Drug-eluting coronary stents: faith and hope, but no charity.
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Coronary Disease↗
Biomedical subjects
Merril L Knudtson
Publications and source records attributed to Merril L Knudtson.
Revascularization in patients with heart failure.
BACKGROUND: Although practice guidelines recommend coronary revascularization for patients with heart failure, the evidence to support this recommendation is weak. The objective of our study was to determine the association of coronary revascularization with survival in patients who have had heart failure. METHODS: Data were obtained from the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH), a clinical outcome-monitoring initiative that has captured data on all patients undergoing cardiac catheterization in the province of Alberta since 1995. Our study included data from patients with a history of heart failure and with documented coronary artery disease; patients with normal coronary arteries or prior coronary artery bypass grafting (CABG) were excluded. We constructed survival curves and adjusted them by the corrected group prognosis method (incorporating all clinical variables in APPROACH). Propensity scores were used to account for clinical characteristics that could influence the decision to revascularize. RESULTS: A total of 2538 patients (mean age 68 yr, standard deviation [SD] 11 yr, 31% female) underwent revascularization; 1690 patients (mean age 69 [SD 11] yr, 34% female) did not. Crude 1-year mortality was 11.8% among patients who underwent revascularization, compared with 21.6% among those who did not. Adjusted survival curves diverged early and continued up to 7 years of follow-up (hazard ratio 0.50, 95% confidence interval 0.44-0.57). Propensity scores showed improved survival with revascularization across all quintiles of likelihood of revascularization. INTERPRETATION: This new evidence lends support to practice guidelines, which recommend revascularization in patients with heart failure and coronary disease.
Aged↗
Registry data evaluating the effectiveness of drug-eluting stents for the treatment of symptomatic in-stent restenosis.
BACKGROUND: In this new-era of drug-eluting stents (DES) the impact of symptomatic in-stent restenosis (ISR) is diminishing. However, world wide bare-metal stents remain widely used and therefore, it is imperative to establish a simple and effective form of treatment. The objective of this registry database was to evaluate the 'real-world' effectiveness of DES for the treatment of symptomatic bare-metal stent ISR. METHODS: All patients presenting with symptomatic ISR were evaluated between February 2003 and February 2005. Patients had 9-month angiographic follow-up with primary endpoint evaluation of binary restenosis (>50%). Secondary endpoints included in-segment late loss, target lesion revascularization (TLR) and the difference in late loss between sirolimus (n=23) and paciltaxel (n=36) eluting stents. RESULTS: Fifty eight patients with fifty nine ISR lesions were evaluated, 36% of patients had diabetes mellitus. All procedures were performed safely with no adverse peri-procedural events documented. At 9-month follow-up the median in-segment late loss was 0.24 mm (IQR 0.1, 0.53), with a binary restenosis rate of 17%. At long-term follow-up greater than 1 year, the incidence of TLR was 10%. No difference in the angiographic parameter of in-segment late loss was seen between the sirolimus and paclitaxel-eluting stents. CONCLUSIONS: In this cohort of patients with long-term angiographic and clinical follow-up, DES is an effective and safe treatment for symptomatic bare-metal stent ISR.
Antineoplastic Agents, Phytogenic↗
Quality of life after coronary revascularization in the elderly.
AIMS: To describe health status outcomes at 4 years for a cohort of elderly patients with cardiac disease. METHODS AND RESULTS: Using the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease, an outcomes initiative capturing all patients undergoing cardiac catheterization in Alberta, Canada, health status was measured using the Seattle Angina Questionnaire (SAQ) and crude and risk-adjusted outcomes were determined and compared for patients treated with percutaneous coronary intervention or coronary artery bypass surgery (CABG) vs. medical therapy. Response rates among surviving, consenting patients were 64.8% for patients <70 years (n=7883), 77.3% for patients aged 70-79 years (n=2940), and 77.7% for patients >or=80 years of age (n=439). For patients aged <70 years, and those aged 70-79 years, for all dimensions of the SAQ, scores were significantly better for patients treated with revascularization procedures than with medical therapy. For patients over the age of 80 years, scores for patients treated with CABG in particular were significantly better, with the exception of exertional capacity. At 3 years, all scores remained stable or improved, and continued to favour revascularization. CONCLUSION: Elderly patients undergoing revascularization have better health status at 4 years than do those in the same age group who do not undergo revascularization. These findings suggest that age should not deter against revascularization given the combined survival and quality-of-life benefits.
