Arteriole tortuosity associated with diabetic retinopathy and cholesterol.

PURPOSE: Earlier identification of diabetic eye disease is an important research effort. Retinopathy is widely acknowledged but retinal vessel changes are not evaluated as stringently. Here, we create a multivariate model for the association between retinal vessel tortuosity (RVT) and other health factors in patients with diabetes. METHODS: Three hundred eyes of 150 patients with diabetes were included. Three investigators independently reviewed telemedicine fundus photographs and scored the level of diabetic retinopathy (DR) and RVT. These scores were evaluated for agreement and averaged. Also collected were age, duration of diabetes, presence or absence of diabetic nephropathy or neuropathy, blood pressure, total cholesterol, and hemoglobin A1c. A regression model evaluating the association of tortuosity with other factors was created. RESULTS: There was very high agreement between the three graders for level of DR (κ = 0.84). Agreement between the three graders for RVT varied substantially: poor for venous tortuosity (κ = 0.23) and fair for arteriole tortuosity (κ = 0.44) and overall gut tortuosity (κ = 0.42). The overall gut tortuosity was the most reproducible for the graders with a correlation coefficient of 0.923. There were univariate associations between arteriole tortuosity and venous tortuosity, DR level, and cholesterol. The selected best multivariate model found arteriole tortuosity to be associated with DR and cholesterol levels. CONCLUSIONS: First, RVT, particularly for venules, is difficult to grade consistently; therefore, future studies examining tortuosity should focus on arterioles. Second, the model indicates that there is an association between vessel changes, DR, and systemic cholesterol levels. Although DR and RVT are readily available to assess concurrently on a photograph, the addition of cholesterol to this model indicates that patients with RVT may warrant further follow-up on health factors, such as cholesterol levels.

Correlates of late and very late thrombosis of drug eluting stents.

BACKGROUND: Late and very late thrombosis of coronary drug-eluting stents (DES) has received much attention but essentially remains unpredictable. We sought to identify correlates of stent thrombosis (ST) developing >30 days after DES implantation. METHODS: We analyzed data from our single-center registry on 5,342 consecutive patients, who underwent a first DES implant between May 2003 and December 2006. The Academic Research Consortium definitions were applied to classify definite, probable, and possible ST. Cox regression analysis was performed to identify predictors of ST. RESULTS: Follow-up information was obtained at 6 months and at 1, 2, and 3 years after DES implantation in 97.2%, 95.2%, 92.4%, and 89.8% of patients, respectively. We identified 34 patients who developed definite and 5 with probable ST >30 days after the index stent procedure. The 3-year cumulative incidence of definite and definite + probable ST >30 days was 1.33% and 1.50%, respectively. By Cox multiple variable regression, predictors of definite + probable ST were age (hazard ratio [HR] 0.95, 95% CI 0.92-0.98, P < .001), current smoking (HR 2.55, 95% CI 1.29-5.07, P = .007), prior percutaneous coronary intervention (HR 2.68, 95% CI 1.42-5.05, P = .002), "off-label" DES indication (HR 3.10, 95% CI 1.10-8.75, P = .032), bifurcation stenting (HR 2.37, 95% CI 1.40-3.99, P = .001), and stenting an occluded vessel (HR 3.02, 95% CI 1.59-5.74, P < .001). CONCLUSIONS: We identified several baseline characteristics, which, when combined, may identify patients at risk for late-occurring ST, particularly after off-label DES placement.

Long-term outcomes after management of restenosis or thrombosis of drug-eluting stents.

OBJECTIVES: The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES). BACKGROUND: Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear. METHODS: We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the "DES sandwich" technique or by other treatment methods. RESULTS: In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively. CONCLUSIONS: Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.

Short- and long-term clinical outcomes of coronary drug-eluting stent recipients presenting with chronic renal disease.

BACKGROUND: Randomized trials of drug-eluting stents (DES) excluded patients with severe renal insufficiency. We sought to evaluate the impact of baseline renal function on clinical outcomes in recipients of coronary DES. METHODS: We retrospectively reviewed our hospital databases to identify consecutive patients who underwent DES implantations between May 2003 and December 2004, subgrouped among 4 ranges of glomerular filtration rate (GFR) between > or = 90 ml per minute and < 30 ml per minute, in 30 ml per minute decrements, and 1 group treated with long-term dialysis. Clinical follow up was obtained at 6 months, 1 year and annually thereafter. RESULTS: Our study group included 2,758 patients with long-term outcomes recorded over a mean follow up of 706 +/- 273 days. The rates of in-hospital adverse events increased significantly as GFR decreased, though no major adverse event occurred among the dialyzed patients. Actuarial survival analyses up to 2 years revealed significant between-groups differences in rates of major adverse cardiac events (MACE) and death (both p < 0.001), while the differences in target vessel revascularization (TVR) rates did not reach statistical significance (p = 0.069). By Cox regression analysis, a GFR < 60 ml per minute remained a significant predictor of 2-year mortality (p < 0.001) and MACE (p < 0.001), but not TVR (p = 0.839). CONCLUSIONS: In conclusion, low rates of TVR were observed over 2 years in DES recipients with a wide range of renal function. Low rates of TVR were countered by high rates of death and MACE among renally insufficient patients over the long term.

Bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors in drug-eluting stent implantations in the absence of acute myocardial infarction: clinical and economic results.

BACKGROUND: The use of bivalirudin in percutaneous coronary interventions has been shown to be clinically safe and effective, and may be associated with shorter hospital stays and lower costs than heparin + glycoprotein (GP) IIb/IIIa inhibition. This study compared the utilization, clinical outcomes and costs associated with the planned use of bivalirudin versus heparin + GP IIb/IIIa inhibition in drug-eluting stent (DES) patients without acute myocardial infarction (MI). METHODS: We retrospectively studied 1,842 patients who underwent DES placement between May 2003 and December 2004. Planned treatment with heparin + GP IIb/IIIa inhibition was administered to 1,305 and planned bivalirudin alone was administered to 537 patients. Clinical follow ups (mean = 782 +/- 204 days) were obtained via telephone or mailed surveys in 1,813 patients (98.4%). Propensity analysis was utilized to adjust for between-groups baseline differences. RESULTS: The unadjusted data revealed similar in-hospital outcomes in both groups. After propensity adjustment, the rate of vascular complications was significantly lower in the bivalirudin-treated group (0.2% vs. 1.2%; p = 0.04). At 1 year, clinical outcomes were similar in both groups. The overall unadjusted and adjusted cost analysis revealed similar mean hospital costs (11,384 U.S. dollars vs. 11,018 U.S. dollars; p = ns) and length of stay (2.9 days vs. 2.8 days; p = ns) in both groups. The unadjusted and adjusted mean hospital costs were significantly lower in patients treated with bivalirudin versus patients who received heparin + abciximab. CONCLUSIONS: These observations suggest that bivalirudin is a safe, cost-effective alternative to heparin + GP IIb/IIIa inhibition in patients undergoing DES in the absence of acute MI.