Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but thei...Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design: Prospective, randomized comparative trial(the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting: Ninety hospitals in Europe, Latin America, and Asia. Patients: A total of 1386 patients(mean age, 62.6 years; 73.1% men; 28.0% with diabetes)with angina pectoris and 1 or 2 de novo lesions(2.25-3.00 mm in diameter) in native coronary arteries. Intervention: Patients were randomly assigned in a 1 ∶ 1 ratio to receive a sirolimus-eluting stent(n=701) or a paclitaxel-eluting stent(n=685). Main Outcome Measures: The primary end point was in-lesion binary restenosis(presence of a more than 50% luminal diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results: In-lesion binary restenosis at 8 months occurred in 86 patients(9.6% ) with a sirolimus-eluting stent vs 95(11.1% ) with a paclitaxel-eluting stent(relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean(SD) in-stent late loss was 0.09(0.43) mm vs 0.31(0.44) mm(difference,-0.22 mm; 95% CI,-0.26 to-0.18 mm; P<.001), mean(SD) in-stent diameter stenosis was 23.1% (16.6% ) vs 26.7% (15.8% )(difference,-3.60% ; 95% CI,-5.12% to-2.08% ; P< .001), and the number of major adverse cardiac events at 1 year was 73(10.7% ) vs 76(11.4% )(RR, 0.94; 95% CI, 0.69-1.27; P=.73). Conclusion: In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. Clinical Trial Registration: ClinicalTrials.gov Identifier:展开更多
We assessed(1) angiogenic factors in patients with stable angina and longstanding(< 24 months) total occlusion of a single coronary artery and(2) the relation between plasma levels of angiogenic factors and the dev...We assessed(1) angiogenic factors in patients with stable angina and longstanding(< 24 months) total occlusion of a single coronary artery and(2) the relation between plasma levels of angiogenic factors and the development of collateral vessels as evaluated by coronary angiography. Plasma concentrations of vascular endothelial growth factor(VEGF165), fibroblast growth factor, placenta- derived growth factors(PlGFs), and hepatocyte growth factor were assessed in 96 patients with stable angina and longstanding(< 24 months) total occlusion of a single coronary artery. According to coronary angiographic results, 18 patients had no visible collaterals(group 0), 21 patients had visible collaterals but no filling of the recipient epicardial vessel(group 1), and 57 patients showed filling(partial or complete) of the recipient epicardial vessel by collaterals(group 2). Plasma VEGF165 and PlGF concentrations were higher in group 1 than in groups 0 and 2(VEGF165 75 pg/ml, range 24 to 105, vs 23 pg/ml, range 15 to 29, and 19 pg/ml, range 10 to 41, respectively, F=5.53, p=0.006; PlGF 35 pg/ml, range 3.5 to 105, vs 1 pg/ml, range 1 to 38, and 1 pg/ml, range 1 to 5, respectively, F=7.09, p=0.008). Plasma VEGF165 and PlGF levels were similar in groups 0 and 2. There was no significant difference in plasma levels of fibroblast and hepatocyte growth factor concentrations across the 3 groups. In conclusion, plasma levels of angiogenic growth factors differ among patients with stable angina pectoris and longstanding total coronary occlusion.展开更多
文摘Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design: Prospective, randomized comparative trial(the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting: Ninety hospitals in Europe, Latin America, and Asia. Patients: A total of 1386 patients(mean age, 62.6 years; 73.1% men; 28.0% with diabetes)with angina pectoris and 1 or 2 de novo lesions(2.25-3.00 mm in diameter) in native coronary arteries. Intervention: Patients were randomly assigned in a 1 ∶ 1 ratio to receive a sirolimus-eluting stent(n=701) or a paclitaxel-eluting stent(n=685). Main Outcome Measures: The primary end point was in-lesion binary restenosis(presence of a more than 50% luminal diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results: In-lesion binary restenosis at 8 months occurred in 86 patients(9.6% ) with a sirolimus-eluting stent vs 95(11.1% ) with a paclitaxel-eluting stent(relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean(SD) in-stent late loss was 0.09(0.43) mm vs 0.31(0.44) mm(difference,-0.22 mm; 95% CI,-0.26 to-0.18 mm; P<.001), mean(SD) in-stent diameter stenosis was 23.1% (16.6% ) vs 26.7% (15.8% )(difference,-3.60% ; 95% CI,-5.12% to-2.08% ; P< .001), and the number of major adverse cardiac events at 1 year was 73(10.7% ) vs 76(11.4% )(RR, 0.94; 95% CI, 0.69-1.27; P=.73). Conclusion: In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. Clinical Trial Registration: ClinicalTrials.gov Identifier:
文摘We assessed(1) angiogenic factors in patients with stable angina and longstanding(< 24 months) total occlusion of a single coronary artery and(2) the relation between plasma levels of angiogenic factors and the development of collateral vessels as evaluated by coronary angiography. Plasma concentrations of vascular endothelial growth factor(VEGF165), fibroblast growth factor, placenta- derived growth factors(PlGFs), and hepatocyte growth factor were assessed in 96 patients with stable angina and longstanding(< 24 months) total occlusion of a single coronary artery. According to coronary angiographic results, 18 patients had no visible collaterals(group 0), 21 patients had visible collaterals but no filling of the recipient epicardial vessel(group 1), and 57 patients showed filling(partial or complete) of the recipient epicardial vessel by collaterals(group 2). Plasma VEGF165 and PlGF concentrations were higher in group 1 than in groups 0 and 2(VEGF165 75 pg/ml, range 24 to 105, vs 23 pg/ml, range 15 to 29, and 19 pg/ml, range 10 to 41, respectively, F=5.53, p=0.006; PlGF 35 pg/ml, range 3.5 to 105, vs 1 pg/ml, range 1 to 38, and 1 pg/ml, range 1 to 5, respectively, F=7.09, p=0.008). Plasma VEGF165 and PlGF levels were similar in groups 0 and 2. There was no significant difference in plasma levels of fibroblast and hepatocyte growth factor concentrations across the 3 groups. In conclusion, plasma levels of angiogenic growth factors differ among patients with stable angina pectoris and longstanding total coronary occlusion.
