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A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation
Mehran, Roxana; Aymong, Eve D; Nikolsky, Eugenia; Lasic, Zoran; Iakovou, Ioannis; Fahy, Martin; Mintz, Gary S; Lansky, Alexandra J; Moses, Jeffrey W; Stone, Gregg W; Leon, Martin B; Dangas, George
OBJECTIVES: We sought to develop a simple risk score of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). BACKGROUND: Although several risk factors for CIN have been identified, the cumulative risk rendered by their combination is unknown. METHODS: A total of 8,357 patients were randomly assigned to a development and a validation dataset. The baseline clinical and procedural characteristics of the 5,571 patients in the development dataset were considered as candidate univariate predictors of CIN (increase >or=25% and/or >or=0.5 mg/dl in serum creatinine at 48 h after PCI vs. baseline). Multivariate logistic regression was then used to identify independent predictors of CIN with a p value <0.0001. Based on the odds ratio, eight identified variables (hypotension, intra-aortic balloon pump, congestive heart failure, chronic kidney disease, diabetes, age >75 years, anemia, and volume of contrast) were assigned a weighted integer; the sum of the integers was a total risk score for each patient. RESULTS: The overall occurrence of CIN in the development set was 13.1% (range 7.5% to 57.3% for a low [<or=5] and high [>or=16] risk score, respectively); the rate of CIN increased exponentially with increasing risk score (Cochran Armitage chi-square, p < 0.0001). In the 2,786 patients of the validation dataset, the model demonstrated good discriminative power (c statistic = 0.67); the increasing risk score was again strongly associated with CIN (range 8.4% to 55.9% for a low and high risk score, respectively). CONCLUSIONS: The risk of CIN after PCI can be simply assessed using readily available information. This risk score can be used for both clinical and investigational purposes
PMID: 15464318
ISSN: 0735-1097
CID: 147380
Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis
Nikolsky, Eugenia; Mehran, Roxana; Halkin, Amir; Aymong, Eve D; Mintz, Gary S; Lasic, Zoran; Negoita, Manuela; Fahy, Martin; Krieger, Shoshana; Moussa, Issam; Moses, Jeffrey W; Stone, Gregg W; Leon, Martin B; Pocock, Stuart J; Dangas, George
OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal
PMID: 15364320
ISSN: 0735-1097
CID: 147382
Impact of chronic kidney disease on prognosis of patients with diabetes mellitus treated with percutaneous coronary intervention
Nikolsky, Eugenia; Mehran, Roxana; Turcot, Diane; Aymong, Eve D; Mintz, Gary S; Lasic, Zoran; Lansky, Alexandra J; Tsounias, Emmanouil; Moses, Jeffrey W; Stone, Gregg W; Leon, Martin B; Dangas, George D
Chronic kidney disease (CKD) is a frequent complication of diabetes mellitus. However, the role of CKD in outcomes of patients with diabetes who have undergone percutaneous coronary intervention (PCI) has not been studied specifically. Therefore, we investigated the impact of CKD on prognosis of patients with diabetes who underwent PCI. Of 1,575 diabetic patients who underwent PCI, 1,046 (66%) had preserved renal function, 492 (31%) had CKD (baseline serum creatinine >1.5 mg/dl or estimated glomerular filtration rate <60 ml/min/1.73 m(2)) without dialysis, and 37 (2.3%) were dependent on dialysis. Patients with CKD versus those without CKD had more in-hospital complications, including mortality (2.6% vs 0.5%, respectively; p <0.0001), neurologic events (3.1% vs 0.6%, p = 0.0001), and gastrointestinal bleeding (2.9% vs 0.9%, p = 0.01). Contrast-induced nephropathy after PCI (increase > or =25% and/or > or =0.5 mg/dl of serum creatinine before PCI vs 48 hours after PCI) was found in 15% of patients without CKD versus 27% of those with CKD, and de novo dialysis was instituted in 0.1% versus 3.1%, respectively. Contrast-induced nephropathy was independently predicted (all p <0.0001) by peri-PCI hypotension (odds ratio [OR] 2.62), insulin treatment (OR 1.84), and volume of contrast medium (OR 1.30). The 1-year mortality rate was strikingly higher (all p <0.0001) in patients with CKD who did not receive dialysis (16%) and those on dialysis (44%) compared with the group with preserved renal function (5%). Contrast-induced nephropathy was among the independent predictors of a 1-year mortality rate (OR 2.75, p <0.001)
PMID: 15276092
ISSN: 0002-9149
CID: 147386
Comparison of safety and efficacy between first and second generation of angio-seal closure devices in interventional patients
Lasic, Zoran; Mehran, Roxana; Dangas, George; Mintz, Gary; Nikolsky, Eugenia; Tsounias, Emmanouil; Udani, Paras C; Adamian, Milena; Adamian, Julia; Moussa, Issam; Collins, Michael; Stone, Gregg; Moses, Jeffrey
