Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials.

@article{citeulike:2515478, abstract = {OBJECTIVES: We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials. METHODS: Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6\%) with DM. RESULTS: Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4\% vs. 10.3\%, respectively, p = 0.61), myocardial infarction (6.9\% vs. 8.9\%, p = 0.17), or stent thrombosis (1.4\% vs. 1.2\%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4\% vs. 24.7\%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin. CONCLUSIONS: In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.}, address = {Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10022, USA.}, author = {Kirtane, A. J. and Ellis, S. G. and Dawkins, K. D. and Colombo, A. and Grube, E. and Popma, J. J. and Fahy, M. and Leon, M. B. and Moses, J. W. and Mehran, R. and Stone, G. W. }, citeulike-article-id = {2515478}, doi = {10.1016/j.jacc.2007.10.035}, issn = {1558-3597}, journal = {J Am Coll Cardiol}, keywords = {cardiovascular, diabetes, meta-analysis, mortality, rct}, month = {February}, number = {7}, pages = {708--715}, posted-at = {2008-03-11 16:02:53}, priority = {2}, title = {Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials.}, url = {http://dx.doi.org/10.1016/j.jacc.2007.10.035}, volume = {51}, year = {2008} }

TY - JOUR ID - citeulike:2515478 L3 - citeulike-article-id:2515478 TI - Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. JF - J Am Coll Cardiol VL - 51 IS - 7 SP - 708 EP - 715 AD - Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10022, USA. SN - 1558-3597 N2 - OBJECTIVES: We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). BACKGROUND: Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials. METHODS: Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM. RESULTS: Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin. CONCLUSIONS: In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis. KW - cardiovascular KW - diabetes KW - meta-analysis KW - mortality KW - rct AU - Kirtane, AJ AU - Ellis, SG AU - Dawkins, KD AU - Colombo, A AU - Grube, E AU - Popma, JJ AU - Fahy, M AU - Leon, MB AU - Moses, JW AU - Mehran, R AU - Stone, GW PY - 2008/02/19/ UR - http://dx.doi.org/10.1016/j.jacc.2007.10.035 ER -