Defining Patients at High Risk for Gastrointestinal Hemorrhage after Drug‐Eluting Stent Placement: A Cost Utility Analysis

Introduction: The study goal was to evaluate the cost‐effectiveness of drug‐eluting stent (DES) placement with consideration of gastrointestinal (GI) bleeding risk. DES reduce the need for future coronary revascularization, but require prolonged dual anti‐platelet (DAT) therapy, which may increase the risk for GI bleeding. While DES have been found to be cost‐effective in patients at average risk for GI bleeding, they may not be the most cost‐effective strategy in higher risk patients. Methods: A Markov model was created to compare DES with bare metal stents (BMS). Patients were a hypothetical cohort of 60‐year‐old individuals with coronary artery stenosis that required nonemergent percutaneous coronary revascularization (PCI). The primary outcomes were the threshold incremental risks of GI bleeding from DAT based on willingness to pay (WTP) of $50,000, $100,000, and $150,000 per quality adjusted life year (QALY) gained. Results: For a WTP of $100,000, the relative risk of GI bleeding from DAT could be as high as 10.8 (when compared to aspirin alone) before DES would no longer be cost‐effective. In patients with two risk factors for GI bleeding, the threshold relative risk could be as low as 1.6. Conclusion: In average‐risk patients, the risk of GI bleeding from DAT can be substantial without affecting the cost‐effectiveness of DES. However, DES are unlikely to be cost‐effective in patients with two or more risk factors for GI bleeding. (J Interven Cardiol 2010;23:179‐187)     

Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial

OBJECTIVES: The purpose of this study was to compare the cost of percutaneous coronary intervention (PCI) using bivalirudin with provisional platelet glycoprotein (GP) IIb/IIIa inhibition with that of heparin + routine GP IIb/IIIa inhibition. BACKGROUND: Although GP IIb/IIIa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing PCI, many patients currently do not receive such therapy because of concerns about bleeding complications or cost. Recently, bivalirudin with provisional GP IIb/IIIa inhibition has been validated as an alternative to heparin + routine GP IIb/IIIa inhibition for patients undergoing PCI. However, the cost-effectiveness of this novel strategy is unknown. METHODS: In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, 4,651 U.S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP IIb/IIIa (n = 2,319) versus heparin + routine GP IIb/IIIa (n = 2,332). Resource utilization data were collected prospectively through 30-day follow-up on all U.S. patients. Medical care costs were estimated using standard methods including bottom-up accounting (for procedural costs), the Medicare fee schedule (for physician services), hospital billing data (for 2,821 of 4,862 admissions), and regression-based approaches for the remaining hospitalizations. RESULTS: Among the bivalirudin group, 7.7% required provisional GP IIb/IIIa. Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP IIb/IIIa groups, but bivalirudin resulted in lower rates of major bleeding (2.8% vs. 4.5%, p = 0.002) and minor bleeding (15.1% vs. 28.1%, p < 0.001). Compared with routine GP IIb/IIIa, in-hospital and 30-day costs were reduced by $405 (95% confidence interval [CI] $37 to $773) and $374 (95% CI $61 to $688) per patient with bivalirudin (p < 0.001 for both). Regression modeling demonstrated that, in addition to the costs of the anticoagulants themselves, hospital savings were due primarily to reductions in major bleeding (cost savings = $107/patient), minor bleeding ($52/patient), and thrombocytopenia ($47/patient). CONCLUSIONS: Compared with heparin + routine GP IIb/IIIa inhibition, bivalirudin + provisional GP IIb/IIIa inhibition resulted in similar acute ischemic events and cost savings of $375 to $400/patient depending on the analytic perspective.     

Frequency and impact of bleeding in elective coronary stent clinical trials--utility of three commonly used definitions

