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Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients
Open accessAbstract
Background A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction.Objectives The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization.Methods In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year.Results The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups.Conclusions In multivessel non-ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI]Patients One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984).
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“Diabetes is a frequent comorbidity in patients hospitalized for ACS, with an increasing prevalence over the last decade and a high mortality rate.409”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [409]
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“…composite outcome, myocardial infarction, and unplanned ischemia-driven revascularization, compared to staged CR. Similarly, the SMILE trial [13], which enrolled patients with NSTEMI and multivessel coronary disease, showed that single-stage percutaneous coronary intervention (PCI) during…”
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“Revascularization of the nonculprit vessels was performed in most of the studies guided by visual inspection of the angiographic stenosis while five studies used FFR to guide intervention.(5,15,17,19,23) There were some differences in the assessment of outcomes and not all effi-”
MethodResultInfluentialLim, Y., Jang, J.-H., Lee, S. H., Ahn, J. H., Hong, Y. J., Ahn, Y., Jeong, M. H., Kim, C. J., Hahn, J., Lee, J. M., et al. (2024) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2024.1475483 · Cited by 2
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“Für das NSTEMI-Patientenkollektiv erscheint die Revaskularisierung im Rahmen einer einzigen Prozedur mit einem verbesserten Outcome im Vergleich zu mehreren Eingriffen verbunden zu sein [10].”
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“The only prospective, randomized, multicenter controlled trial conducted exclusively in patients with NSTEMI, the SMILE trial by Sardella et al. [60], which included 584 patients with NSTEMI and MVD, evaluated the advantage of complete revascularization in single-stage vs. multistage PCI in NSTEMI…”
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Bär, S., Kavaliauskaite, R., Otsuka, T., Ueki, Y., Häner, J. D., Lanz, J., Fürholz, M., Praz, F., Hunziker, L., Siontis, G. C. M., et al. (2023) · Journal of the American Heart Association · doi:10.1161/jaha.123.031847 · Cited by 1
“24 For NSTE-ACS, a class IIa (level of evidence C) recommendation is given for immediate complete revascularization 1 based on the RCT SMILE 34 (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) and a meta-anal…”
Zhong, P.-Y., Sun, B., Cao, H.-P., Wang, W., & Xiong, T. (2024) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2506209 · Cited by 1
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Tratamento do enfarte do miocárdio sem elevação de ST: um eterno desafio…
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“The available evidence also supports complete revascularization in NSTEMI,(14) and recent studies recommend that revascularization be performed in a single procedure, since a staged approach is associated with a higher rate of major adverse cardiovascular and cerebrovascular events.(15) The study by Gonzales-Cambeiro…”
Revascularization Strategies in Multivessel Coronary Artery Disease
Caputi, C. G., Ricci, F., Innocentiis, C. D., Caterina, R. D., & Zimarino, M. (2018) · Springer eBooks · doi:10.1007/978-3-319-55994-0_53 · Cited by 1
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“Der Bedarf einer erneuten Revaskularisation konnte mit der „Single-Stage“-Mehrgefäß-PCI sogar signifikant gesenkt werden (HR 0,52, 95%-KI 0,31–0,88, p = 0,01) [8].”
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Complete Revascularization in Non–ST-Segment Elevation Acute Coronary Syndrome
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“Zusätzlich ist die anhand des logistischen EuroSCORE erwartete Letalität deutlich höher als die beobachtete gewesen.”
BackgroundInfluentialMultivessel vs. Culprit-Lesion-Stenting beim akuten Koronarsyndrom
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“However, it is important to note that a trend toward less mortality and reinfarction was also found in patients who underwent singlestage revascularization, with no increase in complications such as contrast-induced nephropathy or periprocedural infarction.(10) Another factor to consider when deciding on the type of r…”
BackgroundMethodThe year in cardiology 2016: acute coronary syndromes
Crea, F., Binder, R. K., & Lüscher, T. F. (2017) · Cardiologia Croatica · doi:10.15836/ccar2017.200
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I want it all, and I want it now
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Non‐ST‐Segment Elevation Acute Coronary Syndrome
Hanna, E. B. (2022) · Wiley eBooks · doi:10.1002/9781119832737.ch1
Editor-in-Chief’s Top Picks From 2016: Part One
Fuster, V. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.01.004
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Risk Stratification Approach to Multivessel Coronary Artery Disease
Greco, A., Buccheri, S., Tamburino, C., & Capodanno, D. (2022) · Interventional Cardiology · doi:10.1002/9781119697367.ch17
PCI Strategies in Acute Coronary Syndromes without ST Segment Elevation (NSTE‐ACS)
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Revascularisation in acute coronary syndromes: change in practice?
