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Biomedical subjects

David R Holmes

Publications and source records attributed to David R Holmes.

At least 91 records · Page 5Linked to original sources
PubMed2004

Association of race with complications and prognosis following acute coronary syndromes.

The baseline characteristics, complications, and survival of 489 black and 6,890 non-black patients with acute coronary syndromes were studied. Important racial differences were observed in demographic features, atherosclerosis risk factors, and treatment strategies; however, despite these differences, no independent difference was observed in clinical outcomes according to race. The 1-year mortality rate was 2.9% for black patients and 2.5% for non-black patients (p = 0.93).

Acute Disease↗
PubMed2004

Comparison of Mayo Clinic risk score and American College of Cardiology/American Heart Association lesion classification in the prediction of adverse cardiovascular outcome following percutaneous coronary interventions.

OBJECTIVES: We compared American College of Cardiology/American Heart Association (ACC/AHA) lesion classification with the recently proposed Mayo Clinic risk score to predict complications following percutaneous coronary intervention (PCI). BACKGROUND: The ability of the ACC/AHA classification system to predict complications following PCI has been modest. With the inclusion of patient demographics, acuity of presentation, and measure of left ventricular function, models with better discriminatory accuracy are presently available. METHODS: The Mayo Clinic risk score is constructed by adding integer scores for the presence of eight variables. We mapped the lesion-specific risk levels to a patient level by counting the number of lesions in each class (A, B1, B2, C, and unknown). RESULTS: In 5,064 PCIs, 183 patients (4%) had the primary end point (death, Q-wave myocardial infarction, stroke, emergency coronary artery bypass graft). Of the 7,632 treated lesions, 891 (12%) were unsuccessfully treated with PCI (residual stenosis >20%). The discriminatory ability of the Mayo Clinic risk score model for prediction of the primary end point, as measured by the c-statistic, was 0.78 (95% confidence interval [CI] 0.74 to 0.81). The Mayo Clinic risk score offered significantly better risk stratification than the ACC/AHA lesion classification counts (95% CI for c-statistic difference: 0.05 to 0.15). Regarding angiographic success, the ACC/AHA lesion classification was a better system (95% CI for c-statistic difference: -0.08 to -0.03 favoring ACC/AHA classification), although its absolute ability was modest (c = 0.58). CONCLUSIONS: Mayo Clinic risk score offers significantly better prediction for cardiovascular complications than the ACC/AHA classification. However, lesion classification by ACC/AHA classification is a better predictor for angiographic success.

Aged↗
PubMed2004

Treatment of left anterior descending coronary artery disease with sirolimus-eluting stents.

BACKGROUND: Revascularization strategies often hinge on the presence and degree of left anterior descending coronary artery (LAD) stenosis. A decision for bypass surgery is often based on the durability of surgical LAD revascularization compared with percutaneous approaches. By decreasing restenosis, drug-eluting stents may have reduced the "reintervention gap" between surgery and percutaneous intervention, making the percutaneous route preferable. METHODS AND RESULTS: Of the 1101 patients in the SIRIUS trial, 459 with an LAD stenosis were randomized to percutaneous intervention with either sirolimus-eluting or bare-metal stents. Baseline demographic, clinical, and angiographic data were obtained. Patients had 1-year clinical and 8-month angiographic follow-up. Baseline characteristics were similar in both groups. The majority of lesions were tubular type B lesions (69.7%) with a mean diameter of 2.73 mm and a mean length of 14.0 mm. The binary in-stent restenosis rate was 2% for the sirolimus stent group and 41.6% for the bare-metal arm (relative risk, 0.05; 95% CI, 0.02 to 0.1; P<0.001). One-year major adverse events (defined as cardiac death, Q-wave and non-Q-wave myocardial infarction, or target vessel revascularization) was decreased 59% in the sirolimus-stent group (9.8% versus 24.9%; relative risk, 0.39; 95% CI, 0.26 to 0.61; P<0.001). Subgroup analysis of 135 patients with proximal LAD lesions showed similar benefits. In-stent restenosis was 0 in the proximal LAD sirolimus-eluting group (n=67), compared with 38% in the bare-metal arm (n=68), and major adverse events demonstrated a similar trend, with a 50% decrease compared with control patients (10.4% versus 20.6%, P=NS). CONCLUSIONS: Sirolimus-eluting stents significantly decrease revascularization rates in LAD lesions. At 1 year, sirolimus-eluting stent revascularization rates are comparable to historic single vessel bypass surgery revascularization rates.

