Cardiac rehabilitation in African Americans: evidence for poorer outcomes compared with whites, especially in women and diabetic participants.

BACKGROUND: Cardiac rehabilitation (CR) improves coronary artery disease risk factors and mortality. Outcomes after CR in African Americans (AAs) compared with whites have not been studied extensively. METHODS: A total of 1,096 patients (169 AAs, 927 whites) were enrolled in a 36-session CR program for ischemic heart disease or postcardiac surgery. The program consisted of exercise, lifestyle modification, and pharmacotherapy. RESULTS: After CR, quality of life, blood pressure, and low-density lipoprotein cholesterol improved significantly in both AAs and whites, although to a lesser degree in AAs. Whites also had significant improvements in weight and triglyceride concentrations. Overall, mean peak exercise capacity, measured in metabolic equivalents (METs), improved by only 1.6 (95% CI 1.3-1.8) in AAs compared with 2.4 (2.3-2.6) in CCs (P< .001 for AAs vs CCs). African American women had the least improvement in METs, but changes were still significant (1.1 [CI 0.9-1.4]). The subgroup with the least improvement in METs was AA diabetic patients (1.4 (CI 1.1-1.7]). CONCLUSION: African Americans derive a significant benefit from CR, but not to the same degree as whites, based on changes in risk factors and in exercise capacity. Within both ethnic groups, both women and diabetic patients appeared to have markedly less improvement.

Cost effectiveness of radial access for diagnostic cardiac catheterization and coronary intervention.

OBJECTIVES: To evaluate the cost effectiveness of diagnostic cardiac catheterizations (CATH) and coronary interventions (PCI) performed using radial artery (RA) access compared to femoral artery (FA) access. BACKGROUND: CATH and PCI performed from the RA reduce access site complications compared to FA, but can increase procedure duration, and equipment and contrast use. Whether resulting increases in utilization costs are offset by reduced costs of complications is uncertain. METHODS: In all, 6,726 CATH and PCI (RA, 3,368; FA, 3,358) were performed from January 2009 to December 2011. Procedural costs and cost of access site complications were compared for propensity-matched CATH (RA and FA, 1,222) and PCI (RA and FA, 570) throughout a complete transition of the lab from a preferred FA to preferred RA strategy. RESULTS: Adjusted mean total costs were $10 more (95% confidence interval $613 less to $610 more) for RA-CATH versus FA-CATH and $732 less ($1,345 less to $156 less) for RA-PCI versus FA-PCI. The incremental cost per vascular or bleeding complication avoided with RA-CATH was $1,265, whereas RA was economically dominant with lower costs and fewer complications compared to FA for PCI and all procedures. CONCLUSIONS: Radial access for CATH and PCI reduced access site complications and overall costs compared to FA procedures with similar baseline clinical and procedural characteristics, making it an economically advantageous strategy.

Transitioning to the radial artery as the preferred access site for cardiac catheterization: an academic medical center experience.

OBJECTIVES: To evaluate procedural and safety metrics of transradial (TR) versus transfemoral (TF) cardiac catheterization (CATH) and percutaneous coronary interventions (PCI) during a complete institutional transition from TF to TR as the preferred access. BACKGROUND: The TR approach has been shown to reduce complications compared to TF for CATH and PCI, but concerns of longer procedure times have limited utilization in the United States. METHODS: 4,172 consecutive CATH and PCI procedures were performed (2,665 TF; 1,507 TR) at Wake Forest Baptist Medical Center from January 2009 to November 2010. We assessed in-hospital procedural and safety metrics. RESULTS: After 6 months of a preferred TR strategy, TR to TF crossover rate was 9.1%, and 65% of all cases were TR procedures. For the cath lab (all TF + TR), we observed small but significant increases in procedural metrics for Preferred TR (last third) compared to Preferred TF (first third). This appeared to be due to increased access times, procedure length, fluoroscopy times, and contrast use for TR versus TF (propensity score matched). Nonetheless, over the course of the study, there was a trend for a decrease in all procedural metrics with TR use. Access site complications (2.3% TF, 1.2% TR) and bleeding (2.5% TF, 2.1% TR), both P < 0.05, decreased over the course of the study. CONCLUSIONS: Our observations support the concept that complete transition of a cath lab to a preferred TR strategy is feasible, achieves lower rates of vascular and bleeding complications but with modest increases in overall procedural metrics.

