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.

CYP2C19 LOF and GOF-Guided Antiplatelet Therapy in Patients with Acute Coronary Syndrome: A Cost-Effectiveness Analysis.

PURPOSE: This study aimed to examine the cost-effectiveness of CYP2C19 loss-of-function and gain-of-function allele guided (LOF/GOF-guided) antiplatelet therapy in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). METHODS: A life-long decision-analytic model was designed to simulate outcomes of three strategies: universal clopidogrel (75 mg daily), universal alternative P2Y12 inhibitor (prasugrel 10 mg daily or ticagrelor 90 mg twice daily), and LOF/GOF-guided therapy (LOF/GOF allele carriers receiving alternative P2Y12 inhibitor, wild-type patients receiving clopidogrel). Model outcomes included clinical event rates, quality-adjusted life-years (QALYs) gained and direct medical costs from perspective of US healthcare provider. RESULTS: Base-case analysis found nonfatal myocardial infarction (5.62%) and stent thrombosis (1.2%) to be the lowest in universal alternative P2Y12 inhibitor arm, whereas nonfatal stroke (0.72%), cardiovascular death (2.42%), and major bleeding (2.73%) were lowest in LOF/GOF-guided group. LOF/GOF-guided arm gained the highest QALYs (7.5301 QALYs) at lowest life-long cost (USD 76,450). One-way sensitivity analysis showed base-case results were subject to the hazard ratio of cardiovascular death in carriers versus non-carriers of LOF allele and hazard ratio of cardiovascular death in non-carriers of LOF allele versus general patients. In probabilistic sensitivity analysis of 10,000 Monte Carlo simulations, LOF/GOF-guided therapy, universal alternative P2Y12 inhibitor, and universal clopidogrel were the preferred strategy (willingness-to-pay threshold = 50,000 USD/QALY) in 99.07%, 0.04%, and 0.89% of time, respectively. CONCLUSIONS: Using both CYP2C19 GOF and LOF alleles to select antiplatelet therapy appears to be the preferred antiplatelet strategy over universal clopidogrel and universal alternative P2Y12 inhibitor therapy for ACS patients with PCI.

Conversations in cardiology: bridging antiplatelet therapy before surgery.

Bridging for antiplatelet therapy remains a subject of debate with data favoring GP blockers but at a risk of bleeding. This Conversation in Cardiology addresses a key and often asked question about use of alternatives to P2Y12 agents in patients requiring surgery within 6 months after drug eluting stent implantation.

Cost-effectiveness analysis of enoxaparin versus unfractionated heparin in the secondary prevention of acute coronary syndrome.

BACKGROUND: The Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) and Thrombolysis in Myocardial Infarction (TIMI) 11B studies revealed that enoxaparin reduced the incidence of death, myocardial reinfarction and recurrent angina in patients with acute coronary syndrome (ACS) compared with unfractionated heparin (UFH). OBJECTIVE: To perform a pharmacoeconomic analysis to evaluate the cost effectiveness of treatment with enoxaparin compared with UFH in Spanish patients with ACS. DESIGN AND SETTING: Retrospective cost-effectiveness analysis using data and costs from Spanish sources, conducted from the perspective of the National Health System. PATIENTS, INTERVENTIONS AND OUTCOMES MEASURES: The study was based on the results of the ESSENCE and TIMI 11B clinical trials, which included more than 7,000 patients with ACS treated with enoxaparin or UFH. The main variables studied were the success rate, expressed as patients with no complications (reinfarction, unstable angina or death), and the decrease in the utilisation of healthcare resources (revascularisation procedures and hospitalisation). RESULTS: The base-case results of the analysis showed superior efficacy and lower total treatment and follow-up costs with enoxaparin compared with UFH. The total savings in direct health costs per patient with enoxaparin ranged between 448 and 659 euros (time horizons of 1 month and 1 year, respectively) [2001 values]. The sensitivity analysis results confirmed the advantage of enoxaparin in all cases, except in one scenario: when simultaneously using all the minimum values of the confidence interval for absolute risk reduction (ARR) in the utilisation of health resources. CONCLUSIONS: This study suggests that enoxaparin is a more effective and less expensive treatment option than UFH in secondary prevention of patients with ACS in Spain, confirming the results obtained in other pharmacoeconomic analyses performed in the UK, USA, France and Canada.

Cost-effectiveness of gamma radiation for treatment of in-stent restenosis: results from the Gamma-1 trial.

BACKGROUND: Recently, several randomized trials have demonstrated that intracoronary brachytherapy can reduce the rates of both angiographic and clinical restenosis in patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis. Whether this practice is cost-effective is unknown. METHODS AND RESULTS: Between December 1997 and July 1998, 252 patients with in-stent restenosis were randomized to receive brachytherapy or placebo after successful PCI as part of the Gamma-1 trial. We collected detailed resource utilization and cost data for each patient's initial hospitalization and for 1 year after randomization. Compared with conventional treatment, intracoronary brachytherapy increased procedure duration, physician services, and equipment costs. As a result, initial costs were increased by nearly $4100 per patient ($15 724 versus $11 675, P<0.001). Over the 1-year follow-up period, brachytherapy reduced the need for repeat revascularization by 21% and reduced the need for bypass surgery by 44%. Although follow-up medical care costs were $2200/patient lower with brachytherapy, total costs remained higher at 1 year ($28 543 versus $26 737, P=0.46). In a sensitivity analysis that incorporated recent technical modifications and the use of prolonged antiplatelet therapy to prevent late thrombotic occlusion, follow-up cost savings increased to $3600/patient, and 1-year costs were slightly lower with brachytherapy ($26 352 versus $26 729, P=0.87). Subgroup analysis demonstrated significant cost savings in patients with diabetes and patients who did not undergo repeat stenting. CONCLUSIONS: As performed in the Gamma-1 trial, coronary brachytherapy for in-stent restenosis improved clinical outcomes but increased 1-year costs compared with standard therapy. If late thrombosis can be eliminated, however, this technology has the potential to reduce overall medical care costs.

A cost-effectiveness model for coronary thrombolysis/reperfusion therapy.

A model was designed to examine the relations between incremental costs and benefits of coronary thrombolysis/reperfusion therapy. The model allows for the study of intravenous and intracoronary streptokinase, intravenous tissue plasminogen activator and primary angioplasty. Three strategies for the management of reocclusion are also compared. It was found that each of the following four variables can be responsible for a 2- to 15-fold variation in the costs per additional survivor: 1) the quantity of jeopardized myocardium, 2) the duration of coronary occlusion before the onset of therapy, 3) the time required from the onset of therapy until reperfusion is achieved, and 4) the reocclusion management strategy. Therapeutic strategies involving intravenous administration of thrombolytic agents were found to be consistently more cost effective than were strategies involving intracoronary administration of thrombolytic agents and primary angioplasty. In patients with a large or moderate-sized infarct, proper selection of intravenous protocols and reocclusion management strategies leads to costs of $7,000 to $100,000/additional survivor, costs that are similar to those of many generally accepted medical practices. Substantially higher costs per additional survivor are incurred with the routine use of thrombolytic therapy in patients with a small infarct or the routine use of coronary artery bypass surgery to reduce the risk of reocclusion after successful thrombolytic therapy. Decisions regarding which patients should receive thrombolysis/reperfusion therapy depend on society's willingness to pay for its incremental benefits.