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Effect of Baseline ASPECTS on Tenecteplase Efficacy Before Thrombectomy in Acute Large-Vessel Occlusion Stroke: A Post Hoc Analysis of the BRIDGE-TNK Randomized Trial.

BACKGROUND AND OBJECTIVES: The impact of ischemic extent on the efficacy and safety of intravenous thrombolysis before thrombectomy remains uncertain. The aim of this study was to evaluate whether the baseline ischemic extent, measured by the Alberta Stroke Program Early Computed Tomography Score (ASPECTS), modifies outcomes of intravenous tenecteplase administered before endovascular thrombectomy. METHODS: This was a post hoc analysis of the BRIDGE-TNK (thrombectomy with vs without rhTNK-tPA in stroke) trial, conducted across China from May 2022 to September 2024. We compared the efficacy and safety of intravenous tenecteplase plus thrombectomy vs thrombectomy alone in acute large-vessel occlusion stroke patients within 4.5 hours of last known well, stratified by baseline ASPECTS (<8 vs 8-10). The outcomes included 90-day functional independence (modified Rankin Scale score of 0-2), 48-hour symptomatic intracranial hemorrhage (sICH), and 90-day mortality. Regression models incorporating a treatment-by-ASPECTS interaction term were used for analysis. RESULTS: Among 550 patients, 241 (43.8%) had ASPECTS <8 (median [interquartile range, IQR] age, 69 [61-77] years; 56.4% male) and 309 had ASPECTS 8-10 (median [IQR] age, 70 [61-77] years; 59.5% male). The rate of functional independence was significantly higher in the tenecteplase plus thrombectomy group than in the thrombectomy-alone group in the ASPECTS <8 subgroup (adjusted risk ratio [aRR], 1.67; 95% CI 1.18-2.35), but not in the ASPECTS 8-10 subgroup (aRR, 0.99; 95% CI 0.84-1.17; pinteraction = 0.007). Rates of sICH did not differ significantly between treatment groups in either ASPECTS subgroups (ASPECTS <8: 10.0% vs 11.2%; ASPECTS 8-10: 7.5% vs 2.8%; pinteraction = 0.11). Ninety-day mortality was comparable between treatment groups in the ASPECTS <8 subgroup, but numerically higher with tenecteplase plus thrombectomy in the ASPECTS 8-10 subgroup (aRR = 1.89, 95% CI 0.99-3.61, pinteraction = 0.04). DISCUSSION: In this exploratory post hoc analysis, a signal of benefit was observed in patients with ASPECTS <8 who received intravenous tenecteplase before thrombectomy, whereas no functional improvement and possible safety concerns were seen in those with ASPECTS 8-10. Prospective confirmation in randomized trials is required before practice change. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; Unique identifier: NCT04733742.

Humans

Long-term results of thrombectomy for late occlusions of aortofemoral bypass.

Sixty-two first episodes of aortofemoral (eight patients) or aortobifemoral (42 patients) bypass thrombosis were operated upon in 50 patients between 1980 and 1985. There were 47 men and three women whose mean age was 58 years. Retrograde thrombectomy through the distal anastomosis was achieved in all cases by using either a balloon catheter or Vollmar rings. If thrombectomy was impossible, revascularization was ensured by an extraanatomic bypass or complete replacement of the graft. Angioplasty, repeat distal anastomosis or femoropopliteal bypass of the native runoff artery were done in 55 (89%) operations. The cause of thrombosis was elucidated in 45 cases. Suture line stenosis and atheromatous stenosis of the native runoff artery were the two most common causes. Three patients died and two required above-knee amputation in the immediate postoperative period. Contralateral embolism occurred in two patients undergoing retrograde thrombectomy. Mean follow-up was 47 months. Thrombectomy was possible in 51 or 62 prosthetic thromboses (Group I). Thirty-nine of these grafts have remained patent. Twelve instances of repeat thrombosis occurred, requiring either repeat thrombectomy or a new bypass. Primary patency in group I was 97.8%, 81.2%, and 71.3% at one, three, and five years, respectively. Thrombectomy was impossible in 11 graft thromboses (Group II). A new bypass was performed in all 11 cases. Primary patency in Group II was 100%, 75% and 50% at one, three, and five years, respectively. Retrograde thrombectomy combined with treatment of native runoff artery anomalies can restore long-term patency when thrombosis occurs late after aortofemoral bypass and is associated with low mortality and morbidity.