Chronic kidney disease and dipstick proteinuria are risk factors for stent thrombosis in patients with myocardial infarction.

BACKGROUND: Kidney failure (stage 5 chronic kidney disease [CKD]) is an independent risk factor for stent thrombosis (ST). Moderate (stage 3-4) CKD and proteinuria are both associated with adverse cardiovascular events, including worse outcomes after myocardial infarction (MI). Whether moderate CKD and proteinuria increase the risk of ST after MI is not known. This study evaluated the risk of ST associated with moderate CKD and dipstick proteinuria. METHODS: We retrospectively analyzed clinical and laboratory data from 956 non-stage 5 CKD patients who were admitted with MI and received intracoronary stenting. Clinical follow-up was collected at 1 year for definite or probable ST, as well as for all-cause mortality, nonfatal MI or death, and target vessel revascularization or coronary artery bypass graft surgery. RESULTS: After adjustment for multiple clinical and biochemical covariates, patients with both estimated glomerular filtration rate (GFR) of 15 to 59 mL min(-1) 1.73 m(-2) and > or =30 mg/dL dipstick proteinuria had increased cumulative incidence of ST (hazard rate [HR] 3.69, 95% CI 1.54-8.89), all-cause mortality (HR 2.68, 95% CI 1.34-5.37), and nonfatal MI or death (HR 3.20, 95% CI 1.77-5.81) at 1 year. In addition, estimated GFR of 15 to 59 mL min(-1) 1.73 m(-2) was a significant independent predictor of ST (HR 2.61, 95% CI 1.33-5.10). Dipstick proteinuria > or =30 mg/dL was associated with a trend toward increased risk for all outcomes. CONCLUSIONS: In an acute MI population, moderate CKD was identified as a novel prognostic marker for ST. In addition, patients with both decreased GFR and proteinuria had higher incidences of all-cause mortality and nonfatal MI or death than patients with either condition alone.

Prognostic implications of vascular complications following PCI.

OBJECTIVES: To evaluate the effect of vascular complications (VC) on the adjusted risk of nonfatal myocardial infarction (MI) or death following percutaneous coronary intervention (PCI) at 1 year in a large contemporary cohort. BACKGROUND: Peri-procedural bleeding increases the risk of adverse clinical outcomes at 1 year. Whether access site VC's identify patients at high risk or independently alter the risk of adverse clinical outcomes at 1 year, however, is uncertain. METHODS: 3,931 PCI procedures performed via a femoral access at a single site (WFUBMC) were evaluated. Access and nonaccess site post procedural bleeding were assessed. The adjusted risk of access site VC's association with 1-year clinical outcomes was evaluated by Cox proportional hazards modeling. RESULTS: Any VC occurred in 1.7%, and any TIMI bleeding in 6.7% after PCI. The hazard ratio (HR) adjusted for baseline and procedural covariates for any VC of nonfatal MI or all cause death at 1 year was 1.68 (1.00-2.81), P = 0.049 and 1.69 (0.92-3.09), P = 0.088 for all cause death alone. However, after adjusting for any TIMI bleeding, the HR for nonfatal MI or death was 0.84 (0.49-1.45), P = 0.527, and for death alone 0.75 (0.39-1.41), P = 0.369. CONCLUSIONS: The occurrence of VC following PCI was an independent predictor of nonfatal MI or death at 1 year, but only if accompanied by TIMI major or minor bleeding. A vascular complication without TIMI bleeding did not alter prognosis at 1 year.

Derived fibrinogen compared with C-reactive protein and brain natriuretic peptide for predicting events after myocardial infarction and coronary stenting.

BACKGROUND: After myocardial infarction (MI), biomarkers can be helpful to identify patients who might benefit from more intensive therapies. The prothrombin time-derived fibrinogen (PTDF) assay is widely available and relatively inexpensive. We determined whether PTDF predicts events in patients with MI and compared this assay with brain natriuretic peptide (BNP) and C-reactive protein (CRP). METHODS: We retrospectively analyzed data from 915 patients admitted with MI. Follow-up was collected at 1 year for major adverse cardiac events (MACE) defined as death from any cause, nonfatal MI or death, target vessel revascularization, or coronary artery bypass grafting. RESULTS: Patients in the fourth quartile of PTDF were older and had more risk factors but fewer ST-elevation MI and lower peak troponin values. The fourth quartiles of PTDF, CRP, and BNP were associated with increased MACE compared with the first quartiles with hazard ratios of 2.08 (1.30-3.33), 1.94 (1.22-3.07), and 2.56 (1.57-4.18), respectively, findings that remained significant after adjustment. When outcomes by strata of PTDF were examined, CRP failed to add additional prognostic value. Higher BNP levels predicted MACE in the upper but not lower stratum of PTDF. CONCLUSION: In patients with MI, PTDF is a predictor of MACE at 1 year, with equivalent value compared to BNP and CRP. With low PTDF levels, neither BNP nor CRP adds prognostic value. At elevated PTDF values, higher BNP, but not CRP, identifies a higher-risk population. Therefore, PTDF can be substituted for CRP, with BNP being useful in the presence of elevated PTDF.

