Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts.
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Angioplasty, Balloon, Coronary↗
Biomedical subjects
Edouard Cheneau
Publications and source records attributed to Edouard Cheneau.
Effectiveness of radioactive tungsten source in the prevention of restenosis in stented porcine coronary arteries.
PURPOSE: Intracoronary radiation has shown the potential to inhibit neointimal proliferation in porcine models of restenosis. The objective of this study was to determine whether intracoronary radiation using a new coiled wire of tungsten-188 ((188)W), a pure beta emitter (half-life 69.4 days) is safe. In addition, a dose of 0 Gy, 18 Gy, or 25 Gy prescribed to 2 mm from the center of the source and delivered intraluminally is sufficient to prevent restenosis and free from adverse effects. METHODS AND MATERIALS: Ten domestic swine underwent 13-mm stent implantation (SI) into two arteries, left anterior descending plus either the left circumflex or right coronary artery. After SI, a closed-end lumen radiation catheter was inserted to the treated artery and a 40-mm coiled (188)W source was manually delivered to cover the stented segment and its margins. A total of 20 arteries were randomized to treatment with a radiation dose of 0, 18 Gy, or 25 Gy delivered to 2 mm depth from the center of the source. Four weeks after the procedure, the swine underwent angiography and intravascular ultrasound using automated pullback at 0.5 mm/s. before being killed and the arteries perfusion fixed. Histopathologic and histomorphometric analyses were performed at 28 days after injury and radiation. RESULTS: Irradiation with (188)W at a dose of 25 Gy after SI significantly inhibited neointima formation (intimal area: 1.05 +/- 0.64 vs. 2.75 +/- 0.99 mm(2), p < 0.01) and at an 18 Gy dose of radiation (intimal area: 1.73 +/- 0.49 vs. 2.75 +/- 0.99 mm(2)), as compared to controls. One artery receiving 18 Gy and two arteries receiving 25 Gy were totally occluded at follow-up due to thrombus formation but no edge stenosis was observed in any of the irradiated arteries. CONCLUSIONS: Intracoronary radiation therapy using a new coiled wire of (188)W source delivered after SI appeared to be safe and well tolerated. The radiation doses demonstrated efficacy in reducing neointima formation in the porcine coronary stent injury model.
Animals↗
Twelve versus six months of clopidogrel to reduce major cardiac events in patients undergoing gamma-radiation therapy for in-stent restenosis: Washington Radiation for In-Stent restenosis Trial (WRIST) 12 versus WRIST PLUS.
BACKGROUND: Intracoronary gamma-radiation reduces recurrent in-stent restenosis (ISR). Late thrombosis was attenuated with 6 months of aspirin and clopidogrel. We aimed to find out whether 12 months of aspirin plus clopidogrel is superior to a strategy of 6 months after radiation therapy for patients with ISR. METHODS AND RESULTS: One hundred twenty consecutive patients with diffuse ISR in native coronaries and vein grafts with lesions <80 mm in length underwent PTCA, laser ablation, or rotational atherectomy. Additional stents were placed in 39 patients (33%). After the intervention, a ribbon with different trains of radioactive 192Ir seeds was positioned to cover the treated site, and a dose of 14 Gy to 2 mm was prescribed. Patients were discharged with clopidogrel and aspirin for 12 months and followed up clinically. The cardiac clinical event rates at 15 months were compared with the gamma-treated (n=120) patients of the WRIST PLUS study (only 6 months of antiplatelet therapy). Whereas the late thrombosis rates were similar (3.3% for the group given 12 months of antiplatelet therapy versus 4.2% for the group given 6 months, P=0.72), the group treated with 12 months of antiplatelet therapy had a rate of 21% for major adverse cardiac events and 20% for target-lesion revascularization compared with 36% (P=0.01) and 35% (P=0.009), respectively, in patients who were treated with only 6 months of clopidogrel. CONCLUSIONS: Twelve months of clopidogrel is superior to 6 months in reducing overall major cardiac events and revascularization rates at 15 months for patients with ISR treated with gamma-radiation. At least 12 months of clopidogrel therapy should be recommended for patients undergoing radiation therapy for ISR.
Aspirin↗
Relation of residual stenosis after angioplasty to long-term outcome of patients treated for in-stent restenosis with intravascular radiation therapy.
