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D O Williams

Publications and source records attributed to D O Williams.

At least 37 records · Page 2Linked to original sources

Effects of intracoronary beta-radiation therapy after coronary angioplasty: an intravascular ultrasound study.

BACKGROUND: Endovascular radiation is emerging as a potential solution for the prevention and treatment of restenosis. Its effects on the morphology of unstented vessels cannot be determined by angiography and therefore require the use of intravascular ultrasound. METHODS AND RESULTS: Through a 5F noncentered catheter for delivery of a 90Sr/Y source train, 12, 14, or 16 Gy at 2 mm was delivered to native coronary arteries after successful balloon angioplasty in 30 patients. Four patients required stent deployment in the first week. Quantitative coronary angiography and IVUS were performed during the initial procedure and at 6-month follow-up. Binary angiographic restenosis was present in 3 of 30 patients, with target lesion and vessel revascularization performed in 3 and 5 patients, respectively. Angiographic late loss was -0.02+/-0.60 mm, with a -0.09+/-0.46 loss index. IVUS demonstrated no significant reduction in lumen area (from 5.69+/-1.72 mm2 after treatment to 6. 04+/-2.63 mm2 at follow-up), with no significant change in external elastic membrane area (13.71+/-4.54 to 14.22+/-4.71 mm2) over the 6-month follow-up. Wall area was 8.01+/-3.85 mm2 after radiation therapy and 8.19+/-3.44 mm2 at follow-up (P=NS). No significant differences were noted between the different dose groups. CONCLUSIONS: beta-Radiation therapy resulted in a low restenosis rate with negligible late loss by angiography. By IVUS, beta-radiation was shown to inhibit neointima formation, with no reduction of total vessel area at 6-month follow-up.

Adult↗

Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: results from the STent Anti-thrombotic Regimen Study (STARS) registry.

OBJECTIVES: This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial. BACKGROUND: Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally. METHODS: In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications. RESULTS: Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use. CONCLUSIONS: In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.

Acute Disease↗

A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators.

BACKGROUND: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting. METHODS: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days. RESULTS: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups. CONCLUSIONS: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.

Aged↗

Endovascular beta-radiation to reduce restenosis after coronary balloon angioplasty: results of the beta energy restenosis trial (BERT).

BACKGROUND: In the porcine overstretch injury model of restenosis, endovascular beta-radiation reduces neointima formation. To determine whether this therapy could be applied to patients with coronary artery disease, a special device was developed to allow delivery of 12 encapsulated 90Sr/Y sources, measuring a total of 30 mm, to various sites within the coronary arterial tree. This study was designed to evaluate the feasibility of the delivery of 12, 14, or 16 Gy at 2 mm after balloon angioplasty of stenoses of native coronary vessels. METHODS AND RESULTS: Delivery of beta-radiation was attempted in 23 patients after successful balloon angioplasty. Source delivery was successful in 21 of the 23 patients (91%). There was no in-hospital or 30-day morbidity or mortality. Follow-up quantitative coronary arteriography in 20 patients demonstrated a late loss of 0.05 mm, a late loss index of 4%, and a restenosis rate of 15%. The use of the beta-emitter 90Sr/Y significantly reduced treatment time and operator exposure compared with previous trials with the gamma-emitter 192Ir. CONCLUSIONS: In this study, the administration of endovascular beta-radiation after angioplasty was safe and feasible and substantially altered the postangioplasty late lumen loss, resulting in a lower-than-expected rate of restenosis. On the basis of these encouraging results, a multicenter, randomized trial with operators and patients blinded to treatment assignment is planned.

Adolescent↗

Radiation vascular therapy: a novel approach to preventing restenosis.

In animal studies, beta and gamma radiation delivered via catheter-based systems to sites of angioplasty after arterial injury has decreased the neointimal proliferation that is a part of the restenotic process. Extending radiotherapy to the clinical setting, results of the double-blind, placebo-controlled, randomized Scripps Coronary Radiation to Inhibit Proliferation Post Stenting (SCRIPPS) study showed dramatic reductions in the rate of restenosis after coronary stenting when catheter-based gamma radiotherapy (with iridium-192) was used. In the Beta Energy Restenosis Trial (BERT), angiographic, intravascular ultrasound, and clinical outcomes were better than expected with beta brachytherapy. Strontium-90/yttrium-90 seeds were delivered via a unique catheter system in 35 patients who underwent coronary angioplasty. Future trials are being planned to confirm these promising results.