Background : Bleeding events are common after percutaneous coronary intervention (PCI) and have been shown to increase mortality in studies of acute coronary syndrome (ACS) and anti‐thrombotic therapy. Despite this evidence, bleeding has not been included as a traditional major endpoint in clinical trials of low‐risk populations enrolled in PCI clinical trials. Thus, the impact of specific bleeding definitions has not been evaluated fully among these patients. Methods and Results : Using patient‐level pooled data from sirolimus and zotarolimus drug‐eluting stent clinical trials, we identified bleeding events using three common definitions of bleeding, ACUITY, TIMI, and GUSTO, and assessed the impact on mortality and MI at 12 months after PCI. The GUSTO, ACUITY, and TIMI classifications identified bleeding rates of 2.3%, 1.9%, and 2.1%, respectively. The GUSTO criteria classified all 118 suspected bleeding events. There were 22 (18.6%) and 8 (6.8%) suspected bleeding events that did not meet ACUITY and TIMI criteria, respectively. The combined endpoint of all‐cause death or myocardial infarction (MI) at 12 months was significantly higher for patients with a bleeding event compared with those who did not bleed [hazard ratio 1.95 (95% CI 1.06–3.60)]. Conclusion : There is a substantial variability in the utility and inclusiveness of three widely used bleeding definitions in identifying clinically significant bleeding events in clinical trials of low risk patients undergoing PCI with DES. Patients with bleeding after elective PCI have an increased one‐year risk of death or MI compared to those patients who do not bleed. © 2012 Wiley Periodicals, Inc.     

Bleeding complications in primary percutaneous coronary intervention of ST-elevation myocardial infarction in a radial center

Objectives : We evaluated the incidence, types, and prognostic impact of bleeding complications in a non‐selected patient population with ongoing STEMI treated with aggressive antithrombotic treatment and routine radial primary PCI. Background : Bleeding complications remain frequent and deleterious in primary PCI through femoral approach. Methods : STEMI patients (n = 671) were evaluated for bleeding complications using a web‐based registry (e‐PARIS). In‐hospital bleeding was adjudicated using the TIMI definition. Results : In this non‐selected, high risk population, 6.1% had cardiogenic shock on admission, 3.9% out‐of‐hospital cardiac arrest. Radial access (88%) was the default strategy as was abciximab (78%). Clopidogrel loading dose ranged from 300 to 900 mg. Pre‐hospital fibrinolysis was rare (7.1%). Hemodynamic support devices (IABP, ECMO, Tandem Heart) were needed in 7.0%. In‐hospital TIMI Major and TIMI Major/minor bleedings occurred in 2.5 and 5.7% of the population, respectively. In‐hospital and 1‐year mortality rates were 5.5 and 8.2%, respectively. Patients with in‐hospital TIMI Major/minor bleeding had a higher 1‐year mortality rate (31.6% vs. 3.8%, P < 0.001). The most frequent bleeding site was gastro‐intestinal. Radial access was a strong predictor of survival (OR 0.33; 95%CI 0.17–0.56; P = 0.002). Conclusions : In the setting of radial primary PCI, the rates and types of bleeding complications are somewhat different from those observed with femoral primary PCI. The gastro‐intestinal tract has become the most frequent site of bleeding after radial primary PCI. The use of radial access appears independently associated with survival. © 2011 Wiley Periodicals, Inc     

Economic outcomes of percutaneous coronary intervention with drug‐eluting stents versus bypass surgery for patients with left main or three‐vessel coronary artery disease: One‐year results from the SYNTAX trial

Objectives: To evaluate the cost‐effectiveness of alternative approaches to revascularization for patients with three‐vessel or left main coronary artery disease (CAD). Background: Previous studies have demonstrated that, despite higher initial costs, long‐term costs with bypass surgery (CABG) in multivessel CAD are similar to those for percutaneous coronary intervention (PCI). The impact of drug‐eluting stents (DES) on these results is unknown. Methods: The SYNTAX trial randomized 1,800 patients with left main or three‐vessel CAD to either CABG (n = 897) or PCI using paclitaxel‐eluting stents (n = 903). Resource utilization data were collected prospectively for all patients, and cumulative 1‐year costs were assessed from the perspective of the U.S. healthcare system. Results: Total costs for the initial hospitalization were $5,693/patient higher with CABG, whereas follow‐up costs were $2,282/patient higher with PCI due mainly to more frequent revascularization procedures and higher outpatient medication costs. Total 1‐year costs were thus $3,590/patient higher with CABG, while quality‐adjusted life expectancy was slightly higher with PCI. Although PCI was an economically dominant strategy for the overall population, cost‐effectiveness varied considerably according to angiographic complexity. For patients with high angiographic complexity (SYNTAX score > 32), total 1‐year costs were similar for CABG and PCI, and the incremental cost‐effectiveness ratio for CABG was $43,486 per quality‐adjusted life‐year gained. Conclusions: Among patients with three‐vessel or left main CAD, PCI is an economically attractive strategy over the first year for patients with low and moderate angiographic complexity, while CABG is favored among patients with high angiographic complexity. © 2011 Wiley Periodicals, Inc.     

Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions

Bleeding related to percutaneous coronary intervention (PCI) occurs relatively frequently. We retrospectively investigated the incidence, predictors, and prognostic impact of periprocedural bleeding and transfusion in 10,974 patients who underwent PCI. Bleeding definitions were based on Thrombolysis In Myocardial Infarction (TIMI) criteria: (1) major bleeding (n = 588; 5.4%): if patients had a hemorrhagic stroke or if hematocrit decreased >15 points or by 10 to 15 points with clinical bleeding; (2) minor bleeding (n = 1,394; 12.7%): if hematocrit decreased <10 points with clinical bleeding or by 10 to 15 points without clinical bleeding; and (3) no bleeding (n = 8,992; 81.9%): if hematocrit decreased <10 points without clinical bleeding. Patients with major bleeding were older than patients with minor or no bleeding (67.8 +/- 11 vs 65.9 +/- 11 vs 63.6 +/- 11 years, respectively; p <0.001) and more often experienced intraprocedural complications, such as emergency use of an intra-aortic balloon pump (13.6% vs 6.5% vs 2.3%, respectively; p <0.001). Multivariate logistic regression analysis identified the use of an intra-aortic balloon pump (odds ratio [OR] 3.0, p <0.0001), procedural hypotension (OR 2.9, p <0.001), and age >80 years (OR 1.9 compared with age <50 years, p = 0.001) as the strongest predictors for major bleeding. Patients who had major bleeding had higher in-hospital and 1-year mortality compared with patients with minor or no bleeding. Bleeding was an independent predictor of in-hospital death. Thus, periprocedural major bleeding occurs relatively frequently and is associated with adverse outcomes. Patients >80 years of age who experience intraprocedural complications are at particularly high risk.     

Abciximab or Eptifibatide in Percutaneous Coronary Intervention: In-Hospital Outcomes and Costs and Six-Month Results

Inhibition of platelet aggregation with glycoprotein (GP) IIb-IIIa receptor blockers has been shown to reduce ischemic complications in patients with acute coronary syndromes (ACS) and in those undergoing percutaneous coronary intervention (PCI) in multiple placebo-controlled, randomized clinical trials. The effect of pharmacologic and cost differences between abciximab and eptifibatide, the only GP IIb-IIIa inhibitors indicated for PCI, on clinical outcomes and total hospital costs for patients undergoing PCI remain to be defined. To determine the rate of clinical events and costs associated with the use of abciximab vs eptifibatide at our centers, we retrospectively reviewed data for the cohort of 188 consecutive patients who underwent PCI and were treated with either abciximab (n = 85) or eptifibatide (n = 103) in the period between January 1998 and June 1999. The choice of a GP IIb-IIIa inhibitor was based on the preference of the interventional cardiologist. In-hospital events evaluated included death, major bleeding, minor bleeding, and hematoma. Additionally, the duration of hospital stay and total in-hospital costs were also assessed. Clinical events at 6 months included combined incidence of death, acute myocardial infarction (MI), or unstable angina (UA), as well as the incidence of hospital readmissions. In-hospital complications were generally more common with abciximab (death: 4.7% vs 0% with eptifibatide; major bleeding: 7.1% vs 4.8%, respectively; minor bleeding: 9.4% vs 5.7%, respectively; hematoma: 21.2% vs 21.4%, respectively), although none of these differences reached statistical significance. However, abciximab therapy was associated with a significantly longer mean duration of hospitalization (4.17 ± 0.48 days vs 2.85 ± 0.26 days with eptifibatide; P = 0.017) and a significantly higher mean total in-hospital costs ($31,396 ± 2,111 vs $25, 135 ± 815; P = 0.007). At six-month follow-up, the combined incidence of death, acute MI, or UA was also significantly higher in the abciximab group (32.9% vs 15.5%; P = 0.01). Additionally, hospital readmissions related to acute coronary syndromes at 6 months occurred significantly more often in the abciximab group (36.7% vs 16.5% with eptifibatide; P = 0.014). Our retrospective analysis of 188 patients undergoing PCI indicates that the use of eptifibatide instead of abciximab is associated with significantly lower in-hospital costs, significantly shorter duration of index hospitalization, and significantly reduced rates of ischemic complications and cardiovascular readmissions at 6-month follow-up. These differences were seen despite the fact that the baseline characteristics of patients in the two groups were generally similar. Therefore, eptifibatide provides a clinically effective and economically more attractive alternative to abciximab.     

