Racial Disparities in Acute Coronary Syndrome Management Within a Universal Healthcare Context: Insights From the AMI-OPTIMA Trial.

BACKGROUND: Although prior studies have demonstrated racial disparities regarding acute coronary syndrome (ACS) care within private or mixed healthcare systems, few researchers have explored such disparities within universal healthcare systems. We aimed to evaluate the quality and outcomes of in-hospital ACS management for White patients vs patients of colour, within a universal healthcare context. METHODS: We performed a post hoc analysis of the Acute Myocardial Infarction - Knowledge Translation to Optimize Adherence to Evidence-Based Therapy study, a cluster-randomized trial evaluating a knowledge-translation intervention at 24 hospitals in Quebec, Canada (years: 2009 and 2012). The primary endpoint was coronary catheterization. The secondary endpoints included in-hospital mortality, percutaneous and surgical coronary revascularization, major bleeding, total stroke, and discharge prescription of evidence-based medical therapy. RESULTS: Of 3444 included patients, 2738 were White, and 706 were people of colour. The mean age was 68.2 years (33.3% women) among White patients and 69.5 years (36.0% women) among patients of colour. Patients of colour were less likely to undergo in-hospital coronary catheterization than were White patients (74.5% vs 80.3%, P = 0.001). This difference was attenuated after adjusting for patient-level characteristics (odds ratio 0.89; 95% confidence interval 0.73-1.09), and it was eliminated after adjusting for hospital-level characteristics (odds ratio 1.04; 95% confidence interval 0.73-1.49). CONCLUSIONS: Racial disparity in coronary catheterization for ACS persists within a universal healthcare context. Patients' comorbidities and hospital-level factors may be partially responsible for this inequality. Future research on cardiovascular healthcare in patients with diverse racial/ethnic backgrounds in universal healthcare systems is needed to remediate racial inequality in ACS management.

CONTEXTE: Bien que des études antérieures aient démontré l'existence de disparités raciales dans la prise en charge du syndrome coronarien aigu (SCA) au sein de systèmes de santé privés ou mixtes, peu de chercheurs ont étudié ces disparités au sein de systèmes universels de soins de santé. Nous avons cherché à évaluer la qualité et les résultats de la prise en charge du SCA à l'hôpital pour les patients blancs par rapport aux patients de couleur, dans un contexte de soins de santé universels. MÉTHODOLOGIE: Nous avons effectué une analyse a posteriori de l'étude AMI-OPTIMA, un essai sur échantillon en grappes aléatoire évaluant une intervention d'application des connaissances dans 24 hôpitaux du Québec, au Canada (années : 2009 et 2012). Le paramètre d'évaluation principal était le cathétérisme coronaire. Les paramètres d'évaluation secondaires comprenaient la mortalité à l'hôpital, la revascularisation coronaire percutanée et chirurgicale, l'hémorragie majeure, l'accident vasculaire cérébral et la prescription au congé d'un traitement médical fondé sur des données probantes. RÉSULTATS: Sur les 3444 patients étudiés, 2738 étaient blancs et 706 étaient des personnes de couleur. L'âge moyen était de 68,2 ans (33,3 % de femmes) chez les patients blancs, et de 69,5 ans (36,0 % de femmes) chez les patients de couleur. Les patients de couleur étaient moins susceptibles de subir un cathétérisme coronaire à l'hôpital que les patients blancs (74,5 % contre 80,3 %, p = 0,001). Cette différence a été atténuée après ajustement pour tenir compte des caractéristiques des patients (rapport de cotes : 0,89; intervalle de confiance [IC] à 95 % : 0,73-1,09), et éliminée après ajustement pour tenir compte des caractéristiques des hôpitaux (rapport de cotes : 1,04; IC à 95 % : 0,73-1,49). CONCLUSIONS: La disparité raciale en ce qui a trait au cathétérisme coronaire pour un SCA persiste dans un contexte de soins de santé universels. Les comorbidités des patients et des facteurs liés à l'hôpital peuvent être partiellement responsables de cette inégalité. De plus amples recherches sur les soins cardiovasculaires chez les patients de diverses origines raciales ou ethniques dans les systèmes universels de soins de santé sont nécessaires pour remédier aux inégalités raciales dans la prise en charge du SCA.