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Analysis of Variance↗
Elderly patients have a favorable outcome after intracoronary radiation for in-stent restenosis.
Intracoronary radiation therapy (IRT) reduces recurrent in-stent restenosis (ISR) by inhibition of smooth muscle cell proliferation. The ability of these cells to replicate is limited with age due to changes in the telomeres. The purpose of this study was to assess the effect of age on outcomes following IRT for ISR. We evaluated 1,088 patients with 6-month clinical follow-up who were enrolled in radiation trials for ISR using gamma- and beta-emitters. Patients were analyzed within and between IRT (n = 861) or placebo therapy (n = 227) in four age groups (< 55, 55-65, 66-75, > 75 years). Baseline characteristics were similar within each age group of IRT patients, except elderly patients (> 75 years) had a lower rate of diabetes (28% in patients > 75 years; P = 0.008) and a higher rate of previous CABG (59% in patients > 75 years; P < 0.001). The rate of target lesion revascularization (TLR) was reduced in the elderly. TLR at 6 months was 18% in patients < 55 years, 21% in 55-65 years, 12% in 66-75 years, and 10% in patients > 75 (P = 0.009). The MACE rate at 6 months was 21% in patients < 55 years, 29% in 55-65 years, 26% in 66-75 years, and 17% in patients > 75 (P = 0.03). No effect of age was seen in placebo patients. IRT-treated patients had reduced MACE compared to placebo in all age groups, driven by reduced target vessel revascularization. Age was an independent predictor of MACE at 6 months (OR = 0.8; CI = 0.70-0.93; P = 0.004). Angiographic restenosis was not clearly associated with need for TLR in patients > 75 years. In elderly patients (> 75 years) treated with IRT for ISR, the rate of TLR was significantly reduced compared to younger patients. However, this reduction in TLR was not associated with a reduction in angiographic restenosis, suggesting that TLR should not be used as a surrogate for angiographic evaluation.
Age Factors↗
Do differences in baseline characteristics or in management account for the poorer in-hospital and subsequent outcome after myocardial infarction in diabetics? Data from a large unselected cohort.
OBJECTIVE: There is an excess mortality after myocardial infarction in diabetics, but also documented significant differences in the characteristics of MI and in management between diabetics and non-diabetics. The aim of this prospective study in a large unselected patient cohort in a single French region was to determine if baseline characteristics, management, or in-hospital and one-year mortality differed in diabetic and non-diabetic patients with myocardial infarction. METHODS AND RESULTS: Data were prospectively collected in consecutive patients with myocardial infarction admitted to all hospitals in three departments in the Rhone-Alpes region between September 1, 1993 and January 31,1995. Among the 2,297 patients, 410 patients (17.8%) were diabetic. Although diabetics were older than non-diabetics (70.3 vs. 67.8 years; p < 0.0004), and less likely to receive thrombolysis (31% vs. 36%; p = 0.043), in-hospital mortality was not significantly higher (17.3% vs. 14.7%) than in non-diabetics. In multivariate analysis, diabetes was a significant predictor of one-year mortality (relative risk: 1.41; 95% CI = 1.10 - 1.79; p = 0.0063) but not of in-hospital mortality (relative risk: 1.2; 95% CI = 0.9 - 1.7; p = 0.25). Multivariate predictors of in-hospital and one-year mortality in diabetics were age and Killip class at admission. CONCLUSIONS: In this large unselected French cohort, diabetes mellitus was a significant predictor of one-year but not of in-hospital mortality after myocardial infarction in a French region. This negative effect of diabetes on mortality was not related to differences in baseline characteristics, or in initial or post-discharge management between diabetics and non-diabetics.
Aged↗
Clinical trials of intracoronary gamma radiation therapy for in-stent restenosis.
The only gamma emitter used in clinical trials for in-stent restenosis is 192Iridium (192Ir). The efficacy of intracoronary gamma radiation therapy in reducing clinical and angiographic restenosis in patients with in-stent restenosis has been established. This review is intended to give an overview of the clinical trials utilizing gamma vascular brachytherapy in patients with in-stent restenosis and give insight into the future of intracoronary radiation therapy.
