Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial

Context  Compared with bare metal stents, sirolimus-eluting 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: NCT00235092      

Impact of biodegradable versus durable polymer drug-eluting stents on clinical outcomes in patients with coronary artery disease: a meta-analysis of 15 randomized trials

Background Drug eluting stents （DESs） made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis （ST） remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST （definite,definite/probable）,mortality,and myocardial infarction （MI）.Efficacy endpoints were major adverse cardiac event （MACE） and target lesion revascularization （TLR）.Results We identified 15 randomized controlled trials （n=17 068） with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk （RR） 0.83; 95% confidence interval （CI） 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST （RR 0.94,95% CI 0.66-1.33,P=0.72）,mortality （RR 0.94,95% C/0.82-1.09,P=0.43）,MI （RR 1.08,95% CI 0.92-1.26.P=0.35）,MACE （RR 0.99,95% CI 0.91-1.09,P=0.85）,and TLR （RR,0.94,95% CI 0.83-1.06,P=0.30） compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times：≤1 year favoring durable polymer DES and 〉1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.     

Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial

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 sirolimus-eluting 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 in-segment 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, 0.14-0.70; 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.      

Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial

Context  In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis. Objectives  To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent. Design, Setting, and Participants  Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003. Interventions  After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group). Main Outcome Measures  Primary end point: angiographic restenosis (diameter stenosis 50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents. Results  Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients. Conclusions  In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.      

Effects of antibiotic therapy on outcomes of patients with coronary artery disease: a meta-analysis of randomized controlled trials

Context  Although Chlamydia pneumoniae infection has been associated with the initiation and progression of atherosclerosis, results of clinical trials investigating antichlamydial antibiotics as adjuncts to standard therapy in patients with coronary artery disease (CAD) have been inconsistent. Objective  To conduct a meta-analysis of clinical trials of antichlamydial antibiotic therapy in patients with CAD. Data Sources  The MEDLINE and Cochrane Central Register of Controlled Trials databases were searched from 1966 to April 2005 for English-language trials of antibiotic therapy in patients with CAD. Bibliographies of retrieved articles were searched for further studies. Presentations at major scientific meetings (2003-2004) were also reviewed. Search terms included antibacterial agents, myocardial infarction, unstable angina, and coronary arteriosclerosis. Study Selection  Eligible studies were prospective, randomized, placebo-controlled trials of antichlamydial antibiotic therapy in patients with CAD that reported all-cause mortality, myocardial infarction, or unstable angina. Of the 110 potentially relevant articles identified, 11 reports enrolling 19 217 patients were included. Data Extraction  Included studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points. End points of interest included all-cause mortality, myocardial infarction (MI), and a combined end point of MI and unstable angina. Data Synthesis  Event rates were combined using a random-effects model. Antibiotic therapy had no impact on all-cause mortality among treated vs untreated patients (4.7% vs 4.6%; odds ratio [OR], 1.02; 95% confidence interval [CI], 0.89-1.16; P = .83), on the rates of MI (5.0% vs 5.4%; OR, 0.92; 95% CI, 0.81-1.04; P = .19), or on the combined end point of MI and unstable angina (9.2% vs 9.6%; OR, 0.91; 95% CI, 0.76-1.07; P = .25). Conclusion  Evidence available to date does not demonstrate an overall benefit of antibiotic therapy in reducing mortality or cardiovascular events in patients with CAD.      

Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials

Context  Patients with unstable angina or non–ST-segment elevation myocardial infarction (NSTEMI) can be cared for with a routine invasive strategy involving coronary angiography and revascularization or more conservatively with a selective invasive strategy in which only those with recurrent or inducible ischemia are referred for acute intervention. Objective  To conduct a meta-analysis that compares benefits and risks of routine invasive vs selective invasive strategies. Data Sources  Randomized controlled trials identified through search of MEDLINE and the Cochrane databases (1970 through June 2004) and hand searching of cross-references from original articles and reviews. Study Selection  Trials were included that involved patients with unstable angina or NSTEMI who received a routine invasive or a selective invasive strategy. Data Extraction  Major outcomes of death and myocardial infarction (MI) occurring from initial hospitalization to the end of follow-up were extracted from published results of eligible trials. Data Synthesis  A total of 7 trials (N = 9212 patients) were eligible. Overall, death or MI was reduced from 663 (14.4%) of 4604 patients in the selective invasive group to 561 (12.2%) of 4608 patients in the routine invasive group (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.72-0.93; P = .001). There was a nonsignificant trend toward fewer deaths (6.0% vs 5.5%; OR, 0.92; 95% CI, 0.77-1.09; P = .33) and a significant reduction in MI alone (9.4% vs 7.3%; OR, 0.75; 95% CI, 0.65-0.88; P<.001). Higher-risk patients with elevated cardiac biomarker levels at baseline benefited more from routine intervention, with no significant benefit observed in lower-risk patients with negative baseline marker levels. During the initial hospitalization, a routine invasive strategy was associated with a significantly higher early mortality (1.1% vs 1.8% for selective vs routine, respectively; OR, 1.60; 95% CI, 1.14-2.25; P = .007) and the composite of death or MI (3.8% vs 5.2%; OR, 1.36; 95% CI, 1.12-1.66; P = .002). But after discharge, the routine invasive strategy was associated with fewer subsequent deaths (4.9% vs 3.8%; OR, 0.76; 95% CI, 0.62-0.94; P = .01) and the composite of death or MI (11.0% vs 7.4%; OR, 0.64; 95% CI, 0.56-0.75; P<.001). At the end of follow-up, there was a 33% reduction in severe angina (14.0% vs 11.2%; OR, 0.77; 95% CI, 0.68-0.87; P<.001) and a 34% reduction in rehospitalization (41.3% vs 32.5%; OR, 0.66; 95% CI, 0.60-0.72; P<.001) with a routine invasive strategy. Conclusions  A routine invasive strategy exceeded a selective invasive strategy in reducing MI, severe angina, and rehospitalization over a mean follow-up of 17 months. But routine intervention was associated with a higher early mortality hazard and a trend toward a mortality reduction at follow-up. Future strategies should explore ways to minimize the early hazard and enhance later benefits by focusing on higher-risk patients and optimizing timing of intervention and use of proven therapies.      

Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial

Context  Although vascular brachytherapy is the only approved therapy for restenosis following bare-metal stent implantation, drug-eluting stents are now being used. Data on the relative merits of each are limited. Objective  To determine the safety and efficacy of the sirolimus-eluting stent compared with vascular brachytherapy for the treatment of patients with restenosis within a bare-metal stent. Design, Setting, and Patients  Prospective, multicenter, randomized trial of 384 patients with in-stent restenosis who were enrolled between February 2003 and July 2004 at 26 academic and community medical centers. Data presented represent all follow-up as of June 30, 2005. Interventions  Vascular brachytherapy (n = 125) or the sirolimus-eluting stent (n = 259). Main Outcome Measure  Target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months postprocedure. Results  Baseline patient characteristics were well matched. Lesion length was similar between vascular brachytherapy and sirolimus-eluting stent patients (mean [SD], 16.76 [8.55] mm vs 17.22 [7.97] mm, respectively; P = .61). Procedural success was 99.2% (124/125) in the vascular brachytherapy group and 97.3% (250/257) in the sirolimus-eluting stent group (P = .28). The rate of target vessel failure was 21.6% (27/125) with vascular brachytherapy and 12.4% (32/259) with the sirolimus-eluting stent (relative risk [RR], 1.7; 95% confidence interval [CI], 1.1-2.8; P = .02). Target lesion revascularization was required in 19.2% (24/125) of the vascular brachytherapy group and 8.5% (22/259) of the sirolimus-eluting stent group (RR, 2.3 [95% CI, 1.3-3.9]; P = .004). At follow-up angiography, the rate of binary angiographic restenosis for the analysis segment was 29.5% (31/105) for the vascular brachytherapy group and 19.8% (45/227) for the sirolimus-eluting stent group (RR, 1.5 [95% CI, 1.0-2.2]; P = .07). Compared with the vascular brachytherapy group, minimal lumen diameter was larger in the sirolimus-eluting stent group at 6-month follow-up (mean [SD], 1.52 [0.63] mm vs 1.80 [0.63] mm; P<.001), reflecting greater net lumen gain in the analysis segment (0.68 [0.60] vs 1.0 [0.61] mm; P<.001) due to stenting and no edge restenosis. Conclusion  Sirolimus-eluting stents result in superior clinical and angiographic outcomes compared with vascular brachytherapy for the treatment of restenosis within a bare-metal stent. Trial Registration  ClinicalTrials.gov Identifier: NCT00231257      

Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial

Gregg W. Stone, MD; Mark Midei, MD; William Newman, MD; Mark Sanz, MD; James B. Hermiller, MD; Jerome Williams, MD; Naim Farhat, MD; Kenneth W. Mahaffey, MD; Donald E. Cutlip, MD; Peter J. Fitzgerald, MD, PhD; Poornima Sood, MD, MPhil; Xiaolu Su, MS; Alexandra J. Lansky, MD; for the SPIRIT III Investigators

JAMA. 2008;299(16):1903-1913.

