coronary artery disease - revascularization with drug eluting stent - diabetic patients clinical trials results meta-analysis

<h1> <a href="TM29-79-revascularization with drug eluting stent-coronary artery disease" > <strong>coronary artery disease</strong> - revascularization with drug eluting stent </a> - diabetic patients trial results systematic overview and meta-analysis </h1> <h2>Main characteristics of the included studies</h2> <table> <tr> <th>Trial</th> <th>Treatments</th> <th>Patients</th> <th>Methods</th> </tr> <tr> <td> <a href="../TRC_t6544.htm"> Tomai, 2008 </a> <br> </td> <td> sirolimus-eluting stent<br>  <i>versus</i> <br> paclitaxel-eluting stent </td> <td> diabetic patient with multiple de novo coronary artery lesions </td> <td> follow-up 8 months<br> n=60/60<br> Cross over<br> NA <br> Italy </td> </tr> <tr> <td> <a href="../TRC_t6569.htm"> DIABETES, 2005 </a> <br> </td> <td> Cypher<br>  <i>versus</i> <br> Bx Velocity/Sonic </td> <td> de novo lesions in native coronary arteriesin 1, 2, or 3 native vessels with symptoms or objective evidence of ischemia; vessel size smaller than 4.0 mm </td> <td> follow-up 9 months<br> n=80/80<br> Parallel groups<br> open <br> Spanish </td> </tr> <tr> <td> <a href="../TRC_t6575.htm"> DECODE, 2005 </a> <br> NCT00489164 </td> <td> CYPHER (Up to 3 stents per patient were allowed)<br>  <i>versus</i> <br> Bx VELOCITY (Up to 3 stents per patient were allowed) </td> <td> Stable or unstable angina in diabetic patients with with up to 2 de novo lesions in up to 2 native coronary vessels </td> <td> follow-up 1 year<br> n=54/29<br> Parallel groups<br> open <br> US, Asia/Pacific </td> </tr> <tr> <td> <a href="../TRC_t6582.htm"> ISAR-DIABETES, 2005 </a> <br> </td> <td> Taxus<br>  <i>versus</i> <br> Cypher </td> <td> Diabetic patients. AP or positive stress, no AMI with clinically significant angiographic stenosis in a native coronary vessel </td> <td> follow-up 9 months<br> n=125/125<br> Parallel groups<br> open <br> Germany </td> </tr> <tr> <td> <a href="../TRC_t6615.htm"> Ravel (diabetics), 2004 </a> <br> </td> <td> coated Bx velocity<br>  <i>versus</i> <br> Bx VELOCITY </td> <td> sub groups of diabetic patients with de novo native coronary arterylesions 2.5 to 3.5 mm in diameter by visualassessment that could be covered by an 18-mm stent </td> <td> follow-up 6 months<br> n=19/25<br> Parallel groups<br> NA <br> Europe </td> </tr> <tr> <td> <a href="../TRC_t6619.htm"> SES-SMARt (diabetics), 2005 </a> <br> </td> <td> Cypher<br>  <i>versus</i> <br> Bx Sonic </td> <td> Diabetic patients with de novo target lesion <=2.75 mm in diameter in a native coronary artery that could be completely covered by a single stent (maximum length 33 mm) </td> <td> follow-up 8 months<br> n=29/45<br> Parallel groups<br> single-blind <br> Italy </td> </tr> <tr> <td> <a href="../TRC_t6620.htm"> TAXUS II (diabetics), 2003 </a> <br> </td> <td> TAXUS<br>  <i>versus</i> <br> NIR stent </td> <td> Diabetic patients with stable or unstable AP, silent ischaemia; single de novo target lesion with estimatedstenosis >50% and <99%, </td> <td> follow-up 12 months<br> n=37/41<br> Parallel groups<br> double-blind <br> Europe </td> </tr> <tr> <td> <a href="../TRC_t6622.htm"> TAXUS IV (diabetics), 2005 </a> <br> NCT00292474 </td> <td> TAXUS<br>  <i>versus</i> <br> EXPRESS </td> <td> Diabetic patients with stable or unstable AP, provokable ischaemia with a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) </td> <td> follow-up 9 months<br> n=155/163<br> Parallel groups<br> double-blind <br> United States </td> </tr> <tr> <td> <a href="../TRC_t6623.htm"> TAXUS