Abstract
The recent SCORES trial demonstrated that lower dilatation pressures seen with self-expanding (SE) stents may be associated with lower rates of target lesion revascularization (TLR). To determine whether SE stents with low-pressure dilatation are as safe and effective as balloon expandable (BE) stents. We randomly assigned 254 patients with 279 coronary lesions to groups receiving either SE with low-pressure dilatation <12 atm (n = 143) or conventional BE stents (n = 136). Thereafter, acute results and long-term outcomes were compared. Baseline patient and angiographic characteristics were similar in two groups. The incidence of procedural complications, such as slow flow, side branch occlusion, and edge dissection were significantly lower in the SE group than in the BE group (overall: SE, 17; BE, 35; P < 0.01), and the occurrence of myocardial infarction tended to be lower in SE than in BE (SE, 1; BE, 4; not significant). Although acute gain was significantly smaller with SE than BE (SE, 2.21 ± 0.65 mm; BE, 2.42 ± 0.62; P < 0.01), probably due to gradual expansion of the SE stent, nearly identical minimum luminal diameters on follow-up angiography (SE, 2.14 ± 0.92 mm vs. BE, 2.22 ± 0.93; not significant) and similar angiographic restenosis (SE, 18.1% vs. BE, 20.5%). and TLR rates (SE, 16.1% vs. BE, 14.0%) were apparent. This prospective randomized trial demonstrates that SE stents with low-pressure dilatation is safe and effective strategy for treating coronary arterial stenosis.
Similar content being viewed by others
References
Han RO, Schwartz RS, Kobayashi Y, Wilson SH, Mann JT, Sketch MH, Safian RD, Lansky A, Popma J, Fitzgerald PJ, Palacios IF, Chazin-Caldie M, Goldberg S (2001) Comparison of selfexpanding and balloon-expandable stents for the reduction of restenosis Am J Cardiol 88:253–259
Kobayashi Y, Honda Y, Christie GL, Teirstein PS, Bailey SR, Brown CL 3rd, Matthews RV, De Franco AC, Schwartz RS, Goldberg S, Popma JJ, Yock PG, Fitzgerald PJ (2001) Long-term vessel response to a self-expanding coronary stent: a serial volumetric intravascular ultrasound analysis from the ASSURE Trial. A Stent vs. Stent Ultrasound Remodeling Evaluation: J Am Coll Cardiol 37:1329–1334
Konig A, Schiele TM, Rieber J, Theisen K, Mudra H, Klauss V (2002) Stent design-related coronary artery remodeling and patterns of neointima formation following self-expanding and balloon expandable stent implantation. Catheter Cardiovasc Interv 56:486–487
Hirayama A, Kodama K, Adachi T, Nanto S, Ohara T, Tamai H, Kyo E, Isshiki T, Ochiai M (2000) Angiographic and clinical outcome of a new self-expanding intracoronary stent (RADIUS): results from multicenter experience in Japan. Catheter Cardiovasc Interv 49:401–407
Bahrmann P, Werner GS, Heusch G, Ferrari M, Poerner TC, Voss A, Figulla HR (2007) Detection of coronary microembolization by Doppler ultrasound in patients with stable angina pectoris undergoing elective percutaneous coronary interventions. Circulation 115:600–608
Veselka J, Prochazkova S, Duchonova R, Homolova I, Tesar D, Bybee KA (2006) Preprocedural statin therapy reduces the risk and extent of cardiac biomarker release following percutaneous coronary intervention. Heart Vessels 21:146–151
Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators (2004) Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation 110:674–678
Dirschinger J, Kastrati A, Neumann FJ, Boekstegers P, Elezi S, Mehilli J, Schuhlen H, Pache J, Alt E, Blasini R, Steinbeck G, Schomig A (1999) Influence of balloon pressure during stent placement in native coronary arteries on early and late angiographic and clinical outcome: A randomized evaluation of high-pressure inflation. Circulation 100:918–923
Uretsky BF, Rosanio S, Lerakis S, Wang FW, Smiley M, Stouffer GA, Tocchi M, Estella P (2000) A prospective evaluation of angiography-guided coronary stent implantation with high versus very high balloon inflation pressure. Am Heart J 140:804–812
Kastrati A, Schomig A, Elezi S, Schuhlen H, Dirschinger J, Hadamitzky M, Wehinger A, Hausleiter J, Walter H, Neumann FJ (1997) Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 30:1428–1436
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323
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 (2005) Comparison of a polymer-based paclitaxeleluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 294:1215–1223
Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A; ISAR-DESIRE Study Investigators (2005) Sirolimus-eluting stent or paclitaxeleluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293:165–171
Uchida T, Bakhai A, Almonacid A, Shibata T, Cox B, Kuntz RE (2006) A meta-analysis of randomized controlled trials of intracoronary gamma-and beta-radiation therapy for in-stent restenosis. Heart Vessels 21:368–374
Leon MB, Teirstein PS, Moses JW, Tripuraneni P, Lansky AJ, Jani S, Wong SC, Fish D, Ellis S, Holmes DR, Kerieakes D, Kuntz RE (2001) Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. N Engl J Med 344:250–256
Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A (2005) Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293:2126–2130
McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 364:1519–1521
Kereiakes DJ, Choo JK, Young JJ, Broderick TM (2004) Thrombosis and Drug-Eluting Stents: A Critical Appraisal. Rev Cardiovasc Med 5:9–15
Kandzari DE, Goldberg S, Schwartz RS, Chazin-Caldie M, Sketch MH Jr, SCORES SVG investigators (2003) Clinical and angiographical efficacy of a self expandable nitinol stent in saphenous vein graft atherosclerotic disease: the Stent Comparative Restenosis (SCORES) Saphenous Vein Graft Registry. Am Heart J 145:868–874
Shah VM, Mintz GS, Apple S, Weissman NJ (2002) Background incidence of late malapposition after bare-metal stent implantation. Circulation 106:1753–1755
Qureshi AI, Suri MF, New G, Wadsworth DC Jr, Dulin J, Hopkins LN (2002) Multicenter study of the feasibility and safety of using the memotherm carotid arterial stent for extracranial carotid artery stenosis. J Neurosurg 96:830–836
Mukherjee D, Kalahasti V, Roffi M, Bhatt DL, Kapadia SR, Bajzer C, Reginelli J, Ziada KM, Hughes K, Yadav JS (2001) Self-expanding stents for carotid interventions: comparison of nitinol versus stainless-steel stents. J Invasive Cardiol 13:732–735
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E (2006) Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 354:1879–888
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Tanaka, S., Watanabe, S., Matsuo, H. et al. Prospective randomized trial comparing a nitinol self-expanding coronary stent with low-pressure dilatation and a high-pressure balloon expandable bare metal stent. Heart Vessels 23, 1–8 (2008). https://doi.org/10.1007/s00380-007-1000-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00380-007-1000-2