Costs and cost‐effectiveness of carotid stenting versus endarterectomy for patients at increased surgical risk: Results from the SAPPHIRE trial

Objectives : To evaluate the cost‐effectiveness of carotid stenting vs. carotid endarterectomy using data from the SAPPHIRE trial. Background : Carotid stenting with embolic protection has been introduced as an alternative to carotid endarterectomy for prevention of cerebrovascular and cardiovascular events among patients at increased surgical risk. Methods : Between August 2000 and July 2002, 310 patients with an accepted indication for carotid endarterectomy but at high risk of complications were randomized to and subsequently underwent either carotid stenting (n = 159) or endarterectomy (n = 151). Clinical outcomes, resource use, costs, and quality of life were assessed prospectively for all patients over a 1‐year period. Life expectancy, quality‐adjusted life expectancy, and health care costs beyond the follow‐up period were estimated for patients alive at 1 year, based on observed clinical events during the first year of follow‐up. Results : Although initial procedural costs were significantly higher for stenting than for endarterectomy (mean difference: $4,081/patient; 95% CI, $3,849–$4,355), mean post‐procedure length of stay was shorter for stenting (1.9 vs. 2.9 days; P < 0.001) with significant associated cost offsets. As a result, initial hospital costs were just $559/patient higher with stenting (95% CI, $3,470 less to $2,289 more). Neither follow‐up costs after discharge nor total 1‐year costs differed significantly. The incremental cost‐effectiveness ratio for stenting compared with endarterectomy was $6,555 per quality‐adjusted life year (QALY) gained, with over 98 percent of bootstrap estimates <$50,000/QALY gained. Conclusions : Although carotid stenting with embolic protection is more costly than carotid endarterectomy, by commonly accepted standards, stenting is an economically attractive alternative to endarterectomy for patients at high surgical risk. © 2011 Wiley‐Liss, Inc.     

Comparative effectiveness analysis of anticoagulant strategies in a large observational database of percutaneous coronary interventions

Background: Percutaneous coronary intervention (PCI) is the most commonly used procedure for coronary revascularization. There are multiple adjuvant anticoagulation strategies available. In this era of cost containment, we performed a comparative effectiveness analysis of clinical outcomes and cost of the major anticoagulant strategies across all types of PCI procedures in a large observational database. Methods: A retrospective, comparative effectiveness analysis of the Premier observational database was conducted to determine the impact of anticoagulant treatment on outcomes. Multiple linear regression and logistic regression models were used to assess the association of initial antithrombotic treatment with outcomes while controlling for other factors. Results: A total of 458,448 inpatient PCI procedures with known antithrombotic regimen from 299 hospitals between January 1, 2004 and March 31, 2008 were identified. Compared to patients treated with heparin plus glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin was associated with a 41% relative risk reduction (RRR) for inpatient mortality, a 44% RRR for clinically apparent bleeding, and a 37% RRR for any transfusion. Furthermore, treatment with bivalirudin alone resulted in a cost savings of $976 per case. Similar results were seen between bivalirudin and heparin in all end‐points. Combined use of both bivalirudin and GPI substantially attenuated the cost benefits demonstrated with bivalirudin alone. Conclusion: Bivalirudin use was associated with both improved clinical outcomes and decreased hospital costs in this large "real‐world" database. To our knowledge, this study is the first to demonstrate the ideal comparative effectiveness end‐point of both improved clinical outcomes with decreased costs in PCI. (J Interven Cardiol 2012;25:278–288)     

Sex‐based differences in bleeding and long‐term adverse events after percutaneous coronary intervention in older patients with coronary artery disease

Objectives

Differences in outcomes for women and men after percutaneous coronary intervention (PCI) in older patients remain controversial. Herein, we compared 2‐year outcomes by sex in Chinese older patients undergoing PCI.

