Biomedical subjects

Steven Sedlis

Publications and source records attributed to Steven Sedlis.

9 recordsLinked to original sources

PubMed2005

Percutaneous intervention versus coronary bypass surgery for patients older than 70 years of age with high-risk unstable angina.

BACKGROUND: The Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) study was a multicenter Veterans Affairs randomized trial and registry that compared long-term survival of percutaneous coronary intervention with coronary artery bypass graft surgery for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for an adverse outcome with bypass. Both the randomized trial and the registry demonstrated comparable 3-year survival. The purpose of this study was to compare bypass and percutaneous intervention survival of AWESOME patients who were older than 70 years of age. METHODS: Over a 5-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of the following five risk factors (prior heart surgery, myocardial infarction within 7 days, left ventricular ejection fraction less than 35%, age > 70 years, intraaortic balloon pump requirement to stabilize) were identified. Of these patients, 1,278 were older than 70 years of age. Eight hundred, seventy-one patients were turned down by at least one physician, 407 were acceptable to both physician and surgeon for randomization, and 236 (60%) consented to randomization. Of the 1,042 eligible patients who were not randomized, 871 had their revascularization directed by a physician who was not involved in the study. One hundred, seventy-one patients who were acceptable for randomization by both the interventional cardiologist and the cardiac surgeon refused consent. RESULTS: Bypass and percutaneous intervention survival were compared using Kaplan-Meier curves and log rank tests. Bypass and percutaneous intervention 36-month survival rates for patients older than 70 years of age were 76% and 75%, respectively, among the eligible patients. Survival was 71% and 78% among those patients who were randomized and 76% and 67% in the physician-directed subgroup. Of those patients who chose their revascularization techniques, the survivals were 79% and 85%, respectively. The survival differences are not large, and none of the global log rank tests of bypass compared with percutaneous intervention survival showed a statistically significant difference over 5 years. CONCLUSIONS: Both the randomized and registry subgroups of patients who were older than 70 years of age support the trial conclusions that either bypass or percutaneous intervention effectively relieves medically refractory ischemia among high-risk unstable angina patients whose age was greater than 70 years.

Age Factors↗

PubMed2005

Routine versus selective functional testing after percutaneous coronary intervention in patients with diabetes mellitus.

Patients with diabetes mellitus who undergo percutaneous coronary intervention (PCI) have higher rates of restenosis and a poorer prognosis than patients without diabetes. The American College of Cardiology/American Heart Association guidelines on exercise testing suggest that patients with diabetes may benefit from routine post-PCI functional testing (FT). To explore this issue, we examined the functional capacity, quality of life, event rates and procedural outcomes among 61 patients with diabetes enrolled in the Aggressive Diagnosis of Restenosis (ADORE) trial. All patients were randomized to either routine FT or selective FT and were followed for a period of 9 months. Patients with diabetes randomized to routine FT had a higher composite clinical event rate than those randomized to the selective FT strategy. Procedural rates did not differ significantly between the two groups. These results suggest that routine post-PCI FT in patients with diabetes is of little clinical value.

Adolescent↗

PubMed2004

Six-month outcomes after single- and multi-lesion percutaneous coronary intervention: results from the ROSETTA registry.

BACKGROUND: The American College of Cardiology/American Heart Association exercise testing guidelines suggest that routine functional testing may benefit patients at high risk of restenosis, such as those undergoing multi-lesion percutaneous coronary intervention (PCI). OBJECTIVES: To compare the six-month post-PCI clinical and procedural outcomes in patients following single- and multi-lesion PCI, and to examine the use of routine functional testing (ie, in all patients) versus selective functional testing (ie, only in those with recurrent symptoms) following multi-lesion PCI. METHODS: Six-month outcomes among 562 patients after single-lesion PCI and 229 patients after multi-lesion PCI were examined. All patients were enrolled in the Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) registry, a prospective, multicentre registry examining the use of functional testing after successful PCI. RESULTS: For single- versus multi-lesion PCI patients, respectively, rates of death (1.8% versus 2.2%, P=0.7) and myocardial infarction (0.7% versus 2.6%, P=0.03) were low in both groups. Rates of unstable angina (12.0% versus 11.7%, P=0.9) and the composite clinical end point of death, myocardial infarction or unstable angina (13.5% versus 13.9%, P=0.9) were similar. Multi-lesion PCI patients had a higher number of repeat PCI procedures (6.6% versus 13.4%, P=0.02) but there was no difference in the rates of coronary artery bypass graft surgery (3.0% versus 2.6%, P=0.7). A routine functional testing strategy was used in 28.0% of single-lesion and 31.6% of multi-lesion patients. In a multivariate analysis of the multi-lesion patients, routine functional testing was not associated with a significant reduction in the composite clinical event rate (odds ratio 0.5, 95% CI 0.2 to 1.7, P=0.27). CONCLUSIONS: During the six-month period following successful PCI, clinical event rates were similar among patients undergoing single- or multi-lesion PCI. Routine functional testing was not associated with a statistically significant benefit in patients after multi-lesion PCI. However, additional study is required to better define the role of routine functional testing in this subgroup of patients.