Angioplasty, Balloon, Coronary↗

Novel perfusion sleeve for use during balloon angioplasty: initial clinical experience.

The perfusion sleeve (PS) is an "over-the-balloon" catheter designed to add perfusion capability to standard PTCA catheters. To evaluate the clinical effectiveness of this device, eight patients underwent standard PTCA with the PS retracted in the guide (Inflation 1-Control) and after deployment of the PS (Inflation 3-Control). Between standard inflations the PS was advanced and aligned with the already positioned PTCA balloon which was inflated for up to 15 minutes (Inflation 2-Perfusion). TIMI III flow was present in 5/7 and TIMI II flow in 2/7 patients during Inflation 2-Perfusion. Absolute ST segment shift (mm) on the ECG was significantly less at 3 minutes and prior to balloon deflation with the PS in place (1.0 +/- 1.4 and 1.1 +/- 1.1 mm) compared to Inflation 1-Control and Inflation 3-Control (2.6 +/- 1.3 and 2.3 +/- 0.3 mm) respectively (P < or = 0.05). Use of the PS in conjunction with standard PTCA is feasible, provides perfusion during prolonged balloon inflations and reduces the magnitude of ischemia.

Aged↗

Clinical and detailed angiographic findings in patients with ambulatory electrocardiographic ischemia without critical coronary narrowing: results from the Asymptomatic Cardiac Ischemia Pilot (ACIP) Study.

BACKGROUND: Patients with ambulatory electrocardiographic (AECG) ST-segment depression and critical coronary narrowing are known to be at increased risk for adverse outcome, but little is known about patients with AECG ST-segment depression without critical coronary narrowing. HYPOTHESIS: The objectives of this study were to characterize the coronary angiographic pathology in patients with AECG ST-segment depression but without critical (< 50% diameter stenosis) coronary narrowing and to compare demographic and clinical findings in these patients with those enrolled in the Asymptomatic Cardiac Ischemia Pilot Study with AECG ST-segment depression and critical (> or = 50% diameter stenosis) coronary narrowing. METHODS: Coronary angiograms from patients with AECG ST-segment depression were reviewed in a central laboratory and quantitative measurement of percent stenosis was performed. Clinical and angiographic comparisons were made between patients with and without critical coronary narrowing. RESULTS: Patients without critical coronary narrowing (n = 64) were younger (p = 0.02), less likely to be male (p < 0.001) or to have risk factors for coronary atherosclerosis or a history of myocardial infarction (p < 0.001), and had fewer ischemic episodes per 24 h on the screening AECG (p = 0.02) than patients with critical coronary narrowing (n = 441). Of patients without critical narrowing, one half had angiographic evidence for coronary artery disease (> or = 20% stenosis) and 60% had an ejection fraction > 70%. CONCLUSIONS: Patients with AECG ST-segment depression without critical coronary narrowing are heterogeneous, with half having measurable coronary artery disease. Demographically and clinically, they appear to be different than patients with AECG ST-segment depression with critical coronary narrowing.

Coronary Angiography↗

Efficacy of beta radiation in prevention of post-angioplasty restenosis. An interim report from the beta energy restenosis trial.

UNLABELLED: Restenosis remains a major limitation of coronary angioplasty in spite of major advances in techniques and technology. Recent studies have demonstrated that ionizing radiation may limit the degree of this problem. Gamma radiation has been shown to be effective in reducing in stent restenosis in humans, and beta radiation following encouraging results in animals has been shown to be feasible in humans. The objective of this study was to assess the feasibility of a 5 F non-centered catheter to deliver beta radiation emitting seeds to the lesion site post angioplasty and its effect on restenosis. Following successful angioplasty, patients were randomized to treatment with 12, 14 or 16 Gy at the angioplasty site. This was delivered with a 5 F non-centered catheter. Twelve beta radiation emitting seeds (90Sr/Y) were delivered to an area 3 cm in length to cover the angioplasty site. Angiographic follow-up was performed at 6 months. Baseline and follow-up angiograms were performed by blinded investigators at a core laboratory. This interim report comprises the first 35 patients to complete 6-month angiographic follow-up. There were no major radiation incidents. Four patients had evidence of angiographic restenosis. The MLD (mm) and percent stenosis were 0.77 +/- 0.27/72.5 +/- 8.6 pre angioplasty, 2.08 +/- 0.4/25.7 +/- 9.8 post angioplasty and radiation and 2.05 +/- 0.59/25.7 +/- 19.8 at follow-up respectively. CONCLUSION: Beta radiation can be feasibly and safely delivered post coronary angioplasty with a very encouraging reduction of restenosis.

