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FRONT-LINE VASCULAR ACCESS DEVICES IN ACUTE LEUKEMIAS - PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) VERSUS TRADITIONAL CENTRAL VENOUS CATHETER (CVC): A PHASE IV RANDOMIZED TRIAL (NCT02405728)
Author(s): ,
Claudio Cerchione
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Maria Di Perna
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Roberta Della Pepa
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Novella Pugliese
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Fabrizio Pane
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
Marco Picardi
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
(Abstract release date: 05/18/17) EHA Library. Cerchione C. 06/24/17; 181791; S504
Dr. Claudio Cerchione
Dr. Claudio Cerchione
Contributions
Abstract

Abstract: S504

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 16:45 - 17:00

Location: Room N109

Background

The use of PICC as an alternative to other CVC devices, particularly for prolonged infusions of cytotoxic agents, blood products and/or other supportive therapy, is becoming very frequent in cancer patients. PICCs are easier to insert, and associated to a lower rate of severe complications than traditional CVCs. However, there is limited information on the feasibility and safety of PICC as primary vascular access device in the setting of high-risk hematological patients.

Aims

Our Hematology Department is conducting a Phase IV randomized trial on this topic. We compare PICCs versus traditional CVCs as front-line venous access device in patients with acute leukemias undergoing intensive chemotherapy for remission induction (NCT02405728; ongoing).
Primary endpoint is the occurrence of catheter-related bloodstream infections and/or thrombosis. Secondary endpoints are the occurrence of other complications, such as pneumothorax or catheter occlusion, and patients’quality of life. Questionnaire covering functional status, sleep and hygiene disturbance had been given to assess patients’ quality of life.

Methods

From April 2015 to February 2017, 152 consecutive patients with acute leukemia planned for remission induction chemotherapy were randomly assigned (1:1) to PICC (Arm A) or traditional CVC (Arm B) (Table 1). Inclusion criteria were age >18 years, expected survival > 4 weeks, and need of central venous access (long-term > 4 weeks). Exclusion criteria were ongoing uncontrolled systemic infection, presence of significant thrombosis/stenosis in arm or central veins, and inability to communicate and/or to sign informed consent.
All insertions were followed by ultrasonography assessments and chest X-ray.

Results

152 patients (130 AML and 22 ALL) with a median age of 47 years (range, 13-82), were randomized in the two arms. In the Arm A, 76 PICCs (power injectable PICCs, in new generation polyurethane, open-ended) were inserted in 76 patients. Double lumen PICCs (5 Fr) were inserted in 70 patients, single lumen PICCs (4 Fr) were inserted in 5 patients, and triple lumen PICC (6 Fr) was inserted in 1 patient. 68 PICCs were inserted in the right basilica vein, 5 PICCs were inserted in the left basilica vein and 3 PICCs were inserted in the left brachial vein. In Arm B, 76 traditional CVCs (untunneled heparin-coated Vialon CVC, Becton-Dickinson) were inserted by the Seldinger technique in other 76 patients. 45 CVCs were inserted in subclavian vein and 31 CVCs were inserted in internal jugular vein.
Overall, the median duration of in situ catheter placement was 5 months: 6 months (range, 3-12) in the arm A vs. 3 months (range, 1-10) in the arm B. In the arm A, catheter-related thrombosis occurred in 8 patients (6 basilica veins, 2 brachial veins) and catheter-related bloodstream infections in 4 patients (4 coagulase-negative staphylococci; of them, 2 meticillin-resistants). In the arm B, 20 cases of catheter-related thrombosis (7 subclavian veins, 13 internal jugular veins) and 15 cases of catheter-related bloodstream infections (10 enterobacteriaceae; 5 coagulase-negative staphylococci, and, of them, 3 meticillin-resistants) were observed. Thus, PICCs were significantly associated with fewer major complications than traditional CVCs (catheter-related thrombosis: 10.5% in the arm A vs. 26% in the arm B, p=0.01 by χ2 test; catheter-related bloodstream infections: 5% in the arm A vs. 19% in the arm B, p= 0.007 by χ2 test) (Figure 1). Questionnaire covering activities of daily living confirmed improvement of quality of life.