Incidence of coronary stent thrombosis based on academic research consortium definitions.

Stent thrombosis occurs infrequently after drug-eluting stent (DES) placement, but concerns have surfaced that identification of stent thrombosis based solely on angiography may underestimate the true incidence of this complication. The purpose of this study was to compare rates of stent thrombosis using Academic Research Consortium (ARC) definitions. From April 2002 to February 2005, bare-metal stents (BMSs) and DESs were placed at Wake Forest University Baptist Medical Center. Rates of ARC definite, probable, and possible stent thrombosis were evaluated. Overall, definite stent thrombosis occurred in 1.4% of BMSs and 1.1% of DESs (p = 0.47); probable stent thrombosis, in 1.0% of BMSs and 0.9% of DESs (p = 0.81); definite plus probable stent thrombosis, in 2.3% of BMSs and 1.9% of DESs (p = 0.48); and possible stent thrombosis, in 6.8% of BMSs and 3.5% of DESs (p <0.001). Rates of definite late (31 days to 1 year) and very late (>1 year) stent thrombosis were 0.9% for BMSs and 0.06% for DESs (p <0.001) and 0.16% for BMSs and 0.56% for DESs, respectively (p = 0.13). Rates of definite plus probable and late and very late stent thrombosis were 1.1% for BMSs and 0.19% for DESs (p <0.001) and 0.40% for BMSs and 0.68% for DESs, respectively (p = 0.31). Rates of possible stent thrombosis increased significantly for each thrombosis interval. In conclusion, rates of stent thrombosis using the proposed ARC definition differed by stent type, definition of stent thrombosis, and thrombosis interval. Use of the ARC probable stent thrombosis paralleled rates of definite stent thrombosis alone, but partially masked the occurrence of late (>1 year) stent thrombosis in DESs compared with BMSs.

Late outcomes of drug-eluting versus bare metal stents in saphenous vein grafts: Propensity score analysis.

OBJECTIVE: To compare late outcomes with the routine use of drug-eluting stents (DES) compared with bare-metal stents (BMS) during percutaneous intervention (PCI) of saphenous vein grafts (SVGs). BACKGROUND: Safety concerns >1 year from stent implantation have been raised about DES used for PCI of SVGs in a small randomized clinical trial. However, there are few studies comparing late outcomes of DES and BMS in routine clinical practice. METHODS: Clinical outcomes (nonfatal MI, cardiac mortality) were assessed in 74 consecutive patients who received BMS and 74 consecutive propensity score matched patients that received DES for PCI of SVGs. Clinical follow-up was censored at 2 years +/- 30 days for both stent groups. RESULTS: At 2 years, the hazard ratio for DES compared with BMS for PCI of SVGs for target vessel revascularization was 0.54 (0.21-1.36), nonfatal MI or cardiac death was 0.68 (0.27-1.68), cardiac mortality 1.19 (0.32-4.45), and stent thrombosis 0.49 (0.09-2.66). Similar outcomes were observed stratified by propensity score quintile. CONCLUSIONS: The routine clinical use of DES for PCI of SVGs was associated with a safety profile that was similar to that of bare metal stents with a clear trend toward a less frequent need for reinterventions.

ABO blood types: influence on infarct size, procedural characteristics and prognosis.

