The Post-AUC Landscape for PCI

There has been a significant reduction in the volume of nonacute percutaneous coronary interventions (PCI) and the proportion of inappropriate nonacute PCIs has declined since the publication of appropriate use criteria (AUC) for coronary revascularization, according to a recent study in JAMA.

The AUC, published in 2009 by the ACC and seven other partnering societies, were developed to evaluate and improve patient selection for PCI. In 2011, the NCDR CathPCI Registry^® began providing hospitals with information regarding the appropriateness of PCIs.

The study, led by Nahir R. Desai, MD, MPH, of Yale-New Haven Hospital, New Haven, CT, examined all PCIs in the CathPCI registry between July 1, 2009, and Dec. 31, 2014. PCIs were classified as acute, nonacute, or nonmappable, and each mappable PCI was assigned a rating of procedural appropriateness—appropriate, uncertain, or inappropriate—based on the 2012 AUC for coronary revascularization.

Over 3.5 million PCIs were performed at 1,561 hospitals. After exclusions, researchers included 2,685,683 PCI procedures at 766 hospitals in the study cohort. Of these, 76.3% of PCIs were for acute indications, 14.8% were for nonacute indications, and 8.9% were nonmappable. The annual volume of PCI declined from 538,076 in 2010 to 456,507 in 2014. While the volume of acute PCI was relatively stable (377.540 to 377,543), the decline in nonacute and nonmappable PCIs was significant (89,704 to 59,375 and 70,832 to 22,589, respectively).

The proportion of nonacute PCIs classified as inappropriate decreased from 26.2% to 13.3% during the study period and the absolute number of inappropriate PCIs decreased from 21,781 to 7,921. The proportion of nonacute PCIs classified as appropriate increased from 30.1% to 53.6% and those considered uncertain decreased from 43.7% to 33.0%. At hospitals, the proportion of nonacute PCIs considered inappropriate decreased from 25.8% to 12.6%.

According to the study authors, four distinct trajectories in changes in rate of inappropriate PCI between 2011 and 2014 were observed among hospitals in the highest quartile for the proportion of nonacute PCI deemed inappropriate. Hospitals in groups 1, 2, and 4 had similar baseline rates of inappropriate PCI, but the 108 hospitals in group 4 showed immediate and steady declines in rates of inappropriate PCI from 43.9% to 15.5%. The 18 hospitals in group 1 had minimal change in the first 2 years but then showed lower rates of inappropriate PCI in the final 2 years of the study. Group 2, made up of 50 hospitals, demonstrated steady but smaller absolute declines in rates of inappropriate PCI compared with groups 1 and 4 from 40.9% to 32.3%. Finally, the 15 hospitals in group 3 had the highest initial rates of inappropriate PCI but also the largest absolute decline over the study period from 70.6% to 9.4%. There were no systematic differences in hospital characteristic, geographic location, financial status, or teaching status across hospital groups.

“This analysis provides detail about changes in the clinical profiles of patients undergoing PCI and suggests that the observed reductions in inappropriate PCI in part reflect improvements in patient selection and clinical decision-making as well as better documentation of the key elements used to determine procedural appropriateness,” the authors said. “Trends consistent with improvements in patient selection include the reduction in nonacute PCI volume and changes in the clinical profile of patients undergoing nonacute PCI.”

Meanwhile, the authors caution that they cannot exclude the possibility that the decrease in inappropriate PCIs may be the result of changes in documentation or intentional up-coding, particularly of subjective data elements such as symptom severity. However, they noted they “did not see evidence that patients were being systematically shifted from nonacute indications for PCI. Rather, they noted, the number of acute PCIs was stable over time, and “the proportion of patients undergoing acute PCI reported to have unstable angina decreased.”

Desai and colleagues also acknowledged that because the cases in their analysis were all performed after the release of the AUC, they could not evaluate the impact of the criteria. While the study’s findings are a description of the changes in patterns of care during this period, it is likely that many factors—including the publication of the COURAGE and BARI 2D trials—influenced practice during this time as well.

