What is the clinical evidence from this study?

Study design: RCT. Population: Acutely-ill, non-surgical patients with cancer (n=3239). Intervention: Certoparin vs. UFH 5,000 IU t.i.d.. Primary outcome: Combined incidence of proximal DVT, symptomatic non-fatal PE and VTE related death (OR 0.73, 95% CI 0.23-2.39, p=0.6078).

July 26, 2011BMC Cancer36 citationsOpen Access

Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY

SHSylvia Haas SSSebastian Schellong UTUlrich Tebbe

Key Result

Certoparin 3,000 U anti-Xa once daily was as effective as unfractionated heparin 5,000 IU three times daily in preventing thromboembolic events in acutely ill medical patients with cancer (4.50% vs 6.03%; OR 0.73).

Study Design

Type

RCT (n=3,239)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does certoparin prevent venous thromboembolic events compared to unfractionated heparin in acutely-ill, non-surgical older patients with cancer?

Population

3,239 acutely ill, non-surgical patients aged ≥70 years (including a subgroup of 274 with cancer) requiring immobilization, treated with certoparin or UFH for 8-20 days.

Intervention

Certoparin 3,000 U anti Xa subcutaneous once daily for 8-20 days

Comparator

Unfractionated heparin (UFH) 5,000 IU subcutaneous three times daily for 8-20 days

Outcome

Combined incidence of proximal DVT, symptomatic non-fatal PE and VTE related death occurring during the core study (covering the treatment period of 8-20 days after which compression ultrasound sonography was performed), adjudicated by a blinded expert committeecomposite

Certoparin and unfractionated heparin are equally effective and safe for the prevention of venous thromboembolism in acutely ill, non-surgical older patients with cancer.

Main Result

Odds Ratio: 0.73 (95% CI 0.23–2.39)

Absolute Event Rate: 4.5% vs 6.03%

p-value: p=0.6078

Limitations

Considerable differences in VTE risk between patients with different cancer types were not captured in sufficient detail.
The subgroup of patients with cancer was small compared to the overall sample size, limiting statistical power.
There is no possibility to explore the absolute efficacy of either heparin in comparison to patients receiving no prophylaxis.
No possibility to explore the absolute efficacy of either heparin in comparison to patients receiving no prophylaxis.

Abstract

BACKGROUND: Patients with cancer have an increased risk of VTE. We compared VTE rates and bleeding complications in 1) cancer patients receiving LMWH or UFH and 2) patients with or without cancer. METHODS: Acutely-ill, non-surgical patients ≥ 70 years with (n = 274) or without cancer (n = 2,965) received certoparin 3,000 UaXa o.d. or UFH 5,000 IU t.i.d. for 8-20 days. RESULTS: 1) Thromboembolic events in cancer patients (proximal DVT, symptomatic non-fatal PE and VTE-related death) occurred at 4.50% with certoparin and 6.03% with UFH (OR 0.73; 95% CI 0.23-2.39). Major bleeding was comparable and minor bleedings (0.75 vs. 5.67%) were nominally less frequent. 7.5% of certoparin and 12.8% of UFH treated patients experienced serious adverse events. 2) Thromboembolic event rates were comparable in patients with or without cancer (5.29 vs. 4.13%) as were bleeding complications. All cause death was increased in cancer (OR 2.68; 95%CI 1.22-5.86). 10.2% of patients with and 5.81% of those without cancer experienced serious adverse events (OR 1.85; 95% CI 1.21-2.81). CONCLUSIONS: Certoparin 3,000 UaXa o.d. and 5,000 IU UFH t.i.d. were equally effective and safe with respect to bleeding complications in patients with cancer. There were no statistically significant differences in the risk of thromboembolic events in patients with or without cancer receiving adequate anticoagulation. TRIAL REGISTRATION: clinicaltrials.gov, NCT00451412.

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