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PubMed2004

Relation of metformin treatment to clinical events in diabetic patients undergoing percutaneous intervention.

Diabetic patients undergoing coronary interventions have worse clinical and angiographic outcomes than do patients without diabetes. Metformin, an insulin sensitizer, may decrease the occurrence of these outcomes. Diabetic patients in the Prevention of Restenosis with Tranilast and its Outcomes Trial were identified through their medical records (n = 2,772). In this trial, 1,110 diabetic patients received nonsensitizer therapy (insulin and/or sulfonylureas) and 887 received sensitizer therapy (metformin with or without additional therapy). Logistic regression was used to obtain odds ratios (ORs) (sensitizer vs nonsensitizer therapy) of any clinical event (death, myocardial infarction, or ischemia-driven target vessel revascularization) and adjusted for multiple risk factors. Multivariate analysis showed no effect of lesion characteristics on clinical outcomes. Compared with patients on nonsensitizer therapy, those on sensitizer therapy showed an adjusted OR of 0.72 (95% confidence interval [CI] 0.57 to 0.91, p = 0.005) for any clinical event. The differences between the nonsensitizer therapy group and the sensitizer group were attributable mainly to decreased rates of death (OR 0.39, 95% CI 0.19 to 0.77, p = 0.007) and myocardial infarction (OR 0.31, 95% CI 0.15 to 0.66, p = 0.002). In our retrospective analysis, use of metformin in diabetics undergoing coronary interventions appeared to decrease adverse clinical events, especially death and myocardial infarction, compared with diabetic patients treated with nonsensitizer therapy.

Angioplasty, Balloon, Coronary↗
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

Routine intravascular ultrasound guidance of percutaneous coronary intervention: a critical reappraisal.

Intravascular ultrasound (IVUS) has played an integral role in the evolution of interventional cardiology. However, routine IVUS guidance of coronary stent implantation is not supported by a critical reappraisal of the available evidence. Although there is a trend toward a benefit with respect to target lumen revascularization favoring IVUS-guided coronary stent implantation, it is likely that this effect is driven by improved outcomes in small vessels, long coronary stenoses, and possibly saphenous vein graft interventions. No consistent trend in the incidence of death or myocardial infarction is apparent. Furthermore, the safety, efficacy, and effectiveness of IVUS should be taken into account when considering the goals, risks, benefits, and alternatives to such a treatment strategy.

Angioplasty, Balloon, Coronary↗
PubMed2004

Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.

BACKGROUND: A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. METHODS AND RESULTS: This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). CONCLUSIONS: These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Aged↗
PubMed2004

Paradigm shifts in cardiovascular medicine.

Cardiovascular medicine is changing rapidly with the development, testing, and introduction of new diagnostic and therapeutic methods. New interventional techniques such as the use of drug-eluting stents have important implications for the care of individual patients and the delivery and economics of health care in general. Drug-eluting stents have been shown to improve outcomes among patients undergoing percutaneous coronary intervention by significantly reducing restenosis rates. Two randomized trials have documented that per 100 patients treated with the sirolimus drug-eluting stent, 12.5 to 13.6 patients avoided the need for subsequent target lesion revascularization, when compared with patients treated with conventional stents. The economic effect of the introduction of these stents, which are projected to be two to three times as expensive as conventional stents, is complex and depends on which segment of health care is considered. These stents will be favorably received by patients, physicians, employers, and society as well as payers. However, hospitals may be adversely affected by having increased procedural costs for the stents, along with fewer procedures for evaluation and treatment of restenosis and probably decreased surgical volumes. Drug-eluting stents are only the first of many new technologic advances that will affect cardiovascular care. These procedures have many features in common, including: 1). replacement of major surgical procedures with less invasive approaches; and 2). redistribution of costs, with a decrease in hospital profits but potentially lower costs of health care delivery for society as a whole.