Angioplasty, Balloon, Coronary↗
Identification of "vulnerable plaque" using virtual histology in angiographically benign looking lesion of proximal left anterior descending artery.
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Coronary Angiography↗
Impact of intravascular ultrasound-guided direct stenting on clinical outcome of patients treated for native coronary disease.
BACKGROUND: Despite the fact that in animal models direct stenting (DS) reduces the vessel injury, in clinical practice this treatment strategy did not reduce late restenosis as compared to conventional strategy with balloon predilatation (PD). However, the influence of DS was not evaluated when stent expansion is optimized by intravascular ultrasound (IVUS) assessment. METHODS: We analyzed the in-hospital and 1-year outcomes of patients at Washington Hospital Center who were treated with percutaneous coronary interventions and stent implantation when percutaneous intervention was guided by IVUS. Only patients treated for single de novo lesions were included. RESULTS: In 1386 patients, 251 (18.1%) were treated with DS and 1135 (71.9%) were treated with PD. Pre- and postprocedure characteristics by angiography and IVUS were similar in both groups. Postprocedure non-Q-wave myocardial infarction (MI) occurred in 4.9% of the DS group and in 12.5% of the PD group (P = .005). At 1-year follow-up, target lesion revascularization (TLR) rate was 4.9% in the DS group and 14.8% in the PD group (P = .005). DS strategy (odds ratio = .46, confidence interval = .25-.85, P = .013) was independently correlated to lower risk for revascularization in multivariate analysis. CONCLUSION: When DS is implemented by IVUS assessment, it is associated with low in-hospital and long-term events.
Angioplasty, Balloon, Coronary↗
Peroxisome proliferator-activated receptor gamma: its role in metabolic syndrome.
Here we review PPARgamma function in relation to human adipogenesis, insulin sensitization, lipid metabolism, blood pressure regulation and prothrombotic state to perhaps provide justification for this nuclear receptor remaining a key therapeutic target for the continuing development of agents to treat human metabolic syndrome.
Adipose Tissue↗
Peroxisome proliferator-activated receptor gamma; Its role in atherosclerosis and restenosis.
Cellular proliferation and migration are fundamental processes that contribute to the injury response in major blood vessels. The resultant pathologies are atherosclerosis and restenosis. As we begin to understand the cellular changes associated with vascular injury, it is critical to determine whether the inhibition of growth and movement of cells in the vasculature could serve as a novel therapeutic strategy to prevent atherosclerosis and restenosis.
Animals↗
Addition of heparin to contrast media is associated with increased bleeding and peripheral vascular complications during percutaneous coronary intervention with bivalirudin and drug-eluting stents.
BACKGROUND: Nonionic radiographic contrast media (CM) is reported to be thrombogenic while performing diagnostic or interventional procedures. To avoid thrombosis, heparin is often added to the CM. Bivalirudin, used to replace heparin during percutaneous coronary intervention (PCI), is reported to be associated with reduced bleeding complications. We aimed to evaluate the impact of adding heparin to the CM during PCI in patients (pts) who underwent sirolimus-eluting stent (SES) implantation when bivalirudin was utilized as the sole antithrombotic agent. METHODS: A total of 664 pts with 756 lesions underwent standard PCI with SES for various coronary artery lesions. Pts were treated with either bivalirudin only (the bivalirudin group; 0.75 mg/kg bolus and 1.75 mg/kg/h infusion, n = 323 pts) or bivalirudin (same dose) plus low-dose heparin added to the CM (the heparin mix group; mean dose = 2101.8+/-882.5 U, n = 341 pts) during PCI. The periprocedural, in-hospital, and 30-day clinical outcomes were compared. RESULTS: Baseline clinical and angiographic parameters were similar between both groups. Periprocedural, in-hospital, and 1-month clinical outcomes, including thrombotic complications, were similar between the two groups. There was no difference in the periprocedural thrombosis rate between the groups. In the heparin mix group, the overall incidence of hematoma was significantly higher (3.8% vs. 8.5%, P = .01), there was a trend toward higher rates of blood transfusion (2.6% vs. 6.6%, P = .06) and overall vascular complications (0.01% vs. 5.3%, P <.001), including pseudoaneurysm (PSA; 0.0% vs. 2.6%, P = .004), and pts who required surgical repair (0.3% vs. 1.8%, P = .07). CONCLUSIONS: The routine addition of low-dose heparin to CM during contemporary PCI does not add any protection value and is associated with higher rates of bleeding and vascular complications.
