New Research Using NCDR Data Highlights Real-World Impacts of Clinical Trial Findings

New research presented at ACC.17 is using data from ACC’s PINNACLE Registry to compare real-world patient outcomes to findings from recent clinical trials. The studies are part of ACC’s Research to Practice (R2P) initiative, which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC’s NCDR clinical registries. Two abstracts are being presented as part of ACC.17, while one study was recently published in the American Journal of Cardiology.

In one study led by Thomas M. MaddoxMD, MSc, FACC, et al., published in JAMA Internal Medicine, acute coronary syndrome (ACS) patients in ACC’s PINNACLE Registry were compared to patients in the IMPROVE-IT trial. The study, which looked at 31,008 ACS patients in the PINNACLE Registry from 2013 to 2014, found that only 35.3 percent (10,960) of current ACS patients would have qualified for the IMPROVE-IT trial. Additionally, ACS patients from the registry had more cardiovascular comorbidities and lower rates of statin, aspirin, ACEI/ARB and beta-blocker use than those in the trial population.

“It is unclear if the benefit seen with simvastatin/ezetimibe used in the trial translates to many current ACS patients,” the authors said. “In addition, with current guidelines recommending high-intensity statins for all ACS patients, the impact (…) is likely further reduced.”

In a second study, researchers found “the proportion of adult outpatients in contemporary cardiovascular practice potentially eligible for PCSK9 inhibitor therapy varied according to LDL-C goal and practice.” The U.S. Food and Drug Administration recently approved PCSK9 inhibitor use in patients with either familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease (ASCVD).

The study, led by Paul Hess, MD, et al., looked at 631,107 patients, 11,244 of whom had suspected FH and 192,176 of whom had ASCVD. The percentage of patients on a high-intensity statin and potentially eligible for PCSK9 therapy inclusive of suspected FH and ASCVD varied according to LDL-C goal for ASCVD (9.9 percent for LDL-C >=70 mg/dL; 4.5 percent for LDL-C >=100 mg/dL; and 1.9 percent for LDL-C >=130 mg/dL). Similarly, the proportion of potentially eligible patients also varied according to the practice (median 9.6 percent).

In a third study, recently published in the American Journal of Cardiology, findings suggest that patients with atrial fibrillation (AFib) may benefit from a structured weight reduction program as seen in the LEGACY trial. The study, led by Anil K. Gehi, MD, et al., found that 56.4 percent (197,255) of 349,999 patients in the PINNACLE Registry met the same enrollment criteria as the trial. However, registry patients were older, more likely to be female and had multiple comorbidities at different proportions, including hypertension, diabetes and coronary artery disease. They also had substantially lower rates of tobacco and alcohol abuse than those in the trial population.

According to the study authors, findings from LEGACY suggested “that significant (>10 percent) weight reduction can result in a 6-fold greater likelihood of AFib-free survival.” Given these findings and the fact that PINNACLE Registry patients had even lower rates of tobacco and alcohol abuse, a structured weight loss program “may lead to an even greater effect of weight loss on AFib burden in U.S. patients,” they said.

The Research to Practice (R2P) initiative was launched in 2015. Analyses under the R2P initiative are intended to help facilitate conversations between practice and research, and identify unanswered questions in current clinical research and future investigation topics to consider. To date, a total of six clinical studies under the oversight of the R2P initiative committee have been presented at national or international cardiology and diabetes conferences and/or published in peer-reviewed journals, including analyses of the PEGASUS-TIMI 54 trial, the AATAC trial and EMPA-REG OUTCOME trial.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Dyslipidemia, Prevention, Atrial Fibrillation/Supraventricular Arrhythmias, Lipid Metabolism, Nonstatins, Novel Agents, Primary Hyperlipidemia, Statins, Hypertension

Keywords: ACC17, ACC Annual Scientific Session, Acute Coronary Syndrome, Alcoholism, Aspirin, Atrial Fibrillation, Azetidines, Comorbidity, Coronary Artery Disease, Diabetes Mellitus, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hyperlipoproteinemia Type II, Hypertension, Outpatients, Registries, Research Personnel, Simvastatin, Tobacco, United States Food and Drug Administration, Weight Loss, Weight Reduction Programs, PINNACLE Registry, National Cardiovascular Data Registries


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