Arterial closure devices are safe and effective in selected patients, with complication rates similar to or lower than manual compression. The purpose of this study was to compare the safety and efficacy of the first- and new-generation Angio-Seal devices in patients undergoing PCI. This study found that the new Angio-Seal STS Platform device can secure hemostasis after PCI in a safe and effective manner similar to the old device. The new platform is easier for the operator and for the patients
PMID: 15282426
ISSN: 1042-3931
CID: 114327
Favorable effect of gamma-radiation for in-stent restenosis: effect of diabetes on angiographic and clinical outcomes
Iakovou, Ioannis; Mehran, Roxana; Dangas, George; Lansky, Alexandra J; Stone, Gregg W; Mintz, Gary S; Aymong, Eve; Ashby, Dale T; Pichard, Augusto D; Satler, Lowell F; Kent, Kenneth; Leon, Martin B; Waksman, Ron
The purpose of this study was to examine the effect of vascular brachytherapy with gamma-radiation (gamma-RT) in patients with diabetes mellitus (DM) with coronary in-stent restenosis (ISR). In the Washington Radiation for In-Stent Restenosis (WRIST) trial, 130 patients with ISR were treated with (192)Ir or placebo. Of the patients enrolled, 44 (34%) had DM (18 of them treated with gamma-RT and 26 with placebo). Gamma-radiation therapy of ISR in diabetics resulted in similar procedural success and in-hospital outcome compared to nondiabetics. At 6-month follow-up, both DM and non-DM patients treated with gamma-RT had significantly lower target lesion revascularization (TLR), target vessel revascularization, and major adverse cardiac event rates compared to placebo. DM remains a powerful predictor of TLR and major adverse cardiac events even after treatment of ISR with gamma-RT
PMID: 15224295
ISSN: 1522-1946
CID: 147388
Prognostic significance of cerebrovascular and peripheral arterial disease in patients having percutaneous coronary interventions
Nikolsky, Eugenia; Mehran, Roxana; Dangas, George D; Lasic, Zoran; Mintz, Gary S; Negoita, Manuela; Lansky, Alexandra J; Stone, Gregg W; Moussa, Issam; Iyer, Sriram; Na, Yingbo; Moses, Jeffrey W; Leon, Martin B
This study shows that cerebrovascular and peripheral arterial diseases frequently co-exist in patients with coronary artery disease who undergo percutaneous coronary interventions. These 2 conditions are associated with adverse in-hospital and 1-year outcomes and independently predict early and 1-year mortality
PMID: 15194030
ISSN: 0002-9149
CID: 114487
Short- and long-term results after multivessel stenting in diabetic patients
Mehran, Roxana; Dangas, George D; Kobayashi, Yoshio; Lansky, Alexandra J; Mintz, Gary S; Aymong, Eve D; Fahy, Martin; Moses, Jeffrey W; Stone, Gregg W; Leon, Martin B
OBJECTIVES: The present study evaluated clinical outcomes in diabetic patients after multivessel stenting. BACKGROUND: Multivessel angioplasty studies have reported decreased survival in diabetic patients undergoing conventional balloon angioplasty compared with coronary artery bypass graft surgery (CABG). However, several studies have demonstrated excellent procedural success and acceptable clinical outcomes after multivessel stenting. METHODS: Multivessel stenting was performed in 689 patients with 1,639 native coronary lesions. Patients were classified into three groups according to diabetes mellitus (DM) status: 1) no DM (501 patients/1,200 lesions); 2) DM treated with oral agents (102 patients/235 lesions); and 3) DM treated with insulin (86 patients/204 lesions). RESULTS: Procedural success was high overall. In-hospital CABG was higher in diabetics treated with insulin compared with the other two groups (3.5% vs. 0.4% vs. 1.0%, p = 0.02). There were no significant differences in the incidence of in-hospital cardiac death and myocardial infarction. Diabetic patients treated with oral agents or insulin had higher one-year target lesion revascularization rates than non-diabetic patients (25% vs. 35% vs. 16%, p < 0.001). Lower one-year survival was observed in diabetic patients treated with either oral agents or insulin, compared with non-diabetic patients (85% vs. 86% vs. 95%, p < 0.001). On multivariable analysis, DM was an independent predictor of one-year mortality, myocardial infarction, and target lesion revascularization after multivessel stenting. CONCLUSIONS: Despite a high technical success rate of multivessel stenting, diabetic patients, especially those treated with insulin, have higher in-hospital CABG, higher subsequent revascularization rates, and lower one-year survival than non-diabetic patients
PMID: 15093865
ISSN: 0735-1097
CID: 147391
Relation of final lumen dimensions in saphenous vein grafts after stent implantation to outcome
Iakovou, Ioannis; Dangas, George; Mintz, Gary S; Mehran, Roxana; Kobayashi, Yoshio; D Aymong, Eve; Hirose, Makoto; Ashby, Dale T; Lansky, Alexandra J; Stone, Gregg W; Leon, Martin B; Moses, Jeffrey W