INTRODUCTION: Patients with non-O blood groups have higher plasma von Willebrand factor (vWF) levels than those with type O. vWF mediates platelet adhesion, aggregation and thrombosis. These considerations likely explain the prior observations that non-O patients have higher rates of arterial and venous thromboembolic events. However, the effect of blood group status on size of MI, procedural findings and outcomes after PCI for MI have not been reported. METHODS: We analyzed 1198 patients who underwent percutaneous coronary intervention for acute myocardial infarction between 10/03 and 8/06, and who had ABO blood group status and clinical follow-up. RESULTS AND CONCLUSIONS: Patients with O blood type were slightly older (62 +/- 13 vs. 60 +/- 13 years; p = 0.017) had a higher prevalence of hypercholesterolemia (67% vs. 58%; p = 0.002), and had a higher burden of atherosclerosis with more vascular disease (17% vs. 13%; p = 0.017) and higher prevalence of previous PCI (22% vs. 17%; p = 0.025). Non-O blood group patients had larger infarcts as measured by median peak troponin (33 vs. 24; p = 0.037), total CK (721 vs. 532; p = 0.012) and CK-MB (101 vs. 68; p = 0.010). At PCI, non-O patients had increased visible thrombus and reduced TIMI flow pre-procedure. However, there were no differences in procedural success, in-hospital blood transfusion or occurrence of MACE at 1 year follow-up. Our data demonstrate that non-O compared to O blood groups patients have higher thrombus burden despite less extensive atherosclerosis. Nevertheless, outcomes at 1 year were similar.

Cocaine use is associated with an increased risk of stent thrombosis after percutaneous coronary intervention.

BACKGROUND: The treatment of cocaine-related acute coronary syndromes presents unique challenges. Although percutaneous coronary intervention in cocaine abusers appears to be safe in the short term, longer-term outcomes have not been reported. We postulated that cocaine use would be associated with increased risk for stent thrombosis. METHODS: We report 30-day and 9-month clinical outcomes including stent thrombosis, myocardial infarction, repeat revascularization, and death in 71 cocaine abusers who underwent percutaneous coronary intervention at our institution (66 of whom received a stent) compared with 3216 control patients. Propensity score-matched analysis was performed to control for statistical bias present in nonrandomized study populations. RESULTS: Stent thrombosis occurred in 5 (7.6%) of the 66 stented cocaine abusers during the 9-month follow-up period compared to a 0.6% rate of stent thrombosis in the control database, a highly statistically significant difference (P < .001). In the propensity analysis, stent thrombosis occurred in 4 stented cocaine abusers and 0 of 70 matched controls (6.2% vs 0%; P = .04) throughout the 9-month follow-up period. There was no significant difference in overall rates of myocardial infarction, death, or repeat revascularization at 9 months. CONCLUSIONS: Because of the increased risk of stent thrombosis, consideration should be given to a more conservative approach in cocaine abusers who present with acute coronary syndromes.

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death.

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

Effect of Chronic Kidney Disease and Supplemental Polyunsaturated Fatty Acid Use on Exercise Levels During Cardiac Rehabilitation in Patients With Coronary Artery Disease.

PURPOSE: The correlation between chronic kidney disease (CKD) and increased cardiovascular disease-related mortality is well established. Cardiac rehabilitation (CR) improves exercise capacity, quality of life, and risk factors in patients with coronary artery disease (CAD). Data on the benefits of CR in patients with CKD are sparse. The purpose of this study was to compare outcomes after CR in patients with CAD but normal renal function, versus those with CAD and CKD. METHODS: We studied 804 patients with CAD entering an exercise-based CR program. Demographics, risk factors, exercise capacity in metabolic equivalent levels (METs), and estimated glomerular filtration rate (GFR) were recorded before and after the 3-month CR program. Use of polyunsaturated fatty acid (PUFA) was determined by medical records review. Stage III-V CKD (GFR <60 mL/min/1.73 m) was present in 170 patients at baseline. RESULTS: After CR, METs improved in all patients, although increases in patients with a GFR 30 to 59 mL/min/1.73 m (Δ1.6) and a GFR <30 (Δ1.2) were smaller than those in patients with a GFR ≥60 (Δ2.6, P < .05 vs GFR 30-59 and GFR <30). In patients with a GFR ≥60 mL/min/1.73 m, PUFA use was associated with a 20% greater increase in MET levels compared with nonusers (Δ3.0 vs Δ2.5, P = .02); and in patients with a GFR 30 to 59, PUFA use was associated with 30% increase in MET level compared with nonusers (Δ2.0 vs Δ1.4, P = .03). These observations persisted after multivariable adjustment for baseline MET level, demographics, and risk factors. CONCLUSIONS: Potential mitigation by PUFA of the smaller improvement in exercise capacity with decreasing GFR requires confirmation in prospective randomized trials.

