Safety, Efficacy, and Effectiveness of Coronary Sinus Reducer Implantation in Refractory Angina
Bibliographic record
Abstract
BACKGROUND: Previous coronary sinus reducer (CSR) meta-analyses in refractory angina (RA) focused on single-arm studies, capturing observed effectiveness-comprising the physical effect of CSR, contextual effects (eg, placebo), and non-treatment-related phenomena (eg, confounding). Efficacy evaluation requires comparative estimates from randomized controlled trials (RCTs), ideally double blind and placebo controlled, to isolate the physical effect. OBJECTIVES: The aims of this study were to evaluate the safety and efficacy of CSR in RA and to compare its efficacy with observed effectiveness. METHODS: The study was preregistered with the International Prospective Register of Systematic Reviews (CRD42023399099). Electronic databases were searched until April 2024. Random-effects models separately pooled single-arm, isolated RCT intervention-arm, and RCT placebo-controlled estimates. Therapeutic outcomes included improvements in Canadian Cardiovascular Society classification, Seattle Angina Questionnaire scores, and treadmill exercise time. Safety outcomes, summarized descriptively, comprised procedural success and adverse events. RESULTS: Three double-blind, placebo-controlled RCTs (n = 180) and 13 single-arm studies (n = 668) were analyzed. The overall unweighted procedural success rate was 98.3% (95% CI: 97.0%-99.1%). Single-arm studies and RCT intervention arms demonstrated statistically significant improvements across therapeutic outcomes. For Canadian Cardiovascular Society classification, placebo-controlled rates were 26% (95% CI: 11%-38%; P < 0.001) for ≥1-class improvement and 17% (95% CI: 2%-37%; P = 0.02) for ≥2-class improvement, representing approximately one-third of single-arm improvement rates. Seattle Angina Questionnaire domain analyses demonstrated insufficient placebo-controlled evidence of benefit. Placebo-controlled exercise time change was 49.62 seconds (95% CI: 1.84-97.40 seconds; P = 0.04). CONCLUSIONS: CSR implantation is safe and feasible and demonstrates promising antianginal efficacy in patients with RA. However, uncertainty in current efficacy findings and susceptibility of effectiveness data to nonphysical influences preclude definitive conclusions about clinical utility, warranting larger placebo-controlled trials.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.034 | 0.060 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.011 | 0.025 |
| Bibliometrics | 0.004 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".