scholarly journals Impact of the Result of Continued Thrombolysis After Stenting Following Pharmacomechanical Thrombectomy for Iliofemoral Deep Vein Thrombosis—A Retrospective Study

2021 ◽  
Vol 27 ◽  
pp. 107602962110411
Author(s):  
Ya-dong Zhou ◽  
Ying-ying Chen ◽  
Ming Xue ◽  
Xue-xun Zheng ◽  
Xing-sheng Chen ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Stent Patency ◽  
Vein Thrombosis ◽  
Clot Removal ◽  
Catheter Directed Thrombolysis ◽  
Direct Stenting ◽  
The Mean ◽  
Deep Vein ◽  
Grade Iii

Objective The aim of this study is to compare the procedure and treatment outcomes of using either direct stenting alone following pharmacomechanical thrombectomy or continued catheter-directed thrombolysis after stenting for treatment of acute left iliofemoral deep vein thrombosis while clot removal degree achieved grade III. Methods From March 2018 to May 2019, 82 patients who underwent iliac venous stenting for treatment of acute left iliofemoral deep vein thrombosis with iliac vein stenosis after pharmacomechanical thrombectomy therapy using the AngioJet system while Clot removal degree achieved grade III were divided into two groups: Direct stenting alone group ( n = 39) and continued catheter-directed thrombolysis after stenting group ( n = 43). Comparisons were made regarding the treatment outcomes, stent patency rate, and Villalta scale between these two groups. Results No serious perioperative complications occurred. The mean urokinase dose and hospitalization time in the stenting alone group and continued catheter-directed thrombolysis after the stenting group were 0.30 million U versus 1.76 ± 0.54 million U and 4.85 ± 0.93 days versus 6.33 ± 1.02 days, ( P < .001). In the first 30 days after the operation, there were 3 recurrent episodes of deep vein thrombosis in the stenting alone group ( P = 0.064). Each patient has completed at least one year of follow-up, the mean follow-up was 15.95 ± 3.44 months. Overall cumulative stent patency rates were 87.2% in stenting alone group and 97.7% in continued catheter-directed thrombolysis after stenting group at 12months ( P = 0.037). The Villalta scores at 12 months had a significant difference between the two groups. The mean Villalta scores in the stenting alone group and continued catheter-directed thrombolysis after the stenting group were 4.44 ± 1.63 and 1.63 ± 1.29, respectively ( P < 0.001). Conclusion When the clot removal degree of pharmacomechanical thrombectomy thrombectomy reaches grade III, both stenting alone and continued catheter-directed thrombolysis after stenting are effective treatment modalities. For young patients with low bleeding risk, continued catheter-directed thrombolysis after stenting has a better patency rate and a lower 1-year post-thrombotic syndrome risk and does not increase major bleeding events. However, it may increase the time and costs of hospitalization accordingly.

A case-controlled study on AngioJet rheolytic thrombectomy and catheter-directed thrombolysis in the treatment of acute lower extremity deep venous thrombosis

Vascular ◽  
2019 ◽  
Vol 28 (2) ◽  
pp. 177-182 ◽  
Author(s):  
Jun Zhu ◽  
Cai-Fang Ni ◽  
Zhen-Yu Dai ◽  
Li-Zheng Yao ◽  
Wen-Hui Li
Keyword(s):  
Deep Vein Thrombosis ◽  
Lower Extremity ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Vein Thrombosis ◽  
Catheter Directed Thrombolysis ◽  
Rheolytic Thrombectomy ◽  
Thrombus Removal ◽  
The Mean ◽  
Deep Vein

