Clinical Trials of Direct Thrombin Inhibitors During Invasive Procedures

• References

• 1 TIMI study group. The thrombolysis in myocardial infarction (TIMI) trial; Phase I findings. N Engl J Med 1985; 312: 932-936
• 2 The GUSTO angiographic investigators. The comparative effects of tissue plasminogen activator, streptokinase, or both on coronary artery patency, ventricular function and survival after acute myocardial infarction. N Engl J Med 1993; 329: 1615-1622
• 3 Cannon CP, McCabe CH, Diver DJ. et al. Comparison of frontloaded recombinant tissue-type plasminogen activator, anistreplase and combination thrombolytic therapy for acute MI: results of the TIMI 4 trial. J Am Coll Cardiol 24 1994; 1602-1610
• 4 Ohman EM, Califf RM, Topol EJ. et al. Consequences of reocclusion after successful reperfusion therapy in acute myocardial infarction. Circ 1990; 82: 781-791
• 5 Meijer A, Verheugt FWA, Werter CJPJ, Lie KI, van der Pol JMJ, van Eenige MJ. Aspirin versus coumadin in the prevention of reocclusion and recurrent ischemia after successful thrombolysis: a prospective placebo-controlled angiographic study. Results of the APRICOT study. Circ 1993; 87: 1524-1530
• 6 Braunwald E, Mark DB, Jones RH. et al. Unstable angina: Diagnosis and management, clinical practice guideline no. 10. Agency for Health Care Policy and Research and the National Heart, Lung and Blood Institute, Public Health Service, US Department of Health and Human Services. 1995: 154
• 7 The TIMI IIIB investigators. Effects of tissue plasminogen activator and a comparison of early invasive and conservative strategies in unstable angina pectoris and non-Q wave myocardial infarction: results of the TIMI IIIB trial. Circulation 1994; 89: 1545-1556
• 8 Landau C, Lange RA, Hillis LD. Percutaneous transluminal coronary angioplasty. N Engl J Med 330 1994; 981-993
• 9 Detre K, Holubkov R, Kelsey S. et al. One year follow-up reults of the 1985-1986 National Heart, Lung, and Blood Institute’s percutaneous transluminal coronary angioplasty registry. Circ 1989; 80: 421-428
• 10 Wolfe MW, Leya F, Bonan R. et al. Predictors of outcome after balloon angioplasty: a prospective multicenter study. Circ 1993; 88 (Suppl. 01) I000-I300
• 11 Myler R, Shaw R, Sterzer SH. Unstable angina and coronary angioplasty. Circulation 1990; 82 (Suppl. 02) 1188-1195
• 12 The EPIC investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 330 1994; 956-961
• 13 Herrman J-PR, Hermans WRM, Vos J, Serruys PW. Pharmacological approaches to the prevention of restenosis following angioplasty. The search for the holy grail. Drugs 1993; 46 (01) 18-52
• 14 Herrman J-PR, Hermans WRM, Vos J, Serruys PW. Pharmacological approaches to the prevention of restenosis following angioplasty. The search for the holy grail? Drugs 1993; 46 (02) 249-262
• 15 Violaris AG, Melkert R, Herrman J-PR, Serruys PW. Role of angiographically identifiable thrombus on long term luminal renarrowing after coronary angioplasty: A quantitative angiographic analysis. Circulation 93 1993; 889-897
• 16 Abel JJ, Rowntree LG, Turner BB. On the removal of diffusible substances from the circulating blood of living animals by dialysis. J Pharmacol Exp Ther 5 1913; 275-316
• 17 Haas G. Versuche der blutauswaschung am lebenden mit hilfe der dialyse. Klin Wochenschr 04 1924; 13-14
• 18 Grütter MG, Priestle JP, Rahuel J, Grossenbacher H, Bode W, Hofsteenge J, Stone SR. Ciystal structure of the thrombin-hirudin complex: a novel mode of serine protease inhibition. The EMBO J 1990; 8 (09) 2361-235
