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Rheolytic thrombectomy is as safe and effective as intracoronary urokinase for people with thrombus-containing lesions
TREATMENT
Rheolytic thrombectomy is as safe and effective as intracoronary urokinase for people with thrombus-containing lesions Abstracted from: Kuntz R, Baim D, Cohen D, Popma J, Carrozza J, Sharma S, McCormick D, Schmidt D, Lansky A, Ho K, Dandreo K, Setum C, Ramee S. A trial comparing rheolytic thrombectomy with intracoronary urokinase for coronary and vein graft thrombus (The Vein Graft AngioJet Study [VeGAS 2]). Am J Cardiol 2002; 89: 326 ^330.
BACKGROUND Percutaneous coronary interventions for thrombus-containing lesions carry a high risk of complications. Rheolytic thrombectomy is a catheterbased procedure, which uses high-velocity water jets to produce a vacuum to extract thrombi before treatment of the underlying lesion. OBJECTIVE To evaluate the e⁄cacy of rheolytic thrombectomy compared with intracoronary urokinase for thrombus-containing lesions in saphenous vein grafts or native coronary arteries. SETTING
United States; timeframe not speci¢ed.
METHOD Randomized trial. PARTICIPANTS Three hundred and forty-nine adults with angiographically evident thrombus undergoing percutaneous revascularization of a native coronary artery or saphenous vein graft lesion. Exclusion criteria were myocardial infarction within past 24 hours; thrombolytic therapy within past 24 hours; contraindications to aspirin or thrombolysis; treatment required in more than one vessel, or target lesion in vessel under 2 mm long. INTERVENTION All participants received aspirin, oral calcium channel blockers and intravenous nitroglycerine before angiography plus intravenous heparin and oral aspirin after the procedure. Glycoprotein IIb/ IIIa inhibitors were allowed. In the rheolytic thrombectomy group, a guiding catheter was placed in the target vessel followed by an AngioJet catheter. Multiple slow passes were used until all ¢lling defects were removed. De¢nitive treatment of the underlying lesion was then undertaken. The urokinase group received up to 250,000 IU bolus delivered into the target vessel over 15 to 30 minutes followed by continuous infusion of at 1361-2611/02/$ - see front matter & 2002 Elsevier Science Ltd. All rights reserved doi:10.1054/ebcm.2002.0494, available online at http://www.idealibrary.com.on
least 20,000 U/hour for 6 to 30 hours. Repeat angiography was performed followed by de¢nitive treatment of the lesion in another session. OUTCOMES Composite of major adverse cardiac events at 30 days (death; Q-wave myocardial infarction; coronary bypass surgery; target lesion revascularization; stent thrombosis; stroke); failure to achieve postprocedure diameter stenosis under 50%; failure to achieve postprocedure TIMI grade 3 £ow; or failure to achieve 20% or greater change in diameter stenosis. MAIN RESULTS AngioJet treatment had higher device success (87% vs 75%, p = 0.005) and procedural success than urokinase therapy (86% vs 72%, p = 0.002). Bradycardia was more common in the AngioJet group (24% vs 2%), as was hemolysis (73% vs 38% urokinase). There was no signi¢cant di¡erence in the primary composite end-point (29% AngioJet vs 30% urokinase). Major adverse events, bleeding and vascular complications were less common in the AngioJet group (Table 1). AUTHORS’ CONCLUSIONS Rheolytic thrombectomy using the AngioJet device is safe and e¡ective for people with thombosis in saphenous vein grafts or native coronary arteries. NOTES No power calculation is provided.The study may lack power to detect clinically important di¡erences in the primary end-point.
