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Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial.

ABSTRACT: Background: Cardiac shock wave therapy (CSWT) is a non-invasive new option for the treatment of chronic refractory angina pectoris (CRAP). This study aimed to evaluate the safety and efficiency of CSWT in the treatment of CRAP. Methods: Eighty-seven patients with CRAP were randomly allocated into CWST group (n = 46) and Control group (n = 41). Canadian Cardiovascular Society (CCS) grade of angina pectoris, Seattle Angina Questionnaire (SAQ) score, 6-min walk test (6MWT), weekly dosage of nitroglycerin, and myocardial perfusion on D-SPECT were determined at baseline and during the follow-up period. Adverse events were also evaluated. Results: CSWT was well-tolerated in the CSWT patients. CSWT significantly improved the CCS grade, SAQ score, and 6MWT (p < 0.05). Imaging examinations showed that the ischemic area was reduced after CSWT. However, no significant changes were observed in the Control group. Conclusions: CSWT may improve the myocardial perfusion and reduce clinical symptoms without increasing adverse effects in CRAP patients. It provides a non-invasive and safe clinical therapy for CRAP patients. Clinical Trial registration: www.ClinicalTrials.gov, identifier: NCT03398096.

SUBMITTER: Weijing L

PROVIDER: S-EPMC8333694 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris.A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires.Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10).In this multicenter feasibility study, ESMR seems to be a safe and efficacious treatment for patients with refractory angina pectoris. However, larger sham-controlled trials will be required to confirm these findings.

Project description:AimTo summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients.MethodsWe 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).ResultsOne 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.ConclusionEven 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.

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Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial.

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