• 19 Weitz JI, Hudoba M, Massel D, Maraganore J, Hirsh J. Clot bound thrombin is protected from inhibition by heparin-anti-hrombin III but is susceptible to inactivation by antithrombin III- independent inhibitors. J Clin Invest 86 1990; 385-391
• 20 Stringer KA, Lindenfeld JA. Hirudins: Anticoagulants. Ann Pharmacother 26 1990; 1535-1540
• 21 Bichler J, Fichtl B, Siebeck M, Fritz H. Pharmacokinetics and pharmacodynamics of hirudin in man after single subcutaneous and intravenous bolus administration. Drug Res 1988; 38: 704-710
• 22 Talbot MD, Ambler J, Butler KD. et al. Recombinant desulphatohirudin (CGP 39 393) anticoagulant and antithrombotic properties in vivo. Thromb Haemost 61 1991; 77-80
• 23 Marbet GA, Verstraete M, Kienast J. et al. Clinical pharmacology of intravenously administered recombinant desulphatohirudin (CGP 39 393) in healthy volunteers. J Cardiovasc Pharmacol 22 1993; 364-372
• 24 Heras M, Chesebro JH, Webster MWI, Mrul JS, Grill DE, Penny WJ, Bowie EJW, Badimon L, Fuster V. Hirudin, heparin and placebo during deep arterial injury in the pig. The in vivo role of thrombosis in platelet-mediated thrombosis. Circ 1990; 82: 1476-1484
• 25 Sarembock IJ, Gertz SD, Gimple LW, Owen RM, Powers ER, Roberts WC. Effectiveness of recombinant desulphato hirudin in reducing restenosis after balloon angioplasty of atherosclerotic femoral arteries in rabbits. Circ 84 1991; 232-243
• 26 Buchwald AB, Sandrock D, Unterberg C, Ebbecke M, Nebendahl K, Luders S, Munz L, Wiegand V. Platelet and fibrin deposition on coronary stents in minipigs: effect of hirudin versus heparin. J Am Coll Cardiol 21 1993; 249-254
• 27 Bos AAvan den, Deckers JW, Heyndrickx GR, Laarman GJ, Suryapranata H, Zijlstra F, Close P, Rijnierse JJMM, Buller HR, Serruys PW. Safety and efficacy of recombinant hirudin (CGP 39393) versus heparin in patients with stable angina undergoing coronary angioplasty. Circulation 88 1993; 2058-2066
• 28 Close P, Bichler J, Kerry R. et al. Weak allergenicity of recombinant hirudin CGP 39 393 (™REVASC) in immunocompetent volunteers. Coronary Artery Disease 05 1994; 943-949
• 29 Serruys PW, Herrman J-PR, Simon R, Rutsch W, Bode C, Laarman G-J, Dijk Rvan, Bos AAvan den, Umans VAWM, Fox KAA, Close Ph, Deckers JW. for the HELVETICA investigators A comparison of hirudin with heparin in the prevention of restenosis after coronary angioplasty. New Engl J Med 333 1995; 757-763
• 30 Cadroy Y, Maraganore JM, Hanson SR, Harker LA. Selective inhibition by a synthetic hirudin peptide of fibrin-dependent thrombosis in baboons. Proc Natl Acad Sci USA 1991; 88: 1177-1181
• 31 Bourdon P, Fenton JW, Maraganore JM. Affinity labeling of lysine-149 in the anion-binding exosite of human alpha-thrombin with an N alpha-(dinitrofluorobenzyl)hirudin C-terminal peptide. Biochem 29 1990; 6379-6384
• 32 Dawson A, Loynds P, Findlen K, Levi E, Mant T, Maraganore J, Hanson D, Wagner J, Fox I. Hirulog-1: a bivalent thrombin inhibitor with potent anticoagulant properties in humans [abstract]. Thromb Haemost 1991; 65: 830
• 33 Fox I, Dawson A, Loynds P. et al. Anticoagulant activity of hirulog, a direct thrombin inhibitor in humans. Thromb Haemost 1993; 69: 157-163
• 34 Topol EJ, Bonan R, Jewitt D. et al. Use of a direct antithrombin, hirulog, in place of heparin during coronary angioplasty. Circ 1993; 87 (05) 1622-1629
• 35 Bittl JA, Strony J, Brinker JA, Ahmed WH, Meckel CR, Chaitman BR, Maraganore J, Deutsch E, Adelman B. for the hirulog angioplasty study investigators Treatment with bivalirudin (hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. New Engl J Med 333 1995; 764-769
