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Biomedical subjects

David O Williams

Publications and source records attributed to David O Williams.

At least 19 recordsLinked to original sources
PubMed2006

Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry.

BACKGROUND: The DEScover Registry was designed to characterize patients selected for drug-eluting stents (DES) in routine clinical practice and their outcomes in the United States. METHODS AND RESULTS: From January to June 2005, data were collected on 6906 patients who underwent percutaneous coronary intervention at 140 medical centers. Baseline characteristics and outcomes were compared on the basis of treatment with > or =1 bare-metal (BMS; n=397), sirolimus-eluting (SES; n=3873), or paclitaxel-eluting (PES; n=2636) stent. Clinical characteristics and the types of lesion treated for BMS patients differed substantially from those treated with DES, but minimal differences were noted between DES patients receiving SES or PES. At 1 year, the unadjusted cumulative incidence of death/myocardial infarction was higher in BMS than in DES patients (9.0% versus 5.2%; P=0.002) but similar in SES and PES patients (5.2% versus 5.3%; P=0.64). After adjustment, risk of death/MI was not significantly lower in DES- compared with BMS-treated patients (adjusted hazard ratio, 0.74; 95% confidence interval, 0.52 to 1.07). Although target vessel revascularization occurred less often in DES patients (9.5% versus 6.0%; P=0.007), rates were similar between SES and PES patients (6.3% versus 5.5%; P=0.20). Rates of stent thrombosis were similar among BMS (0.8%), SES (0.5%), and PES (0.8%) patients. CONCLUSIONS: In DEScover, differences in patient selection were observed between BMS and DES patients but not between SES and PES patients. DES use resulted in lower rates of clinically driven repeat revascularization with similar rates of stent thrombosis. These observations confirm the effectiveness and safety of both SES and PES in unselected patients.

Angioplasty, Balloon, Coronary↗
PubMed2006

Comparison of the efficacy of direct coronary stenting with sirolimus-eluting stents versus stenting with predilation by intravascular ultrasound imaging (from the DIRECT trial).

A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.

Coronary Stenosis↗
PubMed2006

Outcome of percutaneous coronary intervention in unstable angina pectoris versus stable angina pectoris in two different time periods.

Percutaneous coronary intervention (PCI) for unstable angina pectoris (UAP) has traditionally been associated with a higher risk of ischemic complications than that for stable angina pectoris (SAP). However, PCI procedures have evolved, so this study was designed to determine whether PCI for UAP is still associated with less favorable outcomes. In-hospital and 1-year outcomes in Dynamic Registry patients who presented for PCI with UAP (n = 2,994) or SAP (n = 1,457) between 1997 and 2002 were compared. One-year results were also compared with consecutive patients who underwent angioplasty (n = 2,431) from the 1985 to 1986 Percutaneous Transluminal Coronary Angioplasty Registry. Although Dynamic Registry patients with UAP were older and more likely to smoke (p < 0.05), have diabetes mellitus (p = 0.03), or a previous myocardial infarction (p < 0.001), procedural success was higher than in patients with SAP. By 1 year, there was greater risk of death (4.4% vs 2.6%, p < 0.01), death/myocardial infarction (9.9% vs 6.6%, p < 0.001), and death, myocardial infarction, and coronary artery bypass grafting (15.1% vs 11.6%, p < 0.01) in patients with UAP. In patients with UAP, there was no significant difference in adjusted 1-year death and death/myocardial infarction rates when comparing the waves of the Dynamic Registry with those of the Percutaneous Transluminal Coronary Angioplasty Registry, although death/myocardial infarction rates among Dynamic Registry patients were lower. However, in patients with SAP, the adjusted rate for death/myocardial infarction was lower in wave 3, and for death, myocardial infarction, and revascularization, there was a significant decrease in event rates with each successive recruitment period (p < 0.05 for all comparisons). In conclusion, in contradistinction to patients with SAP, death and death/myocardial infarction rates in patients who have undergone PCI for UAP have not significantly decreased over the past 16 years and patients with UAP remain at a greater risk of ischemic events at 1 year compared with patients with SAP.

Angina, Unstable↗
PubMed2006

Recent trends in the percutaneous treatment of chronic total coronary occlusions.

