Table 1. Major characteristics of included studies.
Studies are sorted by date of publication and intervention type (LMWH and DOAC). *Study type: CPST – Acronym for “Cancer-population specific trial” (i.e. a trial exclusively in cancer patients), SA – Acronym for “Subgroup analysis” (i.e. results are subgroup data from a trial including cancer and non-cancer patients), Full report – Data taken from a published manuscript, Abstract – Data taken from a congress report (Abstract available online, full manuscript not yet published); †Follow-up - Event data reported below pertain to this timepoint of follow-up; ‡Six-month risks were calculated by transforming raw event data into a study-specific event rate ri (number of events per person-time at risk assuming that events occurred on average at half of follow-up(†)), and then transforming ri into a 6-month risk pi using the following equation: pi=1-exp^(-0.5*ri); **Weighted risks calculated by taking the sum of each study’s product of the 6-month risk pi and its individual weight wi (wi calculated as the ratio of patients in the study’s VKA arm divided by the total number of patients in the VKA arms of the LMWH or DOAC studies, respectively).
| Study acronym | CANTHANOX | CLOT | ONCENOX | LITE | Romera et al. | CATCH | RECOVER I+ II | HOKUSAI | AMPLIFY | EINSTEIN DVT+PE |
|---|---|---|---|---|---|---|---|---|---|---|
| First Author (Year of publication)Ref. | Meyer G (2002)[29] | Lee AYY (2003)[30] | Deitcher SR (2006)[28] | Hull RD (2007)[31] | Romera A (2008)[32] | Lee AYY (2014)[22] | Schulman S (2013)[24] | Raskob GE (2013)[25] | Agnelli G (2014)[23] | Prins MH (2014)[33] |
| Study type* (Publication status) | CPST (Full Report) | CPST (Full Report) | CPST (Full Report) | SA (Full Report) | SA (Full Report) | CPST (Abstract) | SA (Abstract) | SA (Abstract) | SA (Abstract) | SA (Full Report) |
| Intervention | LMWH (Enoxaparin) | LMWH (Dalteparin) | LMWH (Enoxaparin) | LMWH (Tinzaparin) | LMWH (Tinzaparin) | LMWH (Tinzaparin) | DOAC (Dabigatran) | DOAC (Edoxaban) | DOAC (Apixaban) | DOAC (Rivaroxaban) |
| Comparator | VKA (Warfarin) | VKA (Any type) | VKA (Warfarin) | VKA (Any type) | VKA (Aceno-coumarol) | VKA (Warfarin) | VKA (Warfarin) | VKA (Warfarin) | VKA (Warfarin) | VKA (Warfarin/Acenocoumarol) |
| Follow-up time† | 3 months | 6 months | 6 months | 3 months | 6 months | 6 months | 6 months | 7.3 months | 6 months | 6 months |
| Number of recurrent VTE events in intervention group (N total) | 2 (71) | 27 (336) | 4 (61) | 6 (100) | 2 (36) | 31 (449) | 10 (173) | 4 (109) | 3 (81) | 6 (258) |
| Number of recurrent VTE events in comparator group (N total) | 3 (75) | 53 (336) | 3 (30) | 10 (100) | 3 (33) | 45 (451) | 12 (162) | 7 (99) | 5 (78) | 8 (204) |
| Number of major bleedings in intervention group (N total) | 5 (71) | 19 (338) | 6 (67) | 7 (100) | N/A | 13 (449) | 6 (159) | 5 (109) | 2 (87) | 5 (257) |
| Number of major bleedings in comparator group (N total) | 12 (75) | 12 (335) | 1 (34) | 7 (100) | N/A | 12 (451) | 7 (152) | 3 (99) | 4 (80) | 8 (202) |
| Cancer status definition | Patients with solid or hematologic cancers, either active or in remission with ongoing antitumor treatment (no definition of active cancer reported) | Patients with active cancer (defined as recurrent or meta-static cancers, or cancer diagnosis or treatment within 6 months | Patients not being candidates for curative surgery with active cancer (defined as measurable disease or histo-cyto-logical diagnosis ± elevated tumor markers) | No specific definition reported | No specific definition reported | Patients with active cancer (no specific definition of active cancer reported) | Patients with active cancer (defined as a diagnosis of cancer, recurrent or metastatic disease, or cancer treatment within 5 years) | Patients with active cancer (judged at study entry by local investigators, specific definition for active cancer not reported) | Patients with active cancer (defined as cancer diagnosed or treated within the past 6 months) | Patients with active cancer (judged at study entry by local investigators, specific definition for active cancer not reported) |
| 6-month risk of recurrent VTE in VKA arm (%)‡ | 7.8% | 15.7% | 10.0% | 19.0% | 9.1% | 10.0% | 7.4% | 4.9% | 6.4% | 3.9% |
| 6-month risk of major bleeding in VKA arm (%)‡ | 29.4% | 3.6% | 2.9% | 13.5% | N/A | 2.7% | 4.6% | 2.1% | 5.0% | 4.0% |
| Weighted 6-month risk of recurrent VTE in VKA arm (%)** | 12.6% | 5.5% | ||||||||
| Weighted 6-month risk of major bleeding in VKA arm (%)** | 6.1% | 4.0% | ||||||||