Context  A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.

Objective  To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.

Design, Setting, and Patients  The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.

Interventions  Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).

Main Outcome Measures  The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.

Results  Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, –0.14 [95% CI, –0.23 to –0.05]; P  .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, –1.9% [95% CI, –5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.

Conclusions  In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.

Trial Registration  clinicaltrials.gov Identifier: NCT00180479

     

Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial

Context  Compared with bare metal stents, drug-eluting stents reduce restenosis in noncomplex lesions. The utility of drug-eluting stents has not been evaluated in more difficult stenoses. Objective  To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in a patient population with more complex lesions than previously studied. Design, Setting, and Patients  Prospective, placebo-controlled, double-blind, multicenter randomized trial conducted from February 2003 to March 2004 at 66 academic and community-based institutions with 1156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4%) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) and 9-month clinical and angiographic follow-up. Interventions  Patients were randomly assigned to receive 1 or more bare metal stents (n = 579) or identical-appearing paclitaxel-eluting stents (n = 577). Main Outcome Measure  Ischemia-driven target vessel revascularization at 9 months. Results  Baseline characteristics were well matched. Diabetes was present in 31% of patients. The mean (SD) reference vessel diameter was 2.69 (0.57) mm, the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type B₂/C. A mean (SD) of 1.38 (0.58) stents (total mean [SD] length, 28.4 [13.1] mm) were implanted per lesion; 33% of lesions required multiple stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and 17% of lesions, respectively. Compared with bare metal stents, paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7% to 8.6% (P<.001) and target vessel revascularization from 17.3% to 12.1% (P = .02). Similar rates were observed for cardiac death or myocardial infarction (5.5% for bare metal stent group vs 5.7% for paclitaxel-eluting stent group) and stent thrombosis (0.7% in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in the entire study cohort (P<.001), including among patients receiving 2.25-mm stents (49.4% vs 31.2%; P = .01), 4.0-mm stents (14.4% vs 3.5%; P = .02), and multiple stents (57.8% vs 27.2%; P<.001). Conclusion  Compared with a bare metal stent, implantation of the paclitaxel-eluting stent in a patient population with complex lesions effectively reduces clinical and angiographic restenosis.      

Oral anticoagulant therapy in patients with coronary artery disease: a meta-analysis

CONTEXT: Despite years of use in coronary artery disease (CAD) and several studies of its effectiveness, the role of oral anticoagulants (OAs) remains controversial. OBJECTIVE: To determine the effects of long-term OA therapy, stratified by the intensities of anticoagulation and aspirin therapy, on outcomes in patients with CAD. DATA SOURCES: Studies were identified by MEDLINE, EMBASE, and CURRENT CONTENTS searches (1960-July 1999) and by reviewing reference lists and inquiring with experts and pharmaceutical companies. STUDY SELECTION: Studies were included if they were published between 1960 and July 1999, were randomized, had recruited patients with CAD, who had used OA therapy for at least 3 months. Of 43 articles identified, 30 articles (31 trials) were analyzed. DATA EXTRACTION: Information on type, duration, and method of monitoring OA therapy, as well as rates of death, myocardial infarction (MI), thromboembolic complications, stroke, and bleeding were abstracted by 2 independent observers. DATA SYNTHESIS: With high-intensity (international normalized ratio [INR], 2.8-4.8) OAs vs control (16 trials, 10056 patients), clear reductions in mortality (odds reduction [ORed], 22%; 95% confidence interval [CI], 13%-31%), MIs (ORed, 42%; 95% CI, 34%-48%), and thromboembolic complications including stroke (ORed, 63%; 95% CI, 53-71%) were observed, but were associated with a 6.0-fold (95% CI, 4.4- to 8.2-fold) increase in major bleeding. For moderate OAs (INR, 2-3) vs control (4 trials, 1365 patients) the ORed for death was 18% (95% CI, -6% to 37%); for MI, 52% (95% CI, 37%-64%); and for stroke, 53% (95% CI, 19%-73%), but it increased bleeding by 7.7-fold (95% CI, 3.3- to 18-fold). For moderate- to high-intensity OAs (INR, > or =2) vs aspirin (7 trials, 3457 patients), no reduction in death, MI, or stroke was observed, and it was associated with a 2.4-fold (95% CI, 1.6- to 3.6-fold) increase in major bleeding. For moderate- to high-intensity OAs and aspirin vs aspirin alone (3 trials, 480 patients), the ORed for death, MI, or stroke was 56% (95% CI, 17%-77%) and major bleeding increased by 1.9-fold (0.6- to 6.0-fold). For low-intensity OAs (INR, <2.0) and aspirin vs aspirin alone (3 trials, 8435 patients), no significant reduction in death, MI, or stroke was observed, and major bleeding increased by 1.3-fold (95% CI, 1.0- to 1.8-fold). CONCLUSIONS: Among patients with CAD, high-intensity and moderate-intensity OA are effective in reducing MI and stroke but increase the risk of bleeding. In the presence of aspirin, low-intensity OA does not appear to be superior to aspirin alone, while moderate- to high-intensity OA and aspirin vs aspirin alone appears promising and the bleeding risk is modest, but this requires confirmation from ongoing trials.     

