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Biomedical subjects

William F Penny

Publications and source records attributed to William F Penny.

7 recordsLinked to original sources
PubMed2006

Geographical differences in the rates of angiographic restenosis and ischemia-driven target vessel revascularization after percutaneous coronary interventions: results from the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) Trial.

UNLABELLED: Many cardiologists consider it reasonable to assume in clinical practice that percutaneous coronary intervention using drug-eluting stents ought to be considered equivalent, if not superior, to bypass surgery. In the absence of a definitive clinical trial to support this view, how should the prudent, cutting-edge cardiologist proceed? OBJECTIVES: This study assessed the geographical differences in target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) in the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) trial. BACKGROUND: An aggressive approach to PCI is more common in the U.S. than in other countries. The impact of this approach on restenosis outcomes has not been studied. METHODS: Using the PRESTO trial, we compared nine-month ischemic TVR after PCI in U.S.-treated patients (n = 5,026) with rates in other countries (n = 6,458). We defined TVR as repeat intervention for chest pain/positive stress test. Additionally, angiographic restenosis (> or =50% narrowing or > or =50% loss of gain at nine-month follow-up) was compared between U.S. and non-U.S. patients within the prespecified angiographic subset (n = 2,823). Regression models were developed to adjust for clinical and lesion-related characteristics. RESULTS: Higher rates of TVR (18% vs. 11%), and angiographic restenosis (65% vs. 48%) were observed in patients treated in the U.S. as compared with the other patients (p < 0.01 for both comparisons). Patients treated in the U.S. were more likely to be female, diabetic, not currently smoking, to have unstable angina, and to have a prior PCI. In U.S. patients, lesions tended to be longer, but less likely to be American College of Cardiology/American Heart Association class C. After adjusting for clinical and angiographic variables, PCI in the U.S. was still associated with increased angiographic restenosis and ischemic TVR. CONCLUSIONS: Angiographic restenosis and ischemia-driven TVR rates were higher in patients treated in the U.S. The difference could only partially be explained by the higher prevalence of measured adverse clinical and angiographic features.

Angioplasty, Balloon, Coronary↗
PubMed2005

Predictive factors for ischemic target vessel revascularization in the Prevention of Restenosis with Tranilast and its Outcomes (PRESTO) trial.

OBJECTIVES: The aim of the present study was to determine the rates of target vessel revascularization (TVR) and to determine predictors of TVR from clinical and angiographic variables available in the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) database. BACKGROUND: The rates of TVR after percutaneous revascularization procedures, and its prediction with available clinical and angiographic variables, is less well known. METHODS: We studied nine-month TVR in 11,484 patients enrolled in the PRESTO trial. Clinical, lesion-related, and procedural characteristics were analyzed in a logistic regression model. Study data were divided at random into an 80% training set on which the models were developed and a 20% hold-out set on which the model properties were evaluated. RESULTS: A total of 14% (n = 1,609) had ischemic TVR. Clinical variables with increased risk for TVR included younger age; hypertension; diabetes mellitus; nonsmokers; unstable angina; previous coronary artery bypass grafting; peripheral vascular disease; procedure- and lesion-related such as ostial location, multilesion angioplasty, location in the left anterior descending artery, length > or =20 mm, in-stent restenosis at baseline, and use of rotablator. There was significant increase in the risk of ischemic TVR at U.S. treatment sites. Smoking and stent placement were associated with lower risk of ischemic TVR. The mean area (+/- SD) under the receiver-operating characteristic curve of the bootstrap samples was 0.66, indicating a modest ability of the model to discriminate patients who needed TVR on follow-up. CONCLUSIONS: Despite being the largest prospective trial designed to test restenosis, the discriminatory ability of the clinical and angiographic variables to predict TVR is modest.

Aged↗
PubMed2004

Clinical and angiographic predictors of restenosis after percutaneous coronary intervention: insights from the Prevention of Restenosis With Tranilast and Its Outcomes (PRESTO) trial.

BACKGROUND: Restenosis prediction from published studies is hampered by inadequate sample size and incomplete angiographic follow-up. The prediction of restenosis with the existing variables is poor. The aim of the present study was to include the clinical and angiographic variables commonly associated with angiographic restenosis and develop a prediction model for restenosis from the PRESTO database. METHODS AND RESULTS: This study included 1312 patients with a single lesion enrolled in the angiographic substudy of the PRESTO trial. We constructed 2 risk scores. The first used preprocedural variables (female gender, vessel size [< or =2.5 mm, 2.5 to 3 mm, 3 to 3.5 mm, 3.5 to 4 mm, >4 mm], lesion length >20 mm, diabetes, smoking status, type C lesion, any previous percutaneous coronary intervention [PCI], and unstable angina) derived from previous studies. Estimated restenosis rates and corresponding variability for each possible level of the resultant risk score were obtained via bootstrapping techniques. The area under the receiver-operator characteristic (ROC) curve was 0.63, indicating modest discriminatory ability to predict restenosis. The second approach constructed a multiple logistic regression model considering significant univariate clinical and angiographic predictors of restenosis identified from the PRESTO database (treated diabetes mellitus, nonsmoker, vessel size, lesion length, American College of Cardiology/American Heart Association type C lesion, ostial location, and previous PCI). The area under the ROC curve for this risk score was also 0.63. CONCLUSIONS: The preprocedural clinical and angiographic variables from available studies and from the PRESTO trial have only modest predictive ability for restenosis after PCI.