Incidence and clinical impact of concurrent chronic total occlusion according to gender in ST-elevation myocardial infarction.

OBJECTIVES: To determine the prevalence of a concurrent CTO in men and women and to examine its impact on mortality. BACKGROUND: The impact of chronic total occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) according to gender has not been assessed. METHODS: Patients referred with STEMI were categorized into single vessel disease (SVD), multivessel disease (MVD) without, with 1 or > 1 CTO. The primary end-point was the 1-year mortality. RESULTS: Among the 2020 STEMI patients included between 2006 and 2011, 24% were female. Women were older, had more hypertension and renal failure (P < 0.0001 for all). The prevalence of 1 or > 1 concurrent CTO was similar in both sexes, 7 and 1%, respectively. Early and late mortality was significantly higher in women compared with men (P < 0.0001). In women, the mortality was significantly worse in patients with > 1 CTO (100%) and with 1 CTO (36.4%) compared with those with MVD without CTO (18.4%) or with SVD (10.4%) (P < 0.0001). MVD with and without concurrent CTO were both independent predictors of 1-year mortality in women (HR 3.58; 95 % CI 1.69-7.18 and HR 2.76; 95 % CI 1.33-5.51) whereas only MVD with CTO was predictive in men (HR 2.19; 95% CI 1.20-3.97). CONCLUSIONS: Among unselected STEMI patients, the prevalence of CTO was equal in both sexes whereas early and late mortality remained significantly higher in women. Other factors than the presence of a concurrent CTO must be explored to explain differences in survival after STEMI between women and men.

Economic evaluation of increasing population rates of cardiac catheterization.

BACKGROUND: Increasing population rates of cardiac catheterization can lead to the detection of more people with high risk coronary disease and opportunity for subsequent revascularization. However, such a strategy should only be undertaken if it is cost-effective. METHODS: Based on data from a cohort of patients undergoing cardiac catheterization, and efficacy data from clinical trials, we used a Markov model that considered 1) the yield of high-risk cases as the catheterization rate increases, 2) the long-term survival, quality of life and costs for patients with high risk disease, and 3) the impact of revascularization on survival, quality of life and costs. The cost per quality-adjusted life year was calculated overall, and by indication, age, and sex subgroups. RESULTS: Increasing the catheterization rate was associated with a cost per QALY of CAN$26,470. The cost per QALY was most attractive in females with Acute Coronary Syndromes (ACS) ($20,320 per QALY gained), and for ACS patients over 75 years of age ($16,538 per QALY gained). However, there is significant model uncertainty associated with the efficacy of revascularization. CONCLUSION: A strategy of increasing cardiac catheterization rates among eligible patients is associated with a cost per QALY similar to that of other funded interventions. However, there is significant model uncertainty. A decision to increase population rates of catheterization requires consideration of the accompanying opportunity costs, and careful thought towards the most appropriate strategy.

Economic evaluation of clopidogrel plus aspirin for secondary prevention of cardiovascular events in Canada for patients with established cardiovascular disease: Results from the CHARISMA trial.