Angina, Unstable↗

PubMed2004

Evaluation of routine functional testing after percutaneous coronary intervention.

Following percutaneous coronary intervention, 348 patients were randomized to either routine or selective functional testing strategies. For the primary end point of maximal exercise endurance on a treadmill at 9 months, achievement was similar in the routine and selective groups. For the secondary end points measuring functional status and quality of life, scores were also similar. There was little difference in the rates of invasive cardiac procedures for the 2 groups at 9 months.

Angioplasty, Balloon, Coronary↗

PubMed2004

Utility of routine functional testing after percutaneous transluminal coronary angioplasty: results from the ROSETTA registry.

BACKGROUND: There is little consensus regarding the use of functional testing after percutaneous transluminal coronary angioplasty (PTCA). Some physicians employ a routine functional testing strategy, and others employ a symptom-driven strategy. OBJECTIVE: To examine the effects of routine post-PTCA functional testing on the use of follow-up cardiac procedures and clinical events. METHODS: The Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry is a prospective multicenter observational study examining the use of functional testing after PTCA. A total of 788 patients (pts) were enrolled in the ROSETTA Registry at 13 clinical centers in 5 countries. The frequencies of functional testing, cardiac procedures and clinical events were examined during the first 6 months following a successful PTCA. RESULTS: Patients were predominantly elderly men (mean age, 61+/-11 years; 76% male) who underwent single-vessel PTCA (85%) with stent implantation (58%). During the 6-month follow-up, a total of 237 pts were observed to undergo a routine functional testing strategy (100% having functional testing for routine follow-up), while 551 pts underwent a selective (or clinically-driven) strategy (73% having no functional testing and 27% having functional testing for a clinical indication). Patients in the routine testing group underwent a total of 344 functional tests compared with 165 tests performed in the selective testing group (mean, 1.45 tests/patient versus 0.3 tests/patient; p<0.0001). There was little difference in the rates of follow-up cardiac procedures among the pts undergoing the routine and selective testing strategies [cardiac catheterization, 13.9% versus 17.5% (p=NS); percutaneous coronary intervention (PCI), 8.4% versus 8.7% (p=NS); coronary artery bypass graft surgery, 2.1% versus 3.3% (p=NS)]. However, clinical events were less common among pts who underwent routine functional testing, e.g., unstable angina (6.1% versus 14.4%; p=0.001), myocardial infarction (0.4% versus 1.6%; p=NS), death (0% versus 2.2%; p=0.02) and composite clinical events (6.3% versus 16.3%; p<0.0001). After controlling for baseline clinical and procedural differences, routine functional testing had a persistent independent association with a reduction in the composite clinical event rate (odds ratio, 0.45; 95% confidence interval, 0.24-0.81; p=0.008). CONCLUSION: Routine functional testing after PTCA is associated with a reduction in the frequency of follow-up clinical events. This association may be attributable to the early identification and treatment of pts at risk for follow-up events, or it may be due to clinical differences between pts who are referred for routine and selective functional testing.

Angioplasty, Balloon, Coronary↗

PubMed2003

Medical therapy in patients undergoing percutaneous coronary intervention: results from the ROSETTA registry.

