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The PRESTO (Prevention of Restenosis with Tranilast and its Outcomes) protocol:: A double-blind, placebo-controlled trial

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AMERICAN HEART JOURNAL 2000年第1期139卷 23-31页

作者： Holmes, D Fitzgerald, P Goldberg, S LaBlanche, JM Lincoff, AM Savage, M Serruys, PW Willerson, J Granett, JR Chan, R Shusterman, NH Poland, M Mayo Clin & Mayo Fdn Div Internal Med & Cardiovasc Dis Rochester MN 55905 USA Stanford Univ Stanford CA 94305 USA Cooper Hosp Univ Med Ctr Camden NJ 08103 USA Hosp Cardiol Lille France Cleveland Clin Fdn Cleveland OH 44195 USA Thomas Jefferson Univ Hosp Philadelphia PA 19107 USA Ctr Heart Rotterdam Netherlands Univ Texas Sch Med Houston TX USA Texas Heart Inst Houston TX 77025 USA SmithKline Beecham Collegeville PA 19426 USA

Background Tranilast is a unique drug in clinical development for the prevention of restenosis after percutaneous transluminal coronary revascularization (PTCR). Tranilast interferes with proliferation and migration of vascular medial smooth muscle cells induced by platelet-derived growth factor and transforming growth factor beta 1. Collagen synthesis in vascular medial smooth muscle cells is inhibited by tranilast, which also inhibits the release or production of cyclooxygenase-2 and restores cytokine-induced nitric oxide production. These mechanisms may contribute to the reduction of angiographic restenosis after coronary intervention previously reported in clinical studies. Methods The primary objective of this multicenter study of 11,500 patients is to compare the composite clinical event rate of death, myocardial infarction, or the need for ischemia-driven target vessel revascularization of tranilast (300 and 450 mg twice daily) for I or 3 months with that of placebo in patients undergoing PTCR with or without stenting for single or multiple vessels over a 9-month period. The lesions can be de novo or restenotic. All revascularization procedures and the use of glycoprotein IIb/IIIa agents are permitted. The inclusion criteria are meant to allow an "all comer" approach for generalization of results to the broadest possible PTCR population. A subset population (n = 2000) will undergo 9-month follow-up angiography, 1000 of which will also undergo intravascular ultrasound (n = 1000). This study is the first tranilast trial to be conducted in a Western population to confirm the improved angiographic findings reported in Japanese patients and to determine if the clinical sequelae of restenosis are also reduced. Conclusion This multicenter study is the largest restenosis trial planned to date. It will test whether tranilast, a drug with multiple actions aimed at affecting proliferation and migration of vascular smooth muscle cells, can reduce clinical, angiographic,

关键词：邻氨基苯甲酸类/药代动力学邻氨基苯甲酸类/治疗应用冠状血管造影术冠心病/放射摄影术冠心病/治疗冠心病/超声检查双盲法移植物闭塞血管/血液移植物闭塞血管/诊断移植物闭塞血管/死亡率移植物闭塞血管/预防和控制心肌血管重建术/方法血小板聚集抑制剂/药代动力学血小板聚集抑制剂/治疗应用复发/预防和控制安全存活率治疗结果超声检查介入性美国/流行病学青少年人类

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Pedal bypass for limb salvage: Impact of diabetes on long-term outcome

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ANNALS OF VASCULAR SURGERY 2000年第6期14卷 640-647页

作者： Panneton, JM Gloviczki, P Bower, TC Rhodes, JM Canton, LG Toomey, BJ Mayo Clin Div Vasc Surg Rochester MN 55905 USA

Use of pedal bypass can salvage limbs of patients with critical ischemia. The aim of this study was to evaluate the results of surgical revascularization of pedal arteries in diabetic patients and to assess the impact of diabetes on long-term outcome. We performed a retrospective analysis of all consecutive pedal bypasses done between January 1, 1987 and December 31, 1997. Demographic data, surgical indications, operative variables, and postoperative results including graft patency and limb salvage were compared between diabetic and nondiabetic patients. The results of this comparison showed that pedal bypass can safely and effectively relieve critical ischemia in diabetic patients. Diabetics have less early graft thrombosis and superior long-term graft patency. Despite higher incidence of renal insufficiency or failure and more tissue loss, diabetics can achieve similar excellent limb salvage rates. This outcome justifies aggressive revascularization of pedal arteries in diabetic as well as nondiabetic patients with critical limb ischemia.