V (diabetics), 2005 </a> <br> </td> <td> TAXUS<br>  <i>versus</i> <br> BMS </td> <td> Diabetic patients with stable or unstable AP, silent ischaemia with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) </td> <td> follow-up 9 months<br> n=178/171<br> Parallel groups<br> double-blind <br> United States </td> </tr> <tr> <td> <a href="../TRC_t6624.htm"> TAXUS VI (diabetics), 2005 </a> <br> NCT00297804 </td> <td> TAXUS<br>  <i>versus</i> <br> Express2 stent </td> <td> Diabetic patients with stable or unstable AP, silent ischaemia with long, complex coronary artery lesions </td> <td> follow-up 9 months<br> n=39/50<br> Parallel groups<br> double-blind <br> Europe </td> </tr> <tr> <td> <a href="../TRC_t7984.htm"> SIRTAX diabetics, 2005 </a> <br> NCT00297661 </td> <td> Cypher<br>  <i>versus</i> <br> Taxus </td> <td> Sub groups of diabetics patients with either stable angina or an acute coronary syndrome </td> <td> follow-up 12 months<br> n=108/93<br> Parallel groups<br> single-blind <br> Switzerland </td> </tr> <tr> <td> <a href="../TRC_t7999.htm"> DESSERT, 2008 </a> <br> </td> <td> Cypher andCypher Select<br>  <i>versus</i> <br> Sonic (Cordis) </td> <td> de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for >3 months </td> <td> follow-up 12 months<br> n=75/75<br> Parallel groups<br> single-blind <br> Italy </td> </tr> <tr> <td> <a href="../TRC_t8629.htm"> Kim, 2008 </a> <br> </td> <td> Cypher<br>  <i>versus</i> <br> Taxus </td> <td> Korean diabetic patients with high-grade de novo coronary lesions (stenosis of>70 percent of the luminal diameter) requiring <3 stents </td> <td> follow-up 6 months<br> n=85/84<br> Parallel groups<br> open <br> Korea </td> </tr> <tr> <td> <a href="../TRC_t8630.htm"> TAxi (diabetics), 3000 </a> <br> </td> <td> SES<br>  <i>versus</i> <br> PES </td> <td> </td> <td> follow-up 12 months<br> n=33/36<br> Parallel groups<br> open <br> Switzerland </td> </tr> <tr> <td> <a href="../TRC_t8631.htm"> REALITY (diabetics), 2006 </a> <br> </td> <td> SES<br>  <i>versus</i> <br> PES </td> <td> </td> <td> follow-up 12 months<br> n=187/192<br> Parallel groups<br> open <br> worldwide </td> </tr> <tr> <td> <a href="../TRC_t8632.htm"> SIRIUS (diabetics), 2003 </a> <br> </td> <td> SES<br>  <i>versus</i> <br> BMS </td> <td> sub group of diabetics patients of SIRIUS study </td> <td> follow-up 12 months<br> n=131/148<br> Parallel groups<br> double-blind <br> US </td> </tr> <tr> <td> <a href="../TRC_t8633.htm"> ISAR-test (diabetics), 2006 </a> <br> </td> <td> Taxus<br>  <i>versus</i> <br> rapamycin stent </td> <td> diabetics patients with de novo lesions in native coronary vessels, excluding the left main trunk </td> <td> follow-up 9 months<br> n=73/58<br> Parallel groups<br> open <br> germany </td> </tr> <tr> <td> <a href="../TRC_t8927.htm"> COSTAR II diabetic (sub group), 2008 </a> <br> </td> <td> CoStar stent (PES)<br>  <i>versus</i> <br> Taxus stent (PES) </td> <td> patients with de novo single- or multivessel coronary disease </td> <td> follow-up 8 months<br> n=271/271<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="../TRC_t9151.htm"> DES-DIABETES, 2008 </a> <br> </td> <td> sirolimus-eluting stent<br>  <i>versus</i> <br> paclitaxel-eluting stent </td> <td> diabetic patients with angina pectoris and/or a positive stress test and a native coronary lesion </td> <td> follow-up 9 months (1 year)<br> n=200/200<br> Factorial plan<br> open <br> Korea </td> </tr> <tr> <td> <a href="../TRC_t6639.htm"> DIABEDES IV, 0 </a> <br> NCT00552994 </td> <td> Cypher select plus<br>  <i>versus</i> <br> Xience V </td> <td> diabetic patients </td> <td> follow-up <br> n=-9/-9<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t6644.htm"> Lipsia-Yukon-DM, 0 </a> <br> NCT00368953 </td> <td> Yukon Choice stent system<br>  <i>versus</i> <br> Taxus Liberté stent system </td> <td> Patients With Diabetes Mellitus </td> <td> follow-up 9 months<br> n=-9/-9<br> <br> <br> </td> </tr> <tr> <td> <a href="../TRC_t6658.htm"> PEPCAD IV, 0 </a> <br> NCT00462631 </td> <td> Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment<br>  <i>versus</i> <br> Taxus Liberté </td> <td> patients with diabetes mellitus </td> <td> follow-up <br> n=-9/-9<br> <br> open <br> </td> </tr> </table> <h2>References</h2> <p> <b>Tomai, 2008 : </b> Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffr G, Prati F, Tamburino C, Ribichini F, Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study. <i>Diabetes Care 2008;31:15-9.</i> [PMID 17909090] 10.2337/dc07-1377 </p> <p> <b>DIABETES, 2005 : </b> Sabat M, Jimnez-Quevedo P, Angiolillo DJ, Gmez-Hospital JA, Alfonso F, Hernndez-Antoln R, Goicolea J, Bauelos C, Escaned J, Moreno R, Fernndez C, Fernndez-Avils F, Macaya CRandomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. <i>Circulation 2005;112:2175-83</i> [PMID 16203930] </p> <p> <b>DIABETES, 2005 : </b> Jimnez-Quevedo P, Sabat M, Angiolillo DJ, Alfonso F, Hernndez-Antoln R, SanMartn M, Gmez-Hospital JA, Bauelos C, Escaned J, Moreno R, Fernndez C, Fernndez-Avils F, Macaya CLong-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial. <i>Eur Heart J 2007;28:1946-52</i> [PMID 17562666] </p> <p> <b>DIABETES, 2005 : </b> Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L <i>Am J Cardiol 2009 Feb 1;103:345-9</i> [PMID 19166687] </p> <p> <b>DECODE, 2005 : </b> Chan C, Zambahari R, Kaul U, Cohen SA, Buchbinder M.Outcomesin diabetic patients with multivessel disease and long lesions: resultsfrom the DECODE study <i>Am J Cardiol 2005; 96 (suppl 7A): 31H</i> [PMID ] </p> <p> <b>ISAR-DIABETES, 2005 : </b> Dibra A, Kastrati A, Mehilli J, Pache J, Schhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schmig APaclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. <i>N Engl J Med 2005;353:663-70</i> [PMID 16105990] </p> <p> <b>Ravel (diabetics), 2004 : </b> Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MCSirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. <i>Eur Heart J 2004;25:107-12</i> [PMID 14720526] </p> <p> <b>SES-SMARt (diabetics), 2005 : </b> Ortolani P, Ardissino D, Cavallini C, Bramucci E, Indolfi C, Aquilina M, Marzocchi AEffect of sirolimus-eluting stent in diabetic patients with small coronary arteries (a SES-SMART substudy). <i>Am J Cardiol 2005;96:1393-8</i> [PMID 16275185] </p> <p> <b>TAXUS II (diabetics), 2003 : </b> Hermiller J.Diabetic results: Taxus II, IV and VI <i>TCT</i> [PMID 0] </p> <p> <b>TAXUS IV (diabetics), 2005 : </b> Hermiller JB, Raizner A, Cannon L, Gurbel PA, Kutcher MA, Wong SC, Russell ME, Ellis SG, Mehran R, Stone GWOutcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial. <i>J Am Coll Cardiol 2005;45:1172-9</i> [PMID 15837245] </p> <p> <b>TAXUS V (diabetics), 2005 : </b> Ellis SGTAXUS V trial global results: expanding the randomizeddata <i>2005 American College of CardiologyAnnual Scientific Session</i> [PMID ] </p> <p> <b>TAXUS VI (diabetics), 2005 : </b> Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell MEClinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. <i>Circulation 2005;112:3306-13</i> [PMID 16286586] </p> <p> <b>pooled SIRIUS (diabetics), 0 : </b> Schampaert E.Sirolimus-eluting stents in diabetics: SIRIUS, C-SIRIUSand E-SIRIUS <i>TCT</i> [PMID ] </p> <p> <b>Kirtane (pooled Taxus diabetic patients), 2008 : </b> Kirtane AJ, Ellis SG, Dawkins KD, Colombo A, Grube E, Popma JJ, Fahy M, Leon MB, Moses JW, Mehran R, Stone GW, Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. <i>J Am Coll Cardiol 2008;51:708-15.