Degree and Direction of Change of Body Weight in Cardiac Rehabilitation and Impact on Exercise Capacity and Cardiac Risk Factors.

Cardiac rehabilitation (CR) improves functional capacity and reduces mortality in patients with cardiovascular disease. It also improves cardiovascular risk factors and aids in weight reduction. Because of the increase in morbidly obese patients with cardiovascular disease, the prevalence of obesity and patterns of weight change in those undergoing CR merit fresh study. We studied 1,320 participants in a 12-week CR program at our academic medical center. We compared 5 categories: 69 class III obese (body mass index [BMI] ≥40) patients, 128 class II obese patients (BMI 35.0 to 39.9), 318 class I obese patients (BMI 30.0 to 34.9), 487 overweight patients (BMI 25.0 to 29.9), and 318 normal weight patients (BMI 18.5 to 24.9). Exercise capacity in METs, weight, blood pressure, and fasting lipid profile were measured before and after CR. Overall, 131 patients gained weight, 827 had no significant weight change, and 363 lost weight (176 lost 3% to 5% of their baseline weight, 161 lost 5% to 10%, and 26 lost >10%). Exercise capacity, blood pressure, and low-density lipoprotein cholesterol improved in all patients. Class III obese patients had the smallest improvement in peak METs (p <0.001), but the greatest weight loss. Patients who lost >10% of their baseline weight had the greatest improvements in exercise capacity, low-density lipoprotein, and triglycerides. In conclusion, after CR, a minority of patients lost weight. Most patients had no significant weight change and some even gained weight. The greatest loss was seen in class III obese patients. All patient groups showed improvements in exercise capacity and risk factors, regardless of the direction or degree of weight change.

Effects of cardiac rehabilitation in diabetic patients: both cardiac and noncardiac factors determine improvement in exercise capacity.

BACKGROUND: Diabetic patients have a worse prognosis than nondiabetic patients after myocardial infarction. Although exercise improves risk factors, exercise capacity, and mortality, it is still unclear if these benefits are the same as in nondiabetics. Furthermore, although exercise tolerance is predicted by systolic and diastolic dysfunction in nondiabetics, its role as a predictor of exercise capacity in diabetics remains unclear. HYPOTHESIS: Diabetics and nondiabetics see a similar improvement in their cardiac risk factors and exercise parameters from exercise-based cardiac rehabilitation (CR). METHODS: A series of 370 diabetics and 942 nondiabetics entered a 36-session outpatient CR program after interventions for coronary heart disease or after bypass or cardiac valve surgery. The program consisted of physical exercise, lifestyle modification, and pharmacotherapy. RESULTS: Quality of life, weight, blood pressure, and lipid profiles improved significantly in both groups during the 12-week program. Baseline metabolic equivalents (METs) were lower in diabetics vs nondiabetics at the start of CR (2.4 vs 2.7, P < 0.001). Although both groups increased their exercise capacity, diabetics had less improvement (change in METs 1.7 vs 2.6, P < 0.001). Significant predictors for improvement after CR included age, sex, and weight, as well as both systolic and diastolic function. After adjustment for these, diabetes remained a significant predictor of reduced improvement in exercise capacity. CONCLUSIONS: Diabetics saw a significant benefit in quality of life, weight, exercise tolerance, and cardiac risk factors, but to a lesser extent when compared with nondiabetics. The mechanisms for poorer improvement in diabetics following CR also include noncardiac factors and require further study.

Effect of early enrollment on outcomes in cardiac rehabilitation.

Outpatient cardiac rehabilitation (CR) is most beneficial when delivered 1 to 3 weeks after the index cardiac event. The effects of delayed enrollment on subsequent outcomes are unclear. A total of 1,241 patients were enrolled in CR after recent (<1 year) treatment of cardiac events or postcardiac surgery. Risk factors and metabolic equivalent levels (METs) during aerobic exercise were calculated before and after CR. The mean CR delay time was 34 days (maximum of 327). Delay time >30 days was associated with older age, female gender, nonwhite race, being unemployed, and increased length of hospital stay before CR after index cardiac event (p <0.05 vs 0 to 15 and 16 to 30 days for all comparisons). Patients with delay time >30 days had significant improvements in all CR metrics, but peak METs and weight improvements were lesser in magnitude compared with patients with CR delay times 0 to 15 and 16 to 30 days. After multivariate adjustment, delay time >30 days remained an independent predictor of decreased MET improvement compared with delay time 0 to 15 days (ß = -0.59, p <0.001). In conclusion, time to enrollment in CR varies substantially and is independently linked to demographics and length of index hospital stay. Delayed enrollment in CR is directly related to patient outcomes. Although all patients showed improvements in key metrics regardless of delay time, CR was of greatest benefit, particularly for weight and exercise capacity, when initiated within 15 days of the index event.

