Scope of Sacubitril/Valsartan Eligibility After Heart Failure Hospitalization
2017; Lippincott Williams & Wilkins; Volume: 135; Issue: 21 Linguagem: Inglês
10.1161/circulationaha.117.027773
ISSN1524-4539
AutoresKishan S. Parikh, Steven J. Lippmann, Melissa A. Greiner, Paul A. Heidenreich, Clyde W. Yancy, Gregg C. Fonarow, Adrian F. Hernandez,
Tópico(s)Cardiac electrophysiology and arrhythmias
ResumoHomeCirculationVol. 135, No. 21Scope of Sacubitril/Valsartan Eligibility After Heart Failure Hospitalization Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBScope of Sacubitril/Valsartan Eligibility After Heart Failure HospitalizationFindings From the GWTG-HF Registry (Get With The Guidelines-Heart Failure) Kishan S. Parikh, MD, Steven J. Lippmann, PhD, Melissa Greiner, MS, Paul A. Heidenreich, MD, MS, Clyde W. Yancy, MD, MSc, Gregg C. Fonarow, MD and Adrian F. Hernandez, MD, MHS Kishan S. ParikhKishan S. Parikh From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). , Steven J. LippmannSteven J. Lippmann From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). , Melissa GreinerMelissa Greiner From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). , Paul A. HeidenreichPaul A. Heidenreich From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). , Clyde W. YancyClyde W. Yancy From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). , Gregg C. FonarowGregg C. Fonarow From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). and Adrian F. HernandezAdrian F. Hernandez From Duke Clinical Research Institute (K.S.P., S.J.L., M.A.G., A.F.H.) and Department of Medicine (K.S.P., A.F.H.), Duke University School of Medicine, Durham, NC; Stanford University School of Medicine, Palo Alto, CA (P.A.H.); Bluhm Cardiovascular Institute, Northwestern University, Chicago, IL (C.W.Y.); and Geffen School of Medicine at University of California at Los Angeles (G.C.F.). Originally published23 May 2017https://doi.org/10.1161/CIRCULATIONAHA.117.027773Circulation. 2017;135:2077–2080Sacubitril/valsartan was compared to enalapril in the PARADIGM-HF trial (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure [HF]), which was stopped early after an observed 20% reduction in the composite end point of cardiovascular death or HF hospitalization.1 The US Food and Drug Administration (FDA) approved sacubitril/valsartan for patients with HF with reduced ejection fraction (HFrEF) in July 2015. However, FDA labeling is broader than trial entry criteria, and the scope of potential sacubitril/valsartan use in HFrEF is not well understood. We used the GWTG-HF registry (Get With The Guidelines-Heart Failure) to characterize patients' eligibility and potential barriers for sacubitril/valsartan initiation according to criteria set forth in FDA labeling and PARADIGM-HF. The GWTG-HF registry was started in 2005 by the American Heart Association to improve adherence to quality of care guidelines for patients hospitalized for HF. Patients were eligible for inclusion in the registry if they were admitted for worsening HF or developed significant HF symptoms during a hospitalization.2 We included GWTG-HF registry participants ≥18 years of age hospitalized with HFrEF (EF ≤40%) between January 1, 2011, and December 31, 2013. Patients were excluded if they had in-hospital death or any missing information for variables needed to determine PARADIGM-HF eligibility. To assess clinical outcomes after discharge, participants who were ≥65 years of age with fee-for-service Medicare coverage were linked to Medicare denominator and inpatient claims files.We divided patients into 3 groups: FDA-excluded (not meeting FDA labeling), PARADIGM-HF-excluded (meeting FDA but not PARADIGM-HF criteria), and PARADIGM-HF-like (meeting PARADIGM-HF criteria). FDA labeling requires HFrEF, potassium ≤5.2 mmol/L, and no contraindication or intolerance to ACEI/angiotensin-receptor blocker (ARB). To incorporate real-world considerations, we also required patients to have discharge SBP ≥90 mm Hg because of concern for hypotension with sacubitril/valsartan. The PARADIGM-HF-like group met the following additional criteria: EF ≤35%; BNP ≥150 pg/mL or NT-proBNP ≥600 pg/mL (or, if hospitalized for HF within 6 months, BNP ≥100 pg/mL or NT-proBNP ≥400 pg/mL); on ACEI/ARB and β-blocker at discharge; discharge SBP ≥100 mm Hg; and estimated glomerular filtration rate ≥30 mL/min/1.73 m2. PARADIGM-HF criteria