关键词：血管假体植入糖尿病血管病变/死亡率糖尿病血管病变/外科学随访研究足/血液供给移植物闭塞血管/死亡率缺血/死亡率缺血/外科学存活率治疗结果成年人老年人老年人 80以上女(雌)性人类男(雄)性中年人

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Angiographic changes in saphenous vein grafts are predictors of clinical outcomes

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AMERICAN HEART JOURNAL 2003年第2期145卷 262-269页

作者： Knatterud, GL White, C Geller, NL Campeau, L Forman, SA Domanski, M Forrester, JS Gobel, FL Herd, JA Hickey, A Hoogwerf, BJ Hunninghake, DB Terrin, ML Rosenberg, Y Univ Minnesota Heart Dis Prevent Clin Minneapolis MN USA Cleveland Clin Fdn Cleveland OH 44195 USA Baylor Coll Med Houston TX 77030 USA Minneapolis Heart Inst Fdn Minneapolis MN USA Cedars Sinai Med Ctr Los Angeles CA 90048 USA NHLBI Div Epidemiol & Clin Applicat Bethesda MD 20892 USA Montreal Heart Inst Montreal PQ H1T 1C8 Canada NHLBI Off Biostat Res Bethesda MD 20892 USA Univ Minnesota Angiogram Reading Ctr Minneapolis MN USA Maryland Med Res Inst POST CABG Coordinating Ctr Baltimore MD 21210 USA

Background Previous studies have suggested that angiographic evidence of disease progression in coronary arteries increases the risk of subsequent coronary clinical events. This study ascertained whether patients enrolled in-the Post Coronary Artery Bypass Graft Clinical Trial (POST CABG) who had substantial progression of atherosclerosis in greater than or equal to1 saphenous vein grafts (on the basis of assessment of baseline and follow-up angiograms obtained 4-5 years after study entry), but who had not reported clinical symptoms before follow-up angiography, were at a higher risk of subsequent events than patients who did not have substantial progression of atherosclerosis (decrease greater than or equal to0.6 mm in lumen diameter at site of greatest change from baseline). Methods All 1351 patients enrolled in the trial underwent baseline angiography;only the 961 patients who had follow-up angiography and no coronary events before the follow-up study were included in this analysis. The clinical center staff contacted patients to ascertain the events that had occurred after follow-up angiography (approximately 3.4 years later). Results Sixty-nine patients had died;870 patients or relatives were interviewed, and 22 patients could not be contacted. Univariable estimates of relative risk associated with substantial progression ranged from 2.2 (P < .001) for cardiovascular death or nonfatal myocardial infarction to 3.3 (P < .001) for revascularization. Multivariable and univariable estimates of risk were similar. Conclusions The findings provide evidence that patients who had substantial progression of atherosclerosis in vein grafts are at an increased risk for subsequent coronary events and suggest that angiographic changes in vein grafts are appropriate surrogate measures for clinical outcomes.

关键词：方差分析冠状血管造影术疾病恶化移植物闭塞血管/死亡率移植物闭塞血管/放射摄影术心肌血管重建术/死亡率预后危险隐静脉/放射摄影术隐静脉/移植治疗结果老年人女(雌)性人类男(雄)性中年人

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Prognostic value of thallium-201 single-photon emission computed tomography for patients with multivessel coronary artery disease after revascularization (the emory angioplasty versus surgery trial [EAST])