Adult

Intragraft drug infusion as an adjunct to balloon catheter thrombectomy for salvage of thrombosed infragenicular vein grafts: a preliminary report.

Early infragenicular vein graft thrombosis is associated with poor secondary patency, particularly when no correctable defect is identified. We have attempted to improve patency of thrombosed vein grafts by direct infusion of vasodilator and anticoagulant drugs after surgical thrombectomy. Among 212 infragenicular vein grafts, 16 (7.5%) required thrombectomy within 30 days of surgery (14 in situ saphenous vein, 1 composite vein, and 1 cephalic vein graft). Causes for failure were corrected in four (graft twist, intimal tear, suture failure, and external compression), resulting in prolonged patency. No cause for failure was apparent in the 12 remaining grafts after balloon catheter thrombectomy and arteriography. Two of these grafts occluded within 10 days despite multiple attempts at vein patch angioplasty, distal graft extension, and repeat thrombectomy with systemic anticoagulation. In the remaining 10 grafts, a small polyethylene catheter was placed in a proximal vein branch for direct intragraft drug infusion. Heparin (10 units/min) and nitroglycerin (50 micrograms/min) were the agents infused most frequently, for a mean duration of 52 hours after thrombectomy. Of these 10 infused grafts, 8 remained patent during a mean 17-month follow-up (range, 6 to 38 months). This was accomplished despite previous and repeated failures of thrombectomy and systemic anticoagulation in seven of these eight grafts. Two infused grafts rethrombosed within 30 days of infusion, resulting in amputation. No catheter-related complications occurred. Increased thrombogenicity, intimal injury, and spasm after balloon catheter thrombectomy may contribute to vein graft rethrombosis in the absence of technical defects. Direct intragraft infusion of nitroglycerin and heparin contributed to prolonged salvage of 80% of thrombosed vein grafts in this preliminary experience.

Aged

Heparin, heparin plus ASA and dipyridamole, and arteriovenous fistula as adjuvant methods to prevent rethrombosis after venous thrombectomy. Experimental study in rabbits.

Venous rethrombosis following thrombectomy is a common event. The aim of the present study was to verify the action of heparin, heparin plus acetyl salicylic acid (ASA) and dipyridamole, and of an arteriovenous fistula (AVF) in the prevention of this complication. Thrombosis was induced in 48 male rabbits by the injection of thrombin in a segment of the left jugular vein, in which the blood flow was arrested for 10 minutes. After 48 hours, the animals were randomly allocated into one of 4 groups of treatment: (1) control, (2) subcutaneous heparin (600 S.I. Units/kg--8/8 hours), (3) heparin, in the same dose, plus ASA (10 mg/kg/once a day), and dipyridamole (0.5 mg/kg thrice a day), (4) an AVF was surgically constructed between the left carotid artery and the left maxillar vein. After 30 minutes, thrombectomy was performed. The venous blood flow, the hematocrit, activated partial thromboplastin time and thrombin time tests were performed before, right after the thrombectomy and 48 hours after thrombectomy. Venography was performed after thrombectomy and at the end of the experiment. The animals were killed 48 hours after thrombectomy and the veins were examined macroscopically. Venous rethrombosis was significantly prevented only in the AVF group (9/12), when compared to control group (0/12), heparin group (1/12) and heparin plus antiaggregating agents group (2/12). These results validate further clinical and experimental investigations with the use of AVF to prevent rethrombosis after venous thrombectomy, when a reduction of venous flow is present.

Animals

[Treatment of ilio-femoral venous thromboses with surgical thrombectomy].

Surgical thrombectomy which has been commonly performed in the past is now abandoned by most teams. Nevertheless some surgeons have gone on performing venous thrombectomies with good results. We have performed venous thrombectomy in 91 acute ilio-femoral vein thrombosis associated with inferior vena cava or superficial vein involvement in respectively 35% and 86% of the cases. The mean estimated age of the clot was 5 days. Ilio-femoral thrombectomy was carried out under general anesthesia using a Fogarty catheter introduced through a common femoral venotomy and the removal of the distal clots by mean of massages maneuver. In case of vena cava involvement, direct caval venotomy was carried out by a right sub-costal approach. A temporary arterio-venous fistula in the groin was associated in 89% and a partial interruption of the vena cava in 55% of the cases. No operative death and no peri-operative pulmonary embolism were observed. Post-operative ilio-femoral vein patency rate was 85% without recurrence after closure of the arterio-venous fistula. A venous thrombectomy in selected cases appears to be more efficient than intra-venous heparin or thrombolytic therapy. Indications of venous thrombectomy are ilio-femoral or ilio-caval vein thrombosis of less than 7 days duration. Patients who are non ambulatory or with limited life expectancy are not likely to benefit from surgery. Venous thrombectomy is not recommended in patients with inflammatory or tumoral pelvic or retroperitoneal lesions, coagulopathies, peripheral arterial or significant heart diseases.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent

