Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices.

Real-world data are considered a potentially valuable source of evidence for assessing medical technologies in clinical practice, but their widespread use is hampered by numerous challenges. Using the case of coronary stents in Italy, we investigate the potential of administrative databases for estimating costs and health outcomes associated with the use of medical devices in real world conditions. An administrative dataset was created ad hoc by merging hospital records from patients admitted between 2013 and 2019 for stent implantations with ambulatory records, pharmaceutical use data and vital statistics. Health outcomes were multifold: all-cause and cardiac mortality and myocardial infarction, within 30 days, 1, 2, 5 years. Costs were estimated from the National Health System perspective. We used multivariable Cox models and propensity score (PS) methods (PS matching; stratification on PS; inverse probability of treatment weighting using PS; PS adjustment). 257,907 coronary stents were implanted in 113,912 patients. For all health outcomes and follow-up times, and across all methods, patients receiving drug-eluting stents (DES) presented lower risk. For all-cause mortality, the DES patient advantage over bare-metal stent (BMS) patients declined over time but remained significant even at 5 years. For myocardial infarction, results remained quite stable. The DES group presented lower cumulative total costs (ranging from 3264 to 2363 Euros less depending on methods). Our results confirm the consolidated evidence of the benefits of DES compared to BMS. The consistency of results across methods suggests internal validity of the study, while highlighting strengths and limitations of each depending on research context. Administrative data yield great potential to perform comparative effectiveness and cost-effectiveness analysis of medical devices provided certain conditions are met.

Effect of drug-eluting stents on 1-year risk of new-onset atrial fibrillation in patients with acute myocardial infarction treated with percutaneous coronary intervention.

The use of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) treated with percutaneous coronary intervention is conventional. However, the effect of DES on new-onset atrial fibrillation (AF) after AMI still remains unclear.By using data from Taiwan's National Health Insurance Research Database, a total of 17,741 patients with ST-elevation myocardial infarction (STEMI) and 17,631 patients with non-ST-elevation myocardial infarction (NSTEMI) treated with percutaneous coronary intervention were analyzed to investigate the risk of new-onset AF after index admission of AMI.There were 26.5% (N = 4696) of patients with STEMI and 39.5% (N = 6967) of patients with NSTEMI received DES implantation. Upon 1-year follow-up, we observed that DES placement was associated with a reduced 1-year risk of new-onset AF in the patients with NSTEMI (adjusted hazard ratio [aHR] = 0.74, 95% confidence interval [CI] = 0.59-0.93, P = .009) after adjustment for clinical relevant variables. This benefit was consistent with that in the patients with NSTEMI who were ≥75 years old, had a CHA2DS2-VASc score of ≥2, and did not receive intra-aortic balloon pump insertion (aHR = 0.72, 95% CI = 0.53-0.98, P = .039; aHR = 0.73, 95% CI = 0.586-0.92, P = .006; and aHR = 0.71, 95% CI = 0.56-0.90, P = .004; respectively). However, DES placement had a neutral effect on the risk of new-onset AF in the patients with STEMI.Compared with the use of BMS, the use of DES might reduce the risk of new-onset AF in patients with NSTEMI.

Economic Analysis of Surgical and Interventional Treatments for Patients with Complex Coronary Artery Disease: Insights from a One-Year Single-Center Study.

BACKGROUND Surgical treatment methods for patients with complex coronary artery disease (CAD) who have undergone vascular reconstruction mainly include coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). The purpose of the study aimed to compare a 1-year follow-up for the patient clinical outcomes and costs between PCI and CABG treatment. MATERIAL AND METHODS There were 840 patients enrolled in this study from July 2015 to September 2016. Among the study participants, 420 patients underwent PCI treatment and 420 patients underwent off-pump CABG. Patients costs were assessed from the perspective of the China healthcare and medical insurance system. EuroQOL 5-dimension 3 levels (EQ-5D-3L) questionnaire was used to evaluate the general health status, and the Seattle Angina Questionnaire (SAQ) was used to assess the disease-specific health status. RESULTS After a 1-year follow-up, the all-cause mortality (P=0.0337), the incidence of major adverse cardiac and cerebrovascular events (P<0.001), and additional revascularization (P<0.001) in PCI group were significantly higher than those in CABG group. Both groups have significant sustained benefits in the SAQ subscale. The CABG group had a higher score on the frequency of angina than the PCI group. In addition, the quality-adjusted life year value of PCI and CABG resulted was 0.8. The average total cost for PCI was $14 643 versus CABG cost of $13 842 (P=0.0492). CONCLUSIONS In the short-term, among the CAD patients with stable triple-vessel or left-main, costs and clinical outcomes are substantially higher for CABG than PCI. Long-term, economic, and health benefits analysis, is warranted.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial.