• 36 Kaplan AV, Leung LLK, Leung WH. et al. Roles of thrombin and platelet membrane glycoprotein IIb/IIIa in platelet subendothelial deposition after angioplasty in an ex vivo whole artery model. Circulation 1991; 84 (03) 1279-1288
• 37 Kikumoto R, Tamao Y, Tezuka T. et al. Selective inhibition of thrombin by (2R,4R)-4-methyl-1-[N²-((3-methyl-1,2,3,4-tetrahydro-8-quinolonyl)sulfonyl)-arginyl]-2-piperidine carboxylic acid. Biochemistry 23 1984; 85-90
• 38 Jang DC, Gold HK, Zisking AA, Leinbach RC, Fallon JT, Collen D. Prevention of platelet-rich arterial thrombosis by selective thrombin inhibition. Circulation 81 1990; 18-27
• 39 Jang IK, Gold HK, Leinbach RC. et al. Persistent inhibition of arterial thrombosis by a 1-hour intravenous infusion of argatroban, a selective thrombin inhibitor. Coronary Artery Disease 1992; 03: 407-414
• 40 Gold HK, Torres FW, Garabedian HD. et al. Evidence for a rebound coagulation phenomenon after cessation of a 4-hour infusion of a specific thrombin inhibitor in patients with unstable angina pectoris. J Am Coll Card 1993; 21 (05) 1039-1047
• 41 Herrman JPR, Suryapranata H, den Heyer P, Gabriël L, Serruys PW. Argatroban during percutaneous transluminal coronary angioplasty; results of a dose verification study. J Thromb Thrombolys 03 1996; 367-375
• 42 Tapparelli C, Mettemich R, Ehrhardt C. et al. Synthetic low molecular weight thrombin inhibitors: molecular design and pharmacologic profile. Trends Pharmacol Sci 14 1993; 366-376
• 43 Bock LC, Griffin LC, Latham JA. et al. Selection of singlestranded DNA molecules that bind and inhibit human thrombin. Nature 355 1992; 564-546
• 44 Schror K. Antiplatelet drugs. A comparative review. Drugs 1995; 50 (01) 07-28
• 45 Zoldhelyi P, Fuster V, Chesebro JH. Antithrombins as conjugative therapy in arterial thrombolysis. Coron Artery Dis 03 1992; 1003-1009
• 46 Verstraete M, Zoldhelyi P. Novel antithrombotic drugs in development. Drugs 1995; 49 (06) 856-884
• 47 Kettner C, Mersinger L, Knabb R. The selective inhibition of thrombin by peptides of boroarginine. J Biol Chem 1990; 265: 18289-1897
• 48 Hung DT, Vu TK, Wheaton VI. et al. ‘Mirror image’ antagonism of thrombin induced platelet activation based on thrombin receptor structure. J Clin Invest 89 1992; 444-450
• 49 Knapp A, Degenhardt T, Dodt J. Hirudisins: hirudin-derived thrombin inhibitors with desintegrin activity. J Biol Chem 267 1997; 24230-24234
• 50 Bode C, Hudelmayer M, Mehwald P. et al. Fibrin targeted recombinant hirudin inhibits fibrin deposition on experimental clots more efficiently than recombinant hirudin. Circ 1994; 90: 1956-1963
• 51 Preisack MB, Karsch KR. The paradigm of restenosis following percutaneous transluminal coronary angioplasty. Eur Heart J 1993; 14 (Suppl. 01) 187-192
• 52 Wolinsky H, Thung SN. Use of a perforated balloon catheter to deliver concentrated heparin into the wall of the normal canine artery. J Am Coll Cardiol 15 1990; 475-481
• 53 Moura A, Lam JYT, Hébert D, Letchacovski G, Robitaille D, Grant G, Kaplan A. Local heparin delivery decreases the thrombogenicity of the balloon injured artery [abstract]. Circulation 1994; 90: I000-I449
• 54 Leung WH, Kaplan AV, Grant GW, Leung LLK, Fischell TA. Local delivery of antithrombin agent by an infusion balloon catheter reduces platelet deposition at the site of balloon angioplasty. Coron Artery Dis 02 1991; 699-706
• 55 Nunes GL, Hanson SR, King SB, Sahatjian RA, Scott NA. Local delivery of a synthetic antithrombin with a hydrogel-coated angioplasty balloon catheter inhibits platelet-dependent thrombosis. J Am Coll Cardiol 23 1994; 1578-1583