were modified based on GWTG-HF data availability in 2 instances: (1) natriuretic peptide cutoffs were determined with a 12-month window of previous HF hospitalizations in PARADIGM-HF; and (2) a 2-week run-in period with enalapril 20 mg daily in PARADIGM-HF (no ACEI discharge dose in GWTG-HF). For the primary analysis, we made group comparisons for baseline, in-hospital, and discharge characteristics; for the Medicare-linked analysis, we compared survival and HF hospitalization outcomes at 30 days and 1 year after discharge. The Institutional Review Board of the Duke University Health System approved this study.Among 28 932 hospitalizations of HFrEF patients, 20 083 (69%) were for patients meeting FDA labeling (Table). The stricter PARADIGM-HF criteria limited eligibility to 11 018/20 083 (55%) of the cohort meeting FDA labeling or 11 018/28 932 (38%) of the overall HFrEF cohort. The most common reason to be in the FDA-excluded group was an existing contraindication to ACEI/ARB (89%); low discharge SBP excluded only 11% of patients. Among those in the PARADIGM-HF-excluded group, 34% of patients had EF of 35% to 40%, and 29% had discharge SBP <100 mm Hg. Using the original EF ≤40% PARADIGM-HF criterion3 would have shifted 1780 patients to the PARADIGM-HF-like group; similarly, relaxing the SBP criterion to the postrun in value (≥95 mm Hg) would have shifted 1051. Only 13% of the PARADIGM-HF-excluded patients were not receiving ACEI/ARB therapy. Once discharged, the PARADIGM-HF-like group had the best survival and HF hospitalization rate of all 3 groups (Table).Table. Characteristics and Outcomes, by Sacubitril/Valsartan EligibilityFDA-ExcludedPARADIGM-HF-ExcludedPARADIGM-HF-LikeP-Value*Characteristic N†8849906511 018 Age, mean±SD, y71.8±14.269.3±15.166.8±15.4<0.001 Men, n (%)5631 (64)5406 (60)7040 (64)<0.001 Race, n (%)<0.001 Asian/Pacific Islander129 (2)131 (1)179 (2) Black1472 (17)1556 (17)2209 (20) Native American34 (0)58 (1)56 (0) White4971 (56)4994 (55)5357 (49) Unknown2243 (25)2326 (26)3217 (29)Medical history, n (%) Anemia2321 (26)1910 (21)1350 (12)<0.001 Atrial fibrillation3420 (39)2960 (33)3032 (28)<0.001 Atrial flutter407 (5)350 (4)341 (3)<0.001 Chronic obstructive pulmonary disorder2993 (34)3060 (34)3332 (30)<0.001 Chronic renal insufficiency3451 (39)1874 (21)967 (9)<0.001 Coronary artery disease5266 (60)4922 (54)5360 (49)<0.001 Dialysis (chronic)364 (4)469 (5)30 (0)<0.001 Diabetes mellitus4139 (47)4158 (46)4756 (43)<0.001 Depression1145 (13)1065 (12)1259 (11).003 Hyperlipidemia5069 (57)4953 (55)5630 (51)<0.001 Hypertension6887 (78)7238 (80)8967 (81)<0.001 Previous coronary bypass surgery3905 (44)3525 (39)3741 (34)<0.001 Previous myocardial infarction2706 (31)2533 (28)2783 (25)<0.001 Peripheral vascular disease1426 (16)1205 (13)1212 (11)<0.001 Smoker in past year1531 (17)1972 (22)2834 (26)<0.001 Stroke/transient ischemic attack1592 (18)1394 (15)1522 (14)<0.001 Valvular heart disease2151 (24)1876 (21)1723 (16)<0.001Devices, n (%) CRT-D or CRT-P1493 (17)997 (11)1232 (11)<0.001 Implantable cardioverter-defibrillator1759 (20)1428 (16)1835 (17)<0.001 Pacemaker1357 (15)1314 (15)1357 (12)<0.001In hospital Body mass index at admission, mean±SD, kg/m228±829±929±8<0.001 Ejection fraction, mean±SD, %25.9±8.729.0±9.523.9±7.3<0.001 Length of stay, median (IQR), d6 (4, 9)5 (4, 7)5 (3, 7)<0.001 SBP at admission, mean±SD, mm Hg130±29139±30141±28<0.001Discharge BNP and NT-proBNP BNP, median (Q1, Q3), pg/mL1349 (668, 2532)939 (361, 1969)1110 (616, 1995)<0.001 NT-proBNP, median (Q1, Q3), pg/mL11 002 (5045, 22 570)6382 (2836, 14 301)5539 (2784, 11 105)<0.001 SBP, mean±SD, mm Hg114.5±20.2116.2±20.0121.7±16.0<0.001 Heart rate, mean±SD, bpm77.2±13.776.3±13.376.9±13.3<0.001 Potassium, mean±SD, mEq/L4.2±0.64.0±0.64.0±0.5<0.001 Creatinine, mean±SD, mg/dL2.0±1.21.7±1.31.2±0.4<0.001Heart failure medications, n (%) Renin-angiotensin inhibition ACEI or ARB931 (11)7919 (87)11 018 (100)<0.001 ACEI744 (8)6183 (68)9067 (82)<0.001 ARB199 (2)1815 (20)2079 (19)<0.001 ß-blocker7285 (82)7474 (82)11 018 (100)<0.001 Aldosterone antagonist2170 (25)2804 (31)4492 (41)<0.001Outcome, Medicare subgroup, n‡280228032986Mortality, n (%) 30 days310 (11)161 (6)112 (4)<0.001 1 y1396 (51)1000 (36)860 (29)<0.001Heart failure hospitalization, n (%) 30 days417 (15)257 (9)263 (9)<0.001 1 y1163 (42)958 (35)964 (33)<0.001ACEI indicates angiotensin-converting-enzyme inhibitor; ARB, angiotensin-receptor blocker; BNP, B-type natriuretic peptide; CRT-D, cardiac resynchronization therapy with defibrillator; CRT-P, cardiac resynchronization therapy with pacemaker; FDA, US Food and Drug Administration; NT-proBNP, N-terminal pro B-type natriuretic peptide; PARADIGM-HF, Prospective Comparison of ARNI (Angiotensin Receptor-Neprilysin Inhibitor) with ACEI (Angiotensin-Converting-Enzyme Inhibitor) to Determine Impact on Global Mortality and Morbidity in Heart Failure([HF]); and SBP, systolic blood pressure.