PARADISE-MI – event rates and treatment effect of sacubitril/valsartan v ramipril by the presence or absence of transient pulmonary congestion and/or LVEF less or greater than 40
Bibliographic record
Abstract
Abstract Background/Introduction Sacubitril/valsartan was compared to ramipril in patients with acute myocardial infarction in the PARADISE-MI trial. In the whole trial population sacubitril/valsartan did not reduce the composite primary outcome of CV death or incident heart failure compared to ramipril. Whether or not event rates and/or treatment effects vary in patients with different baseline characteristics is unknown. Purpose To investigate a) event rates b) the treatment effect of sacubitril/valsartan compared to ramipril and c) safety by the presence or absence of transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40%. Methods PARADISE-MI was a double-blind, randomised clinical trial that compared sacubitril/valsartan to ramipril in 5661 patients with an acute myocardial infarction with either LVEF ≤40% and/or transient pulmonary congestion. 3 groups were investigated: 1) LVEF ≤40% with pulmonary congestion (n=2012) and 2) LVEF ≤40% without pulmonary congestion (n=2596) and 3) LVEF not ≤40% with pulmonary congestion (n=1044). Results Patients with pulmonary congestion (with and without LVEF ≤40%) were more likely to have had a prior MI, prior CABG or PCI, had more atrial fibrillation and were more often treated with mineralocorticoid receptor antagonists and diuretics than patients with no pulmonary congestion and LVEF ≤40%. Patients with LVEF ≤40% and pulmonary congestion had more than twice the rate of the primary composite outcome compared to those with LVEF ≤40% without pulmonary congestion: 10.2 (95% CI 9.2–11.3) vs. 4.8 (4.3–5.5) events per 100 patient-years, respectively). Patients with pulmonary congestion and LVEF not ≤40% had an intermediate event rate (6.6, 5.5–7.9, events per 100 patient-years). A similar pattern of event rates was seen for the components of the primary outcome and for all secondary outcomes whether Clinical Events Committee or investigator-reported events were analysed. The treatment effect of sacubitril/ valsartan versus ramipril did not vary between the 3 congestion/ LVEF subgroups. The safety of sacubitril/valsartan compared to ramipril did not vary between congestion/LVEF subgroups. Conclusion Patients with pulmonary congestion with or without LVEF ≤40% had higher rates of primary and all secondary outcomes than those without pulmonary congestion and LVEF ≤40%. The treatment effect, and safety, of sacubitril/valsartan compared to ramipril was consistent in patients with or without pulmonary congestion and with or without LVEF ≤40%. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novartis
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".