Objective This study aims to compare the efficacy and safety of AngioJet rheolytic thrombectomy vs. catheter-directed thrombolysis in patients with acute lower extremity deep vein thrombosis. Methods Between the period of February 2015 and October 2016, 65 patients with documented acute lower extremity deep vein thrombosis were treated with catheter-directed intervention. These patients were divided into two groups: AngioJet group and catheter-directed thrombolysis group. Comparisons were made with regard to efficacy and safety between these two groups. Results In the AngioJet group, complete or partial thrombus removal was accomplished in 23 (72%) and 3 (9%) patients, respectively. In the catheter-directed thrombolysis group, complete or partial thrombus removal was accomplished in 27 (82%) patients and 1 (3%) patient, respectively. In the AngioJet group, the perimeter difference between the suffered limb and healthy one declined from 5.1 ± 2.3 cm to 1.4 ± 1.2 cm ( P <  0.05). In the catheter-directed thrombolysis group, the perimeter difference declined from 4.7 ± 1.6 cm to 1.5 ± 0.9 cm ( P <  0.05). The mean urokinase dose was 0.264 ± 0.135 million units in the AngioJet group and 1.869 ± 0.528 million units in the catheter-directed thrombolysis group ( P <  0.05). The duration of thrombolysis was 4.2 ± 1.7 h in the AngioJet group and 73.6 ± 18.3 h in the catheter-directed thrombolysis group ( P <  0.05). The occurrence of complications in these two groups was 19% and 18%, respectively (not significant). Conclusion AngioJet rheolytic thrombectomy is a new, safe and effective approach for treating acute lower extremity deep vein thrombosis. When compared to catheter-directed thrombolysis, this treatment provides similar success with lower urokinase dosage and shorter duration of thrombolysis.

Improved Functional Outcome After Additional Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis: Results of a Randomized Controlled Clinical Trial (The CaVenT Study)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. LBA-1-LBA-1
Author(s):  
Tone Rønnaug Enden ◽  
Ylva Haig ◽  
Nils-Einar Kløw ◽  
Carl Erik Slagsvold ◽  
Leiv Sandvik ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Functional Outcome ◽  
Standard Treatment ◽  
Puncture Site ◽  
Treatment Groups ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Catheter Directed Thrombolysis ◽  
Deep Vein

