The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies
Abstract Aims We applied the restricted mean survival time (RMST) to analyse the survival data reported in the PARADIGM‐HT trial in which sacubitril + valsartan was studied in comparison with enalapril in patients with heart failure. The estimates of this parameter were compared with the published v...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-06-01
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| Series: | ESC Heart Failure |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ehf2.13306 |
| _version_ | 1797976419888791552 |
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| author | Andrea Messori Laura Bartoli Sabrina Trippoli |
| author_facet | Andrea Messori Laura Bartoli Sabrina Trippoli |
| author_sort | Andrea Messori |
| collection | DOAJ |
| description | Abstract Aims We applied the restricted mean survival time (RMST) to analyse the survival data reported in the PARADIGM‐HT trial in which sacubitril + valsartan was studied in comparison with enalapril in patients with heart failure. The estimates of this parameter were compared with the published values of hazard ratio (HR). Methods Two endpoints were evaluated: a composite of death or hospitalization and cardiovascular death. Our analyses were performed by considering the original follow‐up of 41.4 months and on the basis of a lifetime perspective. All statistical calculations were carried out using specific packages developed under the R‐platform. Results According to our RMST analysis, the results for the composite endpoint in the comparison of sacubitril + valsartan vs. enalapril showed an improvement from 32.9 to 34.2 months (gain of 1.25 months). This result is based on a time horizon of 41.4 months. The results for the cardiovascular mortality endpoint showed a RMST of 37.2 months for sacubitril + valsartan vs. 36.2 for enalapril (gain of 0.96 months). In the two lifetime analyses, the improvements were much more relevant and yielded a gain of 25.8 months for the composite endpoint and 27.6 months for survival free from cardiovascular death. Conclusions Using the data of the PARADIGM‐HT trial, our analysis confirmed that the RMST has documented advantages over the HR, particularly when the clinical study is characterized by a long follow‐up. The number needed to treat (NNT) has a more specific methodological role and cannot be replaced by the RMST. |
| first_indexed | 2024-04-11T04:50:38Z |
| format | Article |
| id | doaj.art-0be5d2a270614ac6b973501db09bfbb3 |
| institution | Directory Open Access Journal |
| issn | 2055-5822 |
| language | English |
| last_indexed | 2024-04-11T04:50:38Z |
| publishDate | 2021-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj.art-0be5d2a270614ac6b973501db09bfbb32022-12-27T03:53:07ZengWileyESC Heart Failure2055-58222021-06-01832345234810.1002/ehf2.13306The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studiesAndrea Messori0Laura Bartoli1Sabrina Trippoli2HTA Unit Toscana Region Health Service Florence Toscana Region ItalyHTA Unit Toscana Region Health Service Florence Toscana Region ItalyHTA Unit Toscana Region Health Service Florence Toscana Region ItalyAbstract Aims We applied the restricted mean survival time (RMST) to analyse the survival data reported in the PARADIGM‐HT trial in which sacubitril + valsartan was studied in comparison with enalapril in patients with heart failure. The estimates of this parameter were compared with the published values of hazard ratio (HR). Methods Two endpoints were evaluated: a composite of death or hospitalization and cardiovascular death. Our analyses were performed by considering the original follow‐up of 41.4 months and on the basis of a lifetime perspective. All statistical calculations were carried out using specific packages developed under the R‐platform. Results According to our RMST analysis, the results for the composite endpoint in the comparison of sacubitril + valsartan vs. enalapril showed an improvement from 32.9 to 34.2 months (gain of 1.25 months). This result is based on a time horizon of 41.4 months. The results for the cardiovascular mortality endpoint showed a RMST of 37.2 months for sacubitril + valsartan vs. 36.2 for enalapril (gain of 0.96 months). In the two lifetime analyses, the improvements were much more relevant and yielded a gain of 25.8 months for the composite endpoint and 27.6 months for survival free from cardiovascular death. Conclusions Using the data of the PARADIGM‐HT trial, our analysis confirmed that the RMST has documented advantages over the HR, particularly when the clinical study is characterized by a long follow‐up. The number needed to treat (NNT) has a more specific methodological role and cannot be replaced by the RMST.https://doi.org/10.1002/ehf2.13306Restricted mean survival timeMedianHazard ratioNumber needed to treat |
| spellingShingle | Andrea Messori Laura Bartoli Sabrina Trippoli The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies ESC Heart Failure Restricted mean survival time Median Hazard ratio Number needed to treat |
| title | The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies |
| title_full | The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies |
| title_fullStr | The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies |
| title_full_unstemmed | The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies |
| title_short | The restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long‐term studies |
| title_sort | restricted mean survival time as a replacement for the hazard ratio and the number needed to treat in long term studies |
| topic | Restricted mean survival time Median Hazard ratio Number needed to treat |
| url | https://doi.org/10.1002/ehf2.13306 |
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