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第12期84卷 1369-1374页

作者： Alazraki, NP Krawczynska, EG Kosinski, AS DePuey, EG Ziffer, JA Taylor, AT Pettigrew, RI Vansant, JP Shaw, LJ Weintraub, WS King, SB Emory Univ Sch Med Dept Radiol Div Nucl Med Atlanta GA 30322 USA Emory Univ Sch Med Dept Biostat Rollins Sch Publ Hlth Atlanta GA 30322 USA Emory Univ Sch Med Dept Med Div Cardiol Atlanta GA 30322 USA

The aim of this study was to investigate the relation between reversible thallium single-photon emission computed tomegraphy (SPECT) myocardial perfusion defects at 1-year after revascularization and quantitative indexes in Emery Angioplasty versus Surgery Trial (EAST) and outcomes 3 years after revascularization in 336 patients. EAST was a randomized controlled trial assessing cardiac outcomes for angioplasty versus bypass surgery for patients with multivessel coronary artery disease. During this prospective trial, a substudy included the evaluation of the prognostic value of reversible defects on quantitative thallium SPECT. At 1-year after revascularization, 336 patients underwent SPECT thallium-201 stress myocardial perfusion and 3-hour delayed imaging. Subsequent events, percutaneous transluminal coronary angioplasty, coronary artery bypass graft surgery, myocardial infarction, and death, were recorded at 3 years. A stress-induced reversible thallium-201 defect was defined using a quantitative index of a reversibility score >30% and severity score >500. Reversible defects were observed more frequently in the percutaneous transluminal coronary angioplasty than in the coronary artery bypass graft surgery treatment groups (46% vs 27%, p <0.001). A fetal of 123 patients had stress-induced, reversible thallium defects and more events than patients with other perfusion results (freedem from ail events was 81.3% vs 94% [p <0.001], and freedom from myocardial infarction and death 88.3% vs 95.5% [p = 0.031]). Quantitative thallium SPECT at 1 year after revascularization risk stratifies patients as to their likelihood of major cardiac outcomes. (C) 1999 by Excerpta Medico, Inc.

关键词：血管成形术经腔经皮冠状动脉死亡原因冠状动脉分流术冠状动脉循环/生理学冠心病/死亡率冠心病/放射性核素显像冠心病/外科学运动试验随访研究移植物闭塞血管/死亡率移植物闭塞血管/放射性核素显像心肌梗死/死亡率心肌梗死/放射性核素显像手术后并发症/死亡率手术后并发症/放射性核素显像预后存活率铊放射性同位素/诊断应用体层摄影术发射型计算机单光子老年人人类中年人

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In-hospital and long-term results of stent deployment compared with balloon angioplasty for treatment of narrowing at the saphenous vein graft distal anastomosis site

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第12期84卷 1381-1384页

作者： Gruberg, L Hong, MK Mehran, R Mintz, GS Kornowski, R Lansky, AJ Kent, KM Pichard, AD Satler, LF Dangas, G Wu, HS Stone, GW Leon, MB Washington Hosp Ctr Cardiac Catheterizat Lab Washington DC 20010 USA Washington Hosp Ctr Cardiovasc Res Fdn Washington DC 20010 USA

Disease at the distal anastomosis site of saphenous vein grafts (SVGs) has been successfully treated with balloon angioplasty, with a lower restenosis rate than at sites of the aortoostial or proximal portion of the SVG. The role of stents for these lesions has not been well defined. To compare the in-hospital and long-term outcome of patients who underwent treatment at this site by either balloon angioplasty or tubular stent implantation, we studied 182 consecutive patients who underwent balloon angioplasty and 77 patients who underwent stenting between January 1994 and August 1997. Baseline clinical characteristics for both groups were similar. Angiographically, SVG stenoses treated with stents were older, longer in lesion length, and more restenotic. The in-hospital outcome was similar for both groups, with 98% procedural success rates and 1% major ischemic complications. Long-term follow-up was obtained for 93% of the patients, for an average of 17 +/- 14 months. The mortality rates were similar for patients who underwent balloon angioplasty and stenting (11.6% vs 13%, p = NS). The Q-wave myocardial infarction rates were also similar (1% vs 0%, p = NS). There was a trend toward a higher rate of target lesion revascularization in the balloon angioplasty group (25% vs 14%, p = 0.058). We conclude that percutaneous revascularization of the SVG distal anastomosis sire by either balloon angioplasty or stenting can be performed with a high rate of procedural success and favorable in-hospital and long-term outcomes. Stent deployment may further improve the long-term outcome of these patients by reducing the need for repeat revascularization. (C) 1999 by Excerpta Medico, Inc.