BACKGROUND: The Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial found a statistically significant reduction in cardiovascular events when clopidogrel was added to aspirin in a prespecified subgroup of patients with established cardiovascular disease. However, the economic implications of such a strategy for the Canadian health care system are unknown. METHODS: For each patient in the CHARISMA trial with established cardiovascular disease, costs were estimated by multiplying resource utilization by unit costs derived from populations of Canadian patients in 2008 dollars. Changes in life expectancy due to nonfatal events were estimated with parametric regression models based on the Saskatchewan Health database. RESULTS: For patients with established cardiovascular disease, a strategy of clopidogrel plus aspirin for median duration of 28 months was associated with a 12.5% relative reduction in cardiovascular death, myocardial infarction, or stroke compared with aspirin alone (6.9% vs 7.9%, P =.048). Mean cost per patient was CAD$1,488 higher for clopidogrel plus aspirin, and life expectancy increased by 0.057 years. The resulting incremental cost-effectiveness ratio for adding clopidogrel was CAD$25,969 per life-year gained or CAD$21,549 per quality-adjusted life-year. These results were sensitive to the cost of clopidogrel but relatively insensitive to plausible variations in discount rate, costs other than clopidogrel, and the prognostic impact of nonfatal events. CONCLUSION: Among the subgroup of patients with established cardiovascular disease in the CHARISMA trial, adding clopidogrel to aspirin increases life expectancy at a cost generally considered acceptable in Canada.

The potential economic impact of restricted access to angiotensin-receptor blockers.

BACKGROUND: The use of angiotensin-receptor blockers increased by more than 4000% in Canada from 1996 to 2006. The benefit of these medications over angiotensin-converting-enzyme (ACE) inhibitors has not been proven aside from a reduction in dry cough. We estimated the potential cost savings that might have been achieved had access to angiotensin-receptor blockers been restricted. METHODS: We performed a cost-minimization analysis with a decision-tree model using a societal perspective over a one-year period. Sources of data for model parameters included IMS Health Canada data collected from one-third of all retail pharmacies for the cost and use of angiotensin-receptor blockers and ACE inhibitors in each province, as well as published studies for administrative costs and incidence of dry cough. We used Monte Carlo simulations with 10 000 iterations to test the impact of several model parameters (e.g., drug prices, administrative costs and the incidence of dry cough). All data are in 2006 Canadian dollars. RESULTS: A policy that would have restricted access to angiotensin-receptor blockers might have saved more than $77 million in Canada in 2006. The simulations yielded similar savings for the year (mean $58.3 million, 95% confidence interval $29.3 million to $90.8 million). Every simulation showed a cost savings. INTERPRETATION: Had access to angiotensin-receptor blockers been restricted, the potential cost savings to the Canadian health care system might have been more than $77 million in 2006, likely without any adverse effect on cardiovascular health.

Analysis of willingness to pay for implantable cardioverter-defibrillator therapy.

Despite being effective in the primary and secondary prevention of sudden cardiac arrest, the cost-effectiveness of implantable cardioverter-defibrillator (ICD) therapy remains debated. We attempted to estimate the value ICD recipients place on their ICD device. We used the contingent valuation method to evaluate the willingness to pay (WTP) and the cost benefit of ICD therapy in an unselected population of 237 recipients. A hypothetical scenario was presented to patients in which at the end of their current ICD no public reimbursement for the replacement would occur. Patients were asked to indicate their out-of-pocket WTP for a replacement ICD using a close-ended question format. Seven different "take-it-or-leave-it" bids were randomly varied and assigned to patients. Median WTP was calculated with nonparametric methods, and multiple logistic regression models were generated to identify factors associated with WTP. Only cost of the device was considered. Median WTP was estimated at CAN $4,125, which corresponds to 21% of the cost of the device (CAN $20,000). In multiple logistic regression analysis, a higher bid (odds ratio [OR] 0.95, 95% confidence interval [CI] 0.91 to 0.99, per CAN $1,000 increase) was associated with a lower WTP, whereas a higher gross family income (OR 2.3, 95% CI 0.9 to 9.0) and higher education (OR 2.2, 95% CI 0.9 to 5.1) were associated with a trend for higher WTP. In conclusion, ICD recipients would be willing to pay a substantial amount for a replacement ICD. Considering the expensive price of the device, ICD recipients value favorably the benefits provided by the ICD.