[Acute hepatic artery thrombosis in pediatric liver transplantation: surgical thrombectomy and in situ fibrinolysis].

In pediatric liver transplantation, hepatic artery thrombosis usually leads to graft loss, early due to hepatic necrosis when it occurs during the first week following the transplant procedure, or later due to biliary complications. Liver retransplantation is the usual attitude. However, urgent surgical hepatic arterial thrombectomy to restore the blood flow can be successful when early diagnosis is made with Doppler ultrasound examination and angiography. Four hepatic arterial thrombectomies were performed as an emergency with additional intra-hepatic arterial fibrinolytic treatment, in three children, 1.5, 3 and 5.5 years of age. Mean duration between the first signs of hepatic artery thrombosis and thrombectomy was 16 hours. None of the children had an urgent liver retransplantation. A complete success was obtained in one case, with normal liver function tests and patent hepatic artery on the Doppler ultrasound examination at the present time. In the two other cases, hepatic artery thrombosis recurred, in spite of repeated thrombectomy in one case; following this attempt complications of hepatic artery thrombosis occurred in the two patients: ischemic necrosis of the left lobe (1 case), biliary leak (1 case) and stenosis of the common bile duct (2 cases). A complete success in one case and a partial success in the two others lead us to advocate urgent thrombectomy and in situ fibrinolytic treatment when early diagnosis of hepatic artery thrombosis is made.

Acute Disease

[Deep venous thrombosis of the lower limb: experiences of thrombectomy within and outside the iliacofemoral segment].

A series of 23 venous thrombectomies of the lower limb is presented. In 19 instances indirect thrombectomy of the iliacofemoral segment was performed. 1 direct thrombectomy of the v. cava inferior led to full lumen restoration. Direct thrombectomy of the popliteal vein was attempted in 3 cases, resulting in phlebographic and clinical normalization in 2 instances. In no instance did pulmonary embolism occur during or after venous thrombectomy.

Adult

Long-term results of brachial thrombectomy following cardiac catheterization.

The late results of brachial thrombectomy following cardiac catheterization were evaluated in 20 patients. All patients had a radial pulse present and no symptoms or signs of ischemia of the hand at the time of discharge from the hospital. Late evaluation of these 20 patients revealed 8 in whom the long-term results were classified as failure of the thrombectomy. Four of these had intermittent claudication of the involved arm and hand. None had any tissue loss and four had no symptoms referable to the failed thrombectomy. The one patient who refused surgery had claudication of the affected arm. The mean period of followup was 20.8 months. The rate of failed thrombectomies was twice as high in females than in males. Prolonged time of cardiac catheterization (over 4 hours), delay in diagnosis of more than 24 hours, and omitting the use of systemic heparinization at the time of diagnosis are three factors that appear to increase the likelihood of late failures.

Arm

Re-evaluation of thrombectomy in the management of iliofemoral venous thrombosis.

The authors studied 15 patients with iliofemoral venous thrombosis up to 8 years after the diagnosis was made, to determine whether there was late deterioration in venous function following thrombectomy. Twelve patients were treated by venous thrombectomy and anticoagulants and 3 by anticoagulants alone. Eight of the 12 patients subjected to thrombectomy had an excellent result with limbs that were considered normal. This did not confirm earlier reports which indicated that good early results were not maintained. In 4 of the 12 surgically treated patients minor symptoms of leg pain and swelling were present which also did not progress with time. In all patients treated by anticoagulants alone major symptoms of leg pain and severe swelling persisted. Three of the four patients with persistent minor symptoms after venous thrombectomy were found at operation to have left iliac vein compression syndrome. Only one of eight patients having an excellent clinical result had this syndrome.

