Health-related quality of life in patients with acute coronary syndromes and treated with ticagrelor or clopidogrel.

Evaluation of: Levin LA, Wallentin L, Bernfort L et al. Health-related quality of life of ticagrelor versus clopidogrel in patients with acute coronary syndromes results from the PLATO trial. Value Health 16(4), 574-580 (2013). Antiplatelet therapy is considered essential treatment for acute coronary syndromes with or without ST-segment elevation and after stent procedures. The PLATelet inhibition and patient Outcomes (PLATO) trial compared ticagrelor or clopidogrel for the prevention of cardiovascular events. Prespecified substudies included a health-related quality of life (HRQL) study; the EQ-5D, a self-report, standardized, nondisease-specific utility measure with a single index value for health status, was used to assess HRQL. In the primary HRQL analysis, the mean 12-month HRQL score in 15,212 patients was reported to be 0.840 in the ticagrelor group and 0.832 in the clopidogrel group (p = 0.046). Excluding patients who died resulted in no difference in HRQL between patients treated with ticagrelor or clopidogrel (0.864 and 0.863, respectively; p = 0.69). The improved survival and reduction in cardiovascular events with ticagrelor as demonstrated in the main PLATelet inhibition and patient Outcomes trial are apparently obtained with no difference in quality of life.

Non-compliance is the predominant cause of aspirin resistance in chronic coronary arterial disease patients.

BACKGROUND: Our previous publication showed that 9% of patients with a history of myocardial infarction MI. could be labeled as aspirin resistant; all of these patients were aspirin resistant because of non-compliance. This report compares the relative frequency of aspirin resistance between known compliant and non-compliance subjects to demonstrate that non-compliance is the predominant cause of aspirin resistance. METHODS: The difference in the slopes of the platelet prostaglandin agonist (PPA) light aggregation curves off aspirin and 2 hours after observed aspirin ingestion was defined as net aspirin inhibition. RESULTS: After supposedly refraining from aspirin for 7 days, 46 subjects were judged non-compliant with the protocol. Of the remaining 184 compliant subjects 39 were normals and 145 had a past history of MI. In known compliant subjects there was no difference in net aspirin inhibition between normal and MI subjects. Net aspirin inhibition in known compliant patients was statistically normally distributed. Only 3% of compliant subjects (2 normals and 5 MI) had a net aspirin inhibitory response of less than one standard deviation which could qualify as a conservative designation of aspirin resistance. A maximum of 35% of the 191 post MI subjects could be classified as aspirin resistant and/or non-compliant: 9% aspirin resistant because of non-compliance, 23% non-compliant with the protocol and possibly 3% because of a decreased net aspirin inhibitory response in known compliant patients. CONCLUSION: Our data supports the thesis that the predominant cause of aspirin resistance is noncompliance.

The association between guideline-based treatment instructions at the point of discharge and lower 1-year mortality in Medicare patients after acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) initiative in Michigan.

BACKGROUND: The American College of Cardiology's Guidelines Applied in Practice (GAP) initiative for acute myocardial infarction (AMI) has been shown to increase the use of guideline-based therapies and improve outcomes in patients with AMI. It is unknown whether hospitals that are more successful in using the standard discharge contract--a key component of GAP that emphasizes guideline-based medications, lifestyle modification, and follow-up planning--experience a proportionally greater improvement in patient outcomes. METHODS: Medicare patients treated for AMI in all 33 participating GAP hospitals in Michigan were enrolled. We aggregated the hospitals into 3 tertiles based on the rates of discharge contract use: 0% to 8.4% (tertile 1), >8.4% to 38.0% (tertile 2), and >38.0% to 61.1% (tertile 3). We analyzed 1-year follow-up mortality both pre- and post-GAP and compared the mortality decline post-GAP with discharge contract use according to tertile. RESULTS: There were 1368 patients in the baseline (pre-GAP) cohort and 1489 patients in the post-GAP cohort. After GAP implementation, mortality at 1 year decreased by 1.2% (P = .71), 1.2% (P = .68), and 6.0% (P = .03) for tertiles 1, 2, and 3, respectively. After multivariate adjustment, discharge contract use was significantly associated with decreased 1-year mortality in tertile 2 (odds ratio 0.43, 95% CI 0.22-0.84) and tertile 3 (odds ratio 0.45, 95% CI 0.27-0.75). CONCLUSIONS: Increased hospital utilization of the standard discharge contract as part of the GAP program is associated with decreased 1-year mortality in Medicare patient populations with AMI. Hospital efforts to promote adherence to guideline-based care tools such as the discharge contract used in GAP may result in mortality reductions for their patient populations at 1 year.

Association of a continuous quality improvement initiative with practice and outcome variations of contemporary percutaneous coronary interventions.