Angioplasty, Balloon, Coronary↗
Transepicardial autologous bone marrow-derived mononuclear cell therapy in a porcine model of chronically infarcted myocardium.
OBJECTIVE: Cell therapy is becoming a viable strategy to improve revascularization and myocardial function after myocardial injury. We evaluated the effect of bone marrow-derived mononuclear cell (BMMNC) transplantation on collateral vessel development and myocardial function in a porcine model of chronically infarcted heart. METHODS: Myocardial infarction was produced in 13 domestic swine. At 4 weeks, animals were randomized to receive transepicardial injections of autologous BMMNCs (approximately 24x10(6) cells, n=8) or phosphate buffered saline (PBS; control, n=5) into infarcted and border regions. Collateral growth, angiogenesis, and infarct size were assessed by angiography, immunohistochemistry, and histomorphometry. RESULTS: Regional contractility was assessed by transepicardial echocardiography at baseline and 4 weeks following treatment. Angiography revealed a trend toward increased collateral growth in the BMMNC group. Wall motion score index (myocardial function) was similar in both groups at baseline (1.63+/-0.16 vs. 1.25+/-0.25, P=.21) and at 4 weeks (1.83+/-0.22 vs. 1.63+/-0.38, P=.62). alpha-Actin-positive smooth muscle cells (SMCs) and Factor VIII positive endothelial cells were significantly greater in the BMMNC-injected animals (314.8+/-37.4/0.1 vs. 167.1+/-11.9/0.1 mm(2) in controls, P=.02, and 363.3+/-28.2 cells/0.1 mm(2) vs. 254.4+/-28.1 cells/0.1 mm(2) in controls, P=.03, respectively). The number of blood vessels >50 mum in diameter was significantly increased in the BMMNC group (317.9+/-54.9 vs. 149.1+/-6.1, P<.05). The size of the infarct area was smaller in the BMMNC-transplanted group than in the controls (P=.015). CONCLUSION: BMMNC transplantation appears to improve angiogenesis and reduce infarct size yet results in no improvement in left ventricular function in a chronically infarcted heart.
Animals↗
Late thrombosis in cypher stents after the discontinuation of antiplatelet therapy.
Drug-eluting stents, since their approval in the United States, have become the treatment of choice for de novo coronary artery narrowing due to their ability to reduce restenosis and the need for repeat revascularization. We present two patients who underwent percutaneous coronary intervention for the treatment of multivessel coronary artery disease; both patients were treated with sirolimus-eluting stents (SES) and bare metal stents (BMS).
Adult↗
Bivalirudin compared with IIb/IIIa inhibitors in patients with in-stent restenosis undergoing intracoronary brachytherapy.
BACKGROUND: Bivalirudin is replacing heparin in percutaneous coronary interventions (PCIs), including vascular brachytherapy (VBT). The aim of the study was to compare bivalirudin with eptifibatide in patients with in-stent restenosis (ISR) undergoing PCI and VBT. METHODS: One hundred forty-four patients treated with bivalirudin as a single antithrombotic agent were compared with 150 patients treated with eptifibatide. Bivalirudin as a bolus of 0.75 mg/kg followed by 1.75 mg/kg/h infusion until the end of the procedure, and eptifibatide as a double bolus of 180 microg/kg followed by 2 microg/kg/min infusion for 18 h after the procedure were used. The main outcome measures were in-hospital events and 30-day clinical outcomes. RESULTS: Baseline clinical characteristics were similar except that patients in the eptifibatide group were younger (P=.02) and had more saphenous vein graft lesions (P<.001). Patients in the bivalirudin group had a higher number of lesions in the right coronary artery (P<.001) and a higher number of vessels treated (P<.001). Postprocedure creatinine phosphokinase (CPK)-MB levels were significantly lower in the bivalirudin group (P<.03). In-hospital events showed significantly less minor bleeding (P=.01) and a trend toward lower major bleeding and major adverse cardiac events (MACE) in the bivalirudin group (P=.06). Thirty-day outcomes showed a significantly lower incidence of non-Q-wave myocardial infarction (MI) in the bivalirudin group (P=.004). CONCLUSION: Bivalirudin, as a single antithrombotic agent during PCI and VBT, is associated with significantly lower postprocedural CPK-MB elevation, minor bleeding complications, 30-day non-Q-wave MI rates, and a trend toward lower major bleeding and in-hospital MACE when compared with eptifibatide.