Adult↗

Relation of coagulation parameters to patency and recurrent ischemia in the Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial.

Current protocols for use of tissue-type plasminogen activator in acute myocardial infarction include heparin estimated by the activated partial thromboplastin time (aPTT). Recent reports indicate a risk of recurrent ischemic events with long aPTT values. Longer aPTT values in the Thrombolysis in Myocardial Infarction-II (TIMI II) Trial, obtained within the first 48 hours, were associated with patency at 18 to 48 hours and better left ventricular function at discharge (average 9.6 days), but also with emergency catheterizations within the first 48 hours and, weakly, with recurrent ischemia during the first 18 hours. A moderate decrease in fibrinogen, compared with a "small" decrease, was also associated with patency, but a "large" decrease was associated with hemorrhagic events. Patency was associated with higher fibrinogen values and higher plasminogen values at baseline. The aPTT results support frequent monitoring during the first 24 to 48 hours to ensure optimal clinical outcome. The coagulation factor results suggest that there may be an optimum window for fibrinogenolysis in this setting.

Fibrinogen↗

Long-term analysis of conventional coronary balloon angioplasty and an initial "stent-like" result. The NHLBI PTCA Registry.

OBJECTIVES: We examined the influence of an initial "stent-like" result on long-term outcome in patients in the 1985-86 NHLBI PTCA Registry. BACKGROUND: Stent use in selected patients is associated with improved angiographic and short-term clinical outcome; however, due to potential for in-stent restenosis and high costs of stents, there is interest in a strategy of more optimal dilatation to achieve a "stent-like" result without a stent. The long-term outcome of patients with a "stent-like" percutaneous transluminal coronary angioplasty (PTCA) remains unknown. METHODS: Ten-year outcome was compared between 225 successfully treated patients with and 1,764 successfully treated patients without an initial "stent-like" result ( > or = 1 lesion dilated to < or = 10% stenosis). The sample had 75% and 80% power, respectively, to detect an absolute difference of 8% in the 10-year rate of death and myocardial infarction (MI) between the two groups. RESULTS: Ten-year rates of death and MI were similar between the stent-like and non-stent-like groups (22.3% vs. 22.2%, 17.6% vs. 17.9%), however, there was less target lesion revascularization in the stent-like group (30.2% vs. 36.8%). In subgroup analysis of patients with multivessel disease, those with a stent-like result had less follow-up bypass surgery (25.2% vs. 32.7%), yet more repeat PTCA (53.8% vs. 42.7%). These findings were unaffected by adjustment for differences in baseline characteristics between the two patient groups. CONCLUSIONS: Achievement of an initial stent-like result via balloon angioplasty alone may not appreciably reduce the long-term risk of death or MI, nor confer equivalent clinical benefit as achieving a stent-like result with a stent.

Angioplasty, Balloon, Coronary↗

Documentation of decline in morbidity in women undergoing coronary angioplasty (a report from the 1993-94 NHLBI Percutaneous Transluminal Coronary Angioplasty Registry). National Heart, Lung, and Blood Institute.