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A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240].
BACKGROUND: Although numerous therapies have been shown to be beneficial in the prevention of myocardial infarction and/or death in patients with coronary disease, these therapies are under-used and this gap contributes to sub-optimal patient outcomes. To increase the uptake of proven efficacious therapies in patients with coronary disease, we designed a multifaceted quality improvement intervention employing patient-specific reminders delivered at the point-of-care, with one-page treatment guidelines endorsed by local opinion leaders ("Local Opinion Leader Statement"). This trial is designed to evaluate the impact of these Local Opinion Leader Statements on the practices of primary care physicians caring for patients with coronary disease. In order to isolate the effects of the messenger (the local opinion leader) from the message, we will also test an identical quality improvement intervention that is not signed by a local opinion leader ("Unsigned Evidence Statement") in this trial. METHODS: Randomized trial testing three different interventions in patients with coronary disease: (1) usual care versus (2) Local Opinion Leader Statement versus (3) Unsigned Evidence Statement. Patients diagnosed with coronary artery disease after cardiac catheterization (but without acute coronary syndromes) will be randomly allocated to one of the three interventions by cluster randomization (at the level of their primary care physician), if they are not on optimal statin therapy at baseline. The primary outcome is the proportion of patients demonstrating improvement in their statin management in the first six months post-catheterization. Secondary outcomes include examinations of the use of ACE inhibitors, anti-platelet agents, beta-blockers, non-statin lipid lowering drugs, and provision of smoking cessation advice in the first six months post-catheterization in the three treatment arms. Although randomization will be clustered at the level of the primary care physician, the design effect is anticipated to be negligible and the unit of analysis will be the patient. DISCUSSION: If either the Local Opinion Leader Statement or the Unsigned Evidence Statement improves secondary prevention in patients with coronary disease, they can be easily modified and applied in other communities and for other target conditions.
Journal Article↗
Refined characterization of the association between kidney function and mortality in patients undergoing cardiac catheterization.
AIMS: Chronic kidney disease is associated with an increased risk of cardiovascular morbidity and mortality. The level of kidney function at which this risk increases remains to be determined. We sought to characterize the relationship between kidney function and survival among patients with cardiovascular disease (CVD) undergoing cardiac catheterization using estimated glomerular filtration rate (eGFR) and graded refinements in the classification of kidney function. METHODS AND RESULTS: We included 8521 of 11 778 (72.3%) consecutive patients undergoing cardiac catheterization between 1 January 1999 and 31 December 2001 from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease database. eGFR as a categorical and continuous variable was used to define kidney function. The outcome was all-cause mortality. During a median (interquartile range) follow-up of 2.2 (1.5-3.1) years, and after adjustment for clinical risk factors and severity of coronary disease, there was a steady incremental decrease in survival post-catheterization corresponding to a decline in eGFR categories of 10 mL/min/1.73 m(2). When eGFR was modelled as a continuous variable, there was an increased risk of death noted at an eGFR below 79 mL/min/1.73 m(2). Below an eGFR of 70 mL/min/1.73 m,(2), there was an approximate 17.2% relative increase in risk for every 10 unit decrease in eGFR (95% CI 8.4-26.6%). CONCLUSION: The risk of death post-cardiac catheterization is elevated when eGFR is < or =79 mL/min/1.73 m(2). These findings provide considerable refinement in our understanding of eGFR as a powerful prognostic marker in patients with CVD undergoing cardiac catheterization.
Cardiac Catheterization↗
Ordinal regression model and the linear regression model were superior to the logistic regression models.