Abstract Abstract LBA-1 Background: Following acute deep vein thrombosis (DVT) of the lower limb, approximately 1 in 4 patients treated with anticoagulation (AC) and elastic compression stockings (ECS) in accordance with current guidelines, are still at risk for developing a chronically reduced functional outcome, i.e., the post-thrombotic syndrome (PTS). Additional treatment with catheter-directed thrombolysis (CDT) enhances clot removal and is suggested to favor venous competence and patency, thereby reducing the risk for PTS. This interventional therapy is expensive, associated with life-threatening bleeding, and converts an outpatient disease to an inpatient disease. However, it has become standard care in some centers despite a complete lack of evidence from randomized, controlled trials (RCT). The CaVenT study, representing the first RCT in this area, aimed to evaluate whether additional CDT with alteplase improved the functional outcome by reducing PTS development following acute iliofemoral DVT. Methods: The CaVenT study was an open, multicenter RCT that recruited patients from 20 hospitals in the Norwegian south-eastern health region. Patients of age 18–75 years with a first-time objectively verified acute iliofemoral DVT above mid-thigh level and symptoms for up to 21 days were eligible for recruitment. Study patients were randomly assigned with a 1:1 ratio to standard (control) treatment with AC and ECS grade II (30 mmHg) or to CDT with alteplase in addition to standard treatment. The present report concerns the primary clinical end-point; the frequency of PTS after 24 months follow-up. The study was designed to detect a reduction in PTS from 25% to 10% with a 5% significance level and with 80% power. Follow-up visits were conducted at 6 months ± 2 weeks and 24 months ± 4 weeks and included evaluation of PTS by the Villalta scale as recommended by the International Society on Thrombosis and Haemostasis. Iliofemoral patency was assessed with ultrasonography and air-plethysmography. A two-sided uncorrected Chi-square test was used for comparing dichotomous variables in the two treatment groups. Results: 209 patients with acute iliofemoral DVT were randomized during 2006–2009; 101 patients were allocated the CDT arm and 108 the control arm. At the completion of 24 months follow-up, data on clinical status were available and included in the intention to treat analyzes for 90 patients in the CDT arm and 99 control patients. Mean age was 51.5 years (SD 15.8), 36% were female, and mean duration of symptoms was 6.6 days (SD 4.6). 80/90 patients receiving CDT had successful lysis. At 24 months follow-up 37 (41.1%, 95% CI 31.5–51.4%) allocated additional CDT presented with PTS compared to 55 (55.6%, 95% CI 45.7–65.0%) in the control group (p=0.047), including one control with severe PTS. The difference in PTS corresponds to an absolute risk reduction of 14.4% (95% CI 0.2–27.9), and the number needed to treat was 7 (95% CI 4–502). No patients presented with venous ulcer. In total 20 bleeding complications were reported; 3 were classified as major and 5 as clinically relevant. The majority of bleedings were related to the puncture site. The major bleedings included 1 abdominal wall hematoma requiring blood transfusion, 1 compartment syndrome of the calf requiring surgery, and 1 inguinal puncture site hematoma. No bleeding led to a permanently reduced outcome, and there were no deaths, pulmonary embolism or cerebral hemorrhage related to CDT. Patients who had regained venous patency after 6 months, developed PTS in 38/103 (36.9%, 95% CI 28.2–46.5%) as compared to 49/80 (61.3%, 95% CI 50.3–71.2%) of patients with insufficient recanalization (p<0.001). During follow-up 28 patients experienced recurrent venous thromboembolism and 11 were diagnosed with cancer; the differences were not statistically significant between the two treatment groups. Conclusion: Additional CDT with alteplase significantly reduced the rate of PTS compared to standard treatment alone. CDT resulted in successful lysis in the great majority of patients with iliofemoral DVT. However, it also entailed an additional risk of bleeding, emphasizing the importance of patient selection and safely performed CDT procedures. Overall this first RCT on the efficacy and safety of CDT suggests a net clinical benefit of additional CDT. Our findings have implications for update of guidelines, and CDT should be considered in patients with upper femoral or iliac DVT. Disclosures: No relevant conflicts of interest to declare.

Endovascular management of extensive lower extremity acute deep vein thrombosis with AngioJet rheolytic thrombectomy plus catheter-directed thrombolysis from contralateral femoral access

2018 ◽  
Vol 34 (4) ◽  
pp. 257-265 ◽  
Author(s):  
Guang Liu ◽  
Zhen Zhao ◽  
Chaoyi Cui ◽  
Kaichuang Ye ◽  
Minyi Yin ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Femoral Access ◽  
Technical Success Rate ◽  
Vein Thrombosis ◽  
Catheter Directed Thrombolysis ◽  
Rheolytic Thrombectomy ◽  
Complete Lysis ◽  
Acute Deep Vein Thrombosis ◽  
Deep Vein

Purpose The aim of the present study was to report the clinical outcomes of endovascular treatment for extensive lower limb deep vein thrombosis with AngioJet rheolytic thrombectomy (ART) plus catheter-directed thrombolysis (CDT) using a contralateral femoral approach. Methods A retrospective analysis of consecutive ART+CDT treatments in 38 deep vein thrombosis patients (LET I-III, from September 2014 to March 2016) was performed. Results The technical success rate was 100%. Complete lysis was achieved in 82% of LET III segments (calf veins), 87% of LET II segments (popliteal-femoral veins), and 90% of LET III segments (iliac veins). The best results were obtained in patients treated within seven days of symptom onset. During follow-up, well-preserved, competent femoral valves were observed in 86% of the patients, and recanalization of LET III, LET II, and LET I segments was achieved in 100%, 94%, and 91% of the patients, respectively. The post-thrombotic syndrome rate was 17% during a mean 20-month follow-up.

scholarly journals Treatment of Acute Iliofemoral Deep Vein Thrombosis; Does Catheter Directed Thrombolytic Therapy Change Outcomes?