PURPOSE: Drug-eluting stents (DES) improve clinical and morphological long-term results compared to percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS) in patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial). We performed a cost-effectiveness analysis of DES compared to PTA ± BMS in cooperation with Dutch health insurance company VGZ, using data from the PADI trial. MATERIALS AND METHODS: In the PADI trial, adults with CLI (Rutherford category ≥ 4) and infrapopliteal lesions were randomized to receive DES with paclitaxel or PTA ± BMS. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA ± BMS. The costs were calculated by using the mean costs per stent multiplied by the mean number of stents used per patient (€750 × 1.8 for DES vs €250 × 0.3 for PTA ± BMS). These costs were compared with the costs of major amputation (€16.000) and rehabilitation (first year €15.750, second year €7.375 and third year €3.600). RESULTS: The 5-year major amputation rate was lower in the DES group (19.3% vs 34.0% for PTA ± BMS; p = 0.091). In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1 year, the cost difference per patient between DES and PTA ± BMS is €1.679 in favor of DES and €2.694 after 3 years. CONCLUSION: In our analysis, DES are cost-effective due to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS group. LEVEL OF EVIDENCE: Level 1b, analysis based on clinically sensible costs and randomized controlled trial.

The cost-effectiveness of guideline-driven use of drug-eluting stents: propensity-score matched analysis of a seven-year multicentre experience.

Background: In routine clinical practice, the implantation of a drug-eluting stent (DES) versus a bare metal stent (BMS) for percutaneous coronary intervention (PCI) has been guided by criteria for appropriate use. The cost-effectiveness (CE) of adopting these guidelines, however, is not clear, and was investigated from the perspective of the Australian healthcare payer.Methods and results: Baseline and 12-month follow-up data of 12,710 PCI patients enrolled in the Melbourne Interventional Group (MIG) registry between 2004 and 2011 were analysed. Costs inputs were derived from a clinical costing database and published sources. Propensity-score-matching was performed for DES and BMS groups within sub-groups. Incremental cost-effectiveness ratios (ICERs) were evaluated for all patients, and sub-groups of patients with '0', 1, 2, or ≥3 indications for a DES. The incremental cost per target vessel revascularization avoided for the overall population was $24,683, and for patients with 0, 1, and 2 indications for a DES was $44,635, $33,335, and $23,788, respectively. However, for those with >3 indications, DES compared with BMS was associated with cost savings. At willingness to pay thresholds of $45,000-$75,000, the probability of cost-effectiveness of DES for the overall cohort was 71-91%, '0' indications, 49-67%, 1 indication, 56-82%, 2 indications, 70-90%, and ≥3 indications, 97-99%.Conclusions: The cost-effectiveness of DES compared with BMS increased with increasing risk profile of patients from those who had 1, 2, to ≥3 indications for a DES. When compared with BMS, DES was least cost effective among patients with '0' indications for a DES. Based on these results, selective use of DES implantation is supported. These findings may be useful for evidence-based clinical decision-making.

Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.

BACKGROUND: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. OBJECTIVES: The objective of this article was to perform an economic evaluation of the SENIOR trial. METHODS: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. RESULTS: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. CONCLUSION: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

Pharmaceutical use and costs in patients with coronary artery disease, using Australian observational data.

OBJECTIVES: We aimed to estimate the annual pharmaceutical costs for patients with stable coronary artery disease, using Australian administrative data, comparing patients who had undergone interventional treatment with those had not. We also aimed to compare the duration of dual antiplatelet therapy (DAPT) prescription in the real-world, with recommended guidelines. DESIGN: An observational study using administrative data. PARTICIPANTS: We used data from the QSkin study, a population-based prospective study assessing skin cancer risk. Participants were invited from the Queensland population, not based on perceived skin cancer risk, and had consented to future use of their data for approved research projects. MAIN OUTCOME MEASURES: We calculated 12-month costs of pharmaceutical therapy for coronary artery disease for patients in each of three clinically relevant groups: medical therapy only, following coronary stent implantation and following coronary artery bypass graft surgery. We measured the duration of DAPT following stent implantation and total duration of DAPT, where it was prescribed, in the medical therapy only group. RESULTS: Estimated mean annual pharmaceutical costs were highest in the stent group at AUD$1920, compared with AUD$1481 in the medical therapy group, and AUD$881 in the coronary artery bypass group. There were similar rates of prescriptions of symptom relief drugs following stent insertion, compared with the medical therapy only group. The median duration of DAPT in the stent group was 16, and 31 months in the medical therapy group. CONCLUSIONS: Our results suggest that despite the common expectation that the burden of medical therapy is reduced following coronary stent insertion for stable coronary artery disease, this does not occur in practice. Many patients also appear to continue DAPT longer than guidelines recommend, which may put them at unnecessarily elevated risk of bleeding events.

Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.

BACKGROUND: Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection. METHODS: In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281. FINDINGS: Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function. INTERPRETATION: The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.

