REVIVED-BCIS2: Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

Authors, Journal, Affiliations, Type, DOI

• Authors: Perera D, Clayton T, O'Kane PD, Greenwood JP, Weerackody R, Ryan M, Morgan HP, Dodd M, Evans R, Canter R, Arnold S, Dixon LJ, Edwards RJ, De Silva K, Spratt JC, Conway D, Cotton J, McEntegart M, Chiribiri A, Saramago P, Gershlick A, Shah AM, Clark AL, Petrie MC; for the REVIVED-BCIS2 Investigators
• Journal: New England Journal of Medicine. Published August 27, 2022
• Affiliations: King's College London / Guy's and St. Thomas' NHS Foundation Trust (lead centre); 40 UK centres; statistical coordination: London School of Hygiene and Tropical Medicine
• Type: Prospective, multicentre, randomised, open-label superiority RCT; government-funded (NIHR Health Technology Assessment Programme, award 10/57/67); no industry sponsorship
• DOI: 10.1056/NEJMoa2206606

Overview

REVIVED-BCIS2 is the first adequately powered RCT to test PCI versus optimal medical therapy (OMT) alone in patients with severe ischaemic LV systolic dysfunction (LVEF ≤35%, extensive CAD, demonstrable viability in ≥4 dysfunctional myocardial segments amenable to PCI). Among 700 randomised patients followed for a median of 41 months across 40 UK centres, PCI produced no benefit over OMT for the primary composite of all-cause death or HF hospitalisation (HR 0.99; P=0.96), no incremental improvement in LVEF at 6 or 12 months, and no sustained quality-of-life advantage despite an early KCCQ signal at 6 months (+6.5 points) that eroded by 24 months as the OMT group improved. The result challenges the myocardial hibernation paradigm — viability-guided patient enrichment did not translate to clinical benefit from PCI — and extends prior STICH/STICH-viability substudy findings to the PCI revascularisation modality. It directly informed the 2023 AHA/ACC CCS guideline recommendation that PCI does not confer survival benefit in ischaemic cardiomyopathy.

Keywords

REVIVED-BCIS2, PCI, percutaneous coronary intervention, ischaemic left ventricular dysfunction, ischaemic cardiomyopathy, myocardial viability, myocardial hibernation, optimal medical therapy, LVEF, heart failure, KCCQ, revascularisation, STICH

Key Takeaways

Background

• CAD is the most common cause of HF worldwide. Myocardial hibernation — contractile dysfunction reversible with restored blood supply — is the theoretical basis for revascularisation in ischaemic LV dysfunction
• STICH trial showed CABG benefit on 10-year all-cause and CV mortality in LVEF ≤35%, but early hazard limited short-term benefit; STICH viability substudy (SPECT/dobutamine echo, n=618) showed viability did not discriminate who benefited from CABG
• PCI offers potential revascularisation without CABG operative risk; most prior comparisons excluded patients with severe LV dysfunction (LVEF ≤35%)
• REVIVED-BCIS2 was designed to determine whether PCI could capture revascularisation benefit without surgical hazard in viability-enriched patients

Methods

• Design: Prospective, multicentre, randomised (1:1), open-label RCT; 40 UK centres; August 2013 to March 2020; follow-up concluded March 2022
• Population: LVEF ≤35% (echo or CMR); extensive CAD (BCIS jeopardy score ≥6 on a 0–12 scale); demonstrable viability in ≥4 dysfunctional myocardial segments amenable to PCI
• Exclusions: Acute MI within 4 weeks; acute decompensated HF; sustained VA within 72 hours before randomisation
• Baseline characteristics: Mean age 70 years; predominantly male; mean jeopardy score 9.3; ICD or CRT device in 250 patients (35.7%)
• PCI group (n=347): Revascularisation of all diseased proximal coronary vessels subtending viable myocardium; 96.3% underwent PCI at median 35 days post-randomisation; 80 patients had staged PCI; mean jeopardy score post-PCI 2.7; anatomical revascularisation index 71%
• OMT group (n=353): Individually adjusted pharmacological + device HF therapy; guidelines reviewed periodically by medical therapy committee
• Primary outcome: All-cause death or HF hospitalisation; minimum 24-month follow-up
• Power: 700 patients, 300 events → ≥85% power to detect HR 0.70; actual 263 events → ~82% power; HR 0.99 with CI 0.78–1.27 makes type II error implausible

Results — Primary Outcome and Components

• Primary composite (all-cause death + HF hospitalisation):
  • PCI: 37.2% (129/347); OMT: 38.0% (134/353)
  • HR 0.99 (95% CI 0.78–1.27; P=0.96) — no benefit
  • Effect consistent across all prespecified subgroups; no heterogeneity
• All-cause death:
  • PCI: 31.7% (110); OMT: 32.6% (115)
  • HR 0.98 (95% CI 0.75–1.27)
• HF hospitalisation:
  • PCI: 14.7% (51); OMT: 15.3% (54)
  • HR 0.97 (95% CI 0.66–1.43)