2019 ◽  
Vol 4 (3) ◽  
Keyword(s):  
Quality Of Life ◽  
Deep Vein Thrombosis ◽  
Iliac Vein ◽  
P Value ◽  
Vein Thrombosis ◽  
Catheter Directed Thrombolysis ◽  
Group A ◽  
Deep Vein

Background: Iliofemoral deep vein thrombosis (DVT) is associated with severe post-thrombotic morbidity when treated with anticoagulation alone. Catheter- directed thrombolysis (CDT) allows early removal of thrombus and reduces valvular reflux and Post-thrombotic Syndrome (PTS). Patients and methods: This prospective randomized multi-center controlled two- arm blind study was conducted in 6 centers on 252 patients with iliofemoral DVT. Patients were randomly allocated by using simple random allocation cards method into two groups; Group (A): CDT followed by oral anticoagulation (N=126 (50%)), Group (B): Standard DVT therapy (N=126 (50%)). Follow-up was for 24 months. Results: Patients of group (A) significantly complained less pain at 10 & 30 days (P-Value: 0.02 & 0.04 respectively). Also there was significant decrease in leg circumference in group (A) at 10 & 30 days (P-Value: 0.001 & 0.03 respectively). Patency of iliac vein segment was significantly higher in group (A) during the 24 months follow up (P-Value <0.001 (HS)). Patients in group (A) developed less PTS at six months, at one year and at two years (P-Value: 0.024, 0.017 and 0.035 respectively). Better Quality of life was observed in group (A) (P-Value: 0.003). Conclusion: Addition of catheter-directed thrombolysis in the treatment of acute iliofemoral DVT; was safe and tolerated by most of the patients with better effect to reduce leg pain & circumference. It was considered a protecting weapon to prevent post-thrombotic syndrome and so improve quality of life and was related to achievement of higher iliac vein patency and less reflux.

Endovascular management of proximal lower limb deep venous thrombosis – A prospective study with six-month follow-up

2014 ◽  
Vol 30 (7) ◽  
pp. 441-448 ◽  
Author(s):  
S Patra ◽  
BC Srinivas ◽  
CM Nagesh ◽  
B Reddy ◽  
CN Manjunath
Keyword(s):  
Deep Vein Thrombosis ◽  
Lower Limb ◽  
Vein Thrombosis ◽  
Post Thrombotic Syndrome ◽  
Catheter Directed Thrombolysis ◽  
Grade Ii ◽  
Deep Vein ◽  
Limb Deep Vein Thrombosis ◽  
Proximal Lower Limb

Background Catheter-directed thrombolysis with assisted mechanical thrombolysis is the standard of medical care for proximal deep vein thrombosis. We studied the immediate and intermediate (six months) safety and effectiveness of catheter-directed thrombolysis in patients with proximal lower limb deep vein thrombosis. Methodology Thirty consecutive patients aged between 20 and 70 years with proximal lower limb deep vein thrombosis formed the study group. Catheter-directed thrombolysis was done with streptokinase infuse through a catheter kept in the ipsilateral popliteal vein. Unfractionated heparin was given along with streptokinase. Mechanical thromboaspiration using guiding catheter was performed in addition to thrombolytic therapy. After six months, post-thrombotic syndrome and deep venous patency were assessed by using Villalta scale and duplex ultrasound, respectively. Results Thirty patients with proximal lower limb deep vein thrombosis were treated with catheter-directed thrombolysis. Mean age of the study patients was 41.7 ± 15 years. Mean duration of illness was 13.3 ± 12 days. The mean duration of thrombolysis was 4.5 ± 1.3 days. Grade III (complete) lysis was achieved in 10 (33%) and Grade II (50–90%) lysis in 20 (67%) of patients. Patients with significant residual lesion in Grade II lysis following catheter-directed thrombolysis underwent percutaneous transluminal angioplasty alone (12/20) or venous stenting (8/20). All patients improved clinically following catheter-directed thrombolysis or assisted catheter-directed thrombolysis. Four patients (13%) developed pulmonary embolism during course of hospital stay and among them two (6.5%) patients died. Eleven patients (37%) had minor bleeding or hematoma at local site, and seven (23%) developed anemia requiring blood transfusion and four (13%) patients had thrombocytopenia. After six months, iliofemoral patency was found in 20 (72%) and post-thrombotic syndrome was seen in six (21%) patients. Two (6.5%) patients died during follow-up due to nephrotic syndrome and carcinoma breast. Conclusion Catheter-directed thrombolysis and conventional manual aspiration thrombectomy are an effective treatment for proximal lower extremity deep vein thrombosis with good short and intermediate outcome.

