Background Data from a large patient population regarding very long-term outcomes after BMS implantation are inadequate. This study aimed to evaluate the very long-term (8–17 years) clinical and long-term (3–5 years) angiographic outcomes after intracoronary bare-metal stenting (BMS). Methods and Results From the Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN) registry, a total of 2391 patients with 2966 lesions treated with 3190 BMSs between November 1995 and May 2004 were evaluated. In total, 1898 patients with 2364 lesions, and 699 patients with 861 lesions underwent 6-month and 3- to 5- year angiographic follow-up, respectively. During a mean follow-up period of 149±51 months, 18.6% of the patients died (including 10.8% due to cardiac death), 6.1% developed reinfarction, 16.2% had target lesion revascularization (including 81% of the patients within the first year), 14.5% underwent new lesion stenting (including 72% of the patients after 3 years), 2.4% underwent coronary bypass surgery, and 1.6% had definite stent thrombosis. The overall cardiovascular event-free survival rate was 58.5%. The 6-month angiographic study indicated a 20% restenosis rate. The minimal luminal diameter increased from 0.65±0.44 mm to 3.02±0.46 mm immediately after stenting, decreased to 2.06±0.77 mm at the 6-month follow-up, and increased to 2.27±0.68 mm at the 3- to 5-year follow-up. Conclusions This study provides clinical and angiographic results from a large population of patients who underwent BMS implantations after a long-term follow-up period (149±51 months). The progression of coronary atherosclerosis developed over time, and presented with new lesion required stent implantation. The follow-up angiographic findings reconfirmed the late and sustained improvement in luminal diameter between 6 months and 3–5 years.
References
[1]
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, et al. (1994) A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med 331: 496–501. doi: 10.1056/nejm199408253310802
[2]
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, et al. (1994) A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 331: 489–495. doi: 10.1056/nejm199408253310801
[3]
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, et al. (2002) A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346: 1773–1780. doi: 10.1056/nejmoa012843
[4]
Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, et al. (2005) 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 294: 1215–1223. doi: 10.1001/jama.294.10.1215
[5]
Carrozza JP Jr, Kuntz RE, Levine MJ, Pomerantz RM, Fishman RF, et al. (1992) Angiographic and clinical outcome of intracoronary stenting: immediate and long-term results from a large single-center experience. J Am Coll Cardiol 20: 328–337. doi: 10.1016/0735-1097(92)90098-8
[6]
Savage MP, Fischman DL, Schatz RA, Teirstein PS, Leon MB, et al. (1994) Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group. J Am Coll Cardiol 24: 1207–1212. doi: 10.1016/0735-1097(94)90099-x
[7]
Klugherz BD, DeAngelo DL, Kim BK, Herrmann HC, Hirshfeld JW, et al. (1996) Three-year clinical follow-up after Palmaz-Schatz stenting. J Am Coll Cardiol 27: 1185–1191. doi: 10.1016/0735-1097(95)00574-9
[8]
van Domburg RT, Foley DP, de Jaegere PP, de Feyter P, van den Brand M, et al. (1999) Long term outcome after coronary stent implantation: a 10 year single centre experience of 1000 patients. Heart 82 Suppl 2: II27–34. doi: 10.1080/acc.2.1.27.34
[9]
Karam C, Fajadet J, Beauchet A, Cassagneau B, Marco J (2000) Nine-year follow-up of balloon-expandable Palmaz-Schatz stent in patients with single-vessel disease. Catheter Cardiovasc Interv 50: 170–174. doi: 10.1002/(sici)1522-726x(200006)50:2<170::aid-ccd4>3.3.co;2-z
[10]
Choussat R, Klersy C, Black AJ, Bossi I, Laurent JP, et al. (2001) Long-term (> or = 8 years) outcome after Palmaz-Schatz stent implantation. Am J Cardiol 88: 10–16. doi: 10.1016/s0002-9149(01)01577-6
[11]
Yamaji K, Kimura T, Morimoto T, Nakagawa Y, Inoue K, et al. (2010) Very long-term (15 to 20 years) clinical and angiographic outcome after coronary bare metal stent implantation. Circ Cardiovasc Interv 3: 468–475. doi: 10.1161/circinterventions.110.958249
[12]
Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, et al. (1996) Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med 334: 561–566. doi: 10.1056/nejm199602293340903
[13]
Kimura T, Abe K, Shizuta S, Odashiro K, Yoshida Y, et al. (2002) Long-term clinical and angiographic follow-up after coronary stent placement in native coronary arteries. Circulation 105: 2986–2991. doi: 10.1161/01.cir.0000019743.11941.3b
[14]
Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, et al. (1999) Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 100: 1872–1878. doi: 10.1161/01.cir.100.18.1872
[15]
Inoue K, Abe K, Ando K, Shirai S, Nishiyama K, et al. (2004) Pathological analyses of long-term intracoronary Palmaz-Schatz stenting; Is its efficacy permanent? Cardiovasc Pathol 13: 109–115. doi: 10.1016/s1054-8807(03)00132-7
[16]
Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, et al. (2009) 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol 54: 894–902. doi: 10.1016/j.jacc.2009.04.077
[17]
Auer J, Leitner A, Berent R, Lamm G, Lassnig E, et al. (2010) Long-term outcomes following coronary drug-eluting- and bare-metal-stent implantation. Atherosclerosis 210: 503–509. doi: 10.1016/j.atherosclerosis.2009.12.003
[18]
Kastrati A, Schomig A, Elezi S, Schuhlen H, Dirschinger J, et al. (1997) Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 30: 1428–1436. doi: 10.1016/s0735-1097(97)00334-3
[19]
Kasaoka S, Tobis JM, Akiyama T, Reimers B, Di Mario C, et al. (1998) Angiographic and intravascular ultrasound predictors of in-stent restenosis. J Am Coll Cardiol 32: 1630–1635. doi: 10.1016/s0735-1097(98)00404-5
[20]
Bauters C, Hubert E, Prat A, Bougrimi K, Van Belle E, et al. (1998) Predictors of restenosis after coronary stent implantation. J Am Coll Cardiol 31: 1291–1298. doi: 10.1016/s0735-1097(98)00076-x
[21]
Goldberg SL, Loussararian A, De Gregorio J, Di Mario C, Albiero R, et al. (2001) Predictors of diffuse and aggressive intra-stent restenosis. J Am Coll Cardiol 37: 1019–1025. doi: 10.1016/s0735-1097(01)01107-x
[22]
Kastrati A, Mehilli J, Dirschinger J, Pache J, Ulm K, et al. (2001) Restenosis after coronary placement of various stent types. Am J Cardiol 87: 34–39. doi: 10.1016/s0002-9149(00)01268-6
