Frailty and related outcomes in patients undergoing transcatheter valve therapies in a nationwide cohort.

AIMS: We sought to identify the prevalence and related outcomes of frail individuals undergoing transcatheter mitral valve repair and transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Patients aged 65 and older were included in the study if they had at least one procedural code for transcatheter mitral valve repair or TAVR between 1 January 2016 and 31 December 2016 in the Centers for Medicare and Medicaid Services Medicare Provider and Review database. The Hospital Frailty Risk Score, an International Classification of Diseases, Tenth Revision (ICD-10) claims-based score, was used to identify frailty and the primary outcome was all-cause 1-year mortality. A total of 3746 (11.6%) patients underwent transcatheter mitral valve repair and 28 531 (88.4%) underwent TAVR. In the transcatheter mitral valve repair and TAVR populations, respectively, there were 1903 (50.8%) and 14 938 (52.4%) patients defined as low risk for frailty (score <5), 1476 (39.4%) and 11 268 (39.5%) defined as intermediate risk (score 5-15), and 367 (9.8%) and 2325 (8.1%) defined as high risk (score >15). One-year mortality was 12.8% in low-risk patients, 29.7% in intermediate-risk patients, and 40.9% in high-risk patients undergoing transcatheter mitral valve repair (log rank P < 0.001). In patients undergoing TAVR, 1-year mortality rates were 7.6% in low-risk patients, 17.6% in intermediate-risk patients, and 30.1% in high-risk patients (log rank P < 0.001). CONCLUSIONS: This study successfully identified individuals at greater risk of short- and long-term mortality after undergoing transcatheter valve therapies in an elderly population in the USA using the ICD-10 claims-based Hospital Frailty Risk Score.

Prevalence and Outcomes of Isolated Tricuspid Valve Surgery Among Medicare Beneficiaries.

We sought to characterize the clinical outcomes and to identify predictors of mortality undergoing isolated tricuspid valve surgery in the United States. We identified 5,164 patients undergoing isolated tricuspid valve surgery from the Centers for Medicare and Medicaid Services Medicare Provider Analysis and Review data between January 2003 and December 2014. The primary outcome was all cause 1-year mortality. A backward elimination method was performed to identify predictors of 1-year mortality. Tricuspid valve repair was performed in 2,494 (48.3%) patients and tricuspid valve replacement was performed in 2,670 (51.7%) patients. Perioperative and 1-year mortality rates were 9.9% and 24.1%, respectively. Predictors of 1-year mortality were age (p <0.001), chronic heart failure (p = 0.001, cirrhosis (p <0.001), carcinoid syndrome (p <0.001), chronic kidney disease (p = 0.001), secondary pulmonary hypertension (p = 0.023), endocarditis (p = 0.005), decubitus ulcer (p <0.001), malnutrition (p <0.001), replacement (p = 0.013), emergency procedure (p <0.001), and preprocedural shock (p <0.001). The C-statistic for 1-year mortality was 0.70 (95% confidence interval, 0.67 to 0.73). In conclusion, isolated tricuspid valve surgery is infrequently performed in the United States, and is associated with high 1-year mortality. Patients at higher risk for mortality can be identified based on the presence of a number of comorbidities at the time of surgery.

Cost Implications of Anticoagulation Strategies After Percutaneous Coronary Intervention Among Patients With Atrial Fibrillation (A PIONEER-AF PCI Analysis).

The PIONEER AF-PCI trial demonstrated that in atrial fibrillation patients who underwent intracoronary stenting, either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy (Group 1) or 2.5 mg rivaroxaban twice daily plus dual antiplatelet therapy (DAPT) (Group 2) was associated with fewer recurrent hospitalizations, primarily for bleeding and cardiovascular events, compared with standard-of-care vitamin K antagonist and DAPT (Group 3). Associated costs are unknown. This study estimates costs associated with rivaroxaban strategies compared with vitamin K antagonist and DAPT. Medication costs were estimated using wholesale acquisition costs, medication discontinuation rates, and costs of monitoring. Using a large US healthcare claims database, the mean adjusted increase in 1-year cost of care for individuals with atrial fibrillation and percutaneous coronary intervention (PCI) rehospitalized for bleeding, cardiovascular, and other events was compared with those not rehospitalized. Using adjudicated rehospitalization rates from PIONEER AF-PCI, cost differences were estimated. Rates of rehospitalization for bleeding were 6.5%, 5.4%, 10.5%, and 20.3%, 20.3%, 28.4% for cardiovascular events in Groups 1, 2, and 3. Medication and monitoring costs were $3,942, $4,115, and $1,703. One-year costs for all recurrent hospitalization costs and/or patient for the groups were $24,535, $20,205, and $29,756. One-year cost increase associated with bleeding rehospitalizations and/or patient was $4,160, $3,212, and $6,876 and was $13,264, $11,545, and $17,220 for cardiovascular rehospitalizations and/or patient. Overall estimated cost per patient was $28,476, $24,320, and $31,458. Compared with warfarin, both rivaroxaban treatment strategies had higher medication costs, but these were more than accounted for by fewer hospitalizations.

