Efficacy and Safety of Extended Duration Postoperative Thromboprophylaxis with Low-Molecular-Weight-Heparin Among Subgroups of Patients Undergoing Surgical Resection of Colorectal Cancer: A Post-Hoc Analysis of the Periop-01 Trial
Notice bibliographique
Résumé
Background: Clinical practice guidelines suggest the use of extended duration of postoperative thromboprophylaxis to prevent venous thromboembolic (VTE) complications after any cancer-related major abdominal or pelvic surgeries. However, recent trials including patients undergoing surgical resection of colorectal cancer have reported relatively low rates of symptomatic VTE. Hence, the risk and benefits of extended postoperative thromboprophylaxis need to be carefully assessed in this patient population. We sought to determine the impact of extended duration thromboprophylaxis with low-molecular-weight-heparin on VTE and bleeding events among different subgroups of patients undergoing surgical resection of localized colorectal cancer. Methods: This is a pre-planned post-hoc analysis of the PERIOP-01 randomized controlled trial which compared extended (up to 6 weeks) to standard duration (in hospital only) of perioperative thromboprophylaxis with tinzaparin (4500 IU SC daily) in patients undergoing surgical resection of localized colorectal cancer. Subgroup analyses were performed based on different baseline characteristics. The primary efficacy and safety outcomes were objectively documented major VTE and combination of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events, respectively. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated using the Cox proportional hazards model to compare the treatment effect accounting for clustering at study center level. Results: A total of 614 patients were randomized in the PERIOP-01 trial (307 in the extended and 307 in the standard duration thromboprophylaxis groups). Overall, the mean age of the participants was 61 years, 41% of them were women, and most patients were white (90%). Type of primary cancer was well-balanced with 311 patients having rectal cancer (51%), whereas 303 (49%) had primary colon cancer. During the study period, major VTE events occurred in 2% and 1% of the extended- and standard-duration prophylaxis groups, respectively (P=0.8). Combination of MB and CRNMB events occurred in 3% of each group. No specific characteristics were found to be associated with a decreased risk of major VTE among patients on extended duration thromboprophylaxis (Figure 1). Patients with colon cancer resection receiving extended thromboprophylaxis were at an increased risk of bleeding complication compared to patients with rectal cancer (HR 2.57, 95%CI 1.25-5.3) (Figure 1). Other characteristics that may be associated with an increased risk of bleeding among patient on extended thromboprophylaxis included age >= 75 (HR 2.37, 95%CI 0.47-11.98) and male sex (HR 2.13, 95%CI 0.2-23.17), although these characteristics were not statistically significant. Conclusions: In the PERIOP-01 trial, extended thromboprophylaxis didn't reduce the risk of major VTE in any subgroups of patients. On the other hand, extended duration of thromboprophylaxis may be associated with an increased bleeding risk among male, elderly patients, and those with colon cancer.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,007 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».