Methods

A total of 4926 consecutive patients (33.6% women, age ≥60 years, mean age 67.4 ± 5.7 years) who underwent PCI at a single center in China from January 2013 to December 2013 were included in this study. The primary endpoint was 2‐year risk of bleeding according to the Bleeding Academic Research Consortium definitions. The secondary endpoints included 2‐year risk of major adverse cardiovascular and cerebrovascular events (MACCE). Hazard ratios were generated using multivariable Cox regression.

Results

Compared with men, women had significantly higher rates of in‐hospital all‐cause mortality (0.8% vs 0.2%, P = 0.001), cardiac death (0.5% vs 0.1%, P = 0.006), MACCE (2.4% vs 1.5%, P = 0.017), and bleeding (0.4% vs 0.1%, P = 0.015). At 2‐year follow up, there were no differences between men and women for all‐cause mortality (1.9% vs 1.8%, P = 0.839) and 2‐year MACCE (13.1% vs 11.8%, P = 0.216). However, women had a higher risk of 2‐year bleeding (9.2% vs 6.2%, P < 0.001), which persisted after adjusting for baseline differences and treatment characteristics (hazard ratio 1.35, 95% confidence interval 1.06‐1.71; P = 0.014).

Conclusion

We found that older women undergoing PCI were at increased risk of 2‐year bleeding compared with men. Further dedicated studies are needed to confirm these findings.

     

Catheter Ablation for Atrial Fibrillation on Uninterrupted Warfarin: Can It Be Done Without Echo Guidance?

AF Ablation on Uninterrupted Warfarin. Introduction: Catheter ablation for atrial fibrillation is an effective treatment for symptomatic patients who have failed drug therapy. Recent studies using intracardiac echocardiography have demonstrated that ablation can be performed safely on uninterrupted warfarin and may be superior to bridging low molecular weight heparin (LMWH). We sought to assess the safety of an uninterrupted warfarin protocol using a simplified ablation protocol in a prospective controlled study. Methods: Two anticoagulation regimes for patients undergoing catheter ablation for atrial fibrillation were evaluated—a bridging LMWH group and an uninterrupted warfarin group. Bleeding complications were compared between the 2 groups. Results: In total 198 patients were evaluated (109 bridging LMWH, 89 uninterrupted warfarin). The preprocedure INR in the LMWH group (mean age 60.6 years, 72% male) was 1.2 ± 0.3 compared to 2.3 ± 0.5 in the uninterrupted warfarin group (mean age 60.9 years, 69% male). The primary outcome (a composite of major and minor bleeding complications) was observed in 78% in the LMWH group compared to 56% in the warfarin group (P = 0.001), mainly due to increased pain at the venous access site (41% vs 16%, P = 0.001). Two patients undergoing ablation on warfarin required pericardiocentesis for cardiac tamponade. Drug costs were lower in the warfarin group ($64.77 ± 31.86 vs $20.76 ± 15.60, P = 0.005), but the overall cost of treatment per patient (including bed occupancy costs) was similar in the LMWH group compared to the warfarin group ($883.96 ± 278.78 vs $816.59 ± 182.72, P = 0.06). Conclusion: Catheter ablation for atrial fibrillation can be performed safely on uninterrupted warfarin without intracardiac echocardiography, with a reduced risk of bleeding complications. (J Cardiovasc Electrophysiol, Vol. 22, pp. 265‐270, March 2011)     

Clinical outcomes, resource use, and costs at 1 year in patients with acute coronary syndrome undergoing PCI: results from the multinational APTOR registry

Background: Limited prospectively collected data are available on the total outcomes, cost estimates, and quality of life associated with treatment of acute coronary syndrome (ACS) through 1 year in a nonclinical‐trial setting, or on the impact of new clinical events by 1 year on resource utilization and costs. Methods: The Antiplatelet Therapy Observational Registry (APTOR) 12‐month study followed 1,335 concurrently recruited ACS patients undergoing percutaneous coronary intervention (PCI) and treated with antiplatelet therapy from France, Spain, and the United Kingdom in a “real world” clinical setting. Data were collected on clinical events, resource utilization, quality of life, and cost estimates through 1‐year follow‐up. Results: By 1 year, 14.4% (95% CI 12.7–16.4%) of patients experienced a clinical event of death, MI, stroke, unstable angina, urgent target vessel revascularization, or acute heart failure. Costs by 1 year were higher among those who had a new clinical event (£8,988, 95% CI £7,848, £10,395) as compared with those with no events (£5,809, 95% CI £5,486, £6,161). This increased cost was due to higher postdischarge resource use costs. Using the EQ‐5D assessment at 1 year, quality of life was directionally lower in those patients who had experienced a new clinical event. Conclusions: The risk of experiencing a new clinical event during the year following an ACS, which was treated with PCI, remains high among European patients, with one‐seventh of patients having a new event. These additional clinical outcomes reduce quality of life and increase health care expenditures, expanding the already high cost of treatment for ACS. (J Interven Cardiol 2012;25:19–27)     