BACKGROUND: The objective of this study was to evaluate the association of a continuous quality improvement program with practice and outcome variations of percutaneous coronary intervention (PCI). METHODS AND RESULTS: Data on consecutive PCI were collected in a consortium of 5 hospitals; 3731 PCIs reflected care provided at baseline (January 1, 1998, to December 31, 1998), and 5901 PCIs reflected care provided after implementation of a continuous quality improvement intervention (January 1, 2002, to December 31, 2002). The intervention included feedback on outcomes, working group meetings, site visits, selection of quality indicators, and use of bedside tools for quality improvement and risk assessment. Postintervention data were compared with baseline and with 10,287 PCIs from 7 hospitals added to the consortium in 2002. Quality indicators included use of preprocedural aspirin or clopidogrel, use of glycoprotein IIb/IIIa receptor blockers and postprocedural heparin, and amount of contrast media per case. Outcomes selected included emergency CABG, contrast nephropathy, myocardial infarction, stroke, transfusion, and in-hospital death. Compared with baseline and the control group, the intervention group at follow-up had higher use of preprocedural aspirin and glycoprotein IIb/IIIa blockers, lower use of postprocedural heparin, and a lower amount of contrast media per case (P<0.05). These changes were associated with lower rates of transfusions, vascular complications, contrast nephropathy, stroke, transient ischemic attack, and combined end points (all P<0.05). CONCLUSIONS: Our nonrandomized, observational data suggest that implementation of a regional continuous quality improvement program appears to be associated with enhanced adherence to quality indicators and improved outcomes of PCI. A randomized clinical trial is needed to determine whether this is a "causal" or a "casual" relationship.

Public reporting and case selection for percutaneous coronary interventions: an analysis from two large multicenter percutaneous coronary intervention databases.

OBJECTIVES: The purpose of this research was to determine the potential effect of public reporting on case selection for percutaneous coronary intervention (PCI). BACKGROUND: Previous studies have suggested that public reporting of coronary artery bypass graft surgery (CABG) mortality might result in case selection bias and in denial of care to or out migration of high-risk patients. The potential effect of public reporting on case selection for PCI is unknown. METHODS: We compared demographics, indications, and outcomes of 11,374 patients included in a multicenter (eight hospitals) PCI database in Michigan where no public reporting is present, with 69,048 patients in a statewide (34 hospitals) PCI database in New York, where public reporting is present. The primary end point was in-hospital mortality. RESULTS: Patients in Michigan more frequently underwent PCI for acute myocardial infarction (14.4% vs. 8.7%, p < 0.0001) and cardiogenic shock (2.56% vs. 0.38%, p < 0.0001) than those in New York. The Michigan cohort also had a higher prevalence of congestive heart failure and extracardiac vascular disease. The unadjusted in-hospital mortality rate was significantly lower in New York than in Michigan (0.83% vs. 1.54%, p < 0.0001; odds ratio [OR] 0.54, 95% confidence interval [CI] 0.45 to 0.63). However, after adjustment for comorbidities, there was no significant difference in mortality between the two groups (adjusted OR 1.05, 95% CI 0.84 to 1.31, p = 0.70, c-statistic 0.88). CONCLUSIONS: There are significant differences in case mix between patients undergoing PCI in Michigan and New York that result in marked differences in unadjusted mortality rates. A propensity in New York toward not intervening on higher-risk patients because of fear of public reporting of high mortality rates is a possible explanation for these differences.

Frequency and prognosis of emergency coronary artery bypass grafting after percutaneous coronary intervention for acute myocardial infarction.

We evaluated the frequency and prognosis of emergency coronary artery bypass grafting (CABG) after percutaneous coronary intervention (PCI) for acute myocardial infarction in a large, multicenter registry of contemporary PCI. In this study, emergency CABG occurred in 2% of cases, and was associated with high in-hospital mortality (20%) and with a high incidence of stroke (8%), renal failure requiring dialysis (8.3%), and bleeding (63.3%).

The Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) collaborative quality improvement initiative in percutaneous coronary interventions.

The past decade has been characterized by increased scrutiny of outcomes of surgical and percutaneous coronary interventions (PCIs). This increased scrutiny has led to the development of regional, state, and national databases for outcome assessment and for public reporting. This report describes the initial development of a regional, collaborative, cardiovascular consortium and the progress made so far by this collaborative group. In 1997, a group of hospitals in the state Michigan agreed to create a regional collaborative consortium for the development of a quality improvement program in interventional cardiology. The project included the creation of a comprehensive database of PCIs to be used for risk assessment, feedback on absolute and risk-adjusted outcomes, and sharing of information. To date, information from nearly 20,000 PCIs have been collected. A risk prediction tool for death in the hospital and additional risk prediction tools for other outcomes have been developed from the data collected, and are currently used by the participating centers for risk assessment and for quality improvement. As the project enters into year 5, the participating centers are deeply engaged in the quality improvement phase, and expansion to a total of 17 hospitals with active PCI programs is in process. In conclusion, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium is an example of a regional collaborative effort to assess and improve quality of care and outcomes that overcome the barriers of traditional market and academic competition.