The Value of Claims-Based Nontraditional Risk Factors in Predicting Long-term Mortality After MitraClip Procedure.

BACKGROUND: We sought to identify nontraditional risk factors coded in administrative claims data and evaluate their ability to improve prediction of long-term mortality in patients undergoing percutaneous mitral valve repair. METHODS: Patients undergoing transcatheter mitral valve repair using MitraClip implantation between September 28, 2010, and September 30, 2015 were identified among Medicare fee-for-service beneficiaries. We used nested Cox regression models to identify claims codes predictive of long-term mortality. Four groups of variables were introduced sequentially: cardiac and noncardiac risk factors, presentation characteristics, and nontraditional risk factors. RESULTS: A total of 3782 patients from 280 clinical sites received treatment with MitraClip over the study period. During the follow-up period, 1114 (29.5%) patients died with a median follow-up time period of 13.6 (9.6 to 17.3) months. The discrimination of a model to predict long-term mortality including only cardiac risk factors was 0.58 (0.55 to 0.60). Model discrimination improved with the addition of noncardiac risk factors (c = 0.63, 0.61 to 0.65; integrated discrimination improvement [IDI] = 0.038, P < 0.001), and with the subsequent addition of presentation characteristics (c = 0.67, 0.65 to 0.69; IDI = 0.033, P < 0.001 compared with the second model). Finally, the addition of nontraditional risk factors significantly improved model discrimination (c = 0.70, 0.68 to 0.72; IDI = 0.019, P < 0.001, compared with the third model). CONCLUSIONS: Risk-prediction models, which include nontraditional risk factors as identified in claims data, can be used to predict long-term mortality risk more accurately in patients who have undergone MitraClip procedures.

Impact of a Claims-Based Frailty Indicator on the Prediction of Long-Term Mortality After Transcatheter Aortic Valve Replacement in Medicare Beneficiaries.

Background Prospectively collected frailty markers are associated with an incremental 1-year mortality risk after transcatheter aortic valve replacement (TAVR) compared with comorbidities alone. Whether information on frailty markers captured retrospectively in administrative billing data is similarly predictive of long-term mortality after TAVR is unknown. We sought to characterize the prognostic importance of frailty factors as identified in healthcare billing records in comparison to validated measures of frailty for the prediction of long-term mortality after TAVR. Methods and Results Adult patients undergoing TAVR between August 25, 2011, and September 29, 2015, were identified among Medicare fee-for-service beneficiaries. The Johns Hopkins Claims-based Frailty Indicator was used to identify frail patients. We used nested Cox regression models to identify claims-based predictors of mortality up to 4 years post-procedure. Four groups of variables, including cardiac risk factors, noncardiac risk factors, patient procedural risk factors, and nontraditional markers of frailty, were introduced sequentially, and their integrated discrimination improvement was assessed. A total of 52 338 TAVR patients from 558 clinical sites were identified, with a mean follow-up time period of 16 months. In total, 14 174 (27.1%) patients died within the study period. The mortality rate was 53.9% at 4 years post-TAVR. A total of 34 863 (66.6%) patients were defined as frail. The discrimination of each of the 4 models was 0.60 (95% CI, 0.59-60), 0.65 (95% CI, 0.64-0.65), 0.68 (95% CI, 0.67-0.68), and 0.70 (95% CI, 0.69-0.70), respectively. The addition of nontraditional frailty markers as identified in claims improved mortality prediction above and beyond traditional risk factors (integrated discrimination improvement: 0.019; P<0.001). Conclusions Risk prediction models that include frailty as identified in claims data can be used to predict long-term mortality risk after TAVR. Linkage to claims data may allow enhanced mortality risk prediction for studies that do not collect information on frailty.