OBJECTIVE: Ordinal scales often generate scores with skewed data distributions. The optimal method of analyzing such data is not entirely clear. The objective was to compare four statistical multivariable strategies for analyzing skewed health-related quality of life (HRQOL) outcome data. HRQOL data were collected at 1 year following catheterization using the Seattle Angina Questionnaire (SAQ), a disease-specific quality of life and symptom rating scale. STUDY DESIGN AND SETTING: In this methodological study, four regression models were constructed. The first model used linear regression. The second and third models used logistic regression with two different cutpoints and the fourth model used ordinal regression. To compare the results of these four models, odds ratios, 95% confidence intervals, and 95% confidence interval widths (i.e., ratios of upper to lower confidence interval endpoints) were assessed. RESULTS: Relative to the two logistic regression analysis, the linear regression model and the ordinal regression model produced more stable parameter estimates with smaller confidence interval widths. CONCLUSION: A combination of analysis results from both of these models (adjusted SAQ scores and odds ratios) provides the most comprehensive interpretation of the data.
Adolescent↗
External validation of a percutaneous coronary intervention mortality prediction model in patients with acute coronary syndromes.
BACKGROUND: The recently published Michigan outcome prediction model (MM) for inhospital mortality was developed and validated on a series of consecutive patients undergoing percutaneous coronary intervention (PCI). Our purpose was to externally validate the performance of the MM in 2 separate cohorts of patients with acute coronary syndrome (ACS) undergoing PCI in Canada. METHODS: A validation of the MM and development of an extended MM were performed on data describing 10,050 patients from the APPROACH prospective cohort study between January 1995 and December 2000. Performance of both models was assessed on an external data set of 3259 PCI cases from the British Columbia Cardiac Registries. Only patients with a diagnosis of ACS were included in the study. RESULTS: The original MM predicted death rates ranging from 0.1% to 60.6%, but lacked accuracy to predict inhospital mortality as severity increased. The extended MM predicted death rates more widely from 0.0% to a high of 91.0% with better accuracy to predict inhospital death in patients with ACS undergoing PCI. The areas under the receiver operating characteristic curve for the MM and the extended MM on the external validation data set were 0.93 and 0.95, respectively. CONCLUSION: The MM predicts death after PCI in patients with ACS and identifies a clear gradient of risk. However, the enhanced MM developed specifically for the subset of patients with ACS demonstrated better prediction and cross-validated performance. These prediction rules can be useful for risk-adjustment analyses and for prognostication for individual patients.
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Kaplan-Meier methods yielded misleading results in competing risk scenarios.
BACKGROUND AND OBJECTIVE: Time-to-event curves are routinely presented in the medical literature. The most widely used method is the Kaplan-Meier (K-M) method, but this analysis approach may not be appropriate when an analysis focuses on time-to-first event in scenarios where there are competing events. We compared K-M methods applying various censoring approaches with the lesser-known "cumulative incidence competing risks" (CICR) method in an analysis of competing events. METHODS: A registry containing data on 21,624 patients undergoing cardiac catheterization was analyzed. Time to coronary artery bypass grafting (CABG) was assessed in an analysis for which percutaneous coronary intervention and death were competing events. Time-to-CABG curves were calculated using the "K-M censor all method," "K-M censor death only method," "K-M ignore all method," and the CICR method. RESULTS: One-year CABG rates calculated for the K-M "censor all," "censor death only," and "ignore all" methods were 28.8%, 22.8%, and 22.4%, respectively compared to the "actual" rate of 20.8%. For the CICR method, the corresponding 1-year rate was identical to the "actual" rate. CONCLUSION: In situations with competing risks, and where an analysis focuses on first events, the CICR method is most appropriate, as K-M methods will tend to overestimate event rates.
Angioplasty, Balloon, Coronary↗
Myocardial infarction on snow days: incidence, procedure, use and outcomes.