</i> [PMID 18279734] 10.1016/j.jacc.2007.10.035 </p> <p> <b>SIRTAX diabetics, 2005 : </b> Togni M, Eber S, Widmer J, Billinger M, Wenaweser P, Cook S, Vogel R, Seiler C, Eberli FR, Maier W, Corti R, Roffi M, Lscher TF, Garachemani A, Hess OM, Wandel S, Meier B, Jni P, Windecker SImpact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial. <i>J Am Coll Cardiol 2007;50:1123-31</i> [PMID 17868802] </p> <p> <b>SIRTAX diabetics, 2005 : </b> Windecker S, Remondino A, Eberli FR, Jni P, Rber L, Wenaweser P, Togni M, Billinger M, Tller D, Seiler C, Roffi M, Corti R, Stsch G, Maier W, Lscher T, Hess OM, Egger M, Meier BSirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. <i>N Engl J Med 2005;353:653-62</i> [PMID 16105989] </p> <p> <b>DESSERT, 2008 : </b> Maresta A, Varani E, Balducelli M, Varbella F, Lettieri C, Uguccioni L, Sangiorgio P, Zoccai GBComparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study). <i>Am J Cardiol 2008;101:1560-6</i> [PMID 18489933] </p> <p> <b>Kim, 2008 : </b> Kim MH, Hong SJ, Cha KS, Park HS, Chae SC, Hur SH, Gwon HC, Bae JH, Lim DSEffect of Paclitaxel-eluting versus sirolimus-eluting stents on coronary restenosis in Korean diabetic patients. <i>J Interv Cardiol 2008 Jun;21:225-31</i> [PMID 18341520] </p> <p> <b>REALITY (diabetics), 2006 : </b> Windecker S.Cypher is preferred in diabetics <i>2006 Transcatheter Cardiovascular Therapeutics Annual Meetings</i> [PMID ] </p> <p> <b>SIRIUS (diabetics), 2003 : </b> Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RESirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. <i>N Engl J Med 2003;349:1315-23</i> [PMID 14523139] </p> <p> <b>SIRIUS (diabetics), 2003 : </b> Weisz G, Moses JW, Teirstein PS, Holmes DR Jr, Raizner AE, Satler LF, Mishkel G, Wilensky RL, Wang P, Kuntz RE, Popma JJ, Leon MBSafety of sirolimus-eluting stenting and its effect on restenosis in patients with unstable angina pectoris (a SIRIUS substudy). <i>Am J Cardiol 2007 Apr 15;99:1044-50</i> [PMID 17437725] </p> <p> <b>ISAR-test (diabetics), 2006 : </b> Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schmig ARandomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. <i>Circulation 2006;113:273-9</i> [PMID 16391155] </p> <p> <b>COSTAR II diabetic (sub group), 2008 : </b> Kereiakes DJ, Petersen JL, Batchelor WB, Fitzgerald PJ, Mehran R, Lansky A, Tsujino I, Schofer J, Dubois C, Verheye S, Cristea E, Garg J, Wijns W, Krucoff MWClinical and angiographic outcomes in diabetic patients following single or multivessel stenting in the COSTAR II randomized trial. <i>J Invasive Cardiol 2008;20:335-41</i> [PMID 18599890] </p> <p> <b>DES-DIABETES, 2008 : </b> Lee SW, Park SW, Kim YH, Yun SC, Park DW, Lee CW, Hong MK, Rhee KS, Chae JK, Ko JK, Park JH, Lee JH, Choi SW, Jeong JO, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Kim HS, Park SJ <i>J Am Coll Cardiol 2008 Aug 26;52:727-33</i> [PMID 18718419] </p> <p> <b>DES-DIABETES, 2008 : </b> Lee SW, Park SW, Kim YH, Yun SC, Park DW, Lee CW, Hong MK, Rhee KS, Chae JK, Ko JK, Park JH, Lee JH, Choi SW, Jeong JO, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Kim HS, Park SJA randomized comparison of sirolimus- versus paclitaxel-eluting stent implantation in patients with diabetes mellitus 2-year clinical outcomes of the DES-DIABETES trial. <i>J Am Coll Cardiol 2009 Mar 3;53:812-3</i> [PMID 19245976] </p>