Iliac vein stenting as a durable option for residual stenosis after catheter-directed thrombolysis and angioplasty of iliofemoral deep vein thrombosis secondary to May–Thurner syndrome

2013 ◽  
Vol 29 (7) ◽  
pp. 461-470 ◽  
Author(s):  
Jae Young Park ◽  
Jong Hyuk Ahn ◽  
Yong Sun Jeon ◽  
Soon Gu Cho ◽  
Jang Yong Kim ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Patency Rate ◽  
Iliac Vein ◽  
Primary Patency ◽  
Primary Patency Rate ◽  
Vein Thrombosis ◽  
Catheter Directed Thrombolysis ◽  
Acute Deep Vein Thrombosis ◽  
Deep Vein

Introduction This study aims to evaluate the primary patency and clinical outcomes after stenting for residual iliac venous stenosis during catheter-directed thrombolysis treatment of acute iliofemoral deep vein thrombosis arising from May–Thurner syndome. Methods A retrospective study was done for the all patients who underwent iliac vein stenting after catheter-directed thrombolysis treatment of acute iliofemoral deep vein thrombosis due to May–Thurner syndrome from January 2005 to April 2011 in Inha University Hospital. Patient information was assembled from the electronic medical records, imaging and interview. The patency of iliac vein stent was evaluated with serial computed tomography. Results Fifty-one patients were enrolled. The median age was 70 years (range 44–86). There were 37 females (72.5%). The duration of symptoms of acute deep vein thrombosis before catheter-directed thrombolysis treatment was 6 days (median, range 1–33). Self-expanding stent was used for iliac vein stenting. Initial technical success rate was 94.1%. There were two complications (3.9%): an arteriovenous fistula formation in left popliteal area and a right inguinal hematoma. Mean follow-up was 15.6 months (range 6 days–80.8 months). Primary patency rate after iliac vein stenting was 95.8% at 6 months, 87.5% at 12 months and 84.3% at 24 months. Four patients had recurrent thrombotic occlusion (7.8%) during the follow-up. Conclusion Iliac vein stenting showed good primary patency rate with few complications. Iliac vein stenting is a durable option for residual stenosis after catheter-directed thrombolysis treatment of acute deep vein thrombosis in May–Thurner syndrome.

Safe Treatment of Pulmonary Embolism on An Outpatient Basis.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1979-1979
Author(s):  
Michael J. Kovacs ◽  
Jeffrey D.E. Hawel ◽  
Janelle F. Rekman ◽  
Alejandro Lazo-Langner
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Hospital Admission ◽  
Major Hemorrhage ◽  
Vein Thrombosis ◽  
The Mean ◽  
Risk For Bleeding ◽  
Deep Vein ◽  
Acute Pe

