ACC/AHA 2008 Performance Measures for Adults With ST-Elevation and Non–ST-Elevation Myocardial Infarction

4.1.1. Revised Performance Measure: Statin Therapy at Discharge

Compelling scientific evidence indicates that HMG Co-A reductase inhibitors (statins) reduce the risk of recurrent coronary events and improve survival in patients after MI.^24–28 The benefits of this therapy apply to both men and women, to patients older and younger than 65 years of age, and to diabetics.^29–32 The magnitude of benefit with statins matches or exceeds benefits with other secondary prevention medications such as aspirin, beta-blockers, and angiotensin-converting enzyme inhibitors (ACEIs) in the patient after MI.^26,33 On the basis of available data, the majority of individuals are candidates for statins at the time of discharge for AMI.

Despite the effectiveness of statins in altering subsequent cardiovascular mortality, several prior studies have documented low treatment rates in patients with established coronary artery disease.^34–39 Current gaps in care are less well characterized, however, because many of these studies involved patients from a single or a limited number of centers, enrolled in randomized clinical trials, or treated before dissemination of the most convincing clinical trial evidence.

After careful consideration of the guideline recommendations and the data supporting these recommendations, the writing committee voted to adopt statin therapy at hospital discharge as a performance measure. The writing committee discussed whether to include all forms of lipid-lowering therapy in the numerator of this measure. The ACC/AHA STEMI and UA/NSTEMI guidelines recommend somewhat different approaches to lipid-lowering therapy. Although the 2007 STEMI guideline focused update provides a Class I indication for lipid-lowering therapy with relatively little guidance regarding the specific agent used, the 2007 UA/NSTEMI guidelines specifically provide a Class I indication for statin drugs. Both guidelines, however, acknowledge that the preponderance of evidence with respect to post-MI outcomes and low-density lipoprotein (LDL) lowering has been demonstrated with statins. On the basis of this information, the measure was restricted to statin therapy only.

The writing committee decided to exclude patients with a known LDL less than 100 mg/dL. This decision was made to focus the measure on those who are most likely to benefit and because there was a lack of consensus about whether patients with an LDL less than 100 mg/dL should be placed on statins. This exclusion was felt to assist in the acceptance of the measure.

4.1.2. Test Measure: LDL Cholesterol Testing During Inpatient Hospitalization for AMI

Accumulating data for lipid-lowering therapy, particularly for statin drugs, have substantially increased the proportion of patients with AMI who are potential candidates for lipid-lowering therapy. Indeed, the ACC/AHA UA/NSTEMI guideline considers statin drugs in the absence of contraindications, regardless of baseline LDL cholesterol and diet modification, a Class I recommendation. Both the UA/NSTEMI and STEMI guidelines also consider LDL targets of less than 70 mg/dL reasonable.

Both the STEMI and UA/NSTEMI guidelines support fasting lipid profiles within 24 hours of admission in hospitalized patients to help guide lipid-lowering therapy. The recommendation that such testing be performed earlier is motivated by evidence that lipid values obtained more than 24 hours after an acute coronary event may be misleading.⁴⁰ On the basis of guideline recommendations, the previous ACC/AHA STEMI/NSTEMI Performance Measures included a measure for lipid testing. However, such a measure generates substantial data collection burden, may be difficult to ascertain from chart review, and may not necessarily improve quality regarding the ultimate goal of ensuring that patients appropriate for lipid-lowering therapy receive a discharge prescription. The current writing committee agreed that the modified construction of the measure of statin therapy at discharge largely renders moot a specific performance measure for LDL testing. Nevertheless, there were varying opinions in the group, and because of this, the measure was retained as a test measure.