BACKGROUND: Snowfall can cause chaos in urban centres and put considerable stress on health care systems. Given that myocardial infarction (MI) is a condition that may be triggered or aggravated by stress, and that health system stress could influence the typical care provided to patients with MI, a study was conducted comparing 'snow days' with 'nonsnow days', specifically assessing the incidence of MI, the use of acute procedures and in-hospital mortality. METHODS: Hospital discharge data were used on all patients discharged after MI. These data were merged with data from Environment Canada to determine the amount of snowfall that occurred on any given day. The use of acute procedures was determined by linking to data from the Alberta Provincial PRoject for Outcomes Assessment in Coronary Heart disease (APPROACH). Snow days were defined as days when at least 5 cm of snow fell, and the two subsequent days were included because of the lingering effect of 'urban chaos' that can ensue after significant snowfall. The average incidence of MIs on snow days versus nonsnow days was then determined. Risk-adjusted odds ratios for the use of direct percutaneous coronary intervention and in-hospital mortality were also determined. RESULTS: There were 61 snow days and 575 nonsnow days. The incidence of MI (incidence density ratio of 1.08, 95% CI 0.82 to 3.10) and the use of direct percutaneous coronary intervention (adjusted OR=1.07, 95% CI 0.74 to 1.54) were slightly higher on snow days. In-hospital mortality trended toward being lower (adjusted OR=0.54, 95% CI 0.28 to 1.04) for patients admitted on snow days, although none of these differences were statistically significant. CONCLUSION: Despite the potential for the significant adverse effects of snow days on the incidence of MI, the use of acute procedures and outcomes, these findings suggest only minor effects, if any.
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Treating the right patient at the right time: access to specialist consultation and non-invasive testing.
The Council of the Canadian Cardiovascular Society commissioned working groups to examine issues of access to, and wait times for, various aspects of cardiovascular care. The present article summarizes the deliberations on targets for medically acceptable wait times for access to cardiovascular specialist evaluation and on the performance of noninvasive testing needed to complete this evaluation. Three categories of referral indications were identified: those requiring hospitalization due to substantial ongoing risk of mortality and morbidity; those requiring an expedited early review in an ambulatory setting; and, finally, a larger category in which delays of two to six weeks can be justified. The proposed wait time targets will provide guidance on the timeliness of care to busy clinicians charged with the care of patients with cardiovascular disease, help policy makers appreciate the clinical challenges in providing access to high quality care, and highlight the critical need for a thoughtful review of cardiology human resource requirements. Wait time implementation suggestions are also included, such as the innovative use of disease management and special need clinics. The times proposed assume that available clinical practice guidelines are followed for clinical coronary syndrome management and for treatment of associated conditions such as hypertension, diabetes, renal disease, smoking cessation and lipid disorders. Although media attention tends to focus on wait times for higher profile surgical procedures and high technology imaging, it is likely that patients face the greatest wait-related risk at the earlier phases of care, before the disease has been adequately characterized.
Canada↗
Treating the right patient at the right time: Access to cardiac catheterization, percutaneous coronary intervention and cardiac surgery.
The Canadian Cardiovascular Society Access to Care Working Group was formed with a mandate to use the best science and information available to establish reasonable triage categories and safe wait times for common cardiovascular services and procedures through a series of commentaries. The present commentary discusses the rationale for access benchmarks for cardiac catheterization and revascularization procedures for patients with stable angina, and access benchmarks for cardiac catheterization and surgery for patients with valvular heart disease. Literature on standards of care, wait times and wait list management was reviewed. A survey of cardiac centres in Canada was performed to develop an inventory of current practices in identifying and triaging patients. The Working Group recommends the following medically acceptable wait times for access to cardiac catheterization: 14 days for symptomatic aortic stenosis and six weeks for patients with stable angina and other valvular disease. For percutaneous coronary intervention in stable patients with high-risk anatomy, immediate revascularization or a wait time of 14 days is recommended; six weeks is recommended for all other patients. The target for bypass surgery in those with high-risk anatomy or valve surgery in patients with symptomatic aortic stenosis is 14 days; for all others, the target is six weeks. All stakeholders must affirm the appropriateness of these standards and work continuously to achieve them. There is an ongoing need to continually reassess current risk stratification methods to limit adverse events in patients on waiting lists and assist clinicians in triaging patients for invasive therapies.