• 56 Meyer BJ, Fernández-Oritz A, Mailhac A, Falk E, Badimon L, Michael AD, Chesebro JH, Fuster V, Badimon JJ. Local delivery of r-hirudin by a double-balloon perfusion catheter prevents mural thrombosis and minimizes platelet deposition after angioplasty. Circulation 1994; 90: 2474-2480
• 57 Gimple LW, Gertz SD, Haber HL, Ragosta M, Powers ER, Roberts WC, Sarembock IJ. Effect of chronic subcutaneous or intramural administration of heparin on femoral artery restenosis after balloon angioplasty in hypercholesterolemic rabbits. A quantitative angiographic and histopathological study. Circulation 1992; 86: 1536-1546
• 58 Oberhoff M, Herdeg C, Shamet K, Kranzhöfer A, Baumbach A, Kamenz J, Betz E, Karsch KR. Delivery of low molecular weight heparin via porous balloon catheter for the prevention of smooth muscle cell proliferation [abstract]. Circulation 1993; 88: I000-I661
• 59 Hong MK, Wong C, Haudenschild CC, Bramwell OD, Tjurmin A, Barry JJ, Nam MH, Spiro TE, Leon MB. Efficacy of locally delivered low molecular weight heparin (Enoxaprin) on smooth muscle cell proliferation [abstract]. J Am Coll Cardiol 1995; 25: 376A
• 60 Kaplan AV, Vandormael M, Bartorelli A, Hofmann M, Stoerger H, Simpson JB, Reifart N. Heparin delivery at the site of angioplasty with a novel drug delivery sleeve: initial clinical series [abstract]. J Am Coll Cardiol 1995; 25: 286A
• 61 Camenzind E, Kint PP, DiMario C, Lighthart J, van der Giessen W, Boersma E, Serruys PW. Local intracoronary heparin delivery in man: acute feasibility and longterm result. Circulation. in press
• 62 Camenzind E, Reys A, Ligthart J, Bakker W, van Geijlswijk I, Fioretti P, Krenning E, Serruys PW. Local intracoronary delivery of heparin and of a somatostatin analogue (Octreotide) following angioplasty in man: evaluation of efficacy of delivery by radioisotopic technique [abstract]. J Am Coll Cardiol 1995; 25: 285A
• 63 Camenzind E, van der Giesen W, Ligthart J, Ruygrok P, de Jaegere P, de Feyter P, Serruys PW. Local, low pressure heparin delivery following angioplasty in man: the solution to restenosis [abstract]?. J Am Coll Cardiol 1995; 25: 376A
• 64 Camenzind E, Vrolix M, Hanet C, Legrand V, Bauters C, Aengevaeren W, Wijns W, dan Heijer p, Blanchard D, Montauban van Swijndregt E, van der Meer, Melkert R, Serruys P. Local heparin delivery following balloon angioplasty to prevent restenosis: preliminary results of an open multicenter registry [abstract]. Circulation 1995; 92: I000-I346
• 65 Camenzind E, Legrand V, Vrolix M, Hanet C, Wijns W, Bauters C, Aengevaeren W, Heijer Pden, Gershlick T, Swijndregt EMantouban van, Meer Pvan der, Melkert R, Serruys PW. on behalf of the Dispatch investigators An open multicenter registry to evaluate local heparin delivery following balloon angioplasty for the rpevention of restenosis: preliminary results. J Am Coll Cardiol 1996; 27 (2 Supplement A) 321A
• 66 Oberhoff M, Hermann T, Maier R, Athanasiadis A, Baumbach A, Herdeg C, Bohnet A, Haase KK, Voelker W, Karsch KR. Local drug delivery of low molecular weight heparin after PTCA: first clinical experience using the porous balloon (PILOT-study). J Am Coll Cardiol 1996; (Suppl A) 27 (02) 14A
• 67 Sheth S, Park KD, Dev V, Jacobs H, Kim SW, Lambert T, Forrester JS, Litvack F, Eigler N. Prevention of stent subacute thrombosis by segmented polyurethaneurea-polyethylene oxideheparin coating in the rabbit carotid [abstract]. J Am Coll Cardiol 1994; 23: 187A