4.1.3. Omitted Measure: Early Beta-Blockers

Older clinical trial data show that beta-blockers administered early during AMI hospitalization significantly reduce postinfarction angina and reinfarction.^41,42 Whether early beta-blocker use reduces mortality in AMI patients remains controversial, however. Although some individual clinical trials did show a modest, statistically significant mortality benefit associated with early beta-blocker therapy,⁴¹ a large meta-analysis, published in 1999, of 29 260 patients enrolled in 51 clinical trials of early beta-blocker therapy showed no mortality benefit associated with this approach (odds ratio, 0.96; 95% CI, 0.85 to 1.08).⁴³

More recent data from the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) also raised questions about the early use of beta-blockers in patients with AMI.⁴⁴ In the COMMIT study, 45 852 AMI patients (93% with STEMI and 50% receiving fibrinolytic therapy) were randomized to 15 mg metoprolol intravenously over 10 minutes immediately after presentation and then 50 mg metoprolol orally every 6 hours afterward or placebo. Importantly, patients with cardiogenic shock were excluded, but those with heart failure on presentation (Killip class 2 or 3) were not explicitly excluded.

The primary outcome (composite outcome of death, reinfarction, or cardiac arrest) and all-cause mortality at 30 days were similar between groups. Although beta-blockers significantly reduced the risk of arrhythmic death and reinfarction, they significantly increased the risk of cardiogenic shock within the first 24 hours of hospitalization. The most potent patient risk factors associated with the increased risk of developing cardiogenic shock with early beta-blockers included heart failure (Killip class 3) and hemodynamic instability on presentation.

Balancing the evidence from COMMIT and the earlier studies, the ACC/AHA STEMI and UA/NSTEMI guidelines currently give Class I (Level of Evidence: B) recommendation for early oral beta-blockers, a Class IIa recommendation for early intravenous beta-blockers in hypertensive patients without specific contraindications (including signs of heart failure, evidence of a low output state, increased risk for cardiogenic shock [defined as age more than 70 years, systolic blood pressure less than 120 mm Hg, heart rate of 110 bpm or higher, and increased time since onset of symptoms]), and Class III (Level of Evidence: A) recommendation for intravenous beta-blockers in patients with specific contraindications to early beta-blocker therapy.

The writing committee carefully considered these guideline recommendations. Because of the complexity of integrating these recommendations, which would require the distinction between intravenous and oral administration and the ascertainment of a large number of patient factors that constituted contraindications, the writing committee chose to omit early beta-blocker use from this performance measure set.

4.2.1. Evaluation of Left Ventricular Systolic Function

Left ventricular systolic function (LVSF) is important from a therapeutic and prognostic standpoint for patients with AMI. Patients with left ventricular systolic dysfunction (LVSD) may be candidates for specific drug therapies (eg, ACEI and angiotensin receptor blocker [ARB]) or may warrant prompt invasive management during acute coronary syndrome (ACS) hospitalization (eg, coronary angiography). In addition, systolic dysfunction after AMI predicts long-term survival. Accordingly, clinical practice guidelines have incorporated the assessment of LVSF, by any method, as a Class I recommendation in patients with AMI (NSTEMI or STEMI).

The writing committee discussed modeling the LVSF assessment for AMI measure on the corresponding measure for patients with heart failure. However, given that AMI patients have experienced an event that may acutely affect LVSF, the writing committee felt that LVSF assessments performed before the AMI hospitalization should not be considered as meeting the performance measure.

The writing committee voted to adopt LVSF assessment for AMI patients as a performance measure. As with the existing performance measure for heart failure, credit would also be given in cases in which there is a documented plan for LVSF testing after discharge because there may be instances when it is difficult to obtain the test during the stay (eg, very short stays or weekend admissions).

4.2.2. Timely Reperfusion in STEMI

Acute reperfusion remains an important focus of quality assessment because of both the positive impact of timely reperfusion on clinical outcomes and the understanding of persistent gaps in the delivery of this effective therapy. The measurement of the quality of reperfusion therapy, however, involves greater complexity than many other process measures and has raised questions regarding the scope of the existing reperfusion performance measures and the possible need for additional measures to better characterize quality in this domain.

In response to these questions, the ACC/AHA Performance Measures Task Force convened a workgroup to evaluate the existing reperfusion measures and to suggest additional measures for consideration. A complete discussion of the proceedings of this workgroup is reported elsewhere⁴⁵; however, the reperfusion measures reported in this document reflect a consideration of all of the workgroup’s recommendations.