To determine whether there has been an improvement in the relatively unfavorable outcome of percutaneous transluminal coronary angioplasty (PTCA) in women, the 1993 to 1994 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry collected data from 12 clinical centers that participated in the earlier registries. We compared 274 consecutive women in 1993 to 1994 with 545 consecutive women in 1985 to 1986 undergoing PTCA. Women in the 1993 to 1994 registry were older (64.3 vs 61.0 years, p <0.001) with more diabetes mellitus (34.3% vs 19.9%, p <0.001), congestive heart failure (13.7% vs 8.6%, p <0.05), and comorbid disease (19.5% vs 9.3%, p <0.001). Left ventricular function and multivessel coronary artery disease were similar between groups. Angiographic success (90.9% vs 85.1%, p <0.05) and clinical success (89.4% vs 79.4%, p <0.001) were higher in women undergoing PTCA in 1993 to 1994 than in 1985 to 1986. Whereas there was no difference in in-hospital mortality (1.5% vs 2.6%), the incidence of nonfatal myocardial infarction (1.8% vs 4.6%, p <0.05), emergency coronary artery bypass graft surgery (1.8% vs 4.6%, p <0.05), and the combined end points of death, myocardial infarction, and emergency coronary artery bypass grafting (4.4% vs 9.7%, p <0.01) were lower in women in 1993 to 1994 than in women in 1985 to 1986, respectively. Multivariate analysis revealed an odds ratio of 0.36 (95% confidence interval 0.18 to 0.72) for major complications and of 2.34 (95% confidence interval, 1.49 to 3.69) for clinical success in the 1993 to 1994 versus 1985 to 1986 registry. Therefore, despite a higher risk profile, women undergoing PTCA in 1993 to 1994 have a higher clinical success and lower major complication rate than women treated with PTCA in 1985 to 1986.

Aged↗

Myocardial infarction and cardiac mortality in the Bypass Angioplasty Revascularization Investigation (BARI) randomized trial.

BACKGROUND: Cardiac mortality and myocardial infarction (MI) rates are used to evaluate the efficacy of coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). We compared 5-year cardiac mortality and MI rates in 1829 patients with multivessel disease randomized to CABG or PTCA. METHODS AND RESULTS: The 5-year cardiac mortality rate was 8.0% in patients assigned to PTCA compared with 4.9% in those assigned to CABG (relative risk [RR] of 1.55 with a 95% confidence interval [CI] of 1.07 to 2.23; P=.022). In a subgroup of 1476 nondiabetic patients, there were no significant differences between treatment groups in cardiac mortality either overall (4.6% versus 4.2%; RR= 1.04, 95% CI, 0.65 to 1.66; P=.908) or in subgroups based on symptoms, left ventricular function, number of diseased vessels, or stenotic proximal left anterior descending artery. The two treatment groups had similar event rates for the combined end point of cardiac death or MI. The RR for cardiac mortality in 264 patients who sustained an MI compared with those who did not was 5.9 (P<.001). MIs were more common after CABG during index hospitalization (P=.004), but in the PTCA group, they were more common after discharge (P<.001). CONCLUSIONS: The Bypass Angioplasty Revascularization Investigation (BARI) trial indicates 5-year cardiac mortality in patients with multivessel disease was significantly greater after initial treatment with PTCA than with CABG. The difference was manifest in diabetic patients on drug therapy. There were no significant differences overall for the composite end point of cardiac mortality or MI between treatment groups or for cardiac mortality in nondiabetic patients regardless of symptoms, left ventricular function, number of diseased vessels, or stenotic proximal left anterior descending artery.

Angioplasty, Balloon, Coronary↗

A detailed angiographic analysis of patients with ambulatory electrocardiographic ischemia: results from the Asymptomatic Cardiac Ischemia Pilot (ACIP) study angiographic core laboratory.

OBJECTIVES: The purpose of this Asymptomatic Cardiac Ischemia Pilot (ACIP) data bank study was to characterize angiographic features of coronary pathology of patients enrolled in the ACIP study. BACKGROUND: Ischemia during ambulatory electrocardiographic (AECG) monitoring is associated with increased morbidity and mortality. Reports relating AECG ischemia to severity or complexity of coronary artery disease are few in number and small in size and have produced conflicting results. METHODS: Coronary angiograms from patients with asymptomatic AECG ischemia enrolled in the ACIP study were reviewed at a central core laboratory. Quantitative measurement of percent stenosis and Thrombolysis in Myocardial Infarction flow grades were used to assess the severity of coronary artery disease. Lesions were also evaluated for the presence of intracoronary thrombus, ulceration and lumen contour as indicators of stenosis complexity. In addition, comparisons were made with 27 patients screened for the ACIP study, but who were found ineligible because they did not have AECG ischemia on 48-h Holter monitoring. RESULTS: A total of 329 (75%) of 439 patients with AECG ischemia had multivessel coronary artery disease. Proximal stenoses > or = 50% diameter reduction were common in patients with AECG ischemia (62.2%), as were proximal stenoses > or = 70% (38.7%). Features suggesting complex plaque were found in 50.1% of patients with AECG ischemia. CONCLUSIONS: Multivessel coronary artery disease, severe proximal stenoses and features of complex plaque were observed frequently in patients who exhibited AECG ischemia. The presence of severe and complex coronary artery disease may explain, in part, the increased risk for adverse outcome associated with ischemia during activities of daily life.