An Analysis of Cost-Effectiveness of Stents Used in the Treatment of Coronary Artery Disease

Background: There is only limited information about the cost-effectiveness of drug-eluting stents compared with bare-metal stents in Turkey. Aims: To evaluate bare-metal and drug-eluting stents used in the treatment of coronary artery disease from the perspective of the reimbursement institution with cost-effectiveness analysis. Study Design: Retrospective cost-effectiveness analysis. Methods: In our study, 329 patients diagnosed with coronary artery disease and treated with bare-metal or drug-eluting stents in the cardiology clinics of a public university hospital between January 1 and December 31, 2016 were investigated. Bare-metal and drug-eluting stents used in the treatment of coronary artery disease were evaluated retrospectively with cost-effectiveness analysis from the perspective of the reimbursement institution. Results: The cost of treatment with a bare-metal stent was 2,131.41 Turkish Liras, and the cost of treatment with a drug-eluting stent was 3,546.14 Turkish Liras; the Quality Adjusted Life Years value of treatment with a bare-metal stent was 0.8371, and the Quality Adjusted Life Years value of treatment with a drug-eluting stent was 0.8924. All these data were analyzed by decision tree. As a result of decision tree analysis, the weighted cost of treatment with a bare-metal stent was 2,340.71 Turkish Liras and weighted Quality Adjusted Life Years value was 0.8332; and the weighted cost of treatment with drug-eluting stent was 3,970.90 Turkish Liras and the weighted Quality Adjusted Life Years value of the treatment with drug-eluting stent was 0.8911. With these values, the additional cost-effectiveness ratio was calculated as 28,179.12 Turkish Liras per acquired Quality Adjusted Life Years. The additional cost-effectiveness ratio is in the first zone in the cost-effectiveness plane and below the very threshold of cost-effectiveness. Conclusion: In our study, it was concluded that drug-eluting stents are cost effective compared with bare-metal stents in the treatment of coronary artery disease. Considering the cost and effectiveness of the drug-eluting stent, it is thought that increasing reimbursement for this technology by the reimbursement agency would be beneficial for the service provider.

Health Economic Evaluation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent.

OBJECTIVES: The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating. BACKGROUND: The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI). METHODS: We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews. RESULTS: Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient. CONCLUSIONS: Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Cost-effectiveness analysis of short-duration dual antiplatelet therapy with newer drug-eluting stent platforms versus longer-duration dual antiplatelet therapy with a second-generation drug-eluting stent in elective percutaneous coronary intervention.

BACKGROUND: The cost-effectiveness of newer drug-eluting stents (DES) such as biodegradable-polymer or polymer-free stents with shorter dual antiplatelet therapy (DAPT) duration is unknown. We evaluated the cost-effectiveness of treatment with newer DES that may allow for shorter DAPT duration. PATIENTS AND METHODS: We performed a cost-effectiveness analysis of treatment with newer DES platforms followed by 1 or 3 months of DAPT compared with standard second-generation DES followed by 6 or 12 months of DAPT in patients with stable coronary disease. A Markov model simulated distinct health states over a lifetime. Probabilistic sensitivity analysis and one-way sensitivity analyses were performed. A high-risk bleeding scenario was also evaluated. RESULTS: Among patients with typical bleeding risk, second-generation DES and 6 months of DAPT was less expensive and resulted in marginally higher quality-adjusted life years compared with other strategies. A newer DES platform and 3 months of DAPT was preferred when the risk of fatal bleeding was two times greater than baseline, or when bleeding increased long-term mortality by a factor of 1.5. In a probabilistic sensitivity analysis, second-generation DES and 6 months of DAPT was preferred in 58% of iterations, whereas in a high-risk bleeding patient scenario, a newer DES and 3 months of DAPT was preferred in 52% of iterations. CONCLUSION: A DES that allows 3 months of DAPT without increasing stent-related events is likely to be cost-effective among patients at elevated risk of bleeding, but not in patients with average bleeding risk.

Comparison of the Cost of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Critical Limb Ischemia in the United States.