Angioplasty, Balloon, Coronary↗
Development and validation of a surname list to define Chinese ethnicity.
OBJECTIVE: Surnames have the potential to accurately identify ancestral origins as they are passed on from generation to generation. In this study, we developed and validated a Chinese surname list to define Chinese ethnicity. METHODS: We conducted a literature review, a panel review, and a telephone survey in a randomly selected sample from a Canadian city in 2003 to develop a Chinese surname list. The list was then validated to data from the Canadian Community Health Survey. Both surveys collected information on self-reported ethnicity and surname. RESULTS: Of the 112,452 people analyzed in the Canadian Community Health Survey, 1.6% were self-reported as Chinese. This was similar to the 1.5% identified by the surname list. Compared with self-reported Chinese ethnicity (reference standard), the surname list had 77.7% sensitivity, 80.5% positive predictive value, 99.7% specificity, and 99.6% negative predictive value. When stratifying by sex and marital status, the positive predictive value was 78.9% for married women and 83.6% for never married women. CONCLUSIONS: The Chinese surname list appears to be valid in identifying Chinese ethnicity. The validity may depend on the geographic origins and Chinese dialects in given populations.
Adolescent↗
Population rates of cardiac catheterization and yield of high-risk coronary artery disease.
BACKGROUND: The optimal population rate of cardiac catheterization is unknown. One potential way to determine it would be to examine whether there is a population rate beyond which the yield of high-risk coronary artery disease (CAD) does not rise. METHODS: Using a detailed clinical registry that captures all patients undergoing cardiac catheterization in Alberta, we determined annual population rates of cardiac catheterization and the corresponding yield of cases of high-risk CAD in each of Alberta's 17 health regions from 1995 to 2002. Least squares linear regression analysis and hierarchical modelling methods were then used to assess the linear relation between catheterization rates and rates of high-risk CAD. RESULTS: The age-adjusted average rate of cardiac catheterization among men ranged from 404.9 to 638.1 per 100,000 population aged over 20 years. Among women, the average rate ranged from 171.8 to 314.0 per 100,000. For both sexes, increased regional rates of catheterization were associated with a linearly increasing yield of high-risk CAD, with no evidence of a plateau in yield when more procedures were performed. One additional case of high-risk CAD was identified for every 2.5 additional cardiac catheterization procedures performed among men, and for every 3.7 additional procedures performed among women. INTERPRETATION: The increasing yield of patients with high-risk CAD associated with increased regional population rates of cardiac catheterization, together with the absence of a plateau in yield, suggests that Alberta's population rates of cardiac catheterization are suboptimal to detect people with high-risk CAD.
Adult↗
Economic evaluation of sirolimus-eluting stents.
BACKGROUND: Sirolimus-eluting stents have recently been shown to reduce the risk of restenosis among patients who undergo percutaneous coronary intervention (PCI). Given that sirolimus-eluting stents cost about 4 times as much as conventional stents, and considering the volume of PCI procedures, the decision to use sirolimus-eluting stents has large economic implications. METHODS: We performed an economic evaluation comparing treatment with sirolimus-eluting and conventional stents in patients undergoing PCI and in subgroups based on age and diabetes mellitus status. The probabilities of transition between clinical states and estimates of resource use and health-related quality of life were derived from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) database. Information on effectiveness was based on a meta-analysis of randomized controlled clinical trials (RCTs) comparing sirolimus-eluting and conventional stents. RESULTS: Cost per quality-adjusted life year (QALY) gained in the baseline analysis was Can58,721 dollars. Sirolimus-eluting stents were more cost-effective in patients with diabetes and in those over 75 years of age, the costs per QALY gained being 44,135 dollars and 40,129 dollars, respectively. The results were sensitive to plausible variations in the cost of stents, the estimate of the effectiveness of sirolimus-eluting stents and the assumption that sirolimus-eluting stents would prevent the need for cardiac catheterizations in the subsequent year when no revascularization procedure was performed to treat restenosis. INTERPRETATION: The use of sirolimus-eluting stents is associated with a cost per QALY that is similar to or higher than that of other accepted medical forms of therapy and is associated with a significant incremental cost. Sirolimus-eluting stents are more economically attractive for patients who are at higher risk of restenosis or at a high risk of death if a second revascularization procedure were to be required.