In brief, specific issues addressed in detail in the document deserve mention. First, the reperfusion measures contain exclusions for those situations when a patient-centered factor results in a delay in providing therapy. An example of a patient-centered factor is the initial refusal of a patient. Systemic reasons for delay do not result in exclusions. With respect to the measures of primary percutaneous coronary intervention (PCI), the time at which measurement stops is the time of the first use of a device intended to restore flow (eg, balloon, stent, or thrombectomy device). Although this does not account for the relatively small number of cases when flow is present before device deployment, it also does not create penalties for the failure to achieve procedural success.

A particular recommendation of the workgroup was to include a measure for the timeliness of primary PCI in patients who are transferred from the facility to which they present to another facility for the procedure. In the current era, total door-to-balloon time for these transferred patients is less than 2 hours in a little more than 25% of patients, between 2 and 4 hours in a little more than 50% of patients, and 4 hours or greater in about 20% of patients.⁴⁶ The previous measures explicitly excluded such patients, rendering invisible the performance of those institutions that routinely use transfer for PCI as their principal approach to reperfusion. This measure does not have a set benchmark, acknowledging the controversy about a time that represents an unacceptable delay. It is intended to make clear the time involved in obtaining reperfusion therapy for these patients. For patients who can receive fibrinolytic therapy, referring clinicians should have a sense of the time that will be required to provide primary PCI. This knowledge can inform the decision about which form of reperfusion therapy is in the patient’s best interest. Moreover, such knowledge may stimulate efforts for referral and receiving hospitals, along with transportation companies and agencies, to sit together to review and improve their joint performance. The writing committee understands that in rural areas there may be long distances that are required for transfer. The opinion of the group, however, is that if reasonable primary PCI times could not be achieved then fibrinolytic therapy should be administered, which is consistent with recommendations of the STEMI guidelines. Because patients with contraindications to fibrinolytic therapy may have different considerations regarding the time to primary PCI, the committee recommends that that group be reported separately. The committee also recommends that times be collected on all patients, even those with patient reasons for delay, for the purpose of internal quality improvement and review. Two additional measures are included to reflect the timeliness of primary reperfusion: (1) measuring the time from arrival to and discharge from an emergency department in patients transferred for primary PCI (“door-in-door-out” time) and (2) a comprehensive measurement of the time from presentation at the first facility to the time of PCI at the receiving institution.

A consideration in the measurement of time to transfer for primary PCI is the subgroup of patients for whom fibrinolytic therapy is contraindicated. Although the time to transfer is undoubtedly important in this population, because the option of providing fibrinolytic therapy is not available, clinicians may opt for transfer even if the capacity to do so in a timely manner is not available. In contrast, among patients for whom fibrinolytic therapy is a therapeutic option, fibrinolysis should be provided if transfer will be delayed. Thus, the workgroup concluded that these transfer measures should be reported separately for patients with and without documented contraindications to fibrinolytic therapy.

Currently, evidence-based recommendations or accepted national performance benchmarks for measures of the time of transfer for primary PCI do not exist. Thus, although the writing committee believed that targets of 30 minutes for time from presentation to transfer and 90 minutes for time from presentation at 1 facility to PCI at another were reasonable targets given current guideline recommendations for reperfusion timeliness, no specific performance target is prescribed by the measures.

Beyond the specification of these measures, the issue of attribution of these times is critical. In the case of the “door-in-door-out” time (Measure 10), attribution is straightforward (ie, the facility at which the patient presents is largely accountable for all aspects of the process). For the measure of time of presentation to PCI among patients who are transferred (Measure 11), the question of accountability is less clear given the participation of the hospital to which the patient presents, the providers of the transfer, and the hospital at which the PCI occurs. Although arguments for several approaches are reasonable, both institutions providing care for a patient who is transferred for primary PCI should be invested in ensuring that the transfer is performed in a timely manner and, if this is not possible, should consider fibrinolytic therapy. Thus, the writing committee recommends that for the measurement of the time from presentation at 1 hospital to the time of PCI in another, the results should be attributed to both institutions. This approach to attribution will stimulate efforts for both types of institutions to collaborate with each other to optimize the care of their patients with STEMI who require acute reperfusion therapy.