BACKGROUND: Despite significant technical advancement in the last decade, the durability of endovascular management of critical limb ischemia (CLI) remains highly debatable. Drug-eluting stents (DESs) are being popularized for the management of CLI after its precedent success in coronary intervention. Initial reports on the durability of DES are promising. However, little is known on the additional cost of this relatively newer technology. The aim of this study is to compare the cost of the traditional bare metal stents (BMSs) to the newly introduced DES in a large cohort of CLI patients. METHODS: Using the Premier database (2009-2015), we identified all patients with CLI undergoing DES and BMS. A multivariable generalized linear model was implemented to examine in-hospital cost adjusting for patients' characteristics, comorbidities, and regional characteristics. RESULTS: A total of 20,702 patients with CLI underwent peripheral artery revascularization using BMS (18,924 [91.41%]) or DES (1,778 [8.6%]). Majority of patients were males (53%) and whites (71%). Patients undergoing BMS were slightly younger (median age [interquartile range]: 70 [62-79] versus 71 [63-80]) and were more likely to be smokers (46% vs. 39%) and have a history of cerebrovascular disease (10% vs. 8%) and chronic pulmonary disease (24.5% vs. 20.9%) as compared with those undergoing DES (all P < 0.05). On the other hand, DES patients had a high prevalence of diabetes (4% vs. 3%) and renal disease (25% vs. 22%) (both P < 0.05). There was also a significant increase in the proportion of patients undergoing DES and a corresponding decrease in BMS (P < 0.001) over the study period. Median total in-hospitalization cost (BMS: $13,342 [8,574 to 21,166], DES: $13,243 [8,560-20,232], P = 0.76) was similar for both approaches. After adjusting for potential confounders, DES was associated with $407 higher cost than BMS (adjusted mean difference [95% confidence interval]: 407 [17 to 798], P = 0.04). In addition, the cost was $672 higher in teaching hospitals, $1,153 higher in Rural areas, and increased in all regions compared with the Midwest (adjusted mean difference [95% confidence interval]-South: $293 [31 to 555], Northeast: $2,006 [1,517 to 2,495], West: $3,312 [2,930 to 3,695], all P < 0.05). CONCLUSIONS: In this large cohort of CLI patients, after controlling for potential confounders, we demonstrated that the cost of endovascular revascularization is significantly higher in patients undergoing DES than those undergoing BMS. Regional disparities in cost were also observed. Further studies looking at the long-term durability and costs of DES versus BMS are needed.

Real-world cost-effectiveness of drug-eluting stents vs. bare-metal stents for coronary heart disease-A five-year follow-up study.

OBJECTIVE: To evaluate the cost-effectiveness of using drugeluting stents (DES) compared to bare-metal stents (BMS) for coronary heart disease (CHD). DATA SOURCES/STUDY SETTING: Data were obtained from the National Health Insurance Longitudinal Health Insurance Database, which contains claims data for 1,000,000 beneficiaries. The data were randomly sampled from all beneficiaries. STUDY DESIGN: A retrospective claims data analysis. DATA COLLECTION/EXTRACTION METHODS: Patients with stable coronary heart disease who underwent coronary stent implantation from 2007 to 2008 were recruited and followed to the end of 2013. After a 2:1 propensity score matched by gender, age, stent number, and the Charlson comorbidity index (CCI), 852 patients with 568 stents in the BMS group and 284 stents in the DES group were included. The cumulative medical costs for both matched groups were estimated with the Kaplan-Meier Sample Average (KMSA), and then the incremental cost-effectiveness ratio (ICER) was estimated. PRINCIPAL FINDINGS: The ICER of DES vs. BMS was NT$ 663,000 per cardiovascular death averted and NT$ 238,394 per cardiovascular death or coronary event averted in five years from the insurer perspective. CONCLUSION: Percutaneous coronary intervention (PCI) with DES was a more cost-effective strategy than PCI with BMS for CHD patients during the five-year follow-up.

Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial.

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Cost-effectiveness analysis of biodegradable polymer versus durable polymer drug-eluting stents incorporating real-world evidence.

AIM: Compared with second-generation durable polymer drug-eluting stents (DP-DES), the cost-effectiveness of biodegradable polymer drug-eluting stents (BP-DES) remains unclear in the real-world setting. We assessed the cost-effectiveness of BP-DES in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). METHODS: We developed a decision-analytic model to compare the cost-effectiveness of BP-DES to DP-DES over 1 year and 5 years from healthcare payer perspective. Relative treatment effects during the first year post-PCI were obtained from a real-world population analysis while clinical event risks in the subsequent 4 years were derived from a meta-analysis of published studies. RESULTS: At 1 year, based on the clinical data analysis of 497 propensity-score matched pairs of patients, BP-DES were associated with an incremental cost-effectiveness ratio (ICER) of USD20 503 per quality-adjusted life-year (QALY) gained. At 5 years, BP-DES yielded an ICER of USD4062 per QALY gained. At the willingness-to-pay threshold of USD50 400 (one gross domestic product per capita in Singapore in 2015), BP-DES were cost-effective. Sensitivity analysis showed that the cost of stents had a significant impact on the cost-effectiveness of BP-DES. Threshold analysis demonstrated that if the cost difference between BP-DES and DP-DES exceeded USD493, BP-DES would not be cost-effective in patients with 1 year of follow-up. CONCLUSIONS: Biodegradable polymer drug-eluting stents were cost-effective compared with DP-DES in patients with coronary artery disease at 1 year and 5 years after PCI. It is worth noting that the cost of stents had a significant impact on the findings.