Cost implications of intraprocedural thrombotic events and bleeding in percutaneous coronary intervention: Results from the CHAMPION PHOENIX ECONOMICS Study.

BACKGROUND: Despite improvements in percutaneous coronary intervention (PCI), intraprocedural thrombotic events (IPTE) and bleeding complications occur and are prognostically important. These have not been included in prior economic studies. METHODS: PHOENIX ECONOMICS was a substudy of the CHAMPION PHOENIX trial, evaluating cangrelor during PCI. Hospital bills were reviewed from 1,171 patients enrolled at 22 of 63 US sites. Costs were estimated using standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. Bleeding and IPTE, defined as abrupt vessel closure (transient or sustained), new/suspected thrombus, new clot on wire/catheter, no reflow, side-branch occlusion, procedural stent thrombosis or urgent need for CABG were identified. Costs were calculated according to whether a complication occurred and type of event. Multivariate analyses were used to estimate the incremental costs of IPTE and postprocedural events. RESULTS: IPTE occurred in 4.3% and were associated with higher catheterization laboratory and overall index hospitalization costs by $2,734 (95%CI $1,117, $4,351; P = 0.001) and $6,354 (95% CI $4,122, $8,586; P < 0.001), respectively. IPTE were associated with MI (35.4% vs. 3.6%; P < 0.001), out-of-laboratory stent thrombosis (4.2% vs. 0.1%; 0 = 0.005), ischemia driven revascularization (12.5% vs. 0.3%; P < 0.001), but not mortality (2.1% vs. 0.2%; P = 0.12) vs. no procedural thrombotic complication. By comparison, ACUITY minor bleeding increased hospitalization cost by $1,416 (95%CI = 312, $2,519; P = 0.012). ACUITY major bleeding increased cost of hospitalization by $7,894 (95%CI $4,154, $11,635; P < 0.001). CONCLUSIONS: IPTE and bleeding complications, though infrequent, are associated with substantial increased cost. These complications should be collected in economic assessments of PCI.

National trends, predictors of use, and in-hospital outcomes in mechanical circulatory support for cardiogenic shock.

AIMS: Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO). METHODS AND RESULTS: Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p<0.0001). Growth in CS hospitalisations (214.4%) outpaced annual MCS use (160.0%), with relative declines in intra-aortic balloon pump use starting in 2008. Right heart catheterisation rates for both groups remained low (MCS vs. non-MCS: 5.9% vs. 3.3%; p<0.0001). In-hospital mortality declined but remained high in both groups (MCS vs. non-MCS [2014]: 32.7% vs. 41.5%; p<0.0001). CONCLUSIONS: In-hospital mortality for CS has declined but remains high. Rates of CS have outpaced MCS utilisation which remains uncommon in non-MI hospitalisations with shock. MCS is associated with utilisation of other procedures during hospitalisation.

Management of Patients With Cardiac Arrest Complicating Myocardial Infarction in New York Before and After Public Reporting Policy Changes.

BACKGROUND: In 2010, New York State began excluding selected patients with cardiac arrest and coma from publicly reported mortality statistics after percutaneous coronary intervention. We evaluated the effects of this exclusion on rates of coronary angiography, revascularization, and mortality among patients with acute myocardial infarction and cardiac arrest. METHODS AND RESULTS: Using statewide hospitalization files, we identified discharges for acute myocardial infarction and cardiac arrest January 2003 to December 2013 in New York and several comparator states. A difference-in-differences approach was used to evaluate the likelihood of coronary angiography, revascularization, and in-hospital mortality before and after 2010. A total of 26 379 patients with acute myocardial infarction and cardiac arrest (5619 in New York) were included. Of these, 17 141 (65%) underwent coronary angiography, 12 183 (46.2%) underwent percutaneous coronary intervention, and 2832 (10.7%) underwent coronary artery bypass grafting. Before 2010, patients with cardiac arrest in New York were less likely to undergo percutaneous coronary intervention compared with referent states (adjusted relative risk, 0.79; 95% confidence interval, 0.73-0.85; P<0.001). This relationship was unchanged after the policy change (adjusted relative risk, 0.82; 95% confidence interval, 0.76-0.89; interaction P=0.359). Adjusted risks of in-hospital mortality between New York and comparator states after 2010 were also similar (adjusted relative risk, 0.94; 95% confidence interval, 0.87-1.02; P=0.152 for post- versus pre-2010 in New York; adjusted relative risk, 0.88; 95% confidence interval, 0.84-0.92; P<0.001 for comparator states; interaction P=0.103). CONCLUSIONS: Exclusion of selected cardiac arrest cases from public reporting was not associated with changes in rates of percutaneous coronary intervention or in-hospital mortality in New York. Rates of revascularization in New York for cardiac arrest patients were lower throughout.