Sources offunding: Possis Medical Inc, Minnesota. Correspondence to: Dr Kuntz, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02215, USA (E-mail: [email protected]). Evidence-based Cardiovascular Medicine (2002) 6,135^136
135
Table 1 Outcomes for people with thrombus-containing lesions treated with AngioJet or urokinase % AngioJet (n = 180)
% Urokinase (n = 169)
p-value
86 87 16 2 14 3 3 3 5 4 2 6 17 89
72 75 33 3 31 4 5 4 12 18 0 15 19 83
0.002 0.005 o0.001 0.5 o0.001 1.0 0.6 0.6 0.03 o0.001 0.2 0.004 0.6 0.2
Procedure success Device success Any major adverse cardiac event Death Myocardial infarction Revascularization Abrupt closure Subabrupt closure Bleeding complications Vascular complications Stent thrombosis % Diameter stenosis 450% o20% change in diameter stenosis Final TIMI 3 £ow
Commentary
Literature cited
Percutaneous coronary intervention of thrombotic lesions in native and coronary vein grafts carries a high risk of interventional complications (such as abrupt occlusion, myocardial infarction, need for emergency bypass surgery, death and high late restenosis rates).1^3 There is a need for strategies to overcome these hazards.4 ^7 Findings about the efficacy and safety of pharmacological therapies such as thrombolysis or platelet IIb/IIIa receptor antagonists are inconsistent.The role of platelet inhibitors in people with evidence of occlusive thrombotic lesions remains unclear. Catheter removal strategies aim to extract the thrombus and improve blood £ow without distal embolization. Available mechanical devices do not appear to meet these goals.4 ^7 Kuntz and colleagues evaluated the efficacy of a new mechanical thrombectomy technique. Mechanical thrombectomy was more successful than conventional treatment with urokinase, although there was no difference in restoring final TIMI 3 flow. Sixteen per cent of the intervention group suffered myocardial infarction, which compares favourably to the ROBUST trial.8 The study suggests that the AngioJet system might be an effective strategy in high-risk patients.9,10 The value of the AngioJet device compared with other debulking systems such as X-SIZER Thrombectomy (EndiCor Medical, San Clemente, California, USA) or the RescueTM Thrombus Management System (Boston Scientific Scimed, Minnesota, USA) remains unclear. The major limitation of all mechanical thrombectomy devices is vessel perforation and distal embolization. These complications occur in 2% to 7% of people and have severe consequences (such as pericardial effusion and microvessel occlusion). Procedural complications may be reduced with distal embolization protection systems and adjunctive pharmacological therapy. Removing thrombotic lesions prior to percutaneous intervention might be an even better way to treat high-risk groups.
1. White CJ, Ramee RS, Collins TJ, et al. Coronary thrombi increase PTCA risk: angioscopy as a clinical toll. Circulation 1996; 93: 253^258. 2. Singh M, Berger PB, Ting HH, et al. Influence of coronary thrombus and outcome of percutaneous coronary angioplasty in the current era (the Mayo Clinic Experience). Am J Cardiol 2001; 88: 1091^1096. 3. Violaris AG, Melkert R, Herman JP, Serruys PW. Role of angiographically identifiable thrombus on long-term luminal renarrowing after coronary angioplasty: a quantitative angiographic analysis.Circulation 1996; 93: 889^ 897. 4. Ramee Sr, Schatz RA,Carozza P, et al.Results of theVEGAS I pilot study of the Possis coronary AngioJet thrombectomy catheter. Circulation 1996; 94: 3622. 5. Van den Boss AA, van OmmenVG, Corbeij HM, et al. A new thrombusuction catheter for coronary use: initial results with clinical and angiographic follow-up in seven patients. Cath Cardiovasc Diagn 1997; 40: 192^197. 6. Van Ommen VG, van den Boss AA, Piepre M, et al. Removal of thrombus from aortocoronary bypass grafts and coronary arteries using the 6 Fr hydrolyser. Am J Cardiol 1997; 79: 1012^1016. 7. Ischinger T, for the X-Sizer Study Group. Thrombectomy with the X-SIZERTM catheter system in the coronary circulation: initial results from a multi-center study. J Invas Cardiol 2001; 13: 81^ 88. 8. Hartmann JR, McKeever LS, O‘Neill W W, et al. Recanalization of chronically occluded aortocoronar saphenous vein grafts with long-term, low dose direct infusion of urokinase (ROBUST): a serial trial. J Am Coll Cardiol 1996; 27: 60 ^ 66. 9. Silva JA, Ramee SR,Cohen DJ, et al.Rheolytic thrombectomy during percutaneous revascularization for acute myocardial infarction: experience with the AngioJet catheter. Am Heart J 2001; 141: 353^359. 10. Singh M,Tiede DJ, Mathew V, et al. Rheolytic thrombectomy with AngioJet in thrombus-containing lesions. Cath Cardiovasc Intervent 2002; 56: 1^7.
