Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial

Trials

In-Ho Chae¹  Dong-Ju Choi¹  Tae-Jin Youn¹  Young-Suk Cho¹  Jung-Won Suh¹  Il-Young Oh¹  Chang-Hwan Yoon¹  Sang-Don Park¹ 

[1] Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Bein-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Republic of Korea

关键词: In-segment late loss;    Drug-eluting stent;    Bare metal stent;    Drug-eluting balloon;   

Others  :  1094807
DOI  :  10.1186/1745-6215-14-38

 received in 2012-06-27, accepted in 2013-01-04,  发布年份 2013

【 摘 要 】

Background

The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.

Methods/Design

The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent^® please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex^® Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity™; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study.

Discussion

The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.

Trial registration

Clinical Trials.gov: NCT01539603

【 授权许可】

   
2013 Park et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Elezi S, Kastrati A, Neumann FJ, Hadamitzky M, Dirschinger J, Schomig A: Vessel size and long-term outcome after coronary stent placement. Circulation 1998, 98:1875-1880.
• [2]Hoffmann R, Mintz GS, Dussaillant GR, Popma JJ, Pichard AD, Satler LF, Kent KM, Griffin J, Leon MB: Patterns and mechanisms of in-stent restenosis. A serial intravascular ultrasound study. Circulation 1996, 94:1247-1254.
• [3]Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P: Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007, 370:937-948.
• [4]Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R: Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation 2008, 118:1138-1145.
• [5]Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R: Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006, 48:193-202.
• [6]Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R: Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol 2007, 27:1500-1510.
• [7]Kuriyama N, Kobayashi Y, Nakama T, Mine D, Nishihira K, Shimomura M, Nomura K, Ashikaga K, Matsuyama A, Shibata Y: Late restenosis following sirolimus-eluting stent implantation. JACC Cardiovasc Interv 2011, 4:123-128.
• [8]Kang SJ, Mintz GS, Akasaka T, Park DW, Lee JY, Kim WJ, Lee SW, Kim YH, Whan Lee C, Park SW, Park SJ: Optical coherence tomographic analysis of in-stent neoatherosclerosis after drug-eluting stent implantation. Circulation 2011, 123:2954-2963.
• [9]Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U: Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006, 355:2113-2124.
• [10]De Labriolle A, Pakala R, Bonello L, Lemesle G, Scheinowitz M, Waksman R: Paclitaxel-eluting balloon: from bench to bed. Catheter Cardiovasc Interv 2009, 73:643-652.
• [11]Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G: Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation 2004, 110:810-814.
• [12]Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B: Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology 2006, 240:411-418.
• [13]Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B: Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 2009, 119:2986-2994.
• [14]Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B: Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 2010, 99:165-174.
• [15]Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX: Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial. EuroIntervention 2011, 7:61-65.
• [16]Poss J, Jacobshagen C, Ukena C, Bohm M: Hotlines and clinical trial updates presented at the German Cardiac Society Meeting 2010: FAIR-HF, CIPAMI, LIPSIA-NSTEMI, Handheld-BNP, PEPCAD III, remote ischaemic conditioning, CERTIFY, PreSCD-II, German Myocardial Infarction Registry. DiaRegis. Clin Res Cardiol 2010, 99:411-417.
• [17]ClinicalTrials.gov. http://www.clinicaltrials.gov webcite
• [18]Meredith IT, Worthley S, Whitbourn R, Walters D, Popma J, Cutlip D, Fitzgerald P: The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial. EuroIntervention 2007, 3:50-53.
• [19]Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O’Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME, TAXUS V Investigators:: Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005, 294:1215-1223.
• [20]Marroquin OC, Selzer F, Mulukutla SR, Williams DO, Vlachos HA, Wilensky RL, Tanguay JF, Holper EM, Abbott JD, Lee JS, Smith C, Anderson WD, Kelsey SF, Kip KE: A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med 2008, 358:342-352.
• [21]Roy P, Buch AN, Javaid A, Okabe T, Raya V, Pinto Slottow TL, Steinberg DH, Smith K, Xue Z, Gevorkian N, Satler LF, Kent KM, Suddath WO, Pichard AD, Lindsay J, Waksman R: Impact of ‘off-label’ utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Am J Cardiol 2008, 101:293-299.
• [22]Rosenkranz S, Maier LS, Maack C, Bohm M: Hotline update of clinical trials and registries presented at the German Cardiac Society Meeting 2007: 2L-Registry, Kardio-Pro, EVER, AFFECT, VTACH, ARTS II, OPTAMI, PEPCAD I, PEPCAD II, GERSHWIN, SPICE, FIX-CHF and CREDIT. Clin Res Cardiol 2007, 96:457-468.
• [23]Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A, Wild DH, Brehm BR, Riessen R, Koveker G, Karsch KR: Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 1997, 96:636-645.
• [24]Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G: Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol 2003, 42:1415-1420.
• [25]Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Bohm M, Stoll HP: Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J 2003, 24:1462-1467.
• [26]Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wöhrle J: A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES Study. J Am Coll Cardiol 2012, 59(15):1377-1382.
• [27]Stella PR, Belkacemi A, Dubois C, Nathoe H, Dens J, Naber C, Adriaenssens T, van Belle E, Doevendans P, Agostoni P: A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv 2012, 80(7):1138-1146.
• [28]Wohrle J, Birkemeyer R, Markovic S, Nguyen TV, Sinha A, Miljak T, Spiess J, Rottbauer W, Rittger H: Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease. Heart 2011, 97:1338-1342.