Prognostic implications of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation

Background : Bleeding has emerged as a predictor of early and late mortality after percutaneous coronary interventions. However, the prevalence and predictors of long‐term bleeding events in patients on prolonged dual antiplatelet therapy (DAPT) after drug‐eluting stent (DES) implantation has been poorly explored. Methods : A total of 1,437 patients undergoing DES implantation discharged on DAPT with aspirin and clopidogrel for 1 year were studied. Patients were followed for up to 4 years (34.3 ± 14.4 months) and the prevalence and predictors of in‐hospital and long‐term thrombolysis in myocardial infarction (TIMI) major and minor bleeding events evaluated. The impact of bleeding events on major adverse cardiac events (MACE), overall death, and stent thrombosis (ST) was also assessed. Results : The incidences of 30 days major and minor bleeding were 1.3 and 3.3%, respectively. The incidences of 1‐year major and minor bleeding were 3.0 and 5.6%, respectively. The incidences of major and minor bleeding up to 4‐year follow‐up were 3.6 and 6.9%, respectively. At multivariable analysis, 1‐year major bleeding was positively predicted by use of oral anticoagulants at hospital discharge [odds ratio (OR) = 13.4, 95% confidence interval (CI) 3.0–59.2, P = 0.001], anemia at admission (OR = 6.7, 95% CI = 2.7–16.5, P < 0.001) and use of glycoprotein IIb/IIIa inhibitors (OR = 2.7, 95% CI = 1.1–6.5, P = 0.03) and negatively predicted by male gender (OR = 0.39, 95% CI = 0.16–0.97, P = 0.042). Overall, major bleeding at 1 year and at long‐term follow‐up was associated with an increased risk of MACE, cardiac death and ST. Patients who had any bleeding event were more likely to prematurely discontinue antiplatelet therapy (50% vs. 9.6%, P < 0.001). Conclusions : In DES‐treated patients on prolonged DAPT, major bleeding occurring at 1 year and up to 4 years following DES implantation in patients on prolonged DAPT is associated with poor long‐term prognosis. © 2012 Wiley Periodicals, Inc.     

The impact of unfractionated heparin or bivalirudin on patients with stable coronary artery disease undergoing percutaneous coronary intervention

Objectives

To compare bleeding and clinical events of patients with stable angina or silent ischemia undergoing percutaneous coronary intervention (PCI) treated with unfractionated heparin (UFH) or bivalirudin.

Background

Few direct comparisons between UFH monotherapy versus bivalirudin exist for patients with stable ischemic heart disease undergoing PCI.

Methods

A prospective, investigator‐initiated, single‐center, single‐blinded, randomized trial of UFH versus bivalirudin was conducted. The primary endpoint was all bleeding (major and minor) from index‐hospitalization to 30 days post discharge. Secondary endpoints included major adverse cerebral and cardiovascular events (MACCE) and net adverse clinical events (NACE).

Results

Two‐hundred‐sixty patients were randomized for treatment with either UFH (n = 123) (47%) or bivalirudin (n = 137) (53%) There were no significant differences in baseline clinical and angiographic characteristics between the two groups. Primary endpoint was similar in both groups (10.9% with bivalirudin vs 7.3% with UFH [P = 0.31]). Major bleeding rates were 5.8% and 2.4%, respectively (P = 0.17). There was a higher MACCE (3.5% vs 0%, P = 0.03) and NACE (8.8% vs 2.4%, P = 0.03) rate with bivalirudin compared to UFH, respectively. Bivalirudin had increased odds of NACE (OR = 3.65, 95% CI: 1.00‐13.3.6). Death and stent thrombosis rates were low and similar in both groups. Radial access was associated with fewer bleeding events compared to femoral access but not statistically significant (P = 0.29).