Christian-Michael Gross MD Head of Invasive Cardiology Charite¤, Humboldt University of Berlin Franz Volhard Clinic Germany
136
Evidence-based Cardiovascular Medicine (2002) 6,135^136
Rheolytic thrombectomy is as safe and effective as intracoronary urokinase for people with thrombus-containing lesions Abstracted from: Kuntz R, Baim D, Cohen D, Popma J, Carrozza J, Sharma S, McCormick D, Schmidt D, Lansky A, Ho K, Dandreo K, Setum C, Ramee S. A trial comparing rheolytic thrombectomy with intracoronary urokinase for coronary and vein graft thrombus (The Vein Graft AngioJet Study [VeGAS 2]). Am J Cardiol 2002; 89: 326 ^330.
BACKGROUND Percutaneous coronary interventions for thrombus-containing lesions carry a high risk of complications. Rheolytic thrombectomy is a catheterbased procedure, which uses high-velocity water jets to produce a vacuum to extract thrombi before treatment of the underlying lesion. OBJECTIVE To evaluate the e⁄cacy of rheolytic thrombectomy compared with intracoronary urokinase for thrombus-containing lesions in saphenous vein grafts or native coronary arteries. SETTING
United States; timeframe not speci¢ed.
METHOD Randomized trial. PARTICIPANTS Three hundred and forty-nine adults with angiographically evident thrombus undergoing percutaneous revascularization of a native coronary artery or saphenous vein graft lesion. Exclusion criteria were myocardial infarction within past 24 hours; thrombolytic therapy within past 24 hours; contraindications to aspirin or thrombolysis; treatment required in more than one vessel, or target lesion in vessel under 2 mm long. INTERVENTION All participants received aspirin, oral calcium channel blockers and intravenous nitroglycerine before angiography plus intravenous heparin and oral aspirin after the procedure. Glycoprotein IIb/ IIIa inhibitors were allowed. In the rheolytic thrombectomy group, a guiding catheter was placed in the target vessel followed by an AngioJet catheter. Multiple slow passes were used until all ¢lling defects were removed. De¢nitive treatment of the underlying lesion was then undertaken. The urokinase group received up to 250,000 IU bolus delivered into the target vessel over 15 to 30 minutes followed by continuous infusion of at 1361-2611/02/$ - see front matter & 2002 Elsevier Science Ltd. All rights reserved doi:10.1054/ebcm.2002.0494, available online at http://www.idealibrary.com.on
least 20,000 U/hour for 6 to 30 hours. Repeat angiography was performed followed by de¢nitive treatment of the lesion in another session. OUTCOMES Composite of major adverse cardiac events at 30 days (death; Q-wave myocardial infarction; coronary bypass surgery; target lesion revascularization; stent thrombosis; stroke); failure to achieve postprocedure diameter stenosis under 50%; failure to achieve postprocedure TIMI grade 3 £ow; or failure to achieve 20% or greater change in diameter stenosis. MAIN RESULTS AngioJet treatment had higher device success (87% vs 75%, p = 0.005) and procedural success than urokinase therapy (86% vs 72%, p = 0.002). Bradycardia was more common in the AngioJet group (24% vs 2%), as was hemolysis (73% vs 38% urokinase). There was no signi¢cant di¡erence in the primary composite end-point (29% AngioJet vs 30% urokinase). Major adverse events, bleeding and vascular complications were less common in the AngioJet group (Table 1). AUTHORS’ CONCLUSIONS Rheolytic thrombectomy using the AngioJet device is safe and e¡ective for people with thombosis in saphenous vein grafts or native coronary arteries. NOTES No power calculation is provided.The study may lack power to detect clinically important di¡erences in the primary end-point.
