Abstract
Background
Refractory angina is a debilitating condition that affects the quality of life of
patients worldwide, who after exhausting standard available therapies are regarded
as “no option” patients. Recently, CS (coronary sinus) reducer (Neovasc Reducer) implantation
became available and is gaining popularity in the treatment of refractory angina.
The effectiveness of this therapy was demonstrated in 1 randomised sham-control trial
and numerous uncontrolled prospective studies entailing several hundred patients altogether.
We performed a meta-analysis to incorporate the data and elucidate its efficacy and
safety.
Methods
A meta-analysis of prospective studies assessing the effects of CS narrowing published
in English to June 2021 was performed. The primary outcome was the proportion of patients
improving ≥ 1 class in the Canadian Cardiovascular Society (CCS) angina score. Other
end points included proportion of patients improving ≥ 2 CCS classes, procedural success,
periprocedural complications, changes in Seattle Angina Questionnaire (SAQ) scores,
and 6-minute walk test (6MWT).
Results
Data from 9 studies including 846 patients were included. An improvement of ≥ 1 CCS
class occurred in 76% (95% confidence interval [CI] 73%-80%) of patients. Improvement
of ≥ 2 CCS classes was observed in 40% of patients (95% CI 35%-46%). Procedure success
was 98%, with no major and 3% nonmajor periprocedural complications. Post procedural
SAQ scores and 6MWT distance were significantly improved.
Conclusions
In patients suffering from angina refractory to medical and interventional therapies,
Reducer implantation improves symptoms and quality of life with a low complication
rate. These results are consistent in 1 randomised trial and multiple prospective
uncontrolled studies.
Résumé
Contexte
L'angine réfractaire est une affection débilitante qui affecte la qualité de vie de
patients à travers le monde, qui, après avoir épuisé les thérapies standard disponibles,
sont considérés comme des patients “sans option”. Récemment, l'implantation d'un réducteur
de sinus coronaire (SC) (Neovasc Reducer) est devenue possible et gagne en popularité
dans le traitement de l'angine réfractaire. L'efficacité de ce traitement a été démontrée
dans un essai randomisé comprenant un groupe contrôle avec implantation simulée et
dans de nombreuses études prospectives non contrôlées portant sur plusieurs centaines
de patients au total. Nous avons effectué une méta-analyse pour intégrer les différentes
données et mettre en lumière son efficacité et sa sécurité.
Méthodes
Une méta-analyse des études prospectives évaluant les effets de la réduction du SC,
publiées en anglais jusqu'en juin 2021, a été réalisée. Le critère principal d'évaluation
était la proportion de patients avec une amélioration de leur score classé ≥ 1 sur
l'échelle d'angine de la Société canadienne de cardiologie (SCC). Les autres critères
d'évaluation comprenaient la proportion de patients avec une amélioration de leur
score classé ≥ 2 sur l'échelle de la SCC, le succès de la procédure, les complications
périprocédurales, les changements de scores selon l'échelle du Questionnaire d'angine
de Seattle (QAS) et le test de marche de 6 minutes (TM6).
Résultats
Les données de neuf études incluant 846 patients ont été incluses. Une amélioration
≥ 1 sur l'échelle de la SCC est survenue chez 76% (intervalle de confiance [IC] à
95 % 73 %-80 %) des patients. Une amélioration ≥ 2 sur l'échelle de la SCC a été observée
chez 40 % des patients (IC à 95 % 35 %-46 %). Le succès de l'intervention était de
98 %, sans complication majeure et avec 3% de complications périprocédurales non majeures.
Après la procédure, les scores au QAS et la distance au TM6 ont été significativement
améliorés.
Conclusions
Chez les patients souffrant d'angine réfractaire aux thérapies médicales et interventionnelles,
l'implantation d'un réducteur de SC améliore les symptômes et la qualité de vie avec
un faible taux de complication. Ces résultats sont analogues dans un essai randomisé
et dans de multiples études prospectives non contrôlées.
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Article Info
Publication History
Published online: December 26, 2021
Accepted:
December 19,
2021
Received:
September 14,
2021
Footnotes
See editorial by Perrin and Avram, pages 306–308 of this issue.
See page 382 for disclosure information.
Identification
Copyright
© 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.