Anticoagulants

Ileofemoral venous thrombectomy.

Twentyeight patients with ileofemoral venous thrombosis were treated surgically. Five of the patients had moderate degree of venous congestion, 18 patients had phlegmasia alba dolens and five patients had phlegmasia coerulea dolens. The mean age was 54 years, range 15-80 years, and 15 were men and 13 were women. In all cases the thrombosis was verified by phlebography. Thrombectomy was performed with a Fogarty venous thrombectomy catheter. Peroperative phlebography was used in most cases to guarantee complete extraction of thrombotic material. No operative pulmonary embolism or mortality was encountered. Postoperative continuous heparin infusion in the thrombectomized segment was used for the first week followed by dicumarol treatment. The patients were followed from 6 months to 4 years postoperatively. In two patients thrombectomy was not possible to perform. One of these patients developed a pronounced postthrombotic syndrome, the other developed venous congestion of more moderate degree. Excellent long-term time results were obtained in 82% of the patients and satisfactory in 14%. Thrombectomy is an efficient treatment of ileofemoral venous thrombosis.

Adolescent

[Phlebography for pre- and posttherapeutic control of fibrinolysis and thrombectomy (author's transl)].

The indications for fibrinolysis or thrombectomy when there is suspected fresh ilio-femoral venous thrombosis should be based on accurate phlebography at the earliest possible moment. Early posttherapeutic phlebography under standardised conditions should be used to control further treatment. Later examinations document the final outcome. Early phlebography, when treatment has been discontinued and has been unsuccessful, shows the so-called "Rischhalte phenomenon", which may be an indication for further thrombectomy. Seven cases are reported in which primary fibrinolysis with streptokinase was followed by thrombectomy with a Fogarty catheter. 3-Step-phlebography provides the essential information which governs treatment and demonstrates its results.

Femoral Vein

Clot-trapper device for transjugular thrombectomy from the inferior vena cava.

The clot-trapper device for transjugular thrombectomy was used in 10 dogs with acute thrombosis and two dogs with chronic thrombosis. In eight of these animals, the clots were trapped with the clot-trapper device, then a mechanical thrombectomy device was used to destroy the clots. In 10 animals, including eight with in vitro thrombi and two with in situ thrombi, thrombi were efficiently trapped with the clot-trapper device. In two animals, pulmonary embolism occurred because of a discrepancy between the diameter of the inferior vena cava and the diameter of the bag opening. After increasing the size of the loop to match the diameter of the inferior vena cava, trapping of all thrombi was possible in both experiments (acute and chronic thrombosis). The clot-trapper device, in conjunction with an embolectomy balloon catheter and/or a mechanical thrombectomy device, facilitates the removal of thrombi from the inferior vena cava and iliac veins.

Animals

[Indication and technic of thrombectomy in the therapy of thrombosis].

The problems of appropriate treatment of thrombosis are as follow: 1. the prevention of a lung-embolus, 2. the rapid rehabilitation of the venous circulation, 3. the avoidance of a post-thrombotic syndrom. The best ways of meeting these demands are through fibrinolysis as well as by operative treatment (thrombectomy). According to the author's findings, 58 cases of thrombectomy of acute, deep thrombosis of the veins have been reported with regards to the indication and technic of this method of treatment of thrombosis. Indications for thrombectomy are phlegmasia coerulea dolens and the occurrence of a mobile thrombosis as well as an unsuccessful treatment with fibrinolysis.

Anticoagulants

Deep venous thrombosis: results of thrombectomy versus medical therapy. Presented at the 5th European-American Symposium on Venous Diseases, Vienna, Austria, Nov. 7-11, 1990.