Abstract Background: Acute pulmonary embolism (PE) is a common medical problem in outpatient clinics and emergency rooms. Treatment with heparin and warfarin is well established and effective. In some centres (such as ours) eligible patients with PE are treated as outpatients, however many centres remain reluctant to do so. We review our experience with outpatient treatment of acute PE. Methods: We reviewed hospital charts for all inpatients and thrombosis clinic charts for all outpatients with a diagnosis of acute PE that was made prior to a decision on hospital admission from January 1, 2003 to January 30, 2008. All diagnoses were objectively proven by high probability V/Q scan or non-diagnostic V/Q scan with positive compression U/S or segmental or greater perfusion defect on CTPA. Patients were eligible to be treated as outpatients if they were hemodynamically stable, not high risk for bleeding, not requiring oxygen therapy, not requiring unfractionated heparin due to renal failure, and not having another indication for hospital admission. Most patients were treated with low molecular weight heparin (LMWH) for 5–7 days together with warfarin except for cancer patients who were treated with LMWH alone. All patients were instructed to call the thrombosis service or to go the emergency room if they developed symptoms of new PE or bleeding. Outpatients were seen in follow-up at 1, 4, and 12 weeks in the thrombosis clinic. Inpatient charts were reviewed for demographics and reason for hospital admission. For outpatients, in addition to demographics, charts were reviewed for the three month outcomes of major bleeding, recurrent venous thromboembolism and death. Results: There were a total of 633 patients with PE. 319 were admitted to the hospital whereas 314 (49.7%) were managed entirely as outpatients. The mean age for inpatients was 64 years. Inpatients were admitted for the following reasons: 125 (39%) for concomitant illness, 84 (26%) for hypoxia, 21 (7%) for hemodynamic instability, 14 (4%) for pain control, 1 (0.3%) for thrombolysis, 24 (7%) for other investigations, and 50 (16%) for other or unlcear reasons. For the 314 outpatients the mean age was 55 years and 184 (59%) were female. Eight (2.8%) patients were lost to follow-up. There were 195 (62%) idiopathic PE, 62 (20%) had PE secondary to cancer and 57(18%) to other transient risk factors. There were 247 (79%) patients who were managed with LMWH and warfarin, 51 (16%) managed with LMWH alone and 16 (5%) patients had experimental treatment. At 3 months of follow up there were 3 (1%) patients who developed major hemorrhage (GI bleed, hemoptysis, hemarthrosis), 3 (1%) patients who had objectively documented recurrent thrombosis (1 deep vein thrombosis, 2 PE), and 9 (2.9%) patients died, all of them from cancer progression. None of these events occurred within the first 7 days after diagnosis. Conclusions: To our knowledge this is the largest report of outpatient PE management. In our hospital 50% of ambulatory patients who have a diagnosis of PE are managed entirely as outpatients with a low risk for bleeding or thrombosis recurrence. For those admitted the majority was due to a concomitant illness that required admission itself. Many centres remain hesitant to treat patients with PE in this fashion but will treat patients with deep vein thrombosis as outpatients. Both conditions are at risk of recurrent PE and bleeding but it is not clear how a hospital admission would prevent that from happening. Our findings suggest that uncomplicated PE is not an indication for hospital admission per se. Outpatient management of PE deserves further consideration.

Improved Functional Outcome After Additional Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis: Results of a Randomized Controlled Clinical Trial (The CaVenT Study)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. LBA-1-LBA-1 ◽  
Author(s):  
Tone Rønnaug Enden ◽  
Ylva Haig ◽  
Nils-Einar Kløw ◽  
Carl Erik Slagsvold ◽  
Leiv Sandvik ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Functional Outcome ◽  
Standard Treatment ◽  
Puncture Site ◽  
Treatment Groups ◽  
Vein Thrombosis ◽  
Randomized Controlled ◽  
Catheter Directed Thrombolysis ◽  
Deep Vein

