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Background: The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood., Methods and Results: We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001)., Conclusion: There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

Background: The use of bivalirudin in percutaneous coronary interventions has been shown to be clinically safe and effective, and may be associated with shorter hospital stays and lower costs than heparin + glycoprotein (GP) IIb/IIIa inhibition. This study compared the utilization, clinical outcomes and costs associated with the planned use of bivalirudin versus heparin + GP IIb/IIIa inhibition in drug-eluting stent (DES) patients without acute myocardial infarction (MI)., Methods: We retrospectively studied 1,842 patients who underwent DES placement between May 2003 and December 2004. Planned treatment with heparin + GP IIb/IIIa inhibition was administered to 1,305 and planned bivalirudin alone was administered to 537 patients. Clinical follow ups (mean = 782 +/- 204 days) were obtained via telephone or mailed surveys in 1,813 patients (98.4%). Propensity analysis was utilized to adjust for between-groups baseline differences., Results: The unadjusted data revealed similar in-hospital outcomes in both groups. After propensity adjustment, the rate of vascular complications was significantly lower in the bivalirudin-treated group (0.2% vs. 1.2%; p = 0.04). At 1 year, clinical outcomes were similar in both groups. The overall unadjusted and adjusted cost analysis revealed similar mean hospital costs (11,384 U.S. dollars vs. 11,018 U.S. dollars; p = ns) and length of stay (2.9 days vs. 2.8 days; p = ns) in both groups. The unadjusted and adjusted mean hospital costs were significantly lower in patients treated with bivalirudin versus patients who received heparin + abciximab., Conclusions: These observations suggest that bivalirudin is a safe, cost-effective alternative to heparin + GP IIb/IIIa inhibition in patients undergoing DES in the absence of acute MI.

Objectives. After conventional balloon angioplasty (PTCA) for acute myocardial infarction in 77 patients (77 lesions), we used myocardial fractional flow reserve (FFR(myo)) to assess the endpoint of percutaneous coronary intervention (PCI) and to determine whether adjunctive stenting was required. Of these, a total of 37 lesions with FFR > or = 0.94 after PTCA received no further treatment (FFR-PTCA group), while the remaining 40 lesions (FFR < 0.94) underwent adjunctive stenting (FFR-stent group). A further 78 patients (78 lesions) comprised the control group; these patients underwent direct stenting without FFR measurement (stent-only group). The restenosis rate at 14-day discharge (mean time to discharge) was 5.1% in the two groups treated with FFR guidance (FFR-PTCA and FFR-stent), but was 0% in the control group (p = ns). There were no significant differences in reocclusion rates between the FFR-guided patients (1.7%) and the controls (0%). There was no incidence of in-hospital mortality or reinfarction in any of the groups. The number of balloons used (mean, 1.3 0.6 balloons for FFR patients versus 1.8 0.5 balloons for control patients) and the total cost of hospitalization and treatment ($16,213 versus $19,730 in U.S. currency; 1,945,571 998,726 yen versus 2,367,656 538,444 yen in Japanese currency) were both higher in the control group. Long-term survival rates were comparable in the two groups. These findings indicate that FFR guidance for PCI of acute myocardial infarction is a useful, low-cost technique that results in similar clinical outcomes as primary stenting.

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.

Objective: To determine whether coronary stenting, compared to percutaneous transluminal coronary angioplasty, reduces the incidence of five clinical endpoints during a six-month follow-up period., Background: There is considerable debate concerning whether coronary stents improve clinical outcomes, especially given the rapid growth in the use of coronary stents and their economic impact., Methods: Study population included a total of 6,671 consecutive patients at 32 hospitals in 16 different states who underwent single or multi-vessel revascularization during 1997. Patients were divided into one of two groups: those who only underwent standard balloon angioplasty (PTCA) for all treated vessels and those who received coronary stents (STENT) in all treated vessels., Results: STENT patients were significantly less likely to have emergency coronary artery bypass surgery (CABG) (p = 0.001) or die during initial procedure (p = 0.034) but were more likely than PTCA patients to be treated for hematoma (p = 0.002) and bradycardia (p = 0.004). After accounting for difference in patient characteristics, risk factors, procedure complications, and number of devices utilized, the estimated odds-ratio indicates that coronary stenting, compared to PTCA, significantly (p < 0.05) reduced adverse outcomes for only one clinical event, myocardial infarction., Conclusions: Compared to balloon angioplasty patients, coronary stent patients have no statistically significant differences in regard to additional percutaneous coronary intervention or coronary artery bypass during a six-month follow-up period. Since direct cardiac catheterization lab costs associated with coronary stenting is nearly 2.5 times greater than standard balloon angioplasty, our results suggest the cost-effectiveness of coronary stenting, especially for "hard" clinical outcomes, needs to be established.

The purpose of this study was to compare the clinical outcomes and costs of coronary stenting with conventional percutaneous transluminal coronary angioplasty (PTCA) in patients with coronary artery disease (CAD) in Japan. The increasing use of stent implantation in CAD has raised economic concerns for healthcare decision makers. This decision analysis model, which applies to the Japanese healthcare system and uses recent clinical and economic data, demonstrates coronary stenting to be superior to PTCA, both in terms of effectiveness and cost. Although the procedural costs for the stenting group are substantially higher than for PTCA (1,233,412 yen versus 709,295 yen, respectively; p<0.001), the difference in cost between the two procedures (524,117 yen) is already reduced to 299,408 yen by the time of hospital discharge due to procedural complications and associated bail-out treatments avoided during the in-hospital period. The initial incremental cost of stenting is more than recouped by the end of year one, mainly because of savings realized due to avoided repeat revascularization procedures. The cost neutrality (or small cost saving) is maintained over subsequent years. Thus, coronary artery stenting leads to better results as well as cost neutrality after one, two and three years. This highly desirable outcome implies that stenting rather than PTCA alone should be the treatment of choice and dominant strategy in Japan from the viewpoint of both the patient and the healthcare system.

In today's health care climate, decisions about new technologies need to reflect measures of cost as well as clinical benefit. By estimating the cost-effectiveness ratio for a new treatment compared to a current standard (e.g., stenting as compared to conventional PTCA), it is possible to decide whether the new treatment represents an efficient use of limited health care resources. In this analysis, stenting carried a $2500 greater in-hospital cost, which was partially defrayed by a $1900 savings in follow-up costs due to reductions in abrupt closure and restenosis. The net $600 increase in cumulative costs for stenting "bought" additional quality-adjusted life expectancy at a cost-effectiveness ratio of $33,700/QALY over conventional angioplasty, giving stenting a cost-effectiveness comparable to many other accepted medical therapies. Any future reduction in stent costs (e.g., by reducing length of stay or vascular complications) would improve this estimate of relative cost-effectiveness.