Pustjens, T. F. S., Vriesendorp, P. A., & Hof, A. W. J. V. ’. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00403-8
Impact of IVUS Guidance on Single-Session vs Staged Multivessel PCI
Ozaki, Y. (2023) · JACC Asia · doi:10.1016/j.jacasi.2023.04.009
“828).(5) Conflicting evidence has been provided concerning the timing of PCI for nonculprit lesion in patients with MVD.”
BackgroundBär, S., Kavaliauskaite, R., Otsuka, T., Ueki, Y., Häner, J. D., Lanz, J., Fürholz, M., Praz, F., Hunziker, L., Siontis, G. C. M., et al. (2023) · medRxiv · doi:10.1101/2023.07.24.23292979
Benefits of immediate complete revascularization in patients with acute coronary syndromes
Elscot, J. J., Kakar, H., Plantes, A. Z. D., Diletti, R., & Mieghem, N. M. V. (2024) · Minerva Cardiology and Angiology · doi:10.23736/s2724-5683.23.06473-6
Management von Patienten mit akutem Koronarsyndrom und koronarer Mehrgefäßerkrankung
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“However, these results were mainly driven by the results of the SMILE trial and were not associated with a reduction in long-term cardiovascular death [14–17].”
ResultOktaviono, Y. H., Arnindita, J. N., Saputra, P. B. T., Wairooy, N. A. P., Damayanti, A. A., Hutomo, S. A., Pratama, N. R., Farabi, M. J. A., & Ashari, F. Y. (2025) · PLoS ONE · doi:10.1371/journal.pone.0310695
“Types of stents received were bare metal stent (BMS) in 17,891 patients [11,12,15,17,39,41,43,45,50], drug-eluting stents (DES) in 42,227 patients [7,11,12,15,17,39,41,43–45], and both BMS and DES in 6 patients [17] (Table 3).”
InfluentialRao, C., Zhong, Q., Li, Z., Fu, L., Liu, W., Qin, W., Gao, J., Liu, B., He, K., & Zhou, F. (2025) · Catheterization and Cardiovascular Interventions · doi:10.1002/ccd.31679
“The landmark SMILE trial demonstrated that compared with multistage complete revascularization, single ‐ stage complete revascularization was associated with better clinical outcomes in patients with NSTEMI [35].”
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Complete Revascularization in NSTEMI and MVD
Kuramitsu, S. (2026) · JACC Asia · doi:10.1016/j.jacasi.2026.02.009
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Gabrielli, A., Elscot, J. J., Camilleri, W., Kakar, H., Boersma, E. H., Mieghem, N. M. V., Diletti, R., & den Dekker, W. K. (2026) · Catheterization and Cardiovascular Interventions · doi:10.1002/ccd.70767
“The MULTISTARS AMI and SMILE trials also showed a reduction in MACE with ICR [16, 17].”
Acute coronary syndrome: Non-ST-segment elevation myocardial infarction, emerging perspective 2026
Dhananiwala, A., & Bhandari, S. (2026) · Journal of current cardiology. · doi:10.4103/jcc.jcc_27_26
Metadata
- Authors
- Sardella, G., Lucisano, L., Garbo, R., Pennacchi, M., Cavallo, E., Stio, R. E., Calcagno, S., Ugo, F., Boccuzzi, G., Fedele, F., & Mancone, M.
- Affiliations
- Sapienza University of Rome (IT)
- Ospedale San Giovanni Bosco (IT)
- Corresponding author
- Sardella, Gennaro
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2016-01
- Volume
- 67
- Issue
- 3
- Pages
- 264-272
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2266436320
- Cited by
- 168
- References
- 28
- Citations by year
- 2026: 9 · 2025: 17 · 2024: 25 · 2023: 25 · 2022: 17 · 2021: 18 · 2020: 15 · 2019: 14 · 2018: 11 · 2017: 9 · 2016: 7
- FWCI
- 15.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiac Imaging and Diagnostics
- Keywords
- complete coronary revascularization, major adverse cardiac and cerebrovascular events, target vessel revascularization, cardiovascular mortality, long-term outcomes, multivessel coronary artery disease, reinfarction, stroke, hospital readmission
- MeSH terms
- Coronary Vessels, Humans, Myocardial Infarction, Percutaneous Coronary Intervention
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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