Anticoagulants↗
Comparison of paclitaxel-eluting stent and sirolimus-eluting stent expansion at incremental delivery pressures.
OBJECTIVES: We sought to compare the adequacy of paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) expansion based on intravascular ultrasound (IVUS) imaging criteria at conventional delivery pressures. METHODS: Forty-six patients underwent SES implantation and 42 patients underwent PES implantation for de novo native coronary lesions<33 mm in length with reference lumen diameters of 2.5-3.5 mm. Stents were serially expanded with gradual balloon inflations at 14 and 20 atm. IVUS imaging was performed prior to intervention and after each balloon inflation. Stent expansion (minimal stent cross-sectional area/reference lumen cross-sectional area) was measured. Inadequate stent expansion was defined using the MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen cross-sectional area>80% of the reference or >90% if minimal lumen cross-sectional area was <9 mm2). RESULTS: The baseline characteristics of the two groups were similar except for shorter lesion length, larger mean lumen cross-sectional area, larger lumen diameter, and lower plaque burden in the PES group. Stent expansion was inadequate in 80% of patients with SES versus 63% of patients with PES at 14 atm, although this was not statistically significant. After 20 atm, 48% of patients with SES remained underexpanded as compared with 35% of patients with PES. CONCLUSION: Drug-eluting stents showed significant underexpansion by MUSIC criteria at conventionally used inflation pressures. Higher balloon inflations are required especially during deployment of a SES. IVUS guidance is recommended to ensure optimal results and outcomes with both stents.
Aged↗
Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy.
Although the safety profiles of coronary stents eluting sirolimus or paclitaxel do not seem to differ from those of bare metal stents in the short-to-medium term, concern has arisen about the potential for late stent thromboses related to delayed endothelialisation of the stent struts. We report four cases of angiographically-confirmed stent thrombosis that occurred late after elective implantation of polymer-based paxlitaxel-eluting (343 and 442 days) or sirolimus-eluting (335 and 375 days) stents, and resulted in myocardial infarction. All cases arose soon after antiplatelet therapy was interrupted. If confirmed in systematic long-term follow-up studies, our findings have potentially serious clinical implications.
Aged↗
The initial course of in-stent restenosis influences the response to vascular brachytherapy.
BACKGROUND: Vascular brachytherapy (VBT) reduces the rate of recurrence of in-stent restenosis (ISR) by inhibiting intimal proliferation. However, the rate of cell proliferation, reflected by the speed of ISR development, is variable in ISR lesions and might influence the responsiveness of ISR to radiation. The aim of this study was to determine the influence of the initial ISR course on the clinical outcome of patients undergoing VBT. METHODS: In 1165 patients treated for ISR with VBT in the WRIST studies, we determined the time for ISR (time between initial stent implantation and restenosis), the time for VBT treatment (time between stent implantation and VBT), and previous ISR treatment with conventional strategies. Target lesion revascularization (TLR) at 6 months was available in all patients. RESULTS: Previous ISR treatment did not influence the result of VBT (TLR was 17% vs. 16% without previous angioplasty). Time to ISR influences the outcome of patients undergoing VBT; TLR decreased when ISR occurred later. TLR was 18.2%, 16.7%, and 11.1% when time to ISR was <90, 90-2700, and >270 days, respectively, P=.03. Early ISR (time for ISR <90 days) is a factor for radiation failure (OR=2.1, P<.05). In patients with early ISR, TLR is lower when VBT is delayed; TLR was 11% if performed 90 days after stent implantation as compared to 22% if VBT is performed early (<90 days), P<.05. CONCLUSION: The course of ISR development affects the long-term efficacy of VBT. Early restenosis remains a factor of treatment failure in the VBT era. Delaying VBT beyond 90 days after stent implantation reduces the rate of subsequent revascularization in these patients.
Aged↗