Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction : Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial
BACKGROUND: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure hospitalization; however, patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone.
METHODS: REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within the trial, mean total costs and quality-adjusted life-years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors.
RESULTS: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: -0.015, £6782). For both groups, most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0.
CONCLUSIONS: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920048.
| Errataetall: |
CommentIn: Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010572. - PMID 37929590 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:17 |
|---|---|
| Enthalten in: |
Circulation. Cardiovascular quality and outcomes - 17(2024), 1 vom: 01. Jan., Seite e010533 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Chivardi, Carlos [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 26.01.2024 Date Revised 01.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT01920048 CommentIn: Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010572. - PMID 37929590 Citation Status MEDLINE |
|---|
| doi: |
10.1161/CIRCOUTCOMES.123.010533 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM364214295 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM364214295 | ||
| 003 | DE-627 | ||
| 005 | 20240401232405.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1161/CIRCOUTCOMES.123.010533 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1359.xml |
| 035 | |a (DE-627)NLM364214295 | ||
| 035 | |a (NLM)37929587 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Chivardi, Carlos |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction |b Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 26.01.2024 | ||
| 500 | |a Date Revised 01.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01920048 | ||
| 500 | |a CommentIn: Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010572. - PMID 37929590 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure hospitalization; however, patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone | ||
| 520 | |a METHODS: REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within the trial, mean total costs and quality-adjusted life-years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors | ||
| 520 | |a RESULTS: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: -0.015, £6782). For both groups, most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0 | ||
| 520 | |a CONCLUSIONS: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom | ||
| 520 | |a REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920048 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a coronary artery disease | |
| 650 | 4 | |a heart failure | |
| 650 | 4 | |a humans | |
| 650 | 4 | |a myocardial revascularization | |
| 650 | 4 | |a percutaneous coronary intervention | |
| 700 | 1 | |a Morgan, Holly |e verfasserin |4 aut | |
| 700 | 1 | |a Sculpher, Mark J |e verfasserin |4 aut | |
| 700 | 1 | |a Clayton, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Evans, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Dodd, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Petrie, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Rinaldi, Christopher A |e verfasserin |4 aut | |
| 700 | 1 | |a O'Kane, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Brown, Louise |e verfasserin |4 aut | |
| 700 | 1 | |a Perera, Divaka |e verfasserin |4 aut | |
| 700 | 1 | |a Saramago, Pedro |e verfasserin |4 aut | |
| 700 | 0 | |a REVIVED-BCIS2 Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Perera, Divaka |e investigator |4 oth | |
| 700 | 1 | |a Chiribiri, Amedeo |e investigator |4 oth | |
| 700 | 1 | |a Carr-White, Gerry |e investigator |4 oth | |
| 700 | 1 | |a Pavlidis, Antonis |e investigator |4 oth | |
| 700 | 1 | |a Redwood, Simon |e investigator |4 oth | |
| 700 | 1 | |a Clapp, Brian |e investigator |4 oth | |
| 700 | 1 | |a Rinaldi, Aldo |e investigator |4 oth | |
| 700 | 1 | |a Rahman, Haseeb |e investigator |4 oth | |
| 700 | 1 | |a Briceno, Natalia |e investigator |4 oth | |
| 700 | 1 | |a Arnold, Sophie |e investigator |4 oth | |
| 700 | 1 | |a Raynsford, Amy |e investigator |4 oth | |
| 700 | 1 | |a Wilson, Karen |e investigator |4 oth | |
| 700 | 1 | |a Clack, Lucy |e investigator |4 oth | |
| 700 | 1 | |a Petrie, Mark |e investigator |4 oth | |
| 700 | 1 | |a McEntegart, Margaret |e investigator |4 oth | |
| 700 | 1 | |a Watkins, Stuart |e investigator |4 oth | |
| 700 | 1 | |a Shaukat, Aadil |e investigator |4 oth | |
| 700 | 1 | |a Rocchiccioli, Paul |e investigator |4 oth | |
| 700 | 1 | |a McAdam, Marion |e investigator |4 oth | |
| 700 | 1 | |a McPherson, Elizabeth |e investigator |4 oth | |
| 700 | 1 | |a Cowan, Louise |e investigator |4 oth | |
