborator - University of Bordeaux
Patrick Souverein - Collaborator - Utrecht University
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )

Linkages

HES Admitted Patient Care;ONS Death Registration Data;MINAP