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
This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm(ASA) associated with patent foramen ovale(PFO). Patients with both ASA and PFO are at high risk for recurre...This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm(ASA) associated with patent foramen ovale(PFO). Patients with both ASA and PFO are at high risk for recurrent paradoxical embolism. The procedural, echocardiographic, and clinical outcomes of 141 patients with ASA +PFO and< 1 paradoxical embolic event undergoing transcatheter treatment were compared with 220 patients with PFO alone. Device success(ASA +PFO, 99.3%; PFO alone, 99.5%; p=0.75) and procedural complications(ASA +PFO, 0.7%; PFO alone, 3.2%; p=0.12) were similar in both groups. Maximal atrial septal excursion in patients with ASA +PFO decreased from 16±4 mm before to 4±3 mm after the intervention(p< 0.0001). At 6 months follow-up, right-to-left shunt was abolished in 120(86%) patients with ASA +PFO, compared to 187(85%) patients with PFO alone(p=0.80). Freedom from recurrent transient ischemic attack, stroke, and peripheral embolism at 4 years was 95%(ASA+PFO) and 94%(PFO alone, p=0.70), respectively. A residual right-to-left shunt after the intervention was the only predictor for recurrence(hazard ratio [HR] 6.9; 95%confidence interval [CI] 1.3 to 36.9, p< 0.03) in patients with ASA +PFO. Transcatheter treatment of ASA +PFO is safe and effective in patients with paradoxical embolism. The procedure effectively abolishes right-to-left shunt and decreases atrial septal mobility. Long-term prevention of recurrent events appears favorable when compared to patients with PFO alone.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This study sought to investigate the safety and efficacy of transcatheter treatment of atrial septal aneurysm(ASA) associated with patent foramen ovale(PFO). Patients with both ASA and PFO are at high risk for recurrent paradoxical embolism. The procedural, echocardiographic, and clinical outcomes of 141 patients with ASA +PFO and< 1 paradoxical embolic event undergoing transcatheter treatment were compared with 220 patients with PFO alone. Device success(ASA +PFO, 99.3%; PFO alone, 99.5%; p=0.75) and procedural complications(ASA +PFO, 0.7%; PFO alone, 3.2%; p=0.12) were similar in both groups. Maximal atrial septal excursion in patients with ASA +PFO decreased from 16±4 mm before to 4±3 mm after the intervention(p< 0.0001). At 6 months follow-up, right-to-left shunt was abolished in 120(86%) patients with ASA +PFO, compared to 187(85%) patients with PFO alone(p=0.80). Freedom from recurrent transient ischemic attack, stroke, and peripheral embolism at 4 years was 95%(ASA+PFO) and 94%(PFO alone, p=0.70), respectively. A residual right-to-left shunt after the intervention was the only predictor for recurrence(hazard ratio [HR] 6.9; 95%confidence interval [CI] 1.3 to 36.9, p< 0.03) in patients with ASA +PFO. Transcatheter treatment of ASA +PFO is safe and effective in patients with paradoxical embolism. The procedure effectively abolishes right-to-left shunt and decreases atrial septal mobility. Long-term prevention of recurrent events appears favorable when compared to patients with PFO alone.