Between 1.1.1985 and 1.1.1988, 158 patients were referred because of acute deep venous thrombosis. They were 82 women (median age 48.5) and 76 men (median age 56.5). On admission, 4 patients had already a pulmonary embolism in 3 others embolism occurred during hospitalisation. The segment involved was the isolated iliac in 10, iliofemoral in 53, isolated femoral in 7, femorotibial in 47 and isolated tibial in 41 patients. Anticoagulation and compression therapy was undertaken in 102 and mortality was 21%. At follow-up 63% had at least 1 sign of venous insufficiency, in all 16% had no sequelae and were subjectively symptom-free. Thrombolytic therapy was carried out in 25, mortality was 8%. At follow-up, 72% had at least one sign of venous insufficiency. Venous thrombectomy was performed in 31, combined in 4 with balloon dilatation of an iliac spur. Mortality was low with 3%, 58% had at least one sign of venous insufficiency at follow-up and 39% were subjectively symptom-free. Our results show that an objective assessment is insofar difficult because subjective and clinical results do not correlate; 51% with clinically verified post-therapeutic venous insufficiency had normal venous drainage in strain-gauge plethysmography, whilst 41% without subjective discomforts demonstrated an insufficient drainage. Our results show that a full restitution is seldom achieved, thrombectomy does not prevent chronic venous insufficiency. Best results were observed in isolated iliac thrombosis. We conclude that thrombectomy should be restricted to the phlegmasia caerulea dolens form of DVT, while floating thrombus and ascending thrombus extending into the vena cava should be treated with a cava filter or ligation.

Adult

Iliofemoral venous thrombectomy followed by percutaneous closure of the temporary arteriovenous fistula.

Iliofemoral venous thrombosis treated by anticoagulants alone almost invariably results in postthrombotic sequelae with deep venous reflux alone or combined with an outflow obstruction. This study evaluates the result of iliofemoral venous thrombectomy with temporary proximal arteriovenous fistula (AVF) performed on 48 consecutive patients. In 10 patients the thrombus extended in the inferior vena cava, and the thrombectomy was combined with inferior vena cava interruption. The AVF closed spontaneously in 8 of 48 patients (patency rate, 84%). An attempt to close the AVF by placing a detachable balloon percutaneously under radiographic control was made 6 to 12 weeks later (success rate, 87%; complications, rare). A preclosure arteriovenography of the femoro-iliaco-caval segment revealed 34 of 38 segments open (patency rate, 89%). Four patients had severe stenosis of the iliac segment, and a transvenous percutaneous dilatation was successfully performed in three of the four patients, keeping the fistula. At AVF closure 4 weeks later the arteriovenography showed sustained dilatation in only two patients. Thirty-seven patients were followed for 3 to 48 months (median, 24 months) and 30 of 37 patients (81%) who had no symptoms were not using compression stockings. Doppler investigation revealed patent and competent femoral and popliteal veins and normal photoplethysmography in 56% of the patients. Four iliac veins were occluded (patency rate, 88%). No recurrence of fistula had occurred. Venous iliofemoral thrombectomy seems to better preserve valve function. The percutaneous balloon closure of the AVF has decreased the complication rate, facilitated venographic evaluation of the result, and made possible the performance of percutaneous interventions under the protection of the AVF.

Adolescent

Acute ischemia of the limb in a newborn treated successfully by thrombectomy.

A seven day old dehydrated male infant was found to have acute ischemia of the leg due to acute thrombotic occlusion of an external iliac, common and superficial femoral, and popliteal arteries. Early thrombectomy and arterioplasty resulted in complete remission of ischemia. Our success with direct vascular surgery prompts us to recommend this form of treatment in preventing neonatal gangrene. To our knowledge, this is the first report of successful thrombectomy in a newborn infant.

Acute Disease

Resection of the inferior vena cava or intraluminal vena caval tumor thrombectomy during retroperitoneal lymph node dissection for metastatic germ cell cancer: indications and results.

A total of 42 patients underwent inferior vena caval resection (40) or intraluminal tumor thrombectomy (2) during retroperitoneal lymph node dissection for bulky abdominal metastatic nonseminomatous germ cell cancer (7% of all post-chemotherapy retroperitoneal lymph node dissection cases). The 3 indications for vena caval resection included tumor clearance (38%), vena caval scar occlusion (14%) and vena caval tumor thrombus (48%). En bloc vena caval resection to achieve tumor clearance was justified by subsequent nodal pathology (cancer in 63% of the specimens and teratoma in 31%). Vena caval resection in the presence of scar occlusion was de facto required by virtue of its incorporation in the specimen. Vena caval resection or thrombectomy is indicated for intraluminal tumor thrombus because thrombus pathology (cancer 35%, teratoma 45% and fibrosis 20%) reflected nodal pathology in 71% of the patients with cancer, 78% with teratoma and 100% with fibrosis. The complications of vena caval resection were generally transitory. The 71% survival rate justifies this intensive surgical approach because these patients had exhausted all chemotherapy options.

Adolescent