Willingness to pay to eliminate the risk of restenosis following percutaneous coronary intervention: a contingent valuation.

BACKGROUND: Percutaneous coronary intervention (PCI) remains limited by the risk of restenosis. Patients' perceptions of the health benefits and value of avoiding restenosis are incompletely known. METHODS AND RESULTS: We used a contingent valuation approach to assess the willingness to pay (WTP) for a hypothetical treatment that eliminates the risk of restenosis among 270 PCI patients. Patients were provided with a scenario describing a baseline 10% or 20% probability of restenosis in the year following the procedure, which could lead to repeat PCI or, more rarely, bypass surgery, without any increase in mortality. Six different "take it or leave it" bids ($500, $1000, $1500, $2000, $2500, and $3000) and both risk levels were randomly assigned. Multiple logistic regression was used to identify independent predictors of a positive response to the WTP question. Using nonparametric methods, the median WTP to eliminate the risk of restenosis was estimated at $2802. As expected, higher income was independently associated with a higher probability of a positive response to the WTP question (odds ratio, 2.81; 95% CI, 1.32 to 5.97). Bids also were independently associated with the probability of being willing to pay, and this association followed a quadratic effect. Below $1500, bid had little impact on patient answers. However, as prices increased, the probability of being willing to pay started to decrease sharply. CONCLUSION: The potential to eliminate the risk of restenosis, a benign complication, would have substantial value for patients undergoing PCI.

Economic impact of same-day home discharge after uncomplicated transradial percutaneous coronary intervention and bolus-only abciximab regimen.

OBJECTIVES: This study sought to estimate the economic impact of same-day home discharge compared with overnight hospitalization after transradial percutaneous coronary intervention (PCI). BACKGROUND: Same-day home discharge after transradial PCI and a bolus-only abciximab regimen was found to be clinically noninferior to the abciximab standard therapy and overnight hospitalization in patients with various forms of acute coronary syndromes. METHODS: In the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) trial, 1,005 patients were randomized after a bolus of abciximab and uncomplicated transradial coronary stenting, either to same-day home discharge and no infusion (outpatient group) or to overnight hospitalization and 12-h abciximab infusion (overnight-stay group). We estimated post-PCI health care cost (in Canadian dollars) of trial subjects and short-term economic impact of same-day home discharge. As randomization was done after the procedure, outcomes were similar, and PCI resource use showed minimal and nonsignificant differences, a post-PCI cost-minimization analysis was conducted. Detailed per-patient information of health care resources used immediately after PCI up to 30 days was collected. RESULTS: Mean post-PCI hospital stay was 8.9 h for outpatients versus 26.5 h for overnight-stay patients (p < 0.001). At 30-day follow-up, the mean cumulative medical cost per outpatient was $1,117 ± $1,554 versus $2,258 ± $1,328 for overnight-stay patients. The mean difference of $1,141 (95% confidence interval: $962 to $1,320) was mainly due to the extra night for overnight hospital stay. CONCLUSIONS: In a real-world setting, same-day home discharge after uncomplicated transradial PCI and a bolus-only abciximab regimen resulted in a 50% relative reduction in medical costs. Extension of this outpatient strategy would be welcomed by the hospitals and reimbursement systems in a context of increasing demand for health care cost reduction. (Early Discharge After Transradial Stenting of Coronary Arteries [EASY]; NCT00169819).

The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care.