The workgroup also considered the issue of the use of the time of first system contact rather than the time of hospital presentation as the start time for the reperfusion measures. The workgroup concluded that measures used for the purposes of accountability should migrate toward including the time before hospital presentation in measurement. However, until several issues regarding this approach are resolved, it was proposed that measures starting with the time of first system contact were more appropriate for the purposes of quality improvement within systems and that systems should be encouraged to measure and improve these times.

Finally, it is possible that attempts to decrease the time to reperfusion for STEMI may result in the delivery of reperfusion strategies to patients who do not meet reperfusion criteria. Identifying a population for whom angiography or fibrinolytic therapy is clearly inappropriate through the use of retrospective criteria is likely to pose substantial challenges if public accountability for such measurement is considered. However, for the purposes of quality improvement, it may be useful to review cases of “false alarm” catheterization laboratory activations or cases when fibrinolysis is administered when it is unclear that reperfusion criteria were met. Such measures are proposed as secondary measures for consideration for quality improvement.

4.3.1. Clopidogrel at Discharge

Data on the benefits of dual antiplatelet therapy (aspirin plus clopidogrel) for patients with ACS have accumulated over the past several years. Accordingly, the prescription of clopidogrel for ACS patients has been incorporated into the ACC/AHA clinical practice guideline recommendations. Specifically, clopidogrel at hospital discharge for patients presenting with ACS, including UA, NSTEMI, and STEMI, received a Class I guideline recommendation in the 2007 updates of the STEMI and UA/NSTEMI guidelines. Class I recommendations are relevant to several patient populations, including all patients receiving coronary stents and patients not receiving stents who are managed medically. After careful consideration of the guideline recommendations and the data supporting these recommendations, the writing committee agreed to adopt clopidogrel at hospital discharge for medically treated AMI patients as a test performance measure. The rationale for this recommendation is discussed further below.

Data from the NCDR ACTION Registry-GWTG, a national ACS registry, demonstrate significant variability in the prescription of clopidogrel at hospital discharge for ACS patients depending on in-hospital treatment. Among those undergoing PCI and stenting, clopidogrel is prescribed to a very high percentage of patients. Because rates of clopidogrel prescription are already very high in these patients, the writing committee decided to exclude them from the test measure. This decision was based on balancing considerations of the burden of data abstraction among a population for which evidence suggests that gaps in care are not substantial. The decision does not question the importance of thienopyridine therapy in the population receiving stents.

The writing committee also discussed this therapy among patients undergoing coronary artery bypass graft surgery during AMI hospitalization. Because of the limited data on the benefit of dual antiplatelet therapy in this population, the writing committee concluded that patients undergoing coronary artery bypass graft during AMI hospitalization should also be excluded from the measure.

In contrast, there is evidence of substantially greater variability in rates of clopidogrel prescription at hospital discharge for medically treated patients.⁴⁷ The population that does not undergo angiography and PCI is likely very heterogeneous, including some of the sickest and frailest patients and those who refuse treatment. However, given the demonstrated benefit of clopidogrel in medically treated ACS patients enrolled in clinical trials and the potential gaps in care identified in contemporary registries, the writing committee considered thienopyridine therapy in medically treated patients as a potential opportunity to improve care. A test performance measure focused on these patients would be important in this regard and would provide a better understanding of AMI patients treated medically in clinical practice. Furthermore, as with all performance measures, the heterogeneity of this patient population is acknowledged with the exclusion of those patients for whom a clinician documents any reason for not prescribing the therapy.

The writing committee also discussed whether to restrict the measure to clopidogrel only or to include the entire class of thienopyridine derivatives. Current clinical practice guidelines specify an explicit preference for clopidogrel, reserving ticlopidine for patients with contraindications to clopidogrel. Because of the approach in the guidelines and no evidence for clinically meaningful occurrence of contraindications specific to clopidogrel, the writing committee limited the measure to clopidogrel only. Although emerging evidence suggests the benefits of other agents, current guidelines do not yet include recommendations for their use.

