Context: Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arte...Context: Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated. Objective: To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent. Design, Setting, and Patients: This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003. Intervention: Patients were randomly assigned to receive a sirolimuseluting stent(129 patients)or an uncoated stent having an identical architecture and radiographic appearance(128 patients). Main Outcome Measures: The primary end point was the 8-month binary insegment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events. Results: The mean(SD)reference diameter of the treated segment was 2.2(0.28)mm; the lesion length, 11.84(6.15)mm. After 8 months, the binary in-segment restenosis rate was 53.1%(60/113)in the patients receiving an uncoated stent and 9.8%(12/123)-in those receiving a sirolimus-eluting stent(relative risk [RR], 0.18; 95%confidence interval [CI], 0.10-0.32; P< .001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events(12/129[9.3%] vs 40/128[31.3%]; RR, 0.30; 95%CI, 0.15-0.55; P< .001)mainly because of a reduction in target lesion revascularization(9/129[7%] vs 27/128[21.1%]; RR, 0.33; 95%CI, 0.140.70; P=.002)and myocardial infarction(2/129 [1.6%] vs 10/129[7.8%]; RR, 0.20; 95%CI, 0.01-0.93; P=.04). Conclusion: The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.展开更多
Background: National registries are advocated as instrumental to the solution of rarity-related problems for patients with hypertrophic cardiomyopathy(HCM), including limited access to advanced treatment options. Thus...Background: National registries are advocated as instrumental to the solution of rarity-related problems for patients with hypertrophic cardiomyopathy(HCM), including limited access to advanced treatment options. Thus, an Italian Registry for HCM was created to assess the clinical profile and the level of care nationwide of patients with HCM. Methods: Cardiology centers over the national territory were recruited to provide clinical data of all patients with HCM ever seen at each institution. The enrollment period was from May 2000 to May 2002. Results: The registry enrolled 1677 patients from 40 institutions. Most(69% )were followed at referral centers, whereas 31% were from community centers with intermediate-low patient flow. Patients diagnosed after routine medical examinations or familial screenings were 39% . Most patients were male(62% ), in their fourth to sixth decade of life, and in New York Heart Association class I to II(89% ); 24% had resting left ventricular obstruction and 18% had atrial fibrillation. During a 9.7-year average follow-up, cardiovascular mortality was 1% /y, mostly because of heart failure, with no significant change over the last 3 decades; sudden death was less common(0.4% /y). Only 4% of patients received a defibrillator; 14% of the 401 patients with LV outflow obstruction underwent invasive relief of obstruction; and< 1% were offered genetic analyses or counseling. Conclusions: The Italian Registry represents the first comprehensive attempt to evaluate the clinical impact and management of HCM at a national level. Findings underscore the role of screening strategies for an early diagnosis and suggest limited use of the advanced therapeutic options for HCM.展开更多
文摘Context: Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated. Objective: To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent. Design, Setting, and Patients: This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003. Intervention: Patients were randomly assigned to receive a sirolimuseluting stent(129 patients)or an uncoated stent having an identical architecture and radiographic appearance(128 patients). Main Outcome Measures: The primary end point was the 8-month binary insegment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events. Results: The mean(SD)reference diameter of the treated segment was 2.2(0.28)mm; the lesion length, 11.84(6.15)mm. After 8 months, the binary in-segment restenosis rate was 53.1%(60/113)in the patients receiving an uncoated stent and 9.8%(12/123)-in those receiving a sirolimus-eluting stent(relative risk [RR], 0.18; 95%confidence interval [CI], 0.10-0.32; P< .001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events(12/129[9.3%] vs 40/128[31.3%]; RR, 0.30; 95%CI, 0.15-0.55; P< .001)mainly because of a reduction in target lesion revascularization(9/129[7%] vs 27/128[21.1%]; RR, 0.33; 95%CI, 0.140.70; P=.002)and myocardial infarction(2/129 [1.6%] vs 10/129[7.8%]; RR, 0.20; 95%CI, 0.01-0.93; P=.04). Conclusion: The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.
文摘Background: National registries are advocated as instrumental to the solution of rarity-related problems for patients with hypertrophic cardiomyopathy(HCM), including limited access to advanced treatment options. Thus, an Italian Registry for HCM was created to assess the clinical profile and the level of care nationwide of patients with HCM. Methods: Cardiology centers over the national territory were recruited to provide clinical data of all patients with HCM ever seen at each institution. The enrollment period was from May 2000 to May 2002. Results: The registry enrolled 1677 patients from 40 institutions. Most(69% )were followed at referral centers, whereas 31% were from community centers with intermediate-low patient flow. Patients diagnosed after routine medical examinations or familial screenings were 39% . Most patients were male(62% ), in their fourth to sixth decade of life, and in New York Heart Association class I to II(89% ); 24% had resting left ventricular obstruction and 18% had atrial fibrillation. During a 9.7-year average follow-up, cardiovascular mortality was 1% /y, mostly because of heart failure, with no significant change over the last 3 decades; sudden death was less common(0.4% /y). Only 4% of patients received a defibrillator; 14% of the 401 patients with LV outflow obstruction underwent invasive relief of obstruction; and< 1% were offered genetic analyses or counseling. Conclusions: The Italian Registry represents the first comprehensive attempt to evaluate the clinical impact and management of HCM at a national level. Findings underscore the role of screening strategies for an early diagnosis and suggest limited use of the advanced therapeutic options for HCM.