关键词：吻合术外科血管成形术经腔经皮冠状动脉/仪器和设备冠状血管造影术冠状动脉分流术随访研究移植物闭塞血管/死亡率移植物闭塞血管/放射摄影术移植物闭塞血管/治疗医院死亡率复发支架存活率静脉/移植老年人女(雌)性人类男(雄)性中年人

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Usefulness of cilostazol versus ticlopidine in coronary artery stenting

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第12期84卷 1375-1380页

作者： Yoon, YS Shim, WH Lee, DH Pyun, WB Kim, IJ Jang, Y Cho, SY Yonsei Univ Coll Med Div Cardiol Yonsei Cardiovasc CtrSeodaemun Ku Seoul 120752 South Korea

A combination of ticlopidine and aspirin has been accepted as the standard antithrombotic regimen after coronary stenting. However, ticlopidine poses serious side effects such as neutropenia or thrombocytopenia. Cilostazol, a cyclic adenosine monophosphate phosphodiesterase inhibitor, is a novel antiplatelet agent with vasodilatory properties. We compared the efficacy and safety of cilostarol plus aspirin (C+A) with ticlopidine plus aspirin (T+A) in elective coronary stenting. Three hundred patients were randomly assigned to receive C+A or T+A 2 days before stenting. The primary end point was a composite of angiographic stent thrombosis, or major cardiac events (death, myocardial infarction, bypass surgery, repeat intervention) at 30 days. The secondary end points were bleeding vascular complications, neutropenia, thrombocytopenia, or side effects requiring discontinuation of the drugs at 30 days. The primary end point was reached in 1.4% in the C+A group and 2.0% in the T+A group (p = 1.0). The rate of bleeding vascular complications was 1.4% in the C+A group and 2.0% in the T+A group (p = 1.0). The rate of drug-related side effects was not statistically different between the 2 groups but slightly higher in the T+A group than in the C+A group (2.7% vs 0.7%, p = 0.37). However, neutropenia was seen in 2 patients only in the T+A group. As a poststenting antithrombotic, C+A is as effective as T+A in preventing major cardiac events including stent thrombosis, and safer in that it does not cause neutropenia despite the fact that there is no statistical difference in the incidence of adverse effects and complications. (C) 1999 by Excerpta Medico, Inc.

关键词：阿司匹林/投药和剂量死亡原因冠状血管造影术冠心病/死亡率冠心病/治疗药物疗法联合随访研究移植物闭塞血管/死亡率移植物闭塞血管/预防和控制心肌梗死/死亡率心肌梗死/治疗血小板聚集抑制剂/投药和剂量复发支架存活率四唑类/投药和剂量噻氯匹定/投药和剂量治疗结果成年人老年人女(雌)性人类男(雄)性中年人

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Design and methodology of the ESPRIT trial: Evaluating a novel dosing regimen of eptifibatide in percutaneous coronary intervention

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AMERICAN HEART JOURNAL 2000年第6期140卷 834-839页

作者： O'Shea, JC Madan, M Cantor, WJ Pacchiana, CM Greenberg, S Joseph, DM Kitt, MM Lorenz, TJ Tcheng, JE Duke Clin Res Inst Durham NC 27705 USA Sunnybrook & Womens Coll Hlth Sci Ctr Toronto ON Canada COR Therapeut S San Francisco CA USA