4.3.2. Initial Parenteral Anticoagulant and Antiplatelet Dosing

Recommended doses for anticoagulant therapy and intravenous glycoprotein IIb/IIIa inhibitors are well established. However, excess dosing in patients with UA/NSTEMI is a common occurrence,^48,49 particularly in vulnerable populations (eg, the elderly, those with impaired renal function). Although these patients may stand to benefit the most from anticoagulant therapy, they also are the most likely to receive excess dosing and experience bleeding complications. Importantly, in these observational studies, higher rates of bleeding and in-hospital mortality were associated with excess dosing after accounting for potential confounders.

Given the high frequency of dosing errors that have been reported and their potential negative consequences, the writing committee believed that performance measures focused in this area (and including intravenous glycoprotein IIb/IIIa inhibitors) would have an important impact on quality improvement and patient care despite the lack of definitive randomized clinical trial data and the potential burden of data collection for institutions. The burden of data collection is due primarily to assessments of glomerular filtration rates for many agents. Estimations of glomerular filtration rates are usually performed with either the Cockroft-Gault or the Modification of Diet in Renal Disease formula. Hospitals may vary in their preference for using a specific formula, which could lead to minor differences. It is noteworthy that clinical studies have relied primarily on the Cockroft-Gault formula to generate dosage adjustments. An additional concern is that these agents are frequently administered urgently in the emergency department (particularly for unfractionated heparin) before a patient’s weight is obtained. A measure therefore could potentially delay or diminish the use of these agents in this setting. However, this concern needs to be balanced against the significant risk for bleeding associated with excess dosing. The fact that measures for unfractionated heparin and enoxaparin have an added margin of error well above recommended doses also emphasizes true outlier doses.

The writing committee specifically focused on 5 performance measures for the most commonly used agents (unfractionated heparin, enoxaparin, eptifibatide, tirofiban, and abciximab) and focused on initial doses (bolus and infusion), including recommendations for maximum acceptable doses when applicable. We excluded patients who received treatment initially in the catheterization laboratory because doses for these agents may vary in the setting of PCI or may be adjusted directly by monitoring coagulation studies like activated clotting times. For a similar reason, the performance measure for unfractionated heparin also excluded patients with STEMI who underwent primary PCI because higher doses of unfractionated heparin may be used in anticipation of the procedure. A comparable performance measure focused on dosing of fibrinolytic therapy in STEMI also was considered, although data on the impact of overdosing in this population are less conclusive.⁵⁰ The writing committee believed that because of the smaller number of patients with STEMI and recent declines in the use of fibrinolytic therapy in the United States, the impact of such a measure may be more limited. Future performance measure development efforts may need to reconsider this issue in STEMI. In addition to a process measure assessing the dosing of commonly used anticoagulant and antiplatelet agents, the writing committee has developed 2 structural performance measures that assess formal approaches within a facility to minimize dosing errors for anticoagulant therapy and similar agents. This would be relevant for all patients, including those with NSTEMI, UA, and STEMI.

All measures dedicated to assessing anticoagulation dosing were unanimously considered most appropriate as test measures by the writing committee. Although we recognize that the 5 performance measures related to dosing of specific agents are based primarily on observational studies, are complex, and may add to the potential burden of data collection for institutions, contemporary data suggest that there is a substantial opportunity to improve patient processes of care and outcomes in this area. As test measures, these metrics are considered most appropriate for use for internal quality improvement programs but not other functions (eg, pay for performance, physician ranking, or public reporting) until the validity of these measures and the effort needed to collect the necessary data are better understood.

4.6.1. Early Clopidogrel Therapy

The writing committee investigated early clopidogrel therapy as a potential performance measure. Areas discussed were (1) clopidogrel administration within 24 hours after hospital arrival in patients with aspirin hypersensitivity or intolerance, (2) upstream clopidogrel in patients undergoing early invasive strategy, and (3) clopidogrel administration within 24 hours in patients undergoing conservative strategy. For patients with aspirin hypersensitivity or intolerance, both the STEMI and UA/NSTEMI guidelines recommend administration of clopidogrel in lieu of aspirin therapy. However, the writing committee felt that the number of patients with aspirin hypersensitivity or intolerance would be too small for this potential measure to be useful given the burden of abstraction that would be required.