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) has a lower success rate than PCI for non-CTO lesions. We sought to determine trends in the treatment of CTOs within the current interventional era. Using 4 sequential recruitment waves of the National Heart, Lung, and Blood Institute Dynamic Registry, we assessed the relative prevalence and success rates in treating CTO (n=371) versus non-CTO (n=4,802) lesions over a 7-year period (1997 to 2004). Characteristics of attempted lesions and factors associated with PCI outcome were evaluated. CTO lesion attempts decreased by 41% over time, from 9.6% (1997 to 1998) to 5.7% (2004, p<0.0001 for trend). More contemporary CTO lesions were longer (22.4 vs 17.0 mm, p=0.006 for trend), had thrombus less often (21.3% vs 35.4%, p=0.03 for trend), and were more often treated with stents (69.8% vs 45.4% p=0.02). The rate of successful intervention for CTO lesions decreased nonsignificantly during this time, from 79.7% to 71.4% (p=0.18). Using multivariable analysis, female gender (adjusted odds ratio 0.42, 95% confidence interval 0.20 to 0.88, p=0.02), and thrombus (adjusted odds ratio 0.31, 95% confidence interval 0.15 to 0.61, p=0.0008) were associated with higher success rates, whereas the presence of severe noncardiac disease (adjusted odds ratio 1.91, 95% confidence interval 1.05 to 3.45, p=0.03) was associated with a higher risk for PCI failure. Recruitment wave and patient age were not independently related to lesion success. In conclusion, during the PCI period of 1997 to 2004, CTO lesions were attempted less frequently and success rates did not increase, indicating a need for new operator techniques or device technologies to treat this important lesion subset by a percutaneous approach.

Aged↗
PubMed2006

The impact of ejection fraction on outcomes after percutaneous coronary intervention in patients with congestive heart failure: an analysis of the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry and Dynamic Registry.

BACKGROUND: Patients with congestive heart failure (CHF) have higher rates of adverse outcomes after percutaneous coronary intervention (PCI). A comprehensive analysis of outcomes in patients with CHF in the current era has not been done. We studied the outcomes of patients with CHF who underwent PCI in the National Heart, Lung, and Blood Institute-sponsored Percutaneous Transluminal Coronary Angioplasty (PTCA) and Dynamic registries. METHODS: We evaluated demographic and angiographic characteristics and the clinical outcomes of patients with CHF in the Dynamic Registry and the PTCA Registry, excluding patients with acute myocardial infarction. In the Dynamic Registry, patients with CHF (n = 503) were compared with patients without CHF (n = 4194), and patients with CHF with a preserved ejection fraction (EF) (n = 134) were compared with patients with CHF who have a reduced EF (n = 199). The patients with CHF in the 1997 through 2001 Dynamic Registry (n = 236) were then similarly compared with patients with CHF in the earlier PTCA Registry (n = 117). RESULTS: In the Dynamic Registry, compared with patients without CHF, patients with CHF had a higher-risk clinical and angiographic profile, and a higher mortality rate both inhospital (2.6% vs 0.4%, P < or = .001) and at 1 year (13.1% vs 3.0%, P < .001). Patients with reduced EF had higher inhospital mortality rates and a trend toward higher mortality at 1 year. The patients with CHF in the Dynamic Registry compared with those in the PTCA Registry had a higher risk profile yet had significantly higher procedural success rates and improved clinical outcomes. CONCLUSIONS: Although CHF remains a strong predictor of adverse outcomes after PCI, significant improvement seen in the past decade is likely related to improved procedural techniques and improved medical therapy.

Aged↗
PubMed2006

Marked improvements in outcomes of contemporary percutaneous coronary intervention in patients with diabetes mellitus.

We sought to determine if advances in percutaneous coronary intervention (PCI) are associated with better outcomes among patients with diabetes mellitus (DM). Patients with DM enrolled in the National Heart, Lung, and Blood Institute (NHLBI) early PTCA Registry (1985-1986) were compared to those in the subsequent contemporary Dynamic Registry (1999-2002) for in-hospital and one-year cardiovascular outcomes. The study population included 945 adults with DM, 325 from the PTCA Registry and 620 from the Dynamic Registry. Multivariable Cox regression models were built to estimate the risk of clinical events. Dynamic Registry patients were older, had more noncardiac comorbidities, and a lower mean ejection fraction (50.5% vs 57.8%, P < or = 0.001) compared to the PTCA Registry patients. The incidence of in-hospital mortality (1.9% vs 4.3%, P < or = 0.05), myocardial infarction (MI) (1.0% vs 7.4%, P <or = 0.001), and coronary artery bypass grafting (CABG) (0.8% vs 6.2%, P < or = 0.001) were all significantly lower and independent of the use of stents. One-year adverse events including MI (4.9% vs 11.0%, P < or = 0.001), CABG (6.4% vs 15.0%, P < or = 0.001), and need for repeat revascularization (18.7% vs 33.3%, P < or = 0.001) were all lower in the Dynamic Registry. The relative risk of death at 1 year was significantly less for patients in the Dynamic Registry (RR 0.56, 0.34; 0.92, P = 0.02). Although Dynamic Registry patients with diabetes had more advanced coronary disease, in-hospital and late adverse events were lower. A combination of the use of stents and an increase in adjunctive medical therapy are likely responsible for the observed improvements in outcomes in contemporary PCI.