肝素包被Wiktor支架植入术15例

0　引言　为验证肝素包被 Wiktor支架 (Medtronic公司 ,简称肝素支架 )预防支架血栓作用 ,评估长期疗效 ,我院自 1997-11/ 1998- 0 1为 12例冠心病患者尝试安装肝素支架 ,现总结报道如下 .1　对象和方法1.1　对象　患者 12 (男 11,女 1)例 ,年龄 (5 6 .3± 9.5 )岁 (40～ 70岁 ) .稳定性心绞痛 1例 ,不稳定性心绞痛 7例 ,近期心梗 (≤ 4wk) 4例 .单支、双支、三支病变各 4,6 ,2例 .1.2　介入资料　靶血管 13支 ,L AD(前降支 ) ,L CX(回旋支 ) ,RCA(右冠 )各 6 ,6 ,1例 .靶病变 14处 ,A,B,C型病变各4,5 ,5处 ,其中 4处病变扭曲 ,4处为…     

Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials

CONTEXT: Lowering low-density lipoprotein cholesterol (LDL-C) is known to reduce risk of recurrent coronary heart disease in middle-aged men. However, this effect has been uncertain in elderly people and women. OBJECTIVE: To estimate the risk reduction of coronary heart disease and total mortality associated with statin drug treatment, particularly in elderly individuals and women. DATA SOURCES: Trials published in English-language journals were retrieved by searching MEDLINE (1966-December 1998), bibliographies, and authors' reference files. STUDY SELECTION: Studies in which participants were randomized to statin or control treatment for at least 4 years and clinical disease or death was the primary outcome were included in the meta-analysis (5 of 182 initially identified). DATA EXTRACTION: Information on sample size, study drug duration, type and dosage of statin drug, participant characteristics at baseline, reduction in lipids during intervention, and outcomes was abstracted independently by 2 authors (J.H. and S.V.) using a standardized protocol. Disagreements were resolved by consensus. DATA SYNTHESIS: Data from the 5 trials, with 30 817 participants, were included in this meta-analysis. The mean duration of treatment was 5.4 years. Stati n drug treatment was associated with a20% reduction in total cholesterol, 28% reduction in LDL-C, 13% reduction in triglycerides, and 5% increase in high-density lipoprotein cholesterol. Overall, statin drug treatment reduced risk 31 % in major coronary events (95% confidence interval [CI], 26%-36%) and 21 % in all-cause mortality (95% CI, 14%-28%). The risk reduction in major coronary events was similar between women (29%; 95% Cl, 13 %-42 %) and men (31 %; 95% CI, 26%-35%), and between persons aged at least 65 years (32%; 95% CI, 23%-39%) and persons younger than 65 years (31 %; 95% CI, 24%-36%). CONCLUSIONS: Our meta-analysis indicates that reduction in LDL-C associated with statin drug treatment decreases the risk of coronary heart disease and all-cause mortality. The risk reduction was similar for men and women and for elderly and middle-aged persons.     

Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease

Background Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents （DES） implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease （CAD） in China.
Methods From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up： 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird, After two years of follow-up, there were 2176 patients （1245 Cypher, 558 Taxus and 373 Firebird）. All patients were treated with aspirin and clopidogrel over at least 9 months.
Results Among 8190 patients, 17 patients had acute stent thrombosis （0.24%）： 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis： 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%： 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%： 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%： 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.
Conclusion The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.     

冠状动脉CT成像评价可疑冠心病患者预后的

目的评价冠状动脉CT成像（CCTA）预测可疑冠心病（CAD）患者预后的价值。方法检索PubMed、EMBASE和CochraneI．ibrary数据库。采用Statall．0分析数据,合并灵敏度、特异度、阳性似然比（＋LR）、阴性似然比（-LR）、诊断比值比（DOR）及其95％可信区间,绘制总受试者工作特征（SROc）曲线。结果共纳入19篇文献,合计38150例可疑冠心病患者,中位随访期25个月。阴性CCTA患者中,主要不良心血管事件（MACE）、死亡、心肌梗塞（MI）和血管再通发生率分别为0．48％、0．34％、0．05％和0．02％;阳性CCTA患者中,相应事件发生率分别为7．68％、1．59％、0．89％和1．39％。MACE的合并敏感度、特异度、＋LR、-LR和DOR分别为0．99（95％CI：0．97～1．00）、0．43（95％CI：0．37～0．49）、1．74（95％CI：1．56～1_93）、0．01（95％CI：0．00～0．08）和118．27（95％Cj：20．69～676．06）。结论CCTA时可疑CAD患者具有极好的预后价值,阴性CCTA可基本排除不良心血管事件的发生。     

Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result A prospective, historically controlled, multi-center clinical study

Background  The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. This study was conducted to evaluate the safety and efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.
Methods  Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) within the previous six months and served as historical controls (control group). Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.
Results  The demographic characteristics were similar between the two groups despite more patients in the Firebird 2 group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P=0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P=0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller ((2.79±0.46) mm vs (2.98±0.49) mm, P=0.0175) and more stents were implanted for each lesion (1.28±0.52 vs 1.10±0.30, P=0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2 group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P=0.0168; 1.5% vs 26.5% at 12 month, P<0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05±0.09) mm vs (0.98±0.61) mm; in-segment: (0.05±0.18) mm vs (0.72±0.59) mm; P<0.0001) than the control group. One patient in the Firebird 2 group had in-segment restenosis (1.3%) while the rate in the control group (38.1%) was significantly higher, P<0.0001. Intravascular ultrasound examination was performed in 70.1% of patients in the Firebird 2 group and revealed that the percentage of volumetric obstruction was (1.26±1.05) %. No stent thrombosis was observed in either group at 12-month follow-up.
Conclusion  The Firebird 2 sirolimus-eluting cobalt alloyed stent is safe and feasible in treating patients with coronary artery disease.

     

Impact of the pulmonary artery catheter in critically ill patients: meta-analysis of randomized clinical trials

Context  Randomized clinical trials (RCTs) evaluating the pulmonary artery catheter (PAC) have been limited by small sample size. Some nonrandomized studies suggest that PAC use is associated with increased morbidity and mortality. Objective  To estimate the impact of the PAC device in critically ill patients. Data Sources  MEDLINE (1985-2005), the Cochrane Controlled Trials Registry (1988-2005), the National Institutes of Health ClinicalTrials.gov database, and the US Food and Drug Administration Web site for RCTs in which patients were randomly assigned to PAC or no PAC were searched. Results from the ESCAPE trial of patients with severe heart failure were also included. Search terms included pulmonary artery catheter, right heart catheter, catheter, and Swan-Ganz. Study Selection  Eligible studies included patients who were undergoing surgery, in the intensive care unit (ICU), admitted with advanced heart failure, or diagnosed with acute respiratory distress syndrome and/or sepsis; and studies that reported death and the number of days hospitalized or the number of days in the ICU as outcome measures. Data Extraction  Information on eligibility criteria, baseline characteristics, interventions, outcomes, and methodological quality was extracted by 2 reviewers. Disagreements were resolved by consensus. Data Synthesis  In 13 RCTs, 5051 patients were randomized. Hemodynamic goals and treatment strategies varied among trials. A random-effects model was used to estimate the odds ratios (ORs) for death, number of days hospitalized, and use of inotropes and intravenous vasodilators. The combined OR for mortality was 1.04 (95% confidence interval [CI], 0.90-1.20; P = .59). The difference in the mean number of days hospitalized for PAC minus the mean for no PAC was 0.11 (95% CI, –0.51 to 0.74; P = .73). Use of the PAC was associated with a higher use of inotropes (OR, 1.58; 95% CI, 1.19-2.12; P = .002) and intravenous vasodilators (OR, 2.35; 95% CI, 1.75-3.15; P<.001). Conclusions  In critically ill patients, use of the PAC neither increased overall mortality or days in hospital nor conferred benefit. Despite almost 20 years of RCTs, a clear strategy leading to improved survival with the PAC has not been devised. The neutrality of the PAC for clinical outcomes may result from the absence of effective evidence-based treatments to use in combination with PAC information across the spectrum of critically ill patients.      