Coronary Angiography↗

Results of percutaneous transluminal coronary angioplasty in unstable angina and non-Q-wave myocardial infarction. Observations from the TIMI IIIB Trial.

BACKGROUND: This report describes the results of percutaneous transluminal coronary angioplasty (PTCA) in the Thrombolysis in Myocardial Ischemia (TIMI) IIIB Investigation. METHODS AND RESULTS: PTCA was performed before hospital discharge in 444 of 1473 patients with either unstable angina pectoris or non-Q-wave myocardial infarction (NQWMI) enrolled in TIMI IIIB. Angiographic success was observed in 96.1% of patients. For the entire cohort, the cumulative incidences of death and infarction at 1 year were 2.0% and 8.2%, respectively. The periprocedural incidence of myocardial infarction was 2.7%; emergency coronary bypass surgery, 1.4%; and death, 0.5%. By 1 year of follow-up, 122 patients (28.0%, Kaplan-Meier) had an additional revascularization procedure, 75 (61.5%) had PTCA only, 30 (24.6%) had coronary bypass surgery only, and 17 (13.9%) had both procedures. The results of PTCA were not improved by routine pretreatment with intravenous tissue plasminogen activator (TPA). Periprocedural myocardial infarction was more common among patients receiving TPA than placebo (odds ratio [OR], 2.19; P = .03) and among those with unstable angina than those with NQWMI (OR, 15.5; P = .007). No difference in outcome was observed when patients were analyzed according to age (OR, 1.06; P = .092) or sex (OR, 1.54; P = .51). Variables predictive of poor outcome were PTCA within the first 24 hours of enrollment, PTCA site being the left anterior descending coronary artery, and unsuccessful angiography. CONCLUSIONS: In TIMI IIIB, PTCA was performed for patients with unstable angina and NQWMI with a very high rate of angiographic success and a low incidence of complications. By 1 year, repeat revascularization was performed in 28.0% of patients. Routine pretreatment with thrombolysis did not enhance outcome.

Aged↗

Angiographic correlates of lesion relevance and suitability for percutaneous transluminal coronary angioplasty and coronary artery bypass grafting in the Bypass Angioplasty Revascularization Investigation study (BARI).

The Bypass Angioplasty Revascularization Investigation (BARI) randomized 1,829 patients to percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG). Clinical site angiographers categorized lesions of > or = 50% diameter stenosis (n = 4,977) as clinically significant (86.4%) or nonsignificant (13.6%), and as favorable or nonfavorable for PTCA or CABG. More lesions were considered favorable for revascularization by CABG than by PTCA (91.5% vs 78.4%; p <0.001), particularly in the subgroup of 99% to 100% lesions (77.6% for CABG vs 21.9% for PTCA, p <0.001). Lesion features, characterized by the BARI core laboratory, were correlated with clinical site angiographers' assessment of clinical importance and suitability for PTCA or CABG. By multivariate analysis, positive predictors of clinical importance for 50% to 95% stenoses were greater stenosis severity, more jeopardized myocardium, larger reference diameter, and proximal vessel location. For 99% to 100% occlusions, predictors were shorter duration of occlusion and more jeopardized myocardium. PTCA suitability for 50% to 95% stenoses was inversely related to lesion length, ostial location, location on a bend, difficult access, and age, and was directly associated with greater Thrombolysis in Myocardial Infarction (TIMI) trial flow rate and more jeopardized myocardium. Predictors of PTCA suitability for 99% to 100% lesions were a lower American College of Cardiology/American Heart Association class and higher TIMI grade. Predictors for 50% to 95% stenoses were more jeopardized myocardium, larger reference diameter, and more proximal vessel location, and for 99% to 100% occlusions, more jeopardized myocardium and shorter duration of occlusion. Suitability for PTCA depended on lesion potency (<99%) and multiple morphologic characteristics that contrasted with the few angiographic features that adversely affect CABG suitability.

Angioplasty, Balloon, Coronary↗