Conclusion

The preliminary observations of this ongoing Phase IV randomized study, focusing on front-line use of central venous access device in a high risk hematological population, suggest that the use of PICC represents an advance in terms of decrease of complication rate and improvement of quality of life for patients with acute leukemia.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Randomized, Clinical Trial, Central venous catheter, acute leukemia

Abstract: S504

Type: Oral Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 16:45 - 17:00

Location: Room N109

Background

The use of PICC as an alternative to other CVC devices, particularly for prolonged infusions of cytotoxic agents, blood products and/or other supportive therapy, is becoming very frequent in cancer patients. PICCs are easier to insert, and associated to a lower rate of severe complications than traditional CVCs. However, there is limited information on the feasibility and safety of PICC as primary vascular access device in the setting of high-risk hematological patients.

Aims

Our Hematology Department is conducting a Phase IV randomized trial on this topic. We compare PICCs versus traditional CVCs as front-line venous access device in patients with acute leukemias undergoing intensive chemotherapy for remission induction (NCT02405728; ongoing).
Primary endpoint is the occurrence of catheter-related bloodstream infections and/or thrombosis. Secondary endpoints are the occurrence of other complications, such as pneumothorax or catheter occlusion, and patients’quality of life. Questionnaire covering functional status, sleep and hygiene disturbance had been given to assess patients’ quality of life.

Methods

From April 2015 to February 2017, 152 consecutive patients with acute leukemia planned for remission induction chemotherapy were randomly assigned (1:1) to PICC (Arm A) or traditional CVC (Arm B) (Table 1). Inclusion criteria were age >18 years, expected survival > 4 weeks, and need of central venous access (long-term > 4 weeks). Exclusion criteria were ongoing uncontrolled systemic infection, presence of significant thrombosis/stenosis in arm or central veins, and inability to communicate and/or to sign informed consent.
All insertions were followed by ultrasonography assessments and chest X-ray.

Results

152 patients (130 AML and 22 ALL) with a median age of 47 years (range, 13-82), were randomized in the two arms. In the Arm A, 76 PICCs (power injectable PICCs, in new generation polyurethane, open-ended) were inserted in 76 patients. Double lumen PICCs (5 Fr) were inserted in 70 patients, single lumen PICCs (4 Fr) were inserted in 5 patients, and triple lumen PICC (6 Fr) was inserted in 1 patient. 68 PICCs were inserted in the right basilica vein, 5 PICCs were inserted in the left basilica vein and 3 PICCs were inserted in the left brachial vein. In Arm B, 76 traditional CVCs (untunneled heparin-coated Vialon CVC, Becton-Dickinson) were inserted by the Seldinger technique in other 76 patients. 45 CVCs were inserted in subclavian vein and 31 CVCs were inserted in internal jugular vein.
Overall, the median duration of in situ catheter placement was 5 months: 6 months (range, 3-12) in the arm A vs. 3 months (range, 1-10) in the arm B. In the arm A, catheter-related thrombosis occurred in 8 patients (6 basilica veins, 2 brachial veins) and catheter-related bloodstream infections in 4 patients (4 coagulase-negative staphylococci; of them, 2 meticillin-resistants). In the arm B, 20 cases of catheter-related thrombosis (7 subclavian veins, 13 internal jugular veins) and 15 cases of catheter-related bloodstream infections (10 enterobacteriaceae; 5 coagulase-negative staphylococci, and, of them, 3 meticillin-resistants) were observed. Thus, PICCs were significantly associated with fewer major complications than traditional CVCs (catheter-related thrombosis: 10.5% in the arm A vs. 26% in the arm B, p=0.01 by χ2 test; catheter-related bloodstream infections: 5% in the arm A vs. 19% in the arm B, p= 0.007 by χ2 test) (Figure 1). Questionnaire covering activities of daily living confirmed improvement of quality of life.

Conclusion

The preliminary observations of this ongoing Phase IV randomized study, focusing on front-line use of central venous access device in a high risk hematological population, suggest that the use of PICC represents an advance in terms of decrease of complication rate and improvement of quality of life for patients with acute leukemia.

Session topic: 35. Quality of life, palliative care, ethics and health economics

Keyword(s): Randomized, Clinical Trial, Central venous catheter, acute leukemia

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