Comparison of usefulness of secondary prevention of coronary disease in patients <80 versus ≥80 years of age.

The population older than 80 years is increasing but data on prevention of coronary disease in this age group are sparse. The present study compared the improvement in quality of life, lipid profile, blood pressure, weight, and physical performance after cardiac rehabilitation in patients <80 versus ≥80 years of age. A total of 1,112 patients, of whom 79 were older than 80 years, entered a 36-session outpatient cardiac rehabilitation program after interventions for coronary heart disease. The program consisted of physical exercise, lifestyle modification, and pharmacotherapy. Quality of life improved by 1.3 (95% confidence interval [CI] 0.6 to 2.0) in octogenarians and 1.8 (95% CI 1.5 to 2.1) in younger patients (p = 0.21), whereas weight decreased by 1.7 lbs (95% CI -2.9 to -0.4) and 3.1 lbs (95% CI -3.6 to -2.5, p = 0.04), respectively. In hypertensive patients, systolic blood pressure decreased from 155 ± 11 to 133 ± 20 mm Hg in octogenarians versus 155 ± 13 to 130 ± 20 mm Hg in younger patients, reducing the prevalence of hypertension to approximately 10% in both groups. Low-density lipoprotein cholesterol decreased by 16 mg/dl (95% CI -27 to -5) versus 19 mg/dl (95% CI -22 to -16), increasing the percentage of patients at recommended goals from 32% to 46% in the elderly (p = 0.04) and from 18% to 30% in younger patients (p <0.001). Metabolic equivalent levels increased by 1.0 (95% CI 0.7 to 1.3) in octogenarians versus 2.4 (95% CI 2.2 to 2.5) in younger patients (p <0.001). In conclusion, patients ≥80 years of age in an active secondary prevention program derive a significant benefit in well being, risk factors, and exercise capacity and should not be denied such treatment because of age.

Cost-effectiveness of drug-eluting stents versus bare metal stents in clinical practice.

BACKGROUND: Drug-eluting stents (DES) reduce the need for repeat target revascularization (TVR) compared with bare metal stents (BMS) but are more costly. The objective was to evaluate the cost-effectiveness of DES versus BMS. METHODS AND RESULTS: We evaluated clinical outcomes and costs of care over 3 years in 1147 undergoing BMS before the availability of DES and 1247 DES patients at Wake Forest University Baptist Medical Center from 2002 to 2005. Costs for index stenting, TVR, and clopidogrel use were assessed. The 2 groups were well matched for baseline characteristics. Index stenting costs were $1846 higher per patient for DES versus BMS ($1737 more to $1950 more). At 3 years, absolute TVR rates were 15.2 per 100 DES patients and 24.1 per 100 BMS patients, and as a result, cumulative TVR-related costs were $2065 less per patient for DES versus BMS ($3001 less to $1134 less). Including the cost of clopidogrel, the incremental cost-effectiveness ratio per TVR avoided with DES was $4731 through 1 year, $4703 through 2 years, and $6379 through 3 years. CONCLUSIONS: At 3 years, the higher index cost of DES versus BMS was completely offset by lower TVR-related costs. However, because of extended clopidogrel use for DES, the incremental cost-effectiveness ratio per TVR avoided ranged from $4703 to $6379 over 3 years. These unadjusted observational findings provide support for the continued use of DES in routine practice but highlight the important impact of prolonged dual antiplatelet use on the cost-effectiveness of this technology.

Target lesion revascularization after bare-metal or drug-eluting stents: clinical presentations and outcomes.

