We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary esions. Dr...We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary esions. Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycinD,which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. The multi-center, single-blind, three-arm ACT inomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia(ACTION) trial randomized 360 patients to receive a DES(2.5 or 10 μg/cm2 of actinomycin D) or metallic stent(MS). The primary end points were major adverse cardiac events(MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound(IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8%and 43.1%vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.展开更多
Objectives: To determine the long term outcome after intracoronary βradiation therapy(IRT). Setting: Tertiary referral centre. Methods: The rate of major adverse cardiac events(MACE) was retrospectively determined in...Objectives: To determine the long term outcome after intracoronary βradiation therapy(IRT). Setting: Tertiary referral centre. Methods: The rate of major adverse cardiac events(MACE) was retrospectively determined in 301 consecutive patients who were treated with IRT. MACE was defined as death, myocardial infarction, or any reintervention. Long term clinical outcome was obtained from an electronic database of hospital records and from questionnaires to the patients and referring physicians. Long term survival status was assessed by written inquiries to the municipal civil registries. Results: The mean(SD) follow up was 3.6(1.2) years. The cumulative incidence of MACE at six months was 19.1%, at one year 36.4%, and at four years 58.3%. The target lesion revascularisation(TLR) rate at six months was 12.9%, at one year 28.3%, and at four years 50.4%. From multivariate analysis, dose< 18 Gy was the most significant predictor of TLR. At four years the cumulative incidence of death was 3.8%, of myocardial infarction 13.4%, and of coronary artery bypass surgery 11.3%. Total vessel occlusion was documented in 12.3%of the patients. Conclusions: In the long term follow up of patients after IRT, there are increased adverse cardiac events beyond the first six months.展开更多
文摘We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novo native coronary esions. Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycinD,which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation. The multi-center, single-blind, three-arm ACT inomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia(ACTION) trial randomized 360 patients to receive a DES(2.5 or 10 μg/cm2 of actinomycin D) or metallic stent(MS). The primary end points were major adverse cardiac events(MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound(IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory. The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8%and 43.1%vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction. The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.
文摘Objectives: To determine the long term outcome after intracoronary βradiation therapy(IRT). Setting: Tertiary referral centre. Methods: The rate of major adverse cardiac events(MACE) was retrospectively determined in 301 consecutive patients who were treated with IRT. MACE was defined as death, myocardial infarction, or any reintervention. Long term clinical outcome was obtained from an electronic database of hospital records and from questionnaires to the patients and referring physicians. Long term survival status was assessed by written inquiries to the municipal civil registries. Results: The mean(SD) follow up was 3.6(1.2) years. The cumulative incidence of MACE at six months was 19.1%, at one year 36.4%, and at four years 58.3%. The target lesion revascularisation(TLR) rate at six months was 12.9%, at one year 28.3%, and at four years 50.4%. From multivariate analysis, dose< 18 Gy was the most significant predictor of TLR. At four years the cumulative incidence of death was 3.8%, of myocardial infarction 13.4%, and of coronary artery bypass surgery 11.3%. Total vessel occlusion was documented in 12.3%of the patients. Conclusions: In the long term follow up of patients after IRT, there are increased adverse cardiac events beyond the first six months.