Background Clinical trials of the glycoprotein (GP) IIb/IIIa inhibitors have shown that these potent antiplatelet agents ore effective in reducing the ischemic complications of percutaneous coronary interventions. However, even though stents ore now implanted in >75% of percutaneous interventional procedures, only one study, a trial of the monoclonal antibody abciximab, has formally evaluated adjunctive GP IIb/IIIa inhibition in this setting. Methods and Results Eptifibatide, a nonimmunogenic and rapidly reversible inhibitor of the platelet receptor integrin IIb/IIIa, has also undergone evaluation as an adjunct to coronary intervention. In clinical trials performed heretofore, however, it has appeared to have less relative clinical efficacy than the monoclonal antibody abciximab. Since the early seminal trials, ii has been recognized that the doses of eptifibatide previously used achieved only 30% to 50% of maximal platelet GP IIb/IIIa integrin inhibition. This is considerably less than the 80% level of receptor inhibition that has been proposed to prevent coronary thrombus formation in animal models and that has been achieved in clinical trials with abciximab. Conclusions The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial was designed to test the safety and efficacy of a high-dose, "180/2.0/180" double-bolus regimen of eptifibatide (a 180-mug/kg bolus followed 10 minutes later by a second 180-mug/kg bolus of eptifibatide combined with a 2.0-mug/kg per minute infusion) as an adjunct to nonacute percutaneous coronary intervention with stent implantation. In this report, we review the rationale, design, and methods of this clinical investigation.

关键词：冠心病/治疗移植物闭塞血管/病因学移植物闭塞血管/死亡率移植物闭塞血管/预防和控制注射静脉内肽类/投药和剂量血小板聚集抑制剂/投药和剂量血小板糖蛋白GPⅡb-Ⅲa复合物/拮抗剂和抑制剂研究设计存活率人类

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Stenting the stent:: Initial results and long-term clinical and angiographic outcome of coronary stenting for patients with in-stent restenosis

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AMERICAN JOURNAL OF CARDIOLOGY 2000年第3期85卷 327-332页

作者： Alfonso, F Cequier, A Zueco, J Morís, C Suárez, CP Colman, T Esplugas, E Pérez-Vizcayno, MJ Fernández, C Macaya, C Hosp Univ San Carlos Inst Cardiovasc Serv Cardiol Intervencioista Unidad HemodinamIntervent Cardiol Unit Madrid 28040 Spain Bellvitge Univ Hosp Intervent Cardiol Unit Barcelona Spain Marques De Valdecilla Univ Hosp Intervent Cardiol Unit Santander Spain Cent Asturias Univ Hosp Intervent Cardiol Unit Oviedo Spain

Stent restenosis constitutes a therapeutic challenge affecting an increasing number of patients. Conventional angioplasty and debulking techniques are currently used in these patients. However, the potential role of a second stent implantation in this setting (stenting the stent) remains unknown. Therefore, 65 consecutive patients (12 women, aged 62 +/- 11 years) undergoing stent implantation (42 elective and 23 unplanned) for the treatment of in-stent restenosis (diffuse [>10 mm] in 39 [60%]) were studied. Angiographic success was obtained in all patients. Three patients developed hospital complications: 1 died from refractory heart failure and 2 suffered non-Q-wave myocardial infarctions. During follow-up (mean 17 +/- 11 months) 1 patient died (noncardiac cause) and only 9 (14%) required target vessel revascularization. Kaplan-Meier event-free survival (freedom from death, myocardial infarction, and target vessel revascularization) at 1 year was 84%. Using Cox analysis, patients with unstable symptoms, a short time to stent restenosis, nonelective stenting, and B2-C lesions tended to have poorer prognosis. After adjustment, nonelective stenting was associated (adjusted RR 2.9, 95% confidence interval [CI] 0.82 to 10.3, p = 0.09) with an adverse clinical outcome, On quantitative angiography (core lab) restenosis was found in 13 of 43 patients (30%) (75% of those eligible). Logistic regression analysis identify restenosis length (adjusted RR 1.43, 95% CI 1.04 to 2.14, p = 0.04), and time to restenosis (adjusted RR 0.67, 95% CI 0.47 to 0.94, p = 0.01) as the only independent predictors of recurrent restenosis. Thus, repeat coronary stenting is a safe and efficacious strategy for the treatment of patients with in-stent restenosis. Both elective and nonelective stenting provide excellent initial results. The long-term clinical and angiographic outcome of these patients is also favorable. (C)2000 by Excerpta Medica, Inc.