• 68 van der Giessen W, Hårdhammer PA, van Beusekom HMM, Emanuelsson HU, Albertsson PA, Verdouw PD, Serruys PW. Reduction of thrombotic events using heparin-coated Palmaz-Schatz stents [abstract]. Circulation 1993; 88: I000-I661
• 69 Serruys PW, Emanuelsson H, Giessen Wvan der, Lunn AC, Kiemeney F, Macaya C, Rutsch W, Heyndrickx G, Suryapranata H, Legrand V, Goy JJ, Mateme P, Bonnier H, Morice M-C, Fajadet J, Belarsi J, Colombo A, Garcia E, Ruygrok P, Jaegere Pde, Morel M-A. on behalf of the Benestent-II Study Group Heparin-coated palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II pilot study. Circ 1996; 93: 412-422
• 70 Serruys PW. on behalf of the Benestent-II Study Group BENESTENT-II pilot study: 6 months follow-up of phase 1, 2 and [abstract]. Circulation 1995; 92: I000-I542
• 71 Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Mateme P, Belardi J, Sigwart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Morel M. for the Benestent Study Group A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994; 331: 489-495
• 72 van Beusekom HMM, Serruys PW, van der Giessen WJ. Coronary stent coatings. Coron Artery Disease 1994; 5: 590-596
• 73 van Beusekom HMM, Serruys PW, van der Giessen WJ. Coronary stent coatings. Coron Artery Disease 1994; 5: 590-596
• 74 Leimgruber PP, Roubin GS, Hollman J, Cotsonis GA, Meier B. et al. Restenosis after successful coronary angioplasty in patients with single-vessel disease. Circ 1986; 73: 710-717
• 75 Rupprecht HJ, Brenneke R, Bernhard G. et al. Analysis of risk factors for restenosis after PTCA. Cathet Cardiovascular Diagnosis 1990; 19: 151-159
• 76 Bourassa MG, Lespérance J, Eastwood C. et al. Clinical, physiologic, anatomic and procedural factors predictive of restenosis after percutaneous transluminal coronary angioplasty. J Am Col Cardiol 1991; 18: 368-376
• 77 Zoldhelyi P, Bichler J, Owen GO. et al. Persistent thrombin generation in humans during specific thrombin inhibition with hirudin. Circulation 1994; 90: 2671-2678
• 78 Topol EJ, Califf RM, Weisman HF. et al. on behalf of the EPIC investigators. Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. The Lancet 1994; 343: 881-886
• 79 Karsch K, Preisack MB, Bonan R. on behalf of the REDUCE study group Low molecular weight heparin, reviparin, in prevention of restenosis after PTCA: Results of the REDUCE trial. J Am Coll Cardiol 1996; 27 (02) (Suppl A) 113A
• 80 Schwartz L, Bourassa MG, Lesperance J. et al. Aspirin and dipyridamole in the prevention of restenosis after percutaneous transluminal coronary angioplasty. N Eng J Med 1988; 318: 1714-1719
• 81 Bertrand ME, Allain H, LaBlanche JM. on behalf of the TACT study Results of a randomized trial of ticlopidine versus placebo for prevention of acute closure and restenosis after coronary angioplasty (PTCA). The TACT study [abstract]. Circulation 1990; 82: 003-190
• 82 The global use of strategies to open occluded coronary arteries (GUSTO) IIa investigators. Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circ 1994; 90: 1631-1637
• 83 Antman E. for the TIMI-9A investigators Hirudin in myocardial infarction. Safety report from the thrombolysis and thrombin inhibition in myocardial infarction (TIMI-9A) trial. Circ 1994; 90: 1624-1630
• 84 Neuhaus KL, Essen Rv, Tebbe U, Jessel A, Heinrichs H, Maurer W, Döring W, Harmjanz D, Kötter V, Kalhammer E, Simon H, Horacek T. Safety observations from the pilot phase of the randomized r-hirudin for improvement of thrombolysis (HIT-III) study. Circ 1994; 90: 1638-1642
• 85 Antman EM, and Braunwald E. Trials and tribulations of thrombin inhibition. Eur H J 1996; 17: 971-973