Moving forward, the authors note that the persistent variation in hospital-level performance of inappropriate PCI suggests the need for ongoing performance improvement initiatives and hospital benchmarking. Identifying the organizational strategies and structures most strongly associated with lower rates of inappropriate PCI is an important area for future research, they said.

On a related note, a research letter published at the same time in JAMA Internal Medicine, also lead by Desai, examined the patterns of institutional review of PCI appropriateness since the AUC was published and found marked heterogeneity, with almost one in four hospitals reporting no review. According to the authors, this finding suggests that many hospitals have not prioritized improving their performance on AUC. There was also variation in the proportion of rarely appropriate PCI across institutions, but there was no association between hospital review of PCI appropriateness with procedural appropriateness, use of guideline-recommended care, or clinical outcomes.

Of note, hospitals with a higher volume of nonacute PCI had a lower proportion or rarely appropriate PCI across all review frequencies. It is not clear whether this is a result of better communication, leadership, and oversight at higher-volume PCI centers. The authors conclude that “there is a pressing need to identify effective strategies that can be used to support institutional improvement of PCI appropriateness.”

Desai NR, Bradley SM, Parzynski CS, et al. JAMA. 2015;doi:10.1001/jama.2015.13764.
Desai NR, Parzynski CS, Krumholz HM, et al. JAMA Internal Medicine. 2015; doi:10.1001/jamainternmed.2015.6217.

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Negative Statin News May Be Associated with Early Discontinuation, CVD Mortality

Negative statin-related news stories may be associated with early statin discontinuation, and consequently may increase the risk of myocardial infarction and cardiovascular disease mortality, according to a study published Dec. 1 in European Heart Journal.

The study looked at 674,900 Danish individuals ages 40 or older who were using statins from 1995 to 2010. The authors identified 1,931 statin-related news stories from Jan. 1995 and onwards in Danish newspapers, magazines, radio, television, websites, and news agencies and assessed the effect on statin discontinuation.

Results showed that individuals on statins increased from <1% in 1995 to 11% in 2010, however, early statin discontinuation increased from 6% in 1995 to 18% in 2010.

“We found that exposure to negative news stories about statins was linked to stopping statins early and explained 2% of all heart attacks and 1% of all deaths from cardiovascular disease associated with early discontinuation of statins,” said Børge Nordestgaard, MD, DMSc, chief physician at Copenhagen University Hospital in Denmark and a co-author of the study.

“Although we cannot say for sure that statin-related negative news stories cause the early discontinuation of statins, our findings suggest that this is likely. And although this type of association research cannot prove causality, our data suggest that early discontinuation of statins leads to unnecessary heart attacks and deaths from cardiovascular disease,” he adds.

The authors conclude that, moving forward, their findings “suggest a need for protocols aimed at increasing early adherence to stain therapy.”

Nielsen SF and Nordestgaard BG. EHJ. 2015;doi:10.1093/eurheartj/ehv641.

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Predicting Risk in Pediatric and Congenital Cardiac Catheterization

In a recent paper published in Circulation, researchers developed and validated a model to predict the occurrence of major adverse events after cardiac catheterization for congenital heart disease.

The researchers, led by Natalie Jayaram, MD, MSB, aimed to apply aspects of prior risk-standardization methodology to develop a risk-standardization tool for the NCDR Improving Pediatric and Adult Congenital Treatment (IMPACT) Registry^®.

The primary outcome was the occurrence of a major adverse event: cardiac arrest, tamponade, embolic stroke or thrombus, device embolization, new requirement for dialysis, event requiring extracorporeal membrane oxygenation, event requiring left ventricular assist device unplanned cardiac or vascular surgery, or subsequent cardiac catheterization. Death was only included in a secondary analysis.

The study cohort included 19,608 cardiac catheterization procedures performed at 58 U.S. centers between Jan. 2011, and March 2013. A major cardiac adverse event occurred in 378 (1.9%) patients. Cardiac arrest was the most frequent, occurring in 158 (0.8%) procedures. Neonates and infants were more likely to experience an adverse event compared with older children and adults. Additionally, patients with single-ventricle physiology and renal insufficiency were more likely to experience an adverse event compared with those that had a chronic lung disease or genetic/congenital condition. Patients requiring inotropic support before the case were significantly more likely to experience an adverse event compared with patients without inotropic needs.