BACKGROUND: Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects. Effective programs to address this problem are lacking. We hypothesized that an information technology-supported management program could help improve blood pressure (BP) control. METHODS AND RESULTS: This randomized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP >130/80 and daytime BP >135/85 mm Hg measured with ambulatory monitoring (ABPM). Intervention subjects received a BP monitor and access to an information technology-supported adherence and BP monitoring system providing nurses, pharmacists, and physicians with monthly reports. Control subjects received usual care. The mean (+/-SD) follow-up was 348 (+/-78) and 349 (+/-84) days in the intervention and control group, respectively. The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic (-11.9 versus -7.1 mm Hg; P<0.001) and diastolic BP (-6.6 versus -4.5 mm Hg; P=0.007). The proportion of subjects that achieved Canadian Guideline target BP (46.0% versus 28.6%) was also greater in the intervention group (P=0.006). We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control. The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents (P=0.03), more antihypertensive classes at study end (P=0.007), and a trend toward improved adherence measured by prescription refills (P=0.07). CONCLUSIONS: This multidisciplinary information technology-supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting.

Long-term trends in use of and expenditures for cardiovascular medications in Canada.

BACKGROUND: Medication expenditures have become the fastest growing sector of costs within the Canadian health care system. Evaluation of the use of cardiovascular medications is important to determine the magnitude of the growth, to identify which medications dominate the landscape and to detect interprovincial differences in utilization. We describe long-term trends in the use of and expenditures for cardiovascular medications in Canada, by drug class and by province. METHODS: For these analyses, we used volume and expenditure data related to prescriptions for cardiovascular medications obtained from IMS Health Canada's CompuScript Audit database for the period 1996-2006. Here, we describe national and provincial patterns of utilization and expenditures for specified classes of cardiovascular medications. RESULTS: The use of cardiovascular medications increased sharply in Canada during the study period, with related costs rising by over 200% during this period to surpass $5 billion in 2006. Changes in population demographics, risk factors and inflation appeared to account for about two-thirds of the observed growth in expenditures. Use of newer medication classes (statins, angiotensin-receptor blockers, angiotensin-converting-enzyme inhibitors), for which patented brand name medications predominate, accounted for almost one-third of the cost increases. Interprovincial differences in total expenditures for cardiovascular drugs portrayed a descending gradient from east to west, with greatest variability for the newer drug classes. INTERPRETATION: Prescriptions and expenditures for cardiovascular medications in Canada escalated over the study period. Projected increases may reach potentially unsustainable levels. Greater emphasis on the use of cost-effective medications is required to limit further increases. Factors influencing interprovincial differences warrant further study.

Cost-effectiveness of drug-eluting stents including the economic impact of late stent thrombosis.

Recent studies examining the effectiveness of drug-eluting stents (DES) have found that the use of DES is associated with a significant increase in the incidence of late stent thrombosis (LST). Previous cost-effectiveness analyses of DES have not accounted for the costs associated with LST. In this study, published research was reviewed to identify studies that compared the cost-effectiveness of DES with that of bare-metal stents and to identify the incidence of LST. Probable costs were assigned to LST-related myocardial infarction and death on the basis of the treatment costs for these outcomes. These costs as well as those of extended clopidogrel therapy were then incorporated into the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) and TAXUS-IV cost-effectiveness data. This review found that the incidence of LST ranged from 0.2% to 0.7%. Assuming a base case LST incidence of 0.5%, a cost per death of $20,000, a cost per myocardial infarction of $20,000, and a cost of an additional 2 years of clopidogrel therapy of $2,428 per patient, the costs per revascularization avoided were $15,056 for the SIRIUS trial and $25,210 for the TAXUS-IV trial. The costs per quality-adjusted life-year gained were $250,935 and $257,591, respectively. Sensitivity analyses revealed that the costs per revascularization avoided varied from $14,618 to $15,830 for the SIRIUS trial and from $24,540 to $26,396 for the TAXUS-IV trial. Similarly, the cost per quality-adjusted life-year gained varied from $243,638 to $263,840 for the SIRIUS trial and from $250,739 to $269,708 for the TAXUS-IV trial. In conclusion, LST-related adverse events and the need for extended clopidogrel therapy substantially increase the costs associated with the implementation of DES. The inclusion of these costs renders the widespread use of DES not cost effective in the United States in terms of cost per quality-adjusted life-year gained and cost per revascularization avoided.