Abstract LBA-1 Background: Following acute deep vein thrombosis (DVT) of the lower limb, approximately 1 in 4 patients treated with anticoagulation (AC) and elastic compression stockings (ECS) in accordance with current guidelines, are still at risk for developing a chronically reduced functional outcome, i.e., the post-thrombotic syndrome (PTS). Additional treatment with catheter-directed thrombolysis (CDT) enhances clot removal and is suggested to favor venous competence and patency, thereby reducing the risk for PTS. This interventional therapy is expensive, associated with life-threatening bleeding, and converts an outpatient disease to an inpatient disease. However, it has become standard care in some centers despite a complete lack of evidence from randomized, controlled trials (RCT). The CaVenT study, representing the first RCT in this area, aimed to evaluate whether additional CDT with alteplase improved the functional outcome by reducing PTS development following acute iliofemoral DVT. Methods: The CaVenT study was an open, multicenter RCT that recruited patients from 20 hospitals in the Norwegian south-eastern health region. Patients of age 18–75 years with a first-time objectively verified acute iliofemoral DVT above mid-thigh level and symptoms for up to 21 days were eligible for recruitment. Study patients were randomly assigned with a 1:1 ratio to standard (control) treatment with AC and ECS grade II (30 mmHg) or to CDT with alteplase in addition to standard treatment. The present report concerns the primary clinical end-point; the frequency of PTS after 24 months follow-up. The study was designed to detect a reduction in PTS from 25% to 10% with a 5% significance level and with 80% power. Follow-up visits were conducted at 6 months ± 2 weeks and 24 months ± 4 weeks and included evaluation of PTS by the Villalta scale as recommended by the International Society on Thrombosis and Haemostasis. Iliofemoral patency was assessed with ultrasonography and air-plethysmography. A two-sided uncorrected Chi-square test was used for comparing dichotomous variables in the two treatment groups. Results: 209 patients with acute iliofemoral DVT were randomized during 2006–2009; 101 patients were allocated the CDT arm and 108 the control arm. At the completion of 24 months follow-up, data on clinical status were available and included in the intention to treat analyzes for 90 patients in the CDT arm and 99 control patients. Mean age was 51.5 years (SD 15.8), 36% were female, and mean duration of symptoms was 6.6 days (SD 4.6). 80/90 patients receiving CDT had successful lysis. At 24 months follow-up 37 (41.1%, 95% CI 31.5–51.4%) allocated additional CDT presented with PTS compared to 55 (55.6%, 95% CI 45.7–65.0%) in the control group (p=0.047), including one control with severe PTS. The difference in PTS corresponds to an absolute risk reduction of 14.4% (95% CI 0.2–27.9), and the number needed to treat was 7 (95% CI 4–502). No patients presented with venous ulcer. In total 20 bleeding complications were reported; 3 were classified as major and 5 as clinically relevant. The majority of bleedings were related to the puncture site. The major bleedings included 1 abdominal wall hematoma requiring blood transfusion, 1 compartment syndrome of the calf requiring surgery, and 1 inguinal puncture site hematoma. No bleeding led to a permanently reduced outcome, and there were no deaths, pulmonary embolism or cerebral hemorrhage related to CDT. Patients who had regained venous patency after 6 months, developed PTS in 38/103 (36.9%, 95% CI 28.2–46.5%) as compared to 49/80 (61.3%, 95% CI 50.3–71.2%) of patients with insufficient recanalization (p<0.001). During follow-up 28 patients experienced recurrent venous thromboembolism and 11 were diagnosed with cancer; the differences were not statistically significant between the two treatment groups. Conclusion: Additional CDT with alteplase significantly reduced the rate of PTS compared to standard treatment alone. CDT resulted in successful lysis in the great majority of patients with iliofemoral DVT. However, it also entailed an additional risk of bleeding, emphasizing the importance of patient selection and safely performed CDT procedures. Overall this first RCT on the efficacy and safety of CDT suggests a net clinical benefit of additional CDT. Our findings have implications for update of guidelines, and CDT should be considered in patients with upper femoral or iliac DVT. Disclosures: No relevant conflicts of interest to declare.

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