OBJECTIVE: We sought to examine the clinical presentations and subsequent clinical outcomes of patients undergoing target lesion revascularization (TLR) after either bare-metal stent (BMS) or drug-eluting stent (DES) placement. BACKGROUND: The widely held notion that BMS TLR is benign has recently been challenged. While DES substantially reduce TLR, little is known about the clinical syndromes accompanying DES TLR and the long-term clinical outcomes after TLR. METHODS: The clinical syndrome at the time of hospitalization when TLR was performed and subsequent clinical outcomes after TLR were assessed in 1,147 BMS patients and 1,246 DES patients who were followed for 3 years. Patients were considered to have TLR when repeat target lesion PCI was required including those with myocardial infarction (MI) and stent thrombosis. RESULTS: At 3 years, the overall incidence of TLR was higher after BMS compared to DES 98/1,147 (9.2%) vs. 56/1,246 (4.5%); p < 0.001. The clinical presentations at the time of TLR were not always benign with non-STelevation myocardial infarction (N-STEMI) or STEMI in 25% of BMS vs. 34% DES; p = 0.217. The risk of non-fatal MI or death outcomes over 3 years were significantly worse in those with TLR compared to those without TLR; hazard ratio (HR) 2.65 (2.00-3.52), independent of stent type. CONCLUSIONS: The clinical presentation at the time of TLR is not always a benign clinical event and identifies a subgroup of stent-treated patients at high risk for non-fatal MI or death in the 3 years following the index percutaneous coronary intervention, independent of stent type.

3-year comparison of drug-eluting versus bare-metal stents.

OBJECTIVES: The aim of this study was to compare 3-year cumulative outcomes to landmark second- and third-year outcomes with the routine use of drug-eluting stents (DES) (>75% "off-label") with a comparable group treated with bare-metal stents (BMS). BACKGROUND: Long-term safety concerns after "off-label" DES use persist, despite recent 2-year data showing comparable safety to BMS use. METHODS: Clinical outcomes (nonfatal myocardial infarction, all-cause mortality) were assessed in 1,147 consecutive patients who received a BMS in the year before the introduction of DES at Wake Forest University Baptist Medical Center and 1,246 consecutive patients that received a DES after it became our routine choice with equivalent complete 3-year follow-up. RESULTS: Stents were used for "off-label" indications in 80% of DES patients. At 3 years, the hazard ratio for DES compared with BMS for cumulative target vessel revascularization was 0.65 (95% confidence interval [CI]: 0.51 to 0.82), nonfatal myocardial infarction or death was 0.85 (95% CI: 0.71 to 1.03), and all-cause mortality 0.80 (95% CI: 0.64 to 1.01). The DES clinical benefits occurred entirely within the first year, with similar rates of these clinical end points in the second and third year. The cumulative hazard ratio of stent thrombosis DES compared with BMS was 1.07 (95% CI: 0.57 to 2.01), with similar rates of stent thrombosis in the third year (p = 0.70). CONCLUSIONS: The routine clinical use of DES for "off-label" indications was associated with lower clinical end points at 3 years than treatment with BMS in a comparable group of patients, with similar cumulative rates of stent thrombosis. There was no evidence of late "catch-up" of adverse DES events.

Effect of length and diameter of drug-eluting stents versus bare-metal stents on late outcomes.

BACKGROUND: The risk of restenosis and other adverse cardiac events with bare-metal stents (BMS) is increased with smaller stent diameters and longer stent lengths. Drug-eluting stents (DES) may reduce this effect in select patients; however, whether this benefit occurs in high-risk lesions and patients in routine practice is not clear. METHODS AND RESULTS: Clinical outcomes (target-vessel revascularization [TVR], stent thrombosis, nonfatal myocardial infarction [MI], and cardiac death) at 2 years stratified by stented length and diameter were compared in 949 consecutive patients who received BMS and 1236 consecutive and comparable patients who received DES for single lesions. The longest tertile of BMS (>23 mm) was associated with increased hazard of TVR, ST, and nonfatal MI or death compared with shorter tertiles of BMS, which was abolished by DES. DES compared with BMS was independently associated with a lower hazard of TVR (HR, 0.34 [0.20 to 0.58]) and nonfatal MI or death (HR, 0.60 [0.39 to 0.92]) in the longest length tertile (>23 mm). No clear association of stented tertile diameter and clinical outcomes for either stent type was observed. However, DES compared with BMS was independently associated with a lower hazard of TVR for all diameter tertiles, and a lower hazard of nonfatal MI or death (0.66 [0.44 to 0.99]) in the largest diameter tertile (>3.4 mm). CONCLUSIONS: Independent of adverse patient and lesion characteristics, DES demonstrated significantly lower hazard of TVR and nonfatal MI or death at 2 years compared with BMS within the longest stented lengths (>23 mm) and largest diameters (>3.4 mm).