Larger final lumen dimensions after percutaneous coronary interventions in native coronary arteries lead to lower restenosis rates. We sought to determine the impact of stent expansion, as assessed by intravascular ultrasound, on clinical results of stent implantation in saphenous vein grafts (SVGs). We identified 226 consecutive patients who underwent intravascular ultrasound-guided stenting of 234 de novo SVG lesions. Patients were divided into 2 groups based on the final stent cross-sectional area (CSA): group I (stent CSA <100% of the reference lumen CSA, n = 176 patients, 182 lesions) and group II (stent CSA >/=100% of the reference lumen CSA, n = 50 patients, 52 lesions). Baseline patient characteristics were similar between the 2 groups with the exception of smaller lesions in group II. More aggressive stent expansion (group II) was associated with (1) increased rates of in-hospital non-Q-wave myocardial infarction (29% vs 17%, p = 0.05), (2) any myocardial infarction (26% vs 8%, p = 0.003) at 1-year follow-up, and (3) no improvement in target vessel revascularization at 1 year (31% vs 26%, p = 0.3). Aggressive stent expansion in SVG lesions resulted in higher myocardial infarction rates and, unlike native arteries, no improvement in target vessel revascularization rate at 1 year. A less aggressive stent implantation strategy in SVGs than in native coronary lesions appears prudent
PMID: 15081436
ISSN: 0002-9149
CID: 147392
Minimally invasive coronary artery bypass grafting versus stenting for patients with proximal left anterior descending coronary artery disease
Shirai, Kazuyuki; Lansky, Alexandra J; Mehran, Roxana; Dangas, George D; Costantini, Costantino O; Fahy, Martin; Slack, Steven; Mintz, Gary S; Stone, Gregg W; Leon, Martin B
The purpose of this study was to compare the clinical outcomes of stenting and minimally invasive coronary artery bypass grafting (MIDCAB) in patients with proximal left anterior descending (LAD) coronary artery disease. The Patency, Outcome, Economics of Minimally invasive direct coronary bypass (POEM) study demonstrated that MIDCAB had similar safety and long-term efficacy for LAD revascularization compared with conventional coronary artery bypass grafting. Although LAD stenting is superior to conventional balloon angioplasty, whether it is comparable to MIDCAB is not known. We identified a matched population of 429 consecutive patients with 1-vessel disease who underwent elective proximal LAD stenting and compared their clinical outcomes with those of the 152 patients in the MIDCAB group of the POEM study. The in-hospital event rate was similar in both groups, except for a shorter length of hospital stay with LAD stenting compared with MIDCAB (2.68 vs 4.07 days, p <0.0001). At 6-month follow-up, the incidence of death and Q-wave myocardial infarction or that of cerebrovascular accident was not significantly different between these 2 groups. However, target vessel revascularization was significantly higher with LAD stenting than MIDCAB (13.3% vs 6.6%, p = 0.045). In the subgroup of patients without diabetes, all clinical events were similar in both groups, and the benefit of a shorter hospital stay associated with stenting was maintained. Compared with MIDCAB, LAD stenting is associated with higher repeat revascularization rates but offers the advantage of shorter hospitalization. For nondiabetics with proximal LAD disease, stenting may be the revascularization strategy of choice
PMID: 15081435
ISSN: 0002-9149
CID: 147393
Comparison of differences in outcome after percutaneous coronary intervention in men versus women <40 years of age
Lansky, Alexandra J; Mehran, Roxana; Dangas, George; Cristea, Ecaterina; Shirai, Kazuyuki; Costa, Ricardo; Costantini, Costantino; Tsuchiya, Yoshihiro; Carlier, Stephane; Mintz, Gary; Cottin, Yves; Stone, Gregg; Moses, Jeffrey; Leon, Martin B
We evaluated the outcomes of 177 consecutive patients (43 women, 134 men) <40 years of age with premature atherosclerosis who underwent percutaneous coronary intervention. Women were younger, had more diabetes mellitus (37% vs 10%; p <0.001), but less hyperlipidemia (58% vs 75%; p <0.001) compared with men. In-hospital vascular complications and 1-year mortality rate or Q-wave myocardial infarction (7.9% vs 0.08%, p <0.01) were higher in women. By multivariable regression analysis, female gender was the only independent predictor of vascular complications (odds ratio, 14.1; 95% confidence intervals, 1.59 to 125, p = 0.01) and of 1-year mortality rate or nonfatal myocardial infarction (odds ratio, 12.5; 95% confidence interval, 1.14 to 111, p = 0.03). Women with premature coronary disease had a distinctive risk factor profile relative to men, with a predominance of diabetes and hypercholesterolemia, and were at higher risk of developing vascular and ischemic complications after percutaneous coronary intervention, warranting aggressive risk factor modification and vigilance in this population
PMID: 15050498
ISSN: 0002-9149
CID: 147395