With regard to the upstream clopidogrel administration, the writing committee felt that the complexity of decision making regarding this therapy precluded translation into a performance measure. The recommendations for clopidogrel in the early stages of AMI are dependent on several factors, including treatment strategy (interventional versus early conservative), and other “upstream” medical therapy with glycoprotein IIb/IIIa inhibitors. Because of the complexity of decision making in the determination of the appropriate antiplatelet therapy in medically managed patients and the difficulty in identifying appropriate populations for the denominator, the writing committee thought that it would be extremely difficult, if not impossible, to develop a meaningful measure in this subgroup of patients.

4.6.2. Early Anticoagulant Therapy

Clinical trial data support the use of anticoagulant therapy in patients with UA/NSTEMI.²¹ However, the specific agent recommended depends on the type of initial treatment approach chosen (ie, early invasive versus selective invasive strategy) and patient factors (ie, high bleeding risk or chronic renal insufficiency). Although the level of evidence for each agent varies, the UA/NSTEMI guidelines currently support 4 options as Class I recommendations: unfractionated heparin, enoxaparin, bivalirudin, and fondaparinux. In patients with STEMI, use of anticoagulant therapy is a Class I recommendation after fibrinolytic therapy with options including unfractionated heparin, enoxaparin, and fondaparinux.²⁰ For primary PCI, use of anticoagulant therapy typically is limited to the cardiac catheterization laboratory.

The writing committee strongly considered a performance measure in this area. Ultimately, however, a measure was not developed for 2 reasons. First, the complexity of clinical options and scenarios involving this therapy made the construction of a measure challenging and potentially confusing for clinicians. Second, use of anticoagulant therapy is already high among patients with ACS, approaching 90% for unfractionated heparin or low-molecular-weight heparin.⁵⁸ This suggests that a performance measure in this area would identify only limited opportunities for quality improvement.

4.6.3. Influenza Vaccination

The writing committee discussed a performance measure centering on the provision of an influenza vaccination for patients after an AMI. The 2007 ACC/AHA UA/NSTEMI guidelines²¹ have a Class I recommendation: An annual influenza vaccination is recommended for patients with cardiovascular disease (Level of Evidence: B). The 2007 STEMI guideline focused update²⁰ also has a Class I recommendation: Patients with cardiovascular disease should have an annual influenza vaccination (Level of Evidence: B). Over the past decade, more chronic diseases have been added to the list of indications for this vaccine, and there appears to be little, if any, risk of harm. However, seasonal administration and the potential difficulty of finding vaccine administration documentation if previously given outside the hospital have presented barriers to measurement feasibility in other settings. Given these challenges, the writing committee felt that influenza vaccination should not be considered for a performance measure specifically for AMI at this time.

4.6.4. Avoidance of Nonsteroidal Antiinflammatory Drugs

The writing committee discussed a performance measure on nonsteroidal antiinflammatory drug (especially COX-2 inhibitor) avoidance in AMI patients. The 2007 ACC/AHA UA/NSTEMI guidelines and the 2007 STEMI guideline focused update both recommend that nonsteroidal antiinflammatory drugs with increasing degrees of relative COX-2 selectivity should not be administered to AMI patients with chronic musculoskeletal discomfort when therapy with acetaminophen, small doses of narcotics, nonacetylated salicylates, or nonselective nonsteroidal antiinflammatory drugs provides acceptable levels of pain relief (Level of Evidence: C). However, previous experience with measures implementation reveals the challenges of constructing a “negative” measure (ie, one focused on measuring a therapy that is given inappropriately) because of the need to identify a denominator for which the therapy is clearly inappropriate. Furthermore, given the extensive publicity regarding COX-2 inhibitors, it is not clear whether these agents are still being prescribed acutely in the hospital setting in this patient population. For these reasons, the writing committee concluded that a measure of avoiding nonsteroidal antiinflammatory drugs and COX-2 inhibitors should not be pursued at this time.