Coronary Disease↗
PubMed2004

Comparison of survival after successful percutaneous coronary intervention of patients with diabetes mellitus receiving insulin versus those receiving only diet and/or oral hypoglycemic agents.

The influence of diabetic treatment status on long-term outcome after percutaneous coronary intervention (PCI) is unclear. Previous reports have suggested that patients who receive insulin treatment have worse long-term outcome compared with patients who do not need insulin. To determine the influence of diabetes treatment status on outcome after PCI, patients with diabetes mellitus who underwent successful PCI from January 1, 1996, to June 30, 2001, were divided into 2 groups based on whether or not they required insulin; patients with shock or recent (< or =7 days) myocardial infarction were excluded. Cox proportional hazards models were utilized to estimate the association between diabetes treatment status and long-term survival. One thousand one hundred four eligible diabetic patients were identified and divided into those treated with insulin (418 patients; median follow-up 35.5 months) and those treated with either an oral agent or diet alone (686 patients; median follow-up 27.9 months). Insulin-treated patients were less likely to be men, and had more previous coronary revascularizations, prior myocardial infarctions, and congestive heart failure on presentation. Angiographic and procedural characteristics were comparable. Unadjusted survival curves were constructed, demonstrating that insulin treatment was associated with worse survival than noninsulin treatment (p = 0.001). After adjusting for differences in baseline characteristics, insulin treatment did not adversely effect survival (odds ratio 1.10, 95% confidence intervals 0.77 to 1.58). Thus, among diabetic patients who underwent successful PCI, patients treated with insulin had worse survival. After adjusting for differences in baseline characteristics, insulin treatment was not independently associated with worse survival.

Administration, Oral↗
PubMed2004

Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis.

BACKGROUND: This study evaluated a large group of patients enrolled in a double-blind randomized trial of the sirolimus-eluting stent to document whether the initial clinical improvement seen in previous smaller series is maintained out to 12 months and to study the potential treatment effect in patient subsets known to be at increased risk of restenosis. METHODS AND RESULTS: A total of 1058 patients with de novo native coronary stenosis undergoing clinically indicated percutaneous coronary intervention were randomly assigned to sirolimus-eluting stent (533) or control bare stent (525). Procedural success and in-hospital outcomes were excellent and did not differ between the 2 groups. At 9 months, clinical restenosis, defined as target-lesion revascularization, was 4.1% in the sirolimus limb versus 16.6% in the control limb (P<0.001). At 12 months, the absolute difference in target-lesion revascularization continued to increase and was 4.9% versus 20% (P<0.001). There were no differences in death or myocardial infarction rates. In high-risk patient subsets, defined by vessel size, lesion length, and presence of diabetes mellitus, there was a 70% to 80% reduction in clinical restenosis at 1 year. CONCLUSIONS: Placement of the sirolimus-eluting stent results in continued clinical improvement at 1 year after initial implantation, with significant reduction in clinical restenosis as defined by target-lesion revascularization. Between 9 and 12 months, the absolute reduction of clinical restenosis continues to increase. Even in high-risk subsets of patients, there is a 70% to 80% relative reduction in clinical restenosis at 12 months with this drug-eluting stent.

Coronary Restenosis↗
PubMed2004

Outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention in the current era: a report from the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial.

BACKGROUND: Diabetes portends an adverse prognosis in patients undergoing percutaneous coronary intervention (PCI). Whether improvements in current clinical practice (stents, IIb/IIIa antagonists) have resulted in substantial improvement of these outcomes remains an issue. The aim of this study was to determine the influence of diabetes on 9-month outcomes of patients undergoing PCI in the current era. METHODS AND RESULTS: The 11 482 patients enrolled in the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial were stratified according to the presence (n=2694) or absence (n=8798) of diabetes. Diabetic patients were older; were more likely to be female; had a higher proportion of congestive failure, hypertension, prior CABG, and unstable angina; and had higher body mass index and lower ejection fraction than nondiabetic patients (P<0.01 for all comparisons). The degree of multivessel disease was similar between the two groups. American College of Cardiology/American Heart Association type C lesions were more common in diabetic patients (17% versus 15%, P<0.01). Angiographic and procedural success rates and in-hospital events were similar between the two groups. The primary end point of death, myocardial infarction, or target vessel revascularization (TVR) was analyzed as time-to-first event within 9 months of the index PCI. After adjusting for certain baseline characteristics, diabetes was independently associated with death at 9 months (relative risk [RR], 1.87; 95% CI, 1.31 to 2.68, P<0.01) and with an increased likelihood of TVR (RR, 1.27; 95% CI, 1.14 to 1.42, P<0.01), as well as the composite end point of death/myocardial infarction/TVR (RR, 1.26; 95% CI, 1.13 to 1.40, P<0.01). CONCLUSIONS: Despite advances in interventional techniques, diabetes remains a significant independent predictor of adverse events in the intermediate term after PCI.