关键词：冠状血管造影术无病生存随访研究移植物闭塞血管/死亡率移植物闭塞血管/外科学 Logistic模型心肌血管重建术比例危险度模型再手术西班牙/流行病学支架女(雌)性人类男(雄)性中年人

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Percutaneous revascularization of the internal mammary artery graft: Short- and long-term outcomes

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第4期35卷 944-948页

作者： Gruberg, L Dangas, G Mehran, R Hong, MK Waksman, R Mintz, GS Kent, KM Pichard, AD Satler, LF Lansky, AJ Stone, GW Leon, MB Cardiovasc Res Fdn New York NY 10022 USA Washington Hosp Ctr Cardiac Catheterizat Lab Washington DC 20010 USA

OBJECTIVES We evaluated the short- and long-term clinical outcomes after percutaneous revascularization of the internal mammary artery (IMA) graft. BACKGROUND Previous reports in a relatively small number of patients have indicated the safety of balloon angioplasty for the treatment of stenoses in the IMA graft. However, the use of alternative interventional techniques and their long-term results have not yet been evaluated. METHODS We analyzed the in-hospital and one-year clinical outcomes of 174 consecutive patients who underwent percutaneous revascularization of 202 lesions located in the IMA graft, by either balloon angioplasty or stenting RESULTS Anastomotic lesions were evident in 128 cases (63%), and they were more commonly treated with balloon angioplasty (116/128, 91%), whereas lesions located at the ostium (n = 16, 8%) were more frequently treated with stents (11/16, 69%). Procedural success was 97% with excellent in-hospital outcome: 0.6% mortality rate, no Q-wave myocardial infarction (MI) and 0.6% rate of urgent bypass surgery. Cumulative one-year rates were: mortality 4.4%, MI 2.9% and target lesion revascularization (TLR) 7.4%. CONCLUSIONS Revascularization of the IMA graft can be performed safely, with high procedural success and a low rate of in-hospital complications. Long-term follow-up showed very low TLR rate. (C) 2000 by the American College of Cardiology.

关键词：血管成形术气囊冠状动脉死亡原因冠状血管造影术冠心病/诊断显像冠心病/死亡率冠心病/外科学移植物闭塞血管/诊断显像移植物闭塞血管/死亡率移植物闭塞血管/治疗心肌梗死/诊断显像心肌梗死/死亡率心肌梗死/外科学心肌血管重建术复发再手术支架存活率治疗结果成年人老年人老年人 80以上女(雌)性人类男(雄)性中年人

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Polytetrafluoroethylene-covered stent for the treatment of narrowings in aorticocoronary saphenous vein grafts

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AMERICAN JOURNAL OF CARDIOLOGY 2000年第3期86卷 343-+页

作者： Briguori, C De Gregorio, J Nishida, T Adamian, M Albiero, R Tucci, G Di Mario, C Colombo, A Ctr Cuore Columbus I-20145 Milan Italy Lenox Hill Hosp New York NY 10021 USA

We compared the outcome of patients with saphenous graft disease treated with polytetrafluoroethylene (PTFE)-covered stents or noncovered stents. Angiographic success was similar;non-Q-wave myocardial infarction was lower in the PTFE group (p = 0.06) and long-term major cardiac events and restenosis rate were similar in the 2 groups. Implantation of PTFE-covered stent in vein graft disease seems to reduce the occurrence of distal embolization.

关键词：包被物质生物相容性冠状动脉分流术移植物闭塞血管/死亡率移植物闭塞血管/治疗心肌梗死/死亡率心肌梗死/预防和控制聚四氟乙烯假体设计复发危险因素支架静脉/移植老年人女(雌)性人类男(雄)性中年人

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