Results — LVEF (Major Secondary Outcome)

• LVEF improved from baseline in both groups over 12 months — objective evidence that OMT alone restores LV function in some patients
• At 6 months: PCI mean difference vs OMT = −1.6 pp (95% CI −3.7 to 0.5) — not significant
• At 12 months: mean difference = +0.9 pp (95% CI −1.7 to 3.4) — not significant
• PCI did not produce incremental LVEF recovery beyond OMT alone despite viability enrichment

Results — Quality of Life (Major Secondary Outcome)

• KCCQ at 6 months: PCI favoured by +6.5 points (95% CI 3.5–9.5) — above the ~5-point MCID; genuine early QoL benefit
• KCCQ at 12 months: PCI favoured by +4.5 points (95% CI 1.4–7.7)
• KCCQ at 24 months: +2.6 points (95% CI −0.7 to 5.8) — no longer significant; OMT group improved progressively over time
• NYHA class and CCS angina class were similar between groups at all time points

Results — Other Secondary Outcomes

• ICD appropriate therapy at 24 months: PCI 5.9% vs OMT 14.0%; risk ratio 0.42 (95% CI 0.17–1.06) — trend toward less VT/VF termination in PCI group but not statistically significant
• Myocardial infarction (overall): Similar — 10.7% PCI vs 10.8% OMT (HR 1.01); but periprocedural MI occurred only in PCI group; more spontaneous MI in OMT
• Unplanned revascularisation: PCI 2.9% vs OMT 10.5% (HR 0.27, 95% CI 0.13–0.53) — significantly less in PCI group, as expected
• NT-proBNP: Decreased in both groups at 6 months; no between-group difference at any time point

Results — Safety

• Major bleeding (year 1): PCI 3.1% vs OMT 0.6%; relative risk 4.95 (95% CI 1.09–22.43) — significantly higher in PCI year 1
• Major bleeding (2 years): RR 1.42 (95% CI 0.55–3.68) — no longer significant
• Serious adverse events: PCI 29.4% vs OMT 29.5% — equivalent overall

Limitations of the Document

• Open-label design: Blinding not possible; may affect patient-reported outcomes (KCCQ, EQ-5D). Mitigated by blind adjudication of HF hospitalisations and core-laboratory LVEF assessment
• Predominantly asymptomatic patients (little or no angina): Findings do not generalise to patients with angina-limiting quality of life — PCI might still benefit this group
• 37 fewer events than planned: 263 vs 300 projected; reduced power from 85% to ~82%; however, HR 0.99 with CI 0.78–1.27 renders a meaningful missed benefit implausible
• Concordance between revascularised vessels and viable segments not confirmed: The trial cannot determine whether the PCI was delivered to the segments identified as viable by imaging; functional completeness of revascularisation likely higher than the 71% anatomical index
• UK-only centres: Generalisability to other healthcare systems and patient populations requires caution
• No CMR-guided viability: Viability was assessed by echocardiography, SPECT, or dobutamine echo — not LGE-CMR; whether CMR-guided selection would identify a subgroup with PCI benefit remains unknown
• Modern GDMT context (but pre-SGLT2i era): SGLT2i were not yet guideline-standard at the time of enrolment; contemporary quadruple GDMT baseline may further reduce any incremental PCI benefit

Key Concepts Mentioned

• concepts/Myocardial-Viability — primary clinical concept tested; viability-guided PCI did not confer benefit
• concepts/Late-Gadolinium-Enhancement — CMR viability assessment context (not the primary method used in REVIVED)

Key Entities Mentioned

• entities/Heart-Failure — ischaemic cardiomyopathy management; REVIVED-BCIS2 as primary evidence that PCI does not improve outcomes
• entities/Chronic-Coronary-Disease — PCI vs GDMT in chronic coronary disease with LV dysfunction
• entities/ICD — ICD appropriate therapy trend (PCI 5.9% vs OMT 14.0% at 24 months; non-significant)

Wiki Pages Updated

• wiki/sources/pci-hf-revived-bcis2-nejm-2022.md — created (this page)
• wiki/concepts/Myocardial-Viability.md — updated (REVIVED-BCIS2 source citation added; expanded detail; new contradiction re: CABG vs PCI divergence; source_count 1→2)
• wiki/entities/Heart-Failure.md — updated (inline REVIVED-BCIS2 source citation added; source_count 23→24)
• wiki/sourceindex.md — updated
• wiki/wikiindex.md — updated