Cardiovascular outcomes after a change in prescription policy for clopidogrel.

BACKGROUND: Drug-reimbursement policies may have an adverse effect on patient outcomes if they interfere with timely access to efficacious medications for acute medical conditions. Clopidogrel in combination with aspirin is the recommended standard of care for patients receiving coronary stents to prevent thrombosis. We examined the population-level effect of a change by a Canadian provincial government in a pharmacy-benefits program from a prior-authorization policy to a less restrictive, limited-use policy on access to clopidogrel among patients undergoing percutaneous coronary intervention (PCI) with stenting after acute myocardial infarction. METHODS: We conducted a population-based, retrospective, time-series analysis from April 1, 2000, to March 31, 2005, of all patients 65 years of age or older with acute myocardial infarction who underwent PCI with stenting in Ontario, Canada. The primary outcome was the composite rate of death, recurrent acute myocardial infarction, PCI, and coronary-artery bypass grafting at 1 year, with adjustment for sex and age. The secondary outcome was major bleeding. RESULTS: The rate of clopidogrel use within 30 days after hospital discharge following myocardial infarction increased from 35% in the prior-authorization period to 88% in the limited-use period. The median time to the first dispensing of a clopidogrel prescription decreased from 9 days in the first period to 0 days in the second period. The 1-year composite cardiovascular outcome significantly decreased from 15% in the prior-authorization group to 11% in the limited-use group (P=0.02). Rates of bleeding in the two groups did not change. CONCLUSIONS: The removal of a prior-authorization program led to improvement in timely access to clopidogrel for coronary stenting and improved cardiovascular outcomes.

Clinical and public health assessment of benefits and risks of statins in primary prevention of coronary events: resolved and unresolved issues.

Peer-reviewed, evidence-based recommendations for statin use in primary prevention of cardiovascular events are limited. A narrative review of published randomized controlled trials and meta-analyses was conducted to critically appraise the benefits and risks of statins in primary prevention. Statins effectively reduce plasma concentrations of low-density lipoprotein cholesterol, and reduce the risk of cardiovascular events and death. The greatest benefits are observed in high-risk subjects, such as patients with diabetes or hypertension. Serious cardiovascular events should not be included among serious adverse events because they are efficacy outcomes and are dependent on the baseline risk of patients. Rates of specific serious adverse events, such as cancer and rhabdomyolysis, seem to be similar between the statin and control arms of the clinical trials examined. Thus, the benefits of statins in primary prevention outweigh the risks, particularly among high-risk patients. However, the benefit-risk ratio would likely be optimized through interventions designed to increase persistence and adherence in a real-life setting.

Comparison of provincial prescription drug plans and the impact on patients' annual drug expenditures.

BACKGROUND: Reimbursement for outpatient prescription drugs is not mandated by the Canada Health Act or any other federal legislation. Provincial governments independently establish reimbursement plans. We sought to describe variations in publicly funded provincial drug plans across Canada and to examine the impact of this variation on patients' annual expenditures. METHODS: We collected information, accurate to December 2006, about publicly funded prescription drug plans from all 10 Canadian provinces. Using clinical scenarios, we calculated the impact of provincial cost-sharing strategies on individual annual drug expenditures for 3 categories of patients with different levels of income and 2 levels of annual prescription burden ($260 and $1000). RESULTS: We found that eligibility criteria and cost-sharing details of the publicly funded prescription drug plans differed markedly across Canada, as did the personal financial burden due to prescription drug costs. Seniors pay 35% or less of their prescription costs in 2 provinces, but elsewhere they may pay as much as 100%. With few exceptions, nonseniors pay more than 35% of their prescription costs in every province. Most social assistance recipients pay 35% or less of their prescription costs in 5 provinces and pay no costs in the other 5. In an example of a patient with congestive heart failure, his out-of-pocket costs for a prescription burden of $1283 varied between $74 and $1332 across the provinces. INTERPRETATION: Considerable interprovincial variation in publicly funded prescription drug plans results in substantial variation in annual expenditures by Canadians with identical prescription burdens. A revised pharmaceutical strategy might reduce these major inequities.