The final model included eight variables: age, single-ventricular anatomy, renal insufficiency, procedure-type risk category, low systemic arterial saturation, low mixed venous saturation, elevated systemic ventricular end-diastolic pressure, and elevated main pulmonary artery systolic mean or pressure. The model had good discrimination.

The authors write that “risk standardization will be of critical importance to institutions participating in IMPACT, allowing them to compare their outcomes with outcomes from other U.S. centers after adjusting for important patient characteristics, thus identifying areas for improvement. Ultimately, this could allow improved care in the setting of catheterization for congenital heart disease.”

Jayaram N, Beekman RH, Benson L, et al. Circulation.2015;132:1863-70.

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Which Stents Are Safest in Surgery?

The safety of surgery in patients with a coronary stent may depend on the type of stent they have, according to a study published Dec. 8 in Circulation: Cardiovascular Quality and Outcomes. Newer generation drug-eluting stents (DES) and bare metal stents (BMS) showed similar safety and were safer than older generation DES.

A significant number of patients receive coronary stents and then need surgery. Risks during surgery include ischemic and bleeding events. The study authors, led by Francesco Saia, MD, examined patients who had undergone PCI and stenting from the multicenter Registro regionale AngiopLastiche dell’Emilia-Romana (REAL) Registry. A total of 13,128 patients underwent 17,226 surgical procedures. The cumulative incidence of any surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively. At 30 days, 6 months and 1 year, the cumulative incidence of noncardiac surgery was 1.3%, 5.1%, and 9.1% and of cardiac surgery was 0.8%, 2.1%, and 2.6%, respectively. The majority of the procedures were noncardiac and about one-third were done on an urgent basis.

BMS was more common in patients who underwent surgery less than 1 year from PCI, possibly reflecting the preference for BMS in patients with planned surgery.

After 30 days post-surgery, 754 (4.4%) patients died, 438 (2.5%) experienced cardiac death, 256 (1.5%) experienced nonfatal myocardial infarction (MI), and a serious bleeding event (SBE) occurred in 1,099 (6.4%) patients. Bleeding was fatal in 115 cases (10.5% of all SBE). Thrombotic risk was independently associated with periprocedural cardiac death/MI, whereas surgical risk and bleeding risk were not. Stent thrombosis risk was not independently associated with periprocedural SBE, but operative risk category was a significant predictor of and bleeding risk category was strongly related to SBE. About 18% of the procedures had a high cardiac risk and 25% had a high bleeding risk.

There was an increased risk of ischemic events with older DES. BMS and newer DES were not significantly different between 6 and 12 months and over 12 months after PCI, but newer DES appeared somewhat safer between 0 and 180 days. Finally, the researchers evaluated the overall effect of surgery and timing of surgery with respect to PCI over cardiovascular mortality during follow-up and found that surgery was associated with an increased risk, which was strongly influenced from the time span between PCI and surgery.

According to the authors, the “study confirms that careful cardiovascular risk stratification, including assessment of intrinsic surgical cardiac risk, bleeding risk, and thrombotic risk associated with the stent, may be helpful in predicting the risk of periprocedural event and should always be adopted.”

In a Journal Scan on ACC.org, Prashant Vaishnava, MD, writes, “Though limited by its retrospective design, this is an important study, which establishes that the incidence of noncardiac surgery after PCI may be higher than has traditionally been reported. The authors re-focus perioperative risk management to an integrated approach that includes consideration of ischemic risk, thrombotic risk, and bleeding risk. As the authors opine and as is accepted, there is a “need for dedicated pharmacological strategies aimed at minimizing both ischemic and bleeding risk in patients with coronary stents undergoing surgery.”

Saia F, Belotti LMB, Guastaroba P, et al. Circ Cardiovasc Qual Outcomes. 2015;doi:10.1161/CIRCOUTCOMES.115.002155.

Keywords: CardioSource WorldNews, Cardiac Catheterization, Drug-Eluting Stents, Myocardial Infarction, Patient Selection, Percutaneous Coronary Intervention, Registries, Stents

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