Bivalirudin is associated with improved clinical and economic outcomes in heart failure patients undergoing percutaneous coronary intervention: Results from an observational database.

BACKGROUND: Outcomes with bivalirudin compare favorably with heparin ± GPIIb/IIIa receptor inhibition (heparin ± GPI) during percutaneous coronary intervention (PCI). Patients with congestive heart failure (CHF) have increased risk for complications. The objective was to investigate clinical and economic outcomes for bivalirudin ± GPI vs. heparin ± GPI among PCI patients with CHF. METHODS: Using the Premier Hospital Database, PCI patients with CHF were stratified by anticoagulant: bivalirudin, bivalirudin ± GPI, heparin and heparin ± GPI. The probability of receiving bivalirudin ± GPI was estimated using individual and hospital variables. Using propensity scores, each bivalirudin ± GPI patient was matched to a heparin ± GPI patient. The primary outcome was in-hospital death. Bleeding rates, transfusion, length of stay and in-hospital cost were ascertained. RESULTS: Overall, 116,313 patients at 315 hospitals received bivalirudin (n = 45,559) bivalirudin + GPI (n = 8,115), heparin (n = 27,972) or heparin + GPI (n = 34,667). Patients had STEMI (21.2%), NSTEMI (29.1%), unstable angina (16.6%), stable angina (5.7%) or other ischemic heart disease (24.2%). Of these, 79.1% of bivalirudin patients matched, resulting in 84,948 analyzed patients. Compared with heparin ± GPI patients, bivalirudin ± GPI patients had fewer deaths (3.3% vs. 3.9%; p < 0.0001), less clinically apparent bleeding (10.2% vs. 11.4%; p < 0.0001), clinically apparent bleeding with transfusion (2.7% vs. 3.2%, p <0.0001), and transfusion (8.5% vs. 9.8%, p < 0.0001). Patients receiving bivalirudin had shorter length of stay (6.3 vs. 6.8 days; p < 0.0001) and lower in-hospital cost (mean $26,706 vs. $27,166 [median $19,414 vs. $19,798]; p < 0.0001). In conclusion, this is the largest retrospective analysis of PCI patients with CHF and demonstrates bivalirudin ± GPI compared with heparin ± GPI is associated with lower inpatient rates of death, bleeding, and cost.

Cost implications of intraprocedural thrombotic events during PCI.

OBJECTIVES: We sought to estimate the direct costs (in-hospital and 30-day) associated with an intraprocedural thrombotic event (IPTE) among patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients with IPTE have higher rates of in-hospital and 30-day major adverse cardiac events than patients without IPTE. The extent to which IPTE also add to medical costs is unknown. METHODS: Hospital costs for patients in the ACUITY Trial were compared between patients with and without IPTE. Adjusted comparisons were performed using generalized linear models (GLMs). All costs are reported in 2012 US dollars. RESULTS: A total of 1,307 patients with both core laboratory-based angiographic assessment and detailed economic data were included in the final study population. IPTE occurred in 52 patients (4.0%). Median in-hospital costs were higher in patients with IPTE than in those without IPTE ($23,719 vs. $18,419, P = 0.01). Thirty-day median costs were also higher for IPTE patients ($23,719 vs. $19,556, P = 0.05). After adjusting for baseline differences, IPTE was associated with 19.5% (95% CI: [2.8-38.8%], P = 0.02) and 18.9% (95% CI: [1.2-39.7%], P = 0.04) increases in in-hospital and 30-day costs, respectively. These relative differences represent median increases of $3,592 in initial hospital costs and $3,696 in 30-day costs. CONCLUSIONS: The occurrence of IPTE during the index PCI in patients with NSTEACS is associated with substantial increases in-hospital and 30-day costs. These findings suggest that strategies to prevent IPTE may be associated with important cost offsets as well as improved clinical outcomes.

Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A).

OBJECTIVES: The aim of this study was to evaluate the cost-effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (AVR) for patients with severe aortic stenosis and high surgical risk. BACKGROUND: TAVR is an alternative to AVR for patients with severe aortic stenosis and high surgical risk. METHODS: We performed a formal economic analysis based on cost, quality of life, and survival data collected in the PARTNER A (Placement of Aortic Transcatheter Valves) trial in which patients with severe aortic stenosis and high surgical risk were randomized to TAVR or AVR. Cumulative 12-month costs (assessed from a U.S. societal perspective) and quality-adjusted life-years (QALYs) were compared separately for the transfemoral (TF) and transapical (TA) cohorts. RESULTS: Although 12-month costs and QALYs were similar for TAVR and AVR in the overall population, there were important differences when results were stratified by access site. In the TF cohort, total 12-month costs were slightly lower with TAVR and QALYs were slightly higher such that TF-TAVR was economically dominant compared with AVR in the base case and economically attractive (incremental cost-effectiveness ratio <$50,000/QALY) in 70.9% of bootstrap replicates. In the TA cohort, 12-month costs remained substantially higher with TAVR, whereas QALYs tended to be lower such that TA-TAVR was economically dominated by AVR in the base case and economically attractive in only 7.1% of replicates. CONCLUSIONS: In the PARTNER trial, TAVR was an economically attractive strategy compared with AVR for patients suitable for TF access. Future studies are necessary to determine whether improved experience and outcomes with TA-TAVR can improve its cost-effectiveness relative to AVR.

Bivalirudin therapy is associated with improved clinical and economic outcomes in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: results from an observational database.

BACKGROUND: Randomized trials show improved outcomes among acute coronary syndrome patients treated with bivalirudin. The objective of this analysis was to compare clinical and economic outcomes in ST-elevation myocardial infarction (STEMI) patients encountered in routine clinical practice undergoing primary percutaneous coronary intervention (PPCI), treated with bivalirudin or heparin+GP IIb/IIIa receptor inhibitor (heparin+GPI). METHODS AND RESULTS: STEMI admissions from January 1, 2004 through March 31, 2008 among patients receiving PPCI and bivalirudin or heparin+GPI in the Premier hospital database were identified. The probability of receiving bivalirudin was estimated using individual and hospital variables; using propensity scores, each bivalirudin patient was matched to 3 heparin+GPI treated patients. The primary outcome was in-hospital death. Rates of bleeding, transfusion, length of stay, and in-hospital cost were secondary outcomes. There were 59,917 STEMI PPCIs receiving bivalirudin (n=6735) or heparin+GPI (n=53,182). Seventy-nine percent of bivalirudin patients matched, resulting in 21,316 STEMI PPCIs for analysis. Compared with heparin+GPI patients, bivalirudin patients had fewer deaths (3.2% versus 4.0%; P=0.011) and less inpatient bleeding (clinically apparent bleeding [6.9% versus 10.5%, P<0.0001], clinically apparent bleeding with transfusion [1.6% versus 3.0%, P<0.0001], and transfusion [5.9% versus 7.6%, P<0.0001]). Patients receiving bivalirudin had shorter average length of stay (mean 4.3 versus 4.5 days; P<0.0001), with lower in-hospital cost (mean $18,640 versus $19,967 [median $14,462 versus $16,003], P<0.0001). CONCLUSIONS: This large "real-world" retrospective analysis demonstrates that bivalirudin therapy compared with heparin+GPI is associated with a lower rate of inpatient death, inpatient bleeding, and decreased overall in-hospital cost in STEMI patients undergoing PPCI.

Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes.