*Ns for the baseline characteristics represent unique hospitalizations; data may be correlated to the extent that patients have multiple hospitalizations during the study period.†P-values for baseline characteristics were derived from Wilcoxon rank-sum tests for continuous variables and χ-square and Fisher exact tests for categorical variables.‡Time-to-event analysis was performed using Kaplan-Meier methods for all-cause mortality outcomes; hospitalization was evaluated using the cumulative incidence function, treating death as a competing risk. P-values for outcomes were derived from log-ranks tests (mortality) and Gray tests (hospitalizations).Discharge from an acute HF hospitalization represents an important opportunity to reevaluate medications, including potentially switching from ACEI/ARB or starting sacubitril/valsartan de novo. In a post hoc analysis of PARADIGM-HF, although most subjects reported New York Heart Association II symptoms, sacubitril/valsartan had similar benefit regardless of risk stratification.4 Further, if a hospitalization occurred in the follow-up period, subjects taking sacubitril/valsartan had reduced 30- and 60-day HF rehospitalization (odds ratio: 0.62).5 It is important to note that sacubitril/valsartan is currently approved and recommended for chronic, ambulatory HFrEF patients only, and our GWTG-HF analysis includes postacute patients with HF at discharge. The ongoing PIONEER-HF trial (comParIson Of Sacubitril/valsartaN Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode) will provide safety/efficacy data on in-hospital initiation. Concerns for sacubitril/valsartan initiation include worsening hypotension, generalizability of trial results, and potential need to have achieved ACEI/ARB target doses before initation. Our assessment of candidacy for sacubitril/valsartan was based on objective criteria that governed PARADIGM-HF and supported the FDA label indications. However, we recognize that physicians are the final arbiters of treatment decisions and that varying thresholds of equipoise may be operative in the decision analysis. We also acknowledge the insurance exigencies in practice and recognize that additional points of inertia may be again operative in access to therapy. Thus, the overall assessment of the potential adaptation of newer HF therapies may be impacted by factors beyond both trial and FDA criteria.Kishan S. Parikh, MDSteven J. Lippmann, PhDMelissa Greiner, MSPaul A. Heidenreich, MD, MSClyde W. Yancy, MD, MScGregg C. Fonarow, MDAdrian F. Hernandez, MD, MHSAcknowledgmentsDamon M. Seils, MA, Duke University, assisted with manuscript preparation. Mr Seils did not receive compensation for his assistance apart from his employment at the institution where the study was conducted.Sources of FundingThe GWTG-HF program is provided by the American Heart Association. The GWTG-HF is sponsored, in part, by Amgen Cardiovascular and has been funded in the past through support from Medtronic, GlaxoSmithKline, Ortho-McNeil, and the American Heart Association Pharmaceutical Roundtable. This project was supported in part by grant number U19HS021092 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. Preparation of the manuscript was supported by grant 5T32GM086330-05 from the National Insitutes of Health (K.S.P.). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.DisclosuresDr Fonarow reported consulting for Amgen, Medtronic, Novartis, and St Jude. Dr Hernandez reported receiving honoraria from Amgen, Gilead, Janssen, Merck & Co, and Novartis; and receiving research funding from Amgen, AstraZeneca, BMS, GlaxoSmithKline, Janssen, Novartis, and Portola.FootnotesCirculation is available at http://circ.ahajournals.org.Correspondence to: Adrian F. Hernandez, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail [email protected]References1. 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