Pilot study with an intensified oral sirolimus regimen for the prevention of in-stent restenosis in de novo lesions: A serial intravascular ultrasound study

Catheterization and Cardiovascular Interventions

Volumn 66, Issue 4, 2005, Pages 535-540

  Chaves, Áurea J ^a   Sousa, Amanda G M R ^a   Mattos, Luiz A ^a   Abizaid, Alexandre ^a   Feres, Fausto ^a   Staico, Rodolfo ^a   Centemero, Marinella ^a   Tanajura, Luiz F ^a   Abizaid, Andrea C ^a   Rodrigues, Arilson ^a   Paes, Ângela ^a   Mintz, Gary S ^b   Sousa, J Eduardo ^a  

^a INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA   (Brazil)

^b CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

Author keywords

Restenosis; Stents; Ultrasonics

Indexed keywords

ACETYLSALICYLIC ACID; CHOLESTEROL; CREATINE KINASE; CREATINE KINASE MB; GLYCERYL TRINITRATE; HEMOGLOBIN; HEPARIN; RAPAMYCIN; TICLOPIDINE; TRIACYLGLYCEROL;

ADULT; AGED; ANGIOCARDIOGRAPHY; ARTICLE; BLOOD VESSEL DIAMETER; CORONARY STENT; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; HEART INFARCTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IN-STENT RESTENOSIS; INTIMA; INTRAVASCULAR ULTRASOUND; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MOUTH ULCER; PNEUMONIA; RASH; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; BLOOD VESSEL PROSTHESIS; CORONARY ANGIOGRAPHY; CORONARY RESTENOSIS; CORONARY VESSELS; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PILOT PROJECTS; PROSTHESIS FAILURE; RETROSPECTIVE STUDIES; SIROLIMUS; STENTS; TREATMENT OUTCOME; ULTRASONOGRAPHY, INTERVENTIONAL;

EID: 28844433563     PISSN: 15221946     EISSN: None     Source Type: Journal    
DOI: 10.1002/ccd.20538     Document Type: Article

References (19)

1. Brara PS, Moussavian M, Grise MA, Reilly JP, Fernandez M, Schatz RA, Teirstein PS. Pilot trial of oral rapamycin for recalcitrant restenosis. Circulation 2003;107:1722-1724.
2. Rodriguez AE, Alemparte MR, Vigo CF, Pereira CF, Llaurado C, Russo M, Virmani R, Ambrose JA. Pilot study of oral rapamycin to prevent restenosis in patients undergoing coronary stent therapy: Argentina Single-Center Study (ORAR Trial). J Invasive Cardiol 2003;15:581-584.
3. Hausleiter J, Kastrati A, Mehilli J, Vogeser M, Zohlnhofer D, Schuhlen H, Goos C, Pache J, Dotzer F, Pogatsa-Murray G, et al. Randomized, double-blind, placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) trial. Circulation 2004;110:790-795.
4. Guarda E, Marchant E, Fajuri A, Martinez A, Moran S, Mendez M, Uriarte P, Valenzuela E, Lazen R. Oral rapamycin to prevent human coronary stent restenosis: a pilot study. Am Heart J 2004;148:e9.
5. Waksman R, Ajani AE, Pichard AD, Torguson R, Pinnow E, Canos D, Satler LF, Kent KM, Kuchulakanti P, Pappas C, et al. Oral rapamycin to inhibit restenosis after stenting of de novo coronary lesions: the Oral Rapamune to Inhibit Restenosis (ORBIT) study. J Am Coll Cardiol 2004;44:1386-1392.
6. Rodriguez AE, Rodriguez-Alemparte M, Vigo CF, Fernandez-Pereira C, Llaurado C, Vetcher D, Pocovi A, Ambrose J. Role of oral rapamycin to prevent restenosis in patients with de novo lesions undergoing coronary stent therapy: results of the Argentina single center study (ORAR Trial). Heart 2005;91:1433-1437.
7. Brito FS Jr, Rosa WC, Arruda JA, Tedesco H, Pestana JO, Lima VC. Efficacy and safety of oral sirolimus to inhibit in-stent intimal hyperplasia. Catheter Cardiovasc Interv 2005;64:413-418.
8. Di Marco GS, de Andrade MC, Felipe CR, Alfieri F, Gooding A, Silva HT Jr, Pestana JO, Casarini DE. Determination of sirolimus blood concentration using high-performance liquid chromatography with ultraviolet detection. Ther Drug Monit 2003;25:558-564.
9. Marx SO, Marks AR. Bench to bedside: the development of rapamycin and its application to stent restenosis. Circulation 2001;104:852-855.
10. Mahalati K, Kahan BD. Clinical pharmacokinetics of sirolimus. Clin Pharmacokinet 2001;40:573-585.
11. Kuchulakanti P, Waksman R. Therapeutic potential of oral antiproliferative agents in the prevention of coronary restenosis. Drugs 2004;64:2379-2388.
12. Dantal J, Soulillou JP. Immunosuppressive drugs and the risk of cancer after organ transplantation. N Engl J Med 2005;352:1371-1373.
13. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780.
14. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 2003;107:38-42.
15. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788-794.
16. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323.
17. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-231.
18. Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, et al. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation 2001;104:2007-2011.
19. Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, et al. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation 2005;111:2326-2329.