Lee, Seung-Whan; Park, Seong-Wook; Kim, Young-Hak; Yun, Sung-Cheol; Park, Duk-Woo; Lee, Cheol Whan; Kang, Soo-Jin; Rhee, Kyoung-Suk; Chae, Jei-Keon; Ko, Jae-Ki; Park, Jae-Hyeong; Lee, Jae-Hwan; Choi, Si-Wan; Jeong, Jin-Ok; Seong, In-Whan; Cho, Yoon-Haeng; Lee, Nae-Hee; Kim, June-Hong; Chun, Kook-Jin; Kim, Hyun-Sook; Park, Seung-Jung
JACC. Cardiovascular interventions
2011Mar ; 4 ( 3 ) :310-6.
PMID : 21435609
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Lee, Seung-Whan -
Park, Seong-Wook -
Kim, Young-Hak -
Yun, Sung-Cheol -
Park, Duk-Woo -
Lee, Cheol Whan -
Kang, Soo-Jin -
Rhee, Kyoung-Suk -
Chae, Jei-Keon -
Ko, Jae-Ki -
Park, Jae-Hyeong -
Lee, Jae-Hwan -
Choi, Si-Wan -
Jeong, Jin-Ok -
Seong, In-Whan -
Cho, Yoon-Haeng -
Lee, Nae-Hee -
Kim, June-Hong -
Chun, Kook-Jin -
Kim, Hyun-Sook -
Park, Seung-Jung -
ABSTRACT
OBJECTIVES: We compared 4-year efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Four-year comparison of SES with PES in diabetic patients has not been evaluated in a randomized manner.
METHODS: This prospective, multicenter, randomized study compared SES (n = 200) and PES (n = 200) implantation in diabetic patients. We evaluated 4-year major adverse cardiac events (MACE) including death, myocardial infarction (MI), and target lesion revascularization (TLR).
RESULTS: The 2 groups had similar baseline characteristics. At 2 years, TLR (3.5% vs. 11.0%, log-rank, p < 0.01) and MACE (3.5% vs. 12.5%, log-rank, p < 0.01) were significantly lower in SES versus PES group with no difference of death or MI. At 4 years there were no differences in death (3.0% vs. 5.0%, p = 0.45) or MI (1.5% vs. 1.0%, p = 0.99) between SES and PES group. The TLR (7.5% vs. 12.0%, log-rank, p = 0.10) and MACE (11.0% vs. 16.0%, log-rank, p = 0.10) were statistically not different between SES and PES group. At multivariate Cox regression, post-procedural minimal lumen diameter (hazard ratio [HR]: 0.44, 95% confidence interval [CI]: 0.24 to 0.81, p < 0.01), hypercholesterolemia (HR: 2.21, 95% CI: 1.29 to 3.79, p < 0.01), and use of intravascular ultrasound (HR: 0.51, 95% CI: 0.26 to 0.99, p = 0.049) were independent predictors of 4-year MACE.
CONCLUSIONS: Superiority of SES over PES during 2 years was attenuated between 2 years and 4 years in diabetic patients. Use of intravascular ultrasound and larger post-procedural minimal lumen diameter were independent predictors of the improved long-term clinical outcomes. CI - Copyright ??2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
coronary artery disease; diabetes mellitus; paclitaxel-eluting stent(s); sirolimus-eluting stent(s)
MESH
Aged, Angioplasty, Balloon, Coronary/adverse effects/*instrumentation/mortality, Cardiovascular Agents/*administration & dosage, Chi-Square Distribution, Coronary Angiography, Coronary Stenosis/complications/diagnosis/mortality/*therapy, *Diabetes Mellitus/mortality, *Drug-Eluting Stents, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction/etiology, Paclitaxel/*administration & dosage, Proportional Hazards Models, Prospective Studies, Prosthesis Design, Republic of Korea, Risk Assessment, Risk Factors, Severity of Illness Index, Sirolimus/*administration & dosage, Thrombosis/etiology, Time Factors, Treatment Outcome, Ultrasonography, Interventional
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