Conclusions

Among patients with stable angina or silent ischemia, there was no difference between UFH and bivalirudin in bleeding rates up to 30‐days post‐PCI. MACCE and NACE were higher among the bivalirudin group. Radial access was associated with a numerically lower rate of bleeding compared with femoral access.     

Bleeding Complications After Contemporary Pharmacoinvasive Therapy for ST Elevation Myocardial Infarction

Background: Pharmacoinvasive therapy for the treatment of ST elevation myocardial infarction (STEMI) is a strategy that combines early restoration of coronary flow via pharmacologically induced thrombolysis with subsequent, prompt percutaneous coronary intervention (PCI). Prior studies suggesting a heightened bleeding risk of PCI performed early after fibrinolysis predated contemporary pharmacoinvasive practice including use of femoral closure devices (CD), fibrin specific thrombolytics, lower doses of heparin and stents. Methods: Consecutive patients were included in this retrospective registry study if they underwent emergent PCI for ST elevation myocardial infarction (STEMI) followed by immediate use of a groin closure device. Between Oct 1, 2002 and Jan 1, 2003, 27 patients were treated with immediate use of CD after post-thrombolytic PCI, performed within 12 hours of thrombolysis (pharmacoinvasive group). 58 patients were treated with immediate use of CD after primary PCI for STEMI. The two groups were compared with respect to the incidence of successful groin closure, bleeding complications, and clinical outcomes. Bleeding events were categorized according to the TIMI criteria. All baseline clinical and treatment variables were compared between the two groups to determine and the association of these variables (including use of thromblytic therapy) with TIMI major and TIMI minor bleeding was determined. Results: Pharmacoinvasive recanalization with PCI occurred 348 ± 183 minutes after initiation of fibrinolytic therapy. Glycoprotein IIb/IIIa inhibitors were used less frequently in the patients treated with a thrombolytic agent (59% vs. 90%, p < 0.01). Successful immediate hemostasis was obtained with CD in greater than 85% of patients in both groups (89% for pharmacoinvasive group vs. 86% for primary PCI group, p = 0.89). No patient required vascular surgical intervention. TIMI major bleeding and transfusion requirements were less than 5% in both groups. Antecedent thrombolytic therapy was not a predictor of bleeding complications after PCI. Conclusions: Use of CD as part of a contemporary pharmacoinvasive strategy is associated with a low rate of major bleeding complications.This revised version was published online in May 2005 with a corrected cover date.     

Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the TAXUS Liberté versus TAXUS express stents

Background: With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. Methods: Markov modeling was developed comparing total costs (Medicare payer perspective) between TAXUS Liberté and TAXUS Express based on 3‐year clinical outcomes from the TAXUS ATLAS Small Vessel and Long Lesion trials. Results: The TAXUS Liberté 2.25‐mm stent provided cost savings relative to TAXUS Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, TAXUS Liberté was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The TAXUS Liberté Long (38 mm) stent was cost neutral relative to TAXUS Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography‐driven revascularizations, TAXUS Liberté 2.25 mm still provided cost savings relative to TAXUS Express ($16,822 vs. $19,139), although TAXUS Liberté Long was more expensive than TAXUS Express ($17,886 vs. $17,652). From a hospital perspective, TAXUS Liberté Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. Conclusions: This analysis confirms the utility of economic modeling in assessing new stent platforms. TAXUS Liberté 2.25 mm is economically dominant relative to TAXUS Express when treating small vessels. TAXUS Liberté Long is cost neutral to modestly more costly than TAXUS Express 2.25 mm from a payer perspective. (J Interven Cardiol 2012;25:353–363)     

Modifying clopidogrel maintenance doses according to vasodilator-stimulated phosphoprotein phosphorylation index improves clinical outcome in patients with clopidogrel resistance

Background:

Despite dual antiplatelet therapy, the rate of major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) remains high. Ex vivo tests of clopidogrel resistance can predict MACE after PCI. The purpose of this study is to evaluate the clinical impact of adjusting phosphorylation analysis in patients with clopidogrel resistance undergoing PCI.

Hypothesis:

We hypothesized that VASP‐guided clopidogrel maintenance doses, compared to fixed doses, improved clinical outcome.