| 700 | 1 | |a Wood, Marie |e investigator |4 oth | |
| 700 | 1 | |a Weerackody, Roshan |e investigator |4 oth | |
| 700 | 1 | |a Davies, Ceri |e investigator |4 oth | |
| 700 | 1 | |a Smith, Elliot |e investigator |4 oth | |
| 700 | 1 | |a Modi, Bhavik |e investigator |4 oth | |
| 700 | 1 | |a Mathew, Bindu |e investigator |4 oth | |
| 700 | 1 | |a Mitchelmore, Oliver |e investigator |4 oth | |
| 700 | 1 | |a Adrego, Rita |e investigator |4 oth | |
| 700 | 1 | |a Andiapen, Mervyn |e investigator |4 oth | |
| 700 | 1 | |a O'Kane, Peter |e investigator |4 oth | |
| 700 | 1 | |a Din, Jehangir |e investigator |4 oth | |
| 700 | 1 | |a Kennard, Sarah |e investigator |4 oth | |
| 700 | 1 | |a Orr, Sarah |e investigator |4 oth | |
| 700 | 1 | |a Purnell, Cathie |e investigator |4 oth | |
| 700 | 1 | |a Greenwood, John |e investigator |4 oth | |
| 700 | 1 | |a Blaxill, Jonathan |e investigator |4 oth | |
| 700 | 1 | |a Mozid, Abdul |e investigator |4 oth | |
| 700 | 1 | |a Anderson, Michelle |e investigator |4 oth | |
| 700 | 1 | |a Somers, Kathryn |e investigator |4 oth | |
| 700 | 1 | |a Dixon, Lana |e investigator |4 oth | |
| 700 | 1 | |a Walsh, Simon |e investigator |4 oth | |
| 700 | 1 | |a Spence, Mark |e investigator |4 oth | |
| 700 | 1 | |a Glover, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Brown, Caroline |e investigator |4 oth | |
| 700 | 1 | |a Amin-Youssef, George |e investigator |4 oth | |
| 700 | 1 | |a Shah, Ajay |e investigator |4 oth | |
| 700 | 1 | |a McDonagh, Theresa |e investigator |4 oth | |
| 700 | 1 | |a Byrne, Jonathan |e investigator |4 oth | |
| 700 | 1 | |a Pareek, Nilesh |e investigator |4 oth | |
| 700 | 1 | |a Breeze, Jonathan |e investigator |4 oth | |
| 700 | 1 | |a Antao, Catherine |e investigator |4 oth | |
| 700 | 1 | |a De Silva, Kalpa |e investigator |4 oth | |
| 700 | 1 | |a Strange, Julian |e investigator |4 oth | |
| 700 | 1 | |a Johnson, Tom |e investigator |4 oth | |
| 700 | 1 | |a Nightingale, Angus |e investigator |4 oth | |
| 700 | 1 | |a Gallego, Laura |e investigator |4 oth | |
| 700 | 1 | |a Medina, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Gershlick, Anthony |e investigator |4 oth | |
| 700 | 1 | |a McCann, Gerald |e investigator |4 oth | |
| 700 | 1 | |a Ladwiniec, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Squire, Iain |e investigator |4 oth | |
| 700 | 1 | |a Davison, Joanna |e investigator |4 oth | |
| 700 | 1 | |a Kenmuir-Hogg, Kris |e investigator |4 oth | |
| 700 | 1 | |a Spratt, James |e investigator |4 oth | |
| 700 | 1 | |a Cosgrove, Claudia |e investigator |4 oth | |
| 700 | 1 | |a Williams, Rupert |e investigator |4 oth | |
| 700 | 1 | |a Firoozi, Sam |e investigator |4 oth | |
| 700 | 1 | |a Lim, Pitt |e investigator |4 oth | |
| 700 | 1 | |a Bonato, Giovanna |e investigator |4 oth | |
| 700 | 1 | |a Sookhoo, Vennessa |e investigator |4 oth | |
| 700 | 1 | |a Conway, Dwayne |e investigator |4 oth | |
| 700 | 1 | |a Brooksby, Paul |e investigator |4 oth | |
| 700 | 1 | |a Wright, Judith |e investigator |4 oth | |
| 700 | 1 | |a Exley, Donna |e investigator |4 oth | |
| 700 | 1 | |a Cotton, James |e investigator |4 oth | |
| 700 | 1 | |a Horton, Richard |e investigator |4 oth | |
| 700 | 1 | |a Metherell, Stella |e investigator |4 oth | |
| 700 | 1 | |a Smallwood, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Hogrefe, Kai |e investigator |4 oth | |
| 700 | 1 | |a Cheng, Adrian |e investigator |4 oth | |
| 700 | 1 | |a Beirnes, Charmaine |e investigator |4 oth | |
| 700 | 1 | |a Sidgwick, Sian |e investigator |4 oth | |
| 700 | 1 | |a Lockie, Tim |e investigator |4 oth | |
| 700 | 1 | |a Patel, Niket |e investigator |4 oth | |
| 700 | 1 | |a Rakhit, Roby |e investigator |4 oth | |
| 700 | 1 | |a Davies, Nina |e investigator |4 oth | |
| 700 | 1 | |a Smit, Angelique |e investigator |4 oth | |
| 700 | 1 | |a Ahmed, Fozia |e investigator |4 oth | |
| 700 | 1 | |a Hendry, Cara |e investigator |4 oth | |
| 700 | 1 | |a Fath-Odoubadi, Farzin |e investigator |4 oth | |
| 700 | 1 | |a Fraser, Douglas |e investigator |4 oth | |
| 700 | 1 | |a Mamas, Mamas |e investigator |4 oth | |
| 700 | 1 | |a Oommen, Anu |e investigator |4 oth | |
| 700 | 1 | |a Charles, Thabitha |e investigator |4 oth | |
| 700 | 1 | |a Behan, Miles |e investigator |4 oth | |
| 700 | 1 | |a Japp, Alan |e investigator |4 oth | |
| 700 | 1 | |a Rif, Belinda |e investigator |4 oth | |
| 700 | 1 | |a Jenkins, Nicholas |e investigator |4 oth | |
| 700 | 1 | |a McClure, Sam |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Circulation. Cardiovascular quality and outcomes |d 2008 |g 17(2024), 1 vom: 01. Jan., Seite e010533 |w (DE-627)NLM193957256 |x 1941-7705 |7 nnns |
| 773 | 1 | 8 | |g volume:17 |g year:2024 |g number:1 |g day:01 |g month:01 |g pages:e010533 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1161/CIRCOUTCOMES.123.010533 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 17 |j 2024 |e 1 |b 01 |c 01 |h e010533 | ||