重叠国产Excel与重叠Cypher雷帕霉素洗脱支架的临床疗效比较

目的:对比研究重叠国产Excel与Cypher药物洗脱支架治疗冠状动脉长病变的疗效。方法:选择接受了重叠国产Excel支架51例患者,支架总长度(46.9±10.6)mm;47例患者接受重叠Cypher支架作为对照组,支架总长度(50.2±8.6)mm。比较两组主要心脏不良事件发生情况。结果:两组1年的新发心肌梗死率为0.8%、1.9%,靶血管的再次血运重建、造影证实的支架再狭窄率为5.8%、3.8%,死亡等主要心脏不良事件差异无统计学意义(P>0.05)。结论:重叠国产Excel雷帕霉素药物洗脱支架与重叠Cypher支架的临床疗效相似,临床效果好,可治疗冠状动脉长病变。     

可降解涂层雷帕霉素洗脱支架(Tivoli支架)治疗冠状动脉性心脏病的疗效

目的 评价国产可降解涂层雷帕霉素洗脱支架(Tivoli支架)用于冠状动脉性心脏病(CHD)患者介入治疗的安全性和近期疗效.方法 2010年9-11月于第二军医大学附属长海医院心血管内科单一植入Tivoli支架的CHD患者167例.术后接受双联抗血小板治疗9个月,观察主要心血管不良事件(MACE)的发生情况,并在术后12个月复查冠状动脉造影.结果 223处靶血管病变共使用Tivoli支架267枚,植入支架成 功率达100％.术后12个月冠状动脉造影随访结果显示,支架内再狭窄的发生率为1.9％(4/211),无1例发生MACE.结论 Tivoli支架治疗CHD是可行的,且具有良好的安全性和满意的近期临床效果.     

Drug-eluting stents improve clinical outcomes in Chinese diabetic patients with de novo coronary artery disease

Diabetes mellitus （DM） has been regarded as an equivalent risk factor as coronary artery disease and is present in nearly 25% of patients who receive percutaneous coronary intervention （PCI）. DM is shown as an adverse predictor for major adverse cardiac events （MACE） after PCI in bare metal stent （BMS） era. Recently, clinical trials have demonstrated the favorable tendency of using drug-eluting stents （DES） in treating diabetic patients with coronary artery disease. This study compared the clinical outcomes between the diabetic patients receiving DES with those receiving BMS in China.     

老年冠心病患者临床特征及PCI术后远期疗效观察

目的 评价老年冠心病患者临床特征及经皮冠状动脉介入术（percutaneous coronary intervention,PCI）后远期安全性及有效性。方法 随机选取2007年1月-2009年1月在解放军总医院心血管内科行冠状动脉支架置入患者632例,将患者分为老年组（≥65岁）和非老年组（〈65岁）,于2012年3月采用电话随访、门诊检查、冠脉造影等随访方式观察患者冠状动脉支架置入后远期不良心血管事件（major adverse cardiac events,MACE）发生情况。结果 老年组与非老年组在女性（24.5%vs 16.8%,P=0.02）、高血压（72.4%vs 59.5%,P=0.001）、吸烟（27.2%vs 53.6%,P=0.001）比例上的差异有统计学意义;PCI术前冠脉造影特征老年组三支病变比例高（44.4%vs 37.3%,P=0.08）;两组MACE发生率差异无统计学意义（12.8%vs 9.1%,P=0.15）,其他不良事件全因死亡率差异有统计学意义（5.5%vs 1.3%,P=0.004）;冠脉造影三支病变中,老年组与非老年组MACE发生率差异无统计学意义（14%vs 8.6%,P=0.23）。结论 老年冠心病患者应当积极控制血压,加强老年女性患者冠心病的筛查。老年冠心病患者冠状动脉支架置入术后远期是安全、有效的。