Sources offunding: Possis Medical Inc, Minnesota. Correspondence to: Dr Kuntz, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA, 02215, USA (E-mail: [email protected]). Evidence-based Cardiovascular Medicine (2002) 6,135^136
135
Table 1 Outcomes for people with thrombus-containing lesions treated with AngioJet or urokinase % AngioJet (n = 180)
% Urokinase (n = 169)
p-value
86 87 16 2 14 3 3 3 5 4 2 6 17 89
72 75 33 3 31 4 5 4 12 18 0 15 19 83
0.002 0.005 o0.001 0.5 o0.001 1.0 0.6 0.6 0.03 o0.001 0.2 0.004 0.6 0.2
Procedure success Device success Any major adverse cardiac event Death Myocardial infarction Revascularization Abrupt closure Subabrupt closure Bleeding complications Vascular complications Stent thrombosis % Diameter stenosis 450% o20% change in diameter stenosis Final TIMI 3 £ow
Commentary
Literature cited
Percutaneous coronary intervention of thrombotic lesions in native and coronary vein grafts carries a high risk of interventional complications (such as abrupt occlusion, myocardial infarction, need for emergency bypass surgery, death and high late restenosis rates).1^3 There is a need for strategies to overcome these hazards.4 ^7 Findings about the efficacy and safety of pharmacological therapies such as thrombolysis or platelet IIb/IIIa receptor antagonists are inconsistent.The role of platelet inhibitors in people with evidence of occlusive thrombotic lesions remains unclear. Catheter removal strategies aim to extract the thrombus and improve blood £ow without distal embolization. Available mechanical devices do not appear to meet these goals.4 ^7 Kuntz and colleagues evaluated the efficacy of a new mechanical thrombectomy technique. Mechanical thrombectomy was more successful than conventional treatment with urokinase, although there was no difference in restoring final TIMI 3 flow. Sixteen per cent of the intervention group suffered myocardial infarction, which compares favourably to the ROBUST trial.8 The study suggests that the AngioJet system might be an effective strategy in high-risk patients.9,10 The value of the AngioJet device compared with other debulking systems such as X-SIZER Thrombectomy (EndiCor Medical, San Clemente, California, USA) or the RescueTM Thrombus Management System (Boston Scientific Scimed, Minnesota, USA) remains unclear. The major limitation of all mechanical thrombectomy devices is vessel perforation and distal embolization. These complications occur in 2% to 7% of people and have severe consequences (such as pericardial effusion and microvessel occlusion). Procedural complications may be reduced with distal embolization protection systems and adjunctive pharmacological therapy. Removing thrombotic lesions prior to percutaneous intervention might be an even better way to treat high-risk groups.
1. White CJ, Ramee RS, Collins TJ, et al. Coronary thrombi increase PTCA risk: angioscopy as a clinical toll. Circulation 1996; 93: 253^258. 2. Singh M, Berger PB, Ting HH, et al. Influence of coronary thrombus and outcome of percutaneous coronary angioplasty in the current era (the Mayo Clinic Experience). Am J Cardiol 2001; 88: 1091^1096. 3. Violaris AG, Melkert R, Herman JP, Serruys PW. Role of angiographically identifiable thrombus on long-term luminal renarrowing after coronary angioplasty: a quantitative angiographic analysis.Circulation 1996; 93: 889^ 897. 4. Ramee Sr, Schatz RA,Carozza P, et al.Results of theVEGAS I pilot study of the Possis coronary AngioJet thrombectomy catheter. Circulation 1996; 94: 3622. 5. Van den Boss AA, van OmmenVG, Corbeij HM, et al. A new thrombusuction catheter for coronary use: initial results with clinical and angiographic follow-up in seven patients. Cath Cardiovasc Diagn 1997; 40: 192^197. 6. Van Ommen VG, van den Boss AA, Piepre M, et al. Removal of thrombus from aortocoronary bypass grafts and coronary arteries using the 6 Fr hydrolyser. Am J Cardiol 1997; 79: 1012^1016. 7. Ischinger T, for the X-Sizer Study Group. Thrombectomy with the X-SIZERTM catheter system in the coronary circulation: initial results from a multi-center study. J Invas Cardiol 2001; 13: 81^ 88. 8. Hartmann JR, McKeever LS, O‘Neill W W, et al. Recanalization of chronically occluded aortocoronar saphenous vein grafts with long-term, low dose direct infusion of urokinase (ROBUST): a serial trial. J Am Coll Cardiol 1996; 27: 60 ^ 66. 9. Silva JA, Ramee SR,Cohen DJ, et al.Rheolytic thrombectomy during percutaneous revascularization for acute myocardial infarction: experience with the AngioJet catheter. Am Heart J 2001; 141: 353^359. 10. Singh M,Tiede DJ, Mathew V, et al. Rheolytic thrombectomy with AngioJet in thrombus-containing lesions. Cath Cardiovasc Intervent 2002; 56: 1^7.
Christian-Michael Gross MD Head of Invasive Cardiology Charite¤, Humboldt University of Berlin Franz Volhard Clinic Germany
136
Evidence-based Cardiovascular Medicine (2002) 6,135^136