4.6.5. Aldosterone Blockade

The writing committee carefully reviewed the evidence and guideline recommendations in regard to aldosterone blockade in patients hospitalized with AMI. The principal evidence for this therapy derives from the Eplerenone Post-AMI Heart Failure Efficacy and Survival Study (EPHESUS), in which aldosterone blockade with eplerenone initiated within 3 to 14 days improved outcomes in post-AMI patients with either heart failure or diabetes.⁵⁹ All patients were receiving optimal medical therapy, including ACEIs, beta-blockers, and aspirin when appropriate. Half of the population was treated with statins. Reflecting these findings, current clinical guidelines give Class I recommendations to long-term aldosterone receptor blockade for AMI patients without significant renal dysfunction or hyperkalemia who are already receiving therapeutic doses of an ACEI, have a left ventricular ejection fraction less than or equal to 0.40, and have either symptomatic heart failure or diabetes mellitus.

The writing committee considered the addition of a new performance measure for aldosterone blockade but believed that a measure for this treatment for hospitalized AMI patients should not be developed. Several factors influenced this decision. First, identifying candidates for the denominator of this measure would create significant abstraction burden and likely identify a relatively small proportion of AMI patients (those with estimated creatinine clearance higher than 30 mL/min, patients with potassium of 5 mEq/L or lower, those receiving therapeutic doses of ACEI, those with left ventricular ejection fraction of 40% or lower, and patients with either symptomatic heart failure or diabetes). Second, patients enrolled in EPHESUS were randomized to eplerenone between 3 and 14 days after AMI, which for most patients represents an early postdischarge period. Accordingly, the writing committee felt that initiation of aldosterone blockade as a layered therapy (in patients treated with ACEI and beta-blockers) may be most appropriate in the early postdischarge setting. Finally, the writing committee also had some concerns about recent evidence in regard to the use of aldosterone blockade in patients with contraindications to this therapy,⁶⁰ which in some cases puts patients at risk for hyperkalemia. The committee believed that, in addition to an outpatient measure for the use of aldosterone antagonists, a parallel measure of inappropriate use may be warranted.

4.6.6. Facilitated PCI

In the 2007 STEMI guideline focused update, facilitated PCI refers to “a strategy of planned immediate PCI after administration of an initial pharmacological regimen intended to improve coronary patency before the procedure.” Pharmacological regimens for facilitated PCI have been variably defined and include high-dose heparin, glycoprotein IIb/IIIa inhibitors, and fibrinolytic therapy. Clinical trial data suggest that the routine use of this approach does not provide any advantages and may result in harm when full-dose fibrinolytic therapy is used as the initial pharmacological regimen. The latter approach was considered a Class III recommendation in the 2007 STEMI guideline focused update. The writing committee considered a performance measure in this area to assess the use of this potentially harmful strategy. In the end, however, the writing committee chose not to pursue this further because of the challenges of constructing a performance measure that could accurately distinguish between facilitated PCI in which full-dose fibrinolytic therapy is used as the initial pharmacological regimen and other forms of facilitated PCI or rescue PCI.

4.6.7. Early Invasive Strategy for High-Risk NSTEMI Patients

The UA/NSTEMI guidelines recommend an early invasive strategy (ie, coronary angiography with PCI if appropriate) for patients with UA/NSTEMI who have evidence of refractory symptoms and hemodynamic or electric instability (Class I; Level of Evidence: B) or an elevated risk for clinical events based on clinical characteristics, including elevated biomarkers or electrocardiographic abnormalities (Class I; Level of Evidence: A). A conservative (or selectively invasive) strategy also is considered reasonable (Class IIb; Level of Evidence: B) for stable patients, including those with elevated biomarkers. The writing committee considered an AMI performance measure to evaluate the use of an early invasive strategy in patients with NSTEMI. However, a measure was not endorsed at this time because of the complexity of the guideline recommendations and the challenges in translating these recommendations into a measure that can be implemented feasibly. Particular considerations include concerns about identifying high-risk clinical characteristics reliably from abstracted data, particularly with respect to the accurate classification of ECG abnormalities, and the importance of considering overuse given the invasive nature of coronary angiography. Current initiatives through registries (eg, ACTION or the National Cardiovascular Data Registry CathPCI) may be valuable in exploring feasible approaches to identifying the “eligible” population for early invasive strategy and to inform the construction of a quality or performance measure on this topic in the future.