Restrictive access to clopidogrel and mortality following coronary stent implantation.

BACKGROUND: In Canada, access to clopidogrel is restricted by most provincial drug insurance plans in order to contain costs. Until April 2007, the Régie de l'assurance maladie du Québec (RAMQ) Prescription Drug Insurance Plan reviewed special access forms before approving reimbursement for clopidogrel prescriptions. We investigated the impact of this restrictive process on patient's filling of prescriptions and on all-cause mortality following coronary stenting. METHODS: We analyzed prescriptions filled and all-cause mortality in the year following a percutaneous coronary intervention among patients who underwent stent implantation between January 2000 and September 2004. We obtained administrative data from the RAMQ databases. We included patients who filled at least 1 prescription for a nonrestricted cardiovascular drug after hospital discharge. We used Cox proportional models to compare mortality rates as a function of delayed or absent outpatient clopidogrel therapy. RESULTS: Of 13,663 patients, 1571 (11.5%) did not fill any clopidogrel prescription despite filling at least 1 nonrestricted cardiovascular drug prescription after a percutaneous coronary intervention, and 1174 (8.6%) patients filled their clopidogrel prescription with a delay of at least 1 day (median delay 5 days) after filling the nonrestricted cardiovascular drug prescription. After controlling for pertinent covariables, not filling a clopidogrel prescription (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.35-2.15) and filling with a delay (HR 1.34, 95% CI 1.01-1.80) were associated with a significant increase in all-cause mortality. INTERPRETATION: Restricted access to clopidogrel was associated with about 20% of patients either not receiving clopidogrel or receiving therapy after a delay. Delay or absence of clopidogrel therapy increased the risk of all-cause mortality after percutaneous coronary intervention with stenting.

Potential shift from coronary bypass surgery to percutaneous coronary intervention for multivessel disease and its economic impact in the drug-eluting stent era.

BACKGROUND: Drug-eluting stents (DES) may promote percutaneous coronary intervention (PCI) procedures in patients traditionally referred for coronary artery bypass graft (CABG) surgery and may save money. OBJECTIVES: The purpose of the present study was to quantify the potential shift from CABG surgery to multivessel PCI in the DES era and to model the economic consequences. METHODS: Based on predefined criteria, the feasibility of PCI was evaluated in patients with multivessel coronary artery disease who underwent CABG surgery before the availability of DES at the Centre Hospitalier de l'Université de Montréal's Notre-Dame Hospital (Montreal, Quebec). Modelling was used to evaluate the potential cost savings using multivessel PCI instead of CABG surgery. Equal one-year outcomes in both groups were assumed, with the exception of a 10% repeat revascularization (RR) rate in the DES group and a 4% RR rate in the CABG group. The impact of those assumptions was evaluated using 1000 Monte Carlo simulations. RESULTS: The authors retrospectively evaluated that, of 289 patients who underwent CABG without concomitant valve surgery between January and December 2003, only 22 patients (8%) were good candidates for multivessel DES implantation. The procedures would have involved an average of 3.6 DES per patient. The average cost per revascularization procedure was $14,402 with surgery and $11,220 for multivessel DES implantation (using $2,200 DES), leading to a savings of $3,182 per patient. However, after including RR procedures, PCI would only have been associated with savings of $812 per surgery avoided. Monte Carlo analysis revealed that surgery may be less expensive than PCI in 36% of patients. CONCLUSIONS: Most patients who underwent CABG surgery in 2003 were retrospectively judged to be ineligible for multivessel PCI with DES. In the rare eligible patient, multivessel PCI with DES is not expected to produce savings to health care costs in Canada unless the DES purchase cost continues to decrease.