Age Factors↗
Characteristics and outcomes of patients with acute myocardial infarction and angiographically normal coronary arteries.
This study on patients undergoing coronary angiography for acute myocardial infarction demonstrated that 2.8% of patients had angiographically normal coronary arteries and that these patients have a better prognosis than patients with angiographically verified coronary artery disease. The trend toward a higher prevalence of malignancy in this unique patient group raises the possibility of malignancy-induced hypercoagulability or inflammation as an underlying etiologic factor.
Aged↗
Association between completeness of percutaneous coronary revascularization and postprocedure outcomes.
BACKGROUND: Multivessel coronary artery revascularization may be accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). The importance of complete revascularization is emphasized in the surgical literature, but little is known about its impact on PCI outcomes. This study evaluated multivessel PCI patients to determine the predictors of complete revascularization and the association of complete revascularization with survival, subsequent CABG, and repeat PCI. METHODS: The Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) is a clinical data collection and outcome-monitoring initiative capturing all patients undergoing cardiac catheterization and revascularization in the province of Alberta, Canada. Characteristics and long-term outcomes of 1308 patients undergoing multivessel PCI with complete revascularization were compared with those of 648 patients with incomplete revascularization. RESULTS: The significant independent predictors of complete revascularization were pre-PCI Duke jeopardy score, the presence of a total occlusion, year of PCI, age > 65 years, renal failure, and left ventricular function. With a median follow-up time of 3.0 +/- 1.8 years, the adjusted hazard ratio (HR) (95% CI) for the association between complete revascularization and outcome was 0.75 (0.54-1.04) for death, 0.55 (0.37-0.84) for subsequent CABG, and 0.93 (0.65-1.34) for repeat PCI. CONCLUSIONS: Baseline angiographic characteristics and other clinical factors can predict complete revascularization in patients undergoing multivessel PCI. Complete multivessel PCI is associated with reduced need for future CABG, a trend toward better survival, and no difference in repeat PCI.
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Absence of bias against smokers in access to coronary revascularization after cardiac catheterization.
OBJECTIVE: Many consider smoking to be a personal choice for which individuals should be held accountable. We assessed whether there is any evidence of bias against smokers in cardiac care decision-making by determining whether smokers were as likely as non-smokers to undergo revascularization procedures after cardiac catheterization. DESIGN: Prospective cohort study. Subjects and setting. All patients undergoing cardiac catheterization in Alberta, Canada. MAIN MEASURE: Patients were categorized as current smokers, former smokers, or never smokers, and then compared for their risk-adjusted likelihood of undergoing revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting) after cardiac catheterization. RESULTS: Among 20406 patients undergoing catheterization, 25.4% were current smokers at the time of catheterization, 36.6% were former smokers, and 38.0% had never smoked. When compared with never smokers (reference group), the hazard ratio for undergoing any revascularization procedure after catheterization was 0.98 (95% CI 0.93-1.03) for current smokers and 0.98 (0.94-1.03) for former smokers. The hazard ratio for undergoing coronary artery bypass grafting was 1.09 (1.00-1.19) for current smokers and 1.00 (0.93-1.08) for former smokers. For percutaneous coronary intervention, the hazard ratios were 0.93 (0.87-0.99) for current smokers and 1.00 (0.94-1.06) for former smokers. CONCLUSION: Despite potential for discrimination on the basis of smoking status, current and former smokers undergoing cardiac catheterization in Alberta, Canada were as likely to undergo revascularization procedures as catheterization patients who had never smoked.
Alberta↗