OBJECTIVES: The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients managed invasively. BACKGROUND: The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors (GPI) for moderate- and high-risk NSTE-ACS. METHODS: In ACUITY, 7,851 U.S. patients were randomized to: 1) heparin (unfractionated or enoxaparin) + GPI; 2) bivalirudin + GPI; or 3) bivalirudin monotherapy. Patients assigned to GPI were also randomized to upstream GPI before catheterization or selective GPI only with percutaneous coronary intervention. Resource use data were collected prospectively through 30-day follow-up. Costs were estimated with standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. RESULTS: At 30 days, ischemic events were similar for all groups. Major bleeding was reduced with bivalirudin monotherapy compared with heparin + GPI or bivalirudin + GPI (p < 0.001). Length of stay was lowest with bivalirudin monotherapy or bivalirudin + catheterization laboratory GPI (p = 0.02). Despite higher drug costs, aggregate hospital stay costs were lowest with bivalirudin monotherapy (mean difference range: $184 to $1,081, p < 0.001 for overall comparison) and at 30 days (mean difference range: $123 to $938, p = 0.005). Regression modeling demonstrated that hospital savings were primarily due to less major and minor bleeding with bivalirudin ($8,658/event and $2,282/event, respectively). CONCLUSIONS: Among U.S. patients in the ACUITY trial, bivalirudin monotherapy compared with heparin + GPI resulted in similar protection from ischemic events, reduced bleeding, and shorter length of stay. Despite higher drug costs, aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy. Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).

Cost-effectiveness of sirolimus-eluting stents compared with vascular brachytherapy for the treatment of in-stent restenosis.

BACKGROUND: Sirolimus-eluting stents (SESs) were recently shown to be superior to vascular brachytherapy for the treatment of restenosis within a bare metal stent. No economic comparison of these alternative strategies has yet been reported. METHODS: We conducted a prospective health economic study involving all patients randomized to SES (n = 259) or brachytherapy (n = 125) in the SISR trial. Procedural, hospital, and outpatient costs, as well as physician fees, were estimated through 12 months based on measured resource use and itemized hospital bills. Cost-effectiveness was assessed in terms of the cost per repeat revascularization avoided, cost per major adverse cardiac event avoided, and cost per event-free patient. RESULTS: Although initial device costs were approximately $1100/patient higher in the SES group, this was offset by higher physician fees associated with brachytherapy, such that initial hospitalization costs were similar for the 2 groups. Because SES significantly reduced repeat revascularization procedures and major adverse cardiac event compared with brachytherapy during follow-up, cumulative 12-month costs were significantly lower in the SES group ($16,482 vs $19,435, mean difference -$2953, 95% CI -$5470 to -$792). Sirolimus-eluting stenting was thus both more effective and less expensive than brachytherapy, as confirmed in >98% of bootstrap replications for each of the cost-effectiveness outcomes. CONCLUSIONS: Compared with vascular brachytherapy, SES is an economically dominant strategy for the treatment of in-stent restenosis.

Current clinical characteristics and economic impact of subacute stent thrombosis.

Subacute stent thrombosis (SAT), while uncommon, continues to produce serious clinical consequences, including major myocardial infarction (MI) in 60 70% of cases, and short-term mortality rates of 20% or higher. A number of procedural and patient factors have been shown to predict the occurrence of SAT, including longer stent length, smaller minimum luminal diameter, persistent dissection, multivessel intervention, and possibly acute coronary syndrome (ACS) presentation. Despite substantial knowledge about the clinical and technical aspects of SAT, the economic impact of these events has not been previously reported. Methods. We retrospectively reviewed 26 cases of SAT that occurred at our institution from 1998-2000. Baseline clinical and procedural data, as well as clinical outcomes for the initial hospital admissions required to treat SAT, were obtained by record review. Direct health care costs for these admissions were calculated based on hospital billing data and measured resource utilization for catheterization laboratory procedures. Results. Most cases of SAT occurred in high-risk circumstances, including ACSs, multi-stent interventions, and treatment of 3.0 mm or smaller vessels. Most patients suffered significant MIs and were treated with repeat percutaneous coronary intervention. The median time to SAT was 3.5 days, with 58% of events occurring on an outpatient basis. Median total hospital costs were $11,100 per patient, with more than half of the costs generated by the catheterization laboratory and pharmacy. Conclusions. Despite its low overall frequency, the clinical and economic costs of SAT are substantial. Specific strategies at preventing its occurrence are warranted, particularly in high-risk situations.