A model for assessing the cost-effectiveness of atorvastatin and simvastatin in achieving Canadian low-density lipoprotein cholesterol targets.

BACKGROUND: Elevated low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor for cardiovascular (CV) disease. Statins differ in their LDL-C-lowering effects and acquisition costs. Atorvastatin and simvastatin are the 2 most commonly used statins in Canada. OBJECTIVE: This analysis compared the cost-effectiveness of atorvastatin and generic simvastatin in terms of annual drug cost per patient treated to Canadian LDL-C targets. It was conducted from the perspective of the Canadian provincial drug-reimbursement plans. METHODS: A hypothetical cohort of 1000 dyslipidemic patients was assigned baseline LDL-C serum concentrations and levels of risk for CV disease based on Canadian population data. Canadian data on statin dosing were combined with efficacy data from a published meta-analysis to determine the proportion of patients who would be expected to achieve LDL-C targets after treatment with atorvastatin or generic simvastatin. Statin acquisition costs were obtained from Ontario and Quebec and reported in 2005 Canadian dollars. The sensitivity of the model to changes in drug costs, effectiveness, and persistence with treatment was tested. RESULTS: The model predicted that more patients would reach the LDL-C target with atorvastatin than with simvastatin (73% vs 57%, respectively). The mean annual drug cost per patient treated to target was $54 higher with atorvastatin ($905 vs $851). The incremental cost-effectiveness ratio, measured as annual drug cost per additional patient treated to target with atorvastatin, was $1088. The model was sensitive to drug cost and effectiveness assumptions. Incorporating real-life rates of adherence into the model had no significant impact on the results. CONCLUSION: In this hypothetical cohort of dyslipidemic patients, treatment with atorvastatin would allow achievement of LDL-C targets in more patients than treatment with simvastatin, at an annual incremental cost of $1088 per additional patient treated to target.

Cost effectiveness of the sirolimus-eluting stent in high-risk patients in Canada: an analysis from the C-SIRIUS trial.

BACKGROUND: The cost effectiveness of drug-eluting stents in Canada is debated and deserves further evaluation in high-risk patients. METHODS: We performed an economic analysis from the third-party payer perspective based on the clinical results and resource-utilization data of the C-SIRIUS (The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients with Long De Novo Lesions in Small Native Coronary Arteries) trial, which examined the safety and efficacy of sirolimus-eluting stents (SES) versus bare metal stents (BMS) in high-risk patients with single long de novo lesions in small coronary arteries. Only inpatient costs were considered, including physician fees. We postulated that the incremental cost required to avoid a repeat revascularization (RR) procedure with BMS versus simple balloon angioplasty (BA) could be considered the willingness to pay (WTP) to avoid restenosis in Canada. We assessed the incremental cost-effectiveness ratio (ICER) of SES compared with BMS in these high-risk patients compared with WTP. Results are expressed in 2003 Canadian dollars. RESULTS: With a 7% absolute reduction in the need for RR compared with BA, BMS are associated on average with an ICER of US dollars 12,551/RR avoided (RRA) in Canada. In C-SIRIUS, SES further reduced the need for RR at 1 year from 22% to 4% (p = 0.015) compared with BMS. With a 1.5 stent-to-lesion (STL) ratio and an SES retail price of US dollars 2,700 compared with US dollars 700 for BMS, the ICER of SES versus BMS was US dollars 11,275/RRA -- borderline cost effective compared with the implicit WTP of US dollars 12,551 for such health benefit in Canada. Using a lower STL ratio (1.2) would improve the ICER to US dollars 7941/RRA. CONCLUSIONS: Treatment of long lesions in small vessels with SES increases net healthcare costs. However, the ICER for SES compares favorably with the currently accepted comparator, i.e. BMS, to reduce coronary restenosis -- at least for higher risk patients undergoing single-vessel revascularization.