Methods:

This monocentric, prospective, randomized study was performed on 306 patients undergoing PCI. Patients were randomized to a control group (n = 156) and to a vasodilator‐stimulated phosphoprotein (VASP)‐guided group (n = 150). In the VASP‐guided group, patients received adjusted maintenance doses of clopidogrel to obtain platelet reactivity index (PRI) of <50% during 1 year after PCI. The primary endpoint was the rate of MACE. The secondary endpoints were major and minor bleeding.

Results:

All patients completed the PCI procedure and 298 patients completed follow‐up. The control and VASP‐guided groups had similar demographic, clinical, and angiographic characteristics. In the VASP‐guided group, PRI was significantly decreased (from 72.1% ± 11.4% to 27.7% ± 8.4%; P = 0.001) in 128 patients (87.1% of all participants). During the 1‐year follow‐up, 14 MACEs were recorded in the VASP‐guided group and 30 MACEs were recorded in the control group (9.3% vs 20.4%, respectively; P = 0.008). There was no difference in the rate of major and minor bleeding in the VASP‐guided group compared with the control group (12.9% vs 16.6%; P = 0.06).

Conclusions:

Modifying clopidogrel maintenance doses according to platelet reactivity monitoring decreases the rate of MACE after PCI without increasing bleeding in patients with clopidogrel resistance during 1‐year follow‐up. © 2011 Wiley Periodicals, Inc. This project was sponsored by Science and Technology Commission of Shanghai Municipality (No. SK08‐6). The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Endovascular treatment of thrombosed dialysis fistulae

Objectives : In the present study, we determined the cumulative costs and outcomes of endovascular treatment of thrombosed autogenous arteriovenous fistulae (AVF) at our medical center. Background : Previous studies examining the salvage procedures of thrombosed AVFs have focused exclusively on clinical outcomes, and, in the absence of costing data, current guidelines do not take into consideration economic issues. Methods : A retrospective cohort study was performed among local hemodialysis patients with completely thrombosed AVFs receiving endovascular treatment in our institution between January 1 and December 31, 2008. Forty‐four patients were enrolled and followed‐up for 1 year. Success and complications were recorded according to consensus definitions, and a comprehensive measurement of total vascular access care‐related costs was obtained. Costs are reported in 2010 in U.S. dollars. Results : Clinical success was achieved in 95% of cases. The primary and secondary patency rates were 63 and 78% at 1 year, respectively. Primary patency rate at 12 months was significantly better for radiocephalic AVFs (70% vs. 43%; P = 0.047). The mean cumulative cost of all vascular access care during year 1 was $2,504 (median $1,484; range, $1,362–$18,279; Table V ) per patient‐year at risk. The mean cumulative cost for maintaining radiocephalic and brachiocephalic AVFs was $1,624 (median $1,381; range, $1,130–$3,116) and $3,578 (median $2,092; range, $1,470–$18,279) per patient‐year at risk, respectively (P = 0.022). Conclusion : The cost of maintenance of a thrombosed AVF by endovascular intervention is high, with patients with clotted radiocephalic fistulae incurring the lowest costs and achieving higher survival times. © 2011 Wiley‐Liss, Inc.     

Practice patterns and outcomes of percutaneous coronary interventions in the United States: 1995 to 1997

Randomized trials have demonstrated the superiority of coronary stents in combination with a platelet-focused pharmacologic approach in percutaneous coronary intervention (PCI). However, nationally representative data examining the impact of these technologies on patient outcomes and costs remain scarce. This study sought to determine the real-world impact of changes in the use of stents and anticoagulant agents in PCI on outcomes and costs. A nationally representative sample of 37,088 patients who underwent PCI from October 1995 to October 1997 was identified from in-patient hospital claims data acquired from HCIASachs. Utilization of coronary stents, antiplatelet and anticoagulant agents, and outcome measurements of in-hospital death, coronary artery bypass grafting (CABG), repeat PCI, bleeding, and costs were analyzed in 6-month intervals. Acute events (death, urgent CABG, or PCI) decreased (p <0.001), whereas use of stents, abciximab, or both, increased (p <0.001). Dosages of heparin and bleeding complications declined significantly (p <0.001) over the 2-year period. Heparin dosages were higher in patients who experienced bleeding or death than in those who did not (p <0.001). The average hospital length of stay decreased significantly (p <0.001), largely driven by a reduction in time between the procedure and hospital discharge. By the end of the study period, bleeding was the most frequent (5.5%) complication of PCI and was associated with considerable costs, adding $10,225 to baseline costs.