Abstract
Long-term safety and efficacy of drug-eluting stents remains controversial. The CREDO-Kyoto registry cohort-2 is a physician-initiated non-company sponsored multi-center registry enrolling consecutive patients undergoing first coronary revascularization in 26 centers in Japan. We compared 3-year outcome between patients treated with sirolimus-eluting stent (SES) only (5092 patients) and bare-metal stent (BMS) only (5405 patients). SES-use as compared with BMS-use was associated with significantly lower adjusted risk for all-cause death [hazard ratio (HR) [95% confidence interval (CI)] 0.72 (0.59–0.87), P = 0.0007], which was mainly driven by the reduction in non-cardiac death [HR (95% CI) 0.64 (0.48–0.85), P = 0.002]. The risk of cardiac death [HR (95% CI) 0.82 (0.63–1.07), P = 0.15], myocardial infarction [HR (95% CI) 0.73 (0.51–1.03), P = 0.07] and definite stent thrombosis [HR (95% CI) 0.62 (0.35–1.09), P = 0.1] was not different between the two groups. Despite longer duration of thienopyridine administration, SES-use was associated with significantly lower risk for bleeding [HR (95% CI) 0.75 (0.6–0.95), P = 0.02] and similar risk for stroke [HR (95% CI) 1.0 (0.75–1.34), P = 1.0]. The risk for target-lesion revascularization (TLR) was markedly lower in the SES group [HR (95% CI) 0.42 (0.36–0.48), P < 0.0001]. The direction and magnitude of the effect of SES relative to BMS in patients presenting acute myocardial infarction (AMI) were similar to those in patients presenting otherwise. In conclusion, SES-use as compared with BMS-use was associated with marked reduction of TLR without any increases in death, myocardial infarction, stent thrombosis, stroke and bleeding in real world clinical practice regardless of clinical presentation including AMI.
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McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364:1519–21.
Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L, SCAAR Study Group. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356:1009–19.
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369:667–78.
Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, BASKET-LATE Investigators, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48:2584–91.
Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, et al. Safety and efficacy of drug-eluting and bare metal stents: comparative meta-analysis of randomized trials and observational studies. Circulation. 2009;119:3198–206.
Tu JV, Bowen J, Chiu M, Ko DT, Austin PC, He Y, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med. 2007;357:1393–402.
Mauri L, Silbaugh TS, Wolf RE, Zelevinsky K, Lovett A, Zhou Z, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation. 2008;118:1817–27.
Park DW, Yun SC, Lee SW, Kim YH, Lee CW, Hong MK, et al. Stent thrombosis, clinical events, and influence of prolonged clopidogrel use after placement of drug-eluting stent: data from an observational cohort study of drug-eluting versus bare-metal stents. J Am Coll Cardiol Interv. 2008;1:494–503.
Shishehbor MH, Goel SS, Kapadia SR, Bhatt DL, Kelly P, Raymond RE, et al. Long-term impact of drug-eluting stents versus bare-metal stents on all-cause mortality. J Am Coll Cardiol. 2008;52:1041–8.
Kimura T, Morimoto T, Furukawa Y, Nakagawa Y, Shizuta S, Ehara N, et al. Long-Term outcomes of coronary-artery bypass graft surgery versus percutaneous coronary intervention for multivessel coronary artery disease in the bare-metal stent era. Circulation. 2008;118:S199–209.
Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, et al. Collaborators developing the Japanese equation for estimated GFR. Revised equation for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009;53:932–5.
Serruys PW, Ong AT, van Herwerden LA, Sousa JE, Jatene A, Bonnier JJ, et al. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005;46:575–81.
Mauri L, Hsieh WH, Massaro JM, Ho KK, D’Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020–9.
The GUSTO Investigators. An inter-national randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993;329:673–82.
Kimura T, Morimoto T, Nakagawa Y, Tamura T, Kadota K, Yasumoto H, et al. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation. 2009;119:987–95.
Bar SS, Leon MB, Stone GW, Mehran R, Moses JW, Brar SK, et al. Use of drug-eluting stents in acute myocardial infarction: a systematic review and meta-analysis. J Am Coll Cardiol. 2009;53:1677–89.
Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009;360:1946–59.
Steg PG, Fox KA, Eagle KA, Furman M, Van de Werf F, Montalescot G, et al. Mortality following placement of drug-eluting and bare-metal stents for ST-segment elevation acute myocardial infarction in the Global Registry of Acute Coronary Events. Eur Heart J. 2009;30:321–9.
Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, et al. 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;118:1138–45.
Wenaweser P, Daeman J, Zwahlen M, van Domburg R, Juni P, Vaina S, et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol. 2008;52:1134–40.
Nakagawa Y, Kimura T, Morimoto T, Nomura M, Saku K, Haruta S, et al. Incidence and risk factors of late target lesion revascularization after sirolimus-eluting stent implantation (3-year follow-up of the j-Cypher Registry). Am J Cardiol. 2010;106:329–36.
Acknowledgments
We appreciate the support and collaboration of the co-investigators participating in the CREDO-Kyoto PCI/CABG Registry Cohort-2. We are indebted to the outstanding effort of the clinical research coordinators for data collection. This study was supported by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Conflict of interest
Takeshi Kimura serves as an advisory board member for Cordis Cardiology, Abbott Vascular and Terumo Company. The remaining authors reported no conflicts of interest.
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On behalf of the CREDO-Kyoto PCI/CABG registry cohort-2 investigators.
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Kimura, T., Morimoto, T., Furukawa, Y. et al. Long-term safety and efficacy of sirolimus-eluting stents versus bare-metal stents in real world clinical practice in Japan. Cardiovasc Interv and Ther 26, 234–245 (2011). https://doi.org/10.1007/s12928-011-0065-0
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DOI: https://doi.org/10.1007/s12928-011-0065-0