Coronary Angiography↗
PubMed2004

Pulse transmission coefficient: a nonhyperemic index for physiologic assessment of procedural success following percutaneous coronary interventions.

Intracoronary pressure measurements and the determination of fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) predict adverse events. Coronary lesions may impair the transmission of pressure waves across a stenosis, potentially acting as a high-frequency filter. The pulse transmission coefficient (PTC) is a nonhyperemic parameter that calculates the transmission of high-frequency components of the pressure signal through a stenosis. It was shown recently that PTC is highly correlated with FFR. This study was designed to examine the change of PTC as compared to FFR following PCI. Pressure signals were obtained by pressure guidewire in 27 lesions pre- and post-PCI and were analyzed with an algorithm that identifies the high-frequency component in the pressure signal. The PTC was calculated at baseline as the ratio between distal and proximal high-frequency components of the pressure waveform across the lesion. FFR measurements were assessed with intracoronary adenosine. There was a significant increase in PTC following PCI (0.15 +/- 0.17 at baseline vs. 0.84 +/- 0.11 post-PCI; P < 0.001). Comparable changes were observed for FFR (0.58 +/- 0.12 at baseline vs. 0.91 +/- 0.05 post-PCI; P < 0.001). PTC is a nonhyperemic parameter for physiologic assessment of coronary artery stenoses. Similar to FFR, PTC is significantly increased following PCI. Thus, it may serve as an adjunct index for the functional assessment of procedural success following PCI.

Aged↗
PubMed2004

Day in and day out.

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Angioplasty, Balloon, Coronary↗
PubMed2004

Comparison of combination therapy of adenosine and nitroprusside with adenosine alone in the treatment of angiographic no-reflow phenomenon.

We sought to compare the combination therapy of adenosine and nitroprusside in no-reflow phenomenon during percutaneous coronary intervention. Improvement in coronary flow from no-reflow to postdrug state was evaluated. Patients who received adenosine (n = 21) were compared to ones who received the combination of adenosine and nitroprusside (n = 20) for treatment. Improvement of TIMI flow grades was higher in the group that received combined therapy (1.5 +/- 1.0 vs. 0.8 +/- 0.6; P < 0.05). Combination therapy of adenosine and nitroprusside is safe and provides better improvement in coronary flow compared to intracoronary adenosine alone in case of impaired flow during coronary interventions.

Adenosine↗
PubMed2004

Applicability of distal protection for aortocoronary vein graft interventions in clinical practice.

Percutaneous revascularization of diseased saphenous vein grafts is associated with increased risk of adverse events, although the use of distal protection mitigates this to a significant extent. However, anatomic characteristics may preclude the use of such devices in a proportion of vein grafts intended for percutaneous treatment. We reviewed our consecutive experience of saphenous vein graft interventions from 1 May 2001 through 30 April 2002 to determine suitability for distal protection. Relevant angiographic characteristics included lesion within 5 mm of the ostium; lesion < 20 mm from the distal anastomosis; planned distal landing site of the occlusion balloon < 3 mm or > 6 mm in diameter; total occlusion of the vein graft; or lesion in a sequential vein graft distal to the first anastomosis. One hundred twenty-seven patients (140 procedures, 147 vein grafts) were treated. One or more of the angiographic exclusion criteria for a balloon occlusion protection system existed in 57% of grafts, while 42% had exclusions for a filter device. A large number of patients with vein graft disease intended for percutaneous treatment have anatomic exclusions to available distal protection technology.

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