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Canadian Journal of Cardiology

Effectiveness of Coronary Sinus Reducer for Treatment of Refractory Angina: A Meta-analysis

Published:December 26, 2021DOI:https://doi.org/10.1016/j.cjca.2021.12.009

      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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