Angioplasty, Balloon, Coronary↗
PubMed2005

Impact of coronary collaterals on outcome following percutaneous coronary intervention (from the National Heart, Lung, and Blood Institute Dynamic Registry).

Coronary collateral circulation is beneficial in patients with coronary artery disease, but controversy still exists regarding the association between angiographic collaterals and outcome after percutaneous coronary intervention (PCI). We compared the baseline characteristics and cumulative 1-year event rates of consecutive patients undergoing PCI by target vessel collateral status-no angiographic evidence of collateral circulation (NC; n = 5051), treated artery supplied collaterals (SC; n = 239), and treated artery received collaterals (RC; n = 893)-using the National Heart, Lung, and Blood Institute Dynamic Registry. Patients in the SC group were older and had more previous coronary bypass surgery, myocardial infarction, co-morbid illness, and heart failure than the NC and RC groups and had less often undergone revascularization for acute myocardial infarction (p <0.01 for all). The total angiographic PCI success was comparable for the SC and NC groups but higher than for the RC group (94.1% vs 94.4% vs 83.9%, respectively; p <0.001). Overall stent use was 77.5% and was highest in the SC group (82.4%, p <0.001). At 1 year, significant differences in outcome were observed by collateral status. Compared with the NC group, patients with PCI of a SC artery had higher adjusted mortality (relative risk [RR] 1.95, 95% confidence interval [CI] 1.27 to 3.01, p = 0.002) and death/myocardial infarction (RR 1.75, 95% CI 1.26 to 2.45, p <0.001) rates. Patients with PCI of a RC vessel, conversely, had lower adjusted death/myocardial infarction (RR 0.72, 95% CI 0.54 to 0.96, p = 0.02) and repeat revascularization (RR 0.73, 95% CI 0.59 to 0.91, p = 0.005) rates. In conclusion, our results suggest that PCI on collateralized vessels is warranted, but that patients with PCI in arteries that supply collaterals are a high-risk group that may benefit from closer follow-up and complete revascularization.

Aged↗
PubMed2005

Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Aged↗
PubMed2005

Importance of the postdischarge interval in assessing major adverse clinical event rates following percutaneous coronary intervention.

In-hospital major adverse clinical event (MACE) rates after percutaneous coronary intervention serve as benchmarks of performance. However, accelerated clinical pathways, decreased lengths of stay, and potential delayed effects of percutaneous coronary intervention may result in an underestimation of this traditional measurement of outcome. Records from patients in the first 3 waves of the National Heart, Lung, and Blood Institute's Dynamic Registry (n = 6,676) were reviewed for rates of composite in-hospital MACEs (death, myocardial infarction, and any repeat target vessel revascularization) and postdischarge MACEs (death, myocardial infarction, repeat hospitalization, and repeat target vessel revascularization) through 30 days. Rates for each composite MACE were compared across waves to assess changes over time. Predictors of each MACE category were identified using multivariate analysis. In-hospital MACE decreased significantly (5.4% of wave 1, 4.9% of wave 2, 3.1% of wave 3, p <0.001), whereas stent implantation increased significantly (67.5% of wave 1, 79.1% of wave 2, 86.2% of wave 3, p <0.001). Postdischarge MACE through 30 days remained unchanged (5.1% of wave 1, 5.1% of wave 2, 4.8% of wave 3, p = 0.6). Mean length of stay decreased (2.7 days for wave 1, 2.2 days for wave 3, p <0.001). Disparate clinical, procedural, and angiographic factors were associated with each MACE. Postdischarge MACE rates through 30 days comprise a significant and unchanging fraction of overall procedurally related MACE rates despite improving in-hospital outcomes. Most postdischarge events derive from pathology related to the controlled vessel. A 30-day MACE rate may serve as a more comprehensive measurement of procedural outcome.

Aged↗