$Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment$
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Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment

Michal Stanak,1 Eleen Rothschedl,1 Piotr Szymanski2 1Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria; 2MSWiA Central Clinical Hospital, Centre of Postgraduate Medical Education, Warsaw, PolandCorrespondence: Michal StanakAustrian Institute for Health Technology Assessmen...

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Autores principales:	Stanak M, Rothschedl E, Szymanski P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	refractory angina pectoris coronary artery disease coronary sinus reducing stent coronary sinus Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/1495cf97d9fb43f3b307f37b4381e711
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spelling	oai:doaj.org-article:1495cf97d9fb43f3b307f37b4381e7112021-12-02T10:12:20ZCoronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment1179-1470https://doaj.org/article/1495cf97d9fb43f3b307f37b4381e7112020-09-01T00:00:00Zhttps://www.dovepress.com/coronary-sinus-reducing-stent-for-the-treatment-of-refractory-angina-p-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Michal Stanak,1 Eleen Rothschedl,1 Piotr Szymanski2 1Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria; 2MSWiA Central Clinical Hospital, Centre of Postgraduate Medical Education, Warsaw, PolandCorrespondence: Michal StanakAustrian Institute for Health Technology Assessment, Garnisongasse 7/20, Vienna 1090, AustriaEmail michal.stanak@protonmail.comAim: To summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients.Methods: We performed a systematic literature search in common databases (n=4). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for Rapid Relative Effectiveness Assessment. Primary outcomes for the clinical effectiveness domain were the proportion of patients with improvement in two or more Canadian Cardiovascular Society (CCS) angina score classes, overall mean reduction of CCS class, and Seattle Angina Questionnaire (SAQ) quality of life (QoL) score improvement. Outcomes for the safety domain were adverse device effects (ADEs) and serious adverse device effects (SADEs).Results: One randomized controlled trial (RCT) was identified. Outcomes that showed statistically significant differences between CSRS and sham treatment (in favor of CSRS) were CCS angina score improvement of one or two classes, overall mean reduction of CCS class, and SAQ QoL score improvement. Concerning safety, the sham-controlled trial data indicate that there were fewer SADEs in the intervention group (19%) than in the control group (46%). SADEs reported in observation studies ranged from none to 30%. The most frequently reported SADEs were death and stable angina. In the RCT, the only case of death occurred in the control group. Concerning clinical effectiveness, the risk of bias (RoB) was rated to be low, and concerning safety, the RoB was rated to range from low to moderate. As assessed by GRADE, the overall strength of evidence for effectiveness and safety was moderate. Internal and external validity of the evidence base were low.Conclusion: Even though the current evidence indicates that the assessed technology, CSRS, is potentially more effective than sham intervention for refractory AP patients, the lack of internal validity of the studies undermines the partially positive results.Keywords: refractory angina pectoris, coronary artery disease, coronary sinus reducing stent, coronary sinusStanak MRothschedl ESzymanski PDove Medical Pressarticlerefractory angina pectoriscoronary artery diseasecoronary sinus reducing stentcoronary sinusMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 13, Pp 259-276 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	refractory angina pectoris coronary artery disease coronary sinus reducing stent coronary sinus Medical technology R855-855.5
spellingShingle	refractory angina pectoris coronary artery disease coronary sinus reducing stent coronary sinus Medical technology R855-855.5 Stanak M Rothschedl E Szymanski P Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
description	Michal Stanak,1 Eleen Rothschedl,1 Piotr Szymanski2 1Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria; 2MSWiA Central Clinical Hospital, Centre of Postgraduate Medical Education, Warsaw, PolandCorrespondence: Michal StanakAustrian Institute for Health Technology Assessment, Garnisongasse 7/20, Vienna 1090, AustriaEmail michal.stanak@protonmail.comAim: To summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients.Methods: We performed a systematic literature search in common databases (n=4). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for Rapid Relative Effectiveness Assessment. Primary outcomes for the clinical effectiveness domain were the proportion of patients with improvement in two or more Canadian Cardiovascular Society (CCS) angina score classes, overall mean reduction of CCS class, and Seattle Angina Questionnaire (SAQ) quality of life (QoL) score improvement. Outcomes for the safety domain were adverse device effects (ADEs) and serious adverse device effects (SADEs).Results: One randomized controlled trial (RCT) was identified. Outcomes that showed statistically significant differences between CSRS and sham treatment (in favor of CSRS) were CCS angina score improvement of one or two classes, overall mean reduction of CCS class, and SAQ QoL score improvement. Concerning safety, the sham-controlled trial data indicate that there were fewer SADEs in the intervention group (19%) than in the control group (46%). SADEs reported in observation studies ranged from none to 30%. The most frequently reported SADEs were death and stable angina. In the RCT, the only case of death occurred in the control group. Concerning clinical effectiveness, the risk of bias (RoB) was rated to be low, and concerning safety, the RoB was rated to range from low to moderate. As assessed by GRADE, the overall strength of evidence for effectiveness and safety was moderate. Internal and external validity of the evidence base were low.Conclusion: Even though the current evidence indicates that the assessed technology, CSRS, is potentially more effective than sham intervention for refractory AP patients, the lack of internal validity of the studies undermines the partially positive results.Keywords: refractory angina pectoris, coronary artery disease, coronary sinus reducing stent, coronary sinus
format	article
author	Stanak M Rothschedl E Szymanski P
author_facet	Stanak M Rothschedl E Szymanski P
author_sort	Stanak M
title	Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
title_short	Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
title_full	Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
title_fullStr	Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
title_full_unstemmed	Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment
title_sort	coronary sinus reducing stent for the treatment of refractory angina pectoris: a health technology assessment
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/1495cf97d9fb43f3b307f37b4381e711
work_keys_str_mv	AT stanakm coronarysinusreducingstentforthetreatmentofrefractoryanginapectorisahealthtechnologyassessment AT rothschedle coronarysinusreducingstentforthetreatmentofrefractoryanginapectorisahealthtechnologyassessment AT szymanskip coronarysinusreducingstentforthetreatmentofrefractoryanginapectorisahealthtechnologyassessment
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Coronary Sinus Reducing Stent for the Treatment of Refractory Angina Pectoris: A Health Technology Assessment

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