BACKGROUND: Previous studies have examined medication use among patients with coronary artery disease who have suffered an acute myocardial infarction (MI). However, little is known about medication use among patients with coronary artery disease who undergo percutaneous coronary intervention (PCI). OBJECTIVE: To examine the patterns of use of medical therapy among patients who undergo PCI; and to examine the determinants of medical therapy in these patients. METHODS: The Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) registry is a prospective multicentre study examining the use of functional testing after PCI. The medication use was examined among 787 patients who were enrolled in the ROSETTA registry at 13 clinical centres in five countries. RESULTS: Most patients were men (mean age 61+/-11 years, 76% male) who underwent single vessel PCI (85%) with stent implantation (58%). At admission, discharge and six months, rates of acetylsalicylic acid use were 77%, 96% and 93%, respectively (discharge versus six months, P<0.0001). Rates of use of other oral antiplatelet agents were 11%, 59% and 2% (P=0.02). For individual anti-ischemic medications, rates of use were as follows: beta-blockers 49%, 58% and 59% (P<0.0001); calcium antagonists 34%, 43% and 42% (P<0.0001); and nitrates 42%, 56% and 43% (P<0.0001). Rates of use of combination anti-ischemic medications were as follows: triple therapy 7%, 9% and 9% (P<0.0001); double therapy 34%, 47% and 38% (P<0.0001); monotherapy 36%, 36% and 41% (P<0.0001); and no anti-ischemic therapy 23%, 8% and 12% (P<0.0001). Rates of use of angiotensin-converting enzyme inhibitors were 25%, 33% and 32% (P<0.0001), and rates of use of lipid lowering agents were 41%, 52% and 61% (P<0.0001). CONCLUSIONS: Trials and guidelines statements have favourably affected the rates of use of acetylsalicylic acid and other antiplatelet agents after PCI. However, in spite of patients undergoing a successful revascularization procedure, physicians do not reduce the use of anti-ischemic medical therapy.

Adrenergic beta-Antagonists↗

PubMed2002

Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients.

OBJECTIVES: This report compares long-term percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) survival among post-CABG patients included in the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial and prospective registry. BACKGROUND: Repeat CABG surgery is associated with a higher risk of mortality than first-time CABG. The AWESOME is the first randomized trial comparing CABG with PCI to include post-CABG patients. METHODS: Over a five-year period (1995 to 2000), patients at 16 hospitals were screened to identify a cohort of 2,431 individuals who had medically refractory myocardial ischemia and at least one of five high-risk factors. There were 454 patients in the randomized trial, of whom 142 had prior CABG. In the physician-directed registry of 1,650 patients, 719 had prior CABG. Of the 327 patient-choice registry patients, 119 had at least one prior CABG. The CABG and PCI survivals for the three groups were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI three-year survival rates were 73% and 76% respectively for the 142 randomized patients (75 and 67 patients) (log-rank = NS). In the physician-directed registry, 155 patients were assigned to reoperation and 357 to PCI (207 received medical therapy); 36-month survivals were 71% and 77% respectively (log-rank = NS). In the patient-choice registry, 32 patients chose reoperation and 74 chose PCI (13 received medical therapy); 36-month survivals were 65% and 86% respectively (log-rank test p = 0.01). CONCLUSIONS: Percutaneous coronary intervention is preferable to CABG for many post-CABG patients.

Aged↗

PubMed2002

Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: The VA AWESOME multicenter registry: comparison with the randomized clinical trial.

OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.

Aged↗

PubMedDate not supplied

Elevated prothrombin and activated protein C resistance in patients with thoracic aortic atheroma.

Patients with protruding aortic atheroma containing mobile emboli are at risk for peripheral emboli and stroke. This risk may possibly be reduced by anticoagulation, but whether or not such patients have an increased prevalence of thrombotic risk factors has not been previously determined. Twenty-two patients were studied (11 with protruding thoracic aortic atheromas and superimposed mobile thrombi on transesophageal echocardiography were compared to 11 age-matched controls). The authors evaluated activated protein C resistance (APC-R) by measuring the prolongation of the partial thromboplastin time (PTT) in response to activated protein C (APC). Concentrations of fibrinogen, antithrombin III (AT III), factor II, factor V, and D-dimer were also determined in all patients. There was significant resistance to APC (a smaller prolongation in PTT) in patients with atheromas and thrombi. They also had significantly higher concentrations of factor II. Factor V and fibrinogen were higher, and AT III lower, in patients than in controls; however, these latter differences did not reach statistical significance. Patients with aortic atheroma and mobile thrombi may have an increased prevalence of thrombotic risk factors. There is significantly increased resistance to activated protein C in patients with protruding atheroma and mobile thrombi in their thoracic aorta. There was also a trend toward elevated fibrinogen, homocysteine, and apo (a) concentrations as well as lower antithrombin III concentrations in these patients.

Aged↗