Advertisement
Research Article|Articles in Press

Applicability of the EXCEL Trial Criteria to an All-Comers Real-World Cohort of Unprotected Left Main Percutaneous Coronary Intervention

Published:February 17, 2023DOI:https://doi.org/10.1016/j.amjcard.2023.01.024
      The Evaluation of XIENCE versus EXCEL (Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial is the largest randomized study comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comer population of ULMD PCI would be eligible for the EXCEL trial and whether these patients show different long-term outcomes than the rest of the ULMD population.
      A total of 246 consecutive patients underwent ULMD PCI between January 2018 and December 2021 and were retrospectively analyzed. After application of the EXCEL trial inclusion and exclusion criteria, 98 patients (39%) were allocated to the “EXCEL-like” cohort and 148 to the “non-EXCEL-like.” Baseline characteristics of the 2 groups were substantially comparable. The mean baseline SYNTAX score was lower in the EXCEL-like patients than the non-EXCEL-like group (20.1 ± 7.1 vs 23.0 ± 11.2, p = 0.025), with the latter also showing a higher degree of incomplete revascularization (residual SYNTAX score >8 : 11% vs 26%, p = 0.005). At 1 year, the cumulative major adverse cardiovascular and cerebral events rate was 7% for the EXCEL-like and 17% for the non-EXCEL-like patients, respectively (p = 0.03). At the last follow-up available, the significant difference in major adverse cardiovascular and cerebral events rate persisted (19% vs 37%, p = 0.02) and a significant difference in any unplanned revascularization was also shown (1.5% vs 13%, p = 0.04). In conclusion, in a contemporary real-world cohort of ULMD PCI, only a minority of patients could be enrolled in the EXCEL trial; the EXCEL-like patients, in our population, showed less clinical events at long-term follow-up than the cohort of patients who were ineligible for EXCEL, despite comparable baseline cardiovascular profiles; these findings may challenge a broad external applicability of the results of the EXCEL trial in routine clinical activity.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Kappetein AP
        • Serruys PW
        • Sabik JF
        • Leon MB
        • Taggart DP
        • Morice MC
        • Gersh BJ
        • Pocock SJ
        • Cohen DJ
        • Wallentin L
        • Ben-Yehuda O
        • van Es GA
        • Simonton CA
        • Stone GW
        Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.
        EuroIntervention. 2016; 12: 861-872
        • Mäkikallio T
        • Holm NR
        • Lindsay M
        • Spence MS
        • Erglis A
        • Menown IBA
        • Trovik T
        • Eskola M
        • Romppanen H
        • Kellerth T
        • Ravkilde J
        • Jensen LO
        • Kalinauskas G
        • Linder RBA
        • Pentikainen M
        • Hervold A
        • Banning A
        • Zaman A
        • Cotton J
        • Eriksen E
        • Margus S
        • Sørensen HT
        • Nielsen PH
        • Niemelä M
        • Kervinen K
        • Lassen JF
        • Maeng M
        • Oldroyd K
        • Berg G
        • Walsh SJ
        • Hanratty CG
        • Kumsars I
        • Stradins P
        • Steigen TK
        • Fröbert O
        • Graham ANJ
        • Endresen PC
        • Corbascio M
        • Kajander O
        • Trivedi U
        • Hartikainen J
        • Anttila V
        • Hildick-Smith D
        • Thuesen L
        • Christiansen EH
        Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.
        Lancet. 2016; 388: 2743-2752
        • Stone GW
        • Kappetein AP
        • Sabik JF
        • Pocock SJ
        • Morice MC
        • Puskas J
        • Kandzari DE
        • Karmpaliotis D
        • Brown WM
        • Lembo NJ
        • Banning A
        • Merkely B
        • Horkay F
        • Boonstra PW
        • van Boven AJ
        • Ungi I
        • Bogáts G
        • Mansour S
        • Noiseux N
        • Sabaté M
        • Pomar J
        • Hickey M
        • Gershlick A
        • Buszman PE
        • Bochenek A
        • Schampaert E
        • Pagé P
        • Modolo R
        • Gregson J
        • Simonton CA
        • Mehran R
        • Kosmidou I
        • Généreux P
        • Crowley A
        • Dressler O
        • Serruys PW
        • EXCEL Trial Investigators
        Five-year outcomes after PCI or CABG for left main coronary disease.
        N Engl J Med. 2019; 381: 1820-1830
        • Garcia-Garcia HM
        • McFadden EP
        • Farb A
        • Mehran R
        • Stone GW
        • Spertus J
        • Onuma Y
        • Morel MA
        • van Es GA
        • Zuckerman B
        • Fearon WF
        • Taggart D
        • Kappetein AP
        • Krucoff MW
        • Vranckx P
        • Windecker S
        • Cutlip D
        • Serruys PW
        • Academic Research Consortium
        Standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document.
        Circulation. 2018; 137: 2635-2650
        • Serruys PW
        • Onuma Y
        • Garg S
        • Sarno G
        • van den Brand M
        • Kappetein AP
        • Van Dyck N
        • Mack M
        • Holmes D
        • Feldman T
        • Morice MC
        • Colombo A
        • Bass E
        • Leadley K
        • Dawkins KD
        • van Es GA
        • Morel MA
        • Mohr FW
        Assessment of the SYNTAX score in the Syntax study.
        EuroIntervention J Eur Collab Work Group Interv Cardiol Eur Soc Cardiol. 2009; 5: 50-56
        • Généreux P
        • Palmerini T
        • Caixeta A
        • Rosner G
        • Green P
        • Dressler O
        • Xu K
        • Parise H
        • Mehran R
        • Serruys PW
        • Stone GW
        Quantification and impact of untreated coronary artery disease after percutaneous coronary intervention: the residual SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) score.
        J Am Coll Cardiol. 2012; 59: 2165-2174
        • Mohammad MA
        • Persson J
        • Buccheri S
        • Odenstedt J
        • Sarno G
        • Angerås O
        • Völz S
        • Tödt T
        • Götberg M
        • Isma N
        • Yndigegn T
        • Tydén P
        • Venetsanos D
        • Birgander M
        • Olivecrona GK
        Trends in clinical practice and outcomes after percutaneous coronary intervention of unprotected left main coronary artery.
        J Am Heart Assoc. 2022; 11e024040
        • Kayaert P
        • Coeman M
        • Hanet C
        • Claeys MJ
        • Desmet W
        • De Pauw M
        • Haine S
        • Taeymans Y
        Practice and long-term outcome of unprotected left main PCI: real-world data from a nationwide registry.
        Acta Cardiol. 2022; 77: 51-58
      1. Tarantini G, Fovino LN, Varbella F, Trabattoni D, Caramanno G, Trani C, De Cesare N, Esposito G, Montorfano M, Musto C, Picchi A, Sheiban I, Gasparetto V, Ribichini FL, Cardaioli F, Saccà S, Cerrato E, Napodano M, Martinato M, Azzolina D, Andò G, Mugnolo A, Caruso M, Rossini R, Passamonti E, Teles RC, Rigattieri S, Gregori D, Tamburino C, Burzotta F. A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study [published online August 31, 2022]. EuroIntervention doi:10.4244/EIJ-D-22-00454.

        • Chalikias G
        • Drosos I
        • Tziakas DN
        Contrast-induced acute kidney injury: an update.
        Cardiovasc Drugs Ther. 2016; 30: 215-228
        • Capodanno D
        Beyond the SYNTAX score–advantages and limitations of other risk assessment systems in left main percutaneous coronary intervention.
        Circ J. 2013; 77: 1131-1138