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PubMed2004

Severe ostial saphenous vein graft disease leading to acute coronary syndromes following proximal aorto-saphenous anastomoses with the symmetry bypass connector device: is it a suture device or a "stent"?

The Symmetry Bypass Connector (St. Jude Medical, St. Paul, Minnesota) is a nitinol, star-shaped device that was designed to facilitate placement of sutureless aorto-saphenous anastomoses during off-pump coronary artery bypass graft surgery (CABG). Although the device is approved for clinical use in Europe and the U.S., its short- and long-term safety and efficacy are not established. We report on 5 of 121 patients undergoing CABG who presented with an acute coronary syndrome two to five months following placement of this device. In each patient, all saphenous vein grafts (SVGs) placed (n = 11) with the device were totally occluded (n = 6) or compromised by ostial stenoses (n = 5). Treatment consisted of repeat CABG in one patient and percutaneous coronary intervention (PCI) in four patients with cutting balloon atherotomy and stenting. Following PCI, two of four patients presented again within two months with near-occlusive ostial restenosis in all stents placed. Intracoronary ultrasound showed severe neointimal hyperplasia, but only at the proximal interface of the device and stent. One patient was treated with brachytherapy in two SVGs but had a recurrence four months later and was treated with drug-eluting stents in both restenotic segments. Recalcitrant neointimal hyperplasia is postulated to be involved in the pathogenesis of anastomotic device stenosis, possibly similar to in-stent restenosis. Prospective randomized clinical trials are needed to assess the clinical safety and efficacy of this device. Pending such studies, consideration should be given in limiting its use to cases of unacceptably high risk of stroke during aortic cross-clamping. Dual antiplatelet agents, evaluation for ischemia, and close follow-up are warranted in patients that have already received the device.

Acute Disease↗
PubMed2003

Patients at low risk for periprocedural myocardial infarction can be identified by assessment immediately following percutaneous coronary intervention.

Despite utilizing optimal anticoagulant therapy during percutaneous coronary intervention (PCI), the incidence of periprocedural myocardial infarction (PPMI) remains 5 7% and evaluation of preprocedural clinical/angiographic characteristics has failed to reliably predict the likelihood of a PPMI. We hypothesized that immediate post-PCI assessment could identify a group of patients at very low risk for PPMI. A consecutive series of 258 PCI patients was stratified into 3 groups based on immediate post-PCI assessment. Group I (PPMI not expected) included those with an acceptable angiographic result of treated vessel (residual stenosis < 50%), TIMI 3 flow and absence of any intraprocedural complications. Group II (PPMI not unexpected) included those with an acceptable angiographic result, TIMI 3 flow but with any/all of the following: saphenous vein graft (SVG) PCI, transient closure of culprit vessel or major sidebranch, intracoronary thrombus, prolonged chest pain, electrocardiographic (ECG) changes, hypotension, resolved slow flow/no reflow, bailout glycoprotein IIb/IIIa inhibitor use, loss of a minor sidebranch or any angiographic residual stenosis > 50% with TIMI 3 flow. Group III (PPMI expected) included those with any angiographic result of native coronary artery or SVG with < TIMI 3 flow, unresolved chest pain, hypotension or ECG changes at the end of the PCI, loss of a major sidebranch or vessel, or persistent no-reflow. Group stratification was analyzed in relation to the incidence of PPMI (CK-MB > 3 times the upper limit of normal; 18 24 hours post-PCI). Rate of PPMI: Group I (1/141; 0.7%), Group II (7/71; 9.9%), Group III (5/11; 45.5%) (p < 0.001). The 3 groups did not differ in age, clinical presentation or stent use (p = NS). Sixty out of 105 patients (57.1%) with unstable angina, seventy-seven out of 146 patients (52.7%) with B2/C lesions, and 105/180 patients (58.3%) with unstable angina or B2/C lesions were stratified to Group I. This study demonstrates that immediate post-PCI evaluation of the clinical/angiographic characteristics can predict the likelihood of PPMI and a group of patients at a very low risk for a PPMI can be identified, in whom implications exist for limited hospitalization and post-procedural antithrombotic therapy.

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