Research AppraisalSystematic Review

Ischaemic and bleeding events after complex versus non-complex PCI: a systematic review and meta-analysis

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of CardiologyPiccolo, Raffaele, Pio Vitale, Antonio, Laino, Angelo et al.6 Apr 2026DOI

Clinical Snapshot

85CEBM
Evidence: StrongSystematic Review

PICO Framework

P — PopulationPatients undergoing percutaneous coronary intervention (PCI) for myocardial revascularisation
I — InterventionComplex PCI procedures
C — ComparatorNon-complex PCI procedures
O — OutcomesPrimary: myocardial infarction and major bleeding. Secondary: all-cause death, stent thrombosis, cardiovascular death, target lesion/vessel revascularisation, and stroke

Bottom Line

This large meta-analysis of nearly 300,000 patients provides robust evidence that complex PCI procedures carry significantly higher risks of both ischaemic and bleeding complications compared to non-complex procedures. The 71% increased risk of myocardial infarction and 24% increased risk of major bleeding represent clinically meaningful differences that should inform procedural decision-making and patient counselling. While the observational nature of included studies limits causal inference, the consistency of findings across outcomes and the high certainty of evidence (moderate to high GRADE ratings) support the clinical validity of these associations. Interventional cardiologists should incorporate these risk estimates into shared decision-making processes, particularly when considering complex procedures in higher-risk patients. The findings emphasise the importance of careful patient selection, optimised medical therapy, and enhanced post-procedural monitoring for patients undergoing complex PCI.

Evidence: Strong

Key Findings

  • P Value: Posterior probability >99% for increased risk across all outcomes

  • Effect Size: Hazard ratios ranging from 1.21 to 1.99 across outcomes

  • Primary Outcome: Complex PCI associated with increased myocardial infarction (HR 1.71, 95% CrI: 1.49-1.96) and major bleeding (HR 1.24, 95% CrI: 1.14-1.35)

  • Nnt Or Sensitivity: Number needed to harm varies by baseline risk; approximately 1.2-2.0 fold increased risk across outcomes

  • Confidence Interval: 95% Bayesian credible intervals provided for all estimates

Clinical Application

Highly applicable as PCI complexity assessment is routine in catheterisation laboratories worldwide Relevant to Australian interventional cardiology practice; aligns with CSANZ PCI guidelines emphasising risk-benefit assessment. Medicare Benefits Schedule items for complex PCI procedures should incorporate these risk considerations Patients being considered for PCI, particularly those requiring complex procedures involving bifurcations, chronic total occlusions, or multivessel disease

Abstract

BACKGROUND: Complex percutaneous coronary intervention (PCI) is increasingly performed among patients undergoing myocardial revascularisation. AIMS: We conducted a systematic review and meta-analysis to evaluate the association between complex PCI and the risk of ischaemic and bleeding outcomes. METHODS: Hazard ratios (HRs) were pooled using a random-effects model within a Bayesian framework. The primary analysis was restricted to studies providing adjusted risk estimates, whereas the secondary analysis included unadjusted risk estimates. The primary outcomes were myocardial infarction and major bleeding. The secondary outcomes were all-cause death, stent thrombosis, cardiovascular death, target lesion or vessel revascularisation, and stroke. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework for prognostic studies was used to determine the level of certainty in the association between complex PCI and the risk of events. RESULTS: We included 290,039 patients, of whom 94,633 (33%) underwent complex PCI. Compared with non-complex PCI, patients undergoing complex PCI had a higher risk of myocardial infarction (adjusted HR 1.71, 95% credible interval [CrI]: 1.49-1.96), major bleeding (adjusted HR 1.24, 95% CrI: 1.14-1.35), all-cause death (adjusted HR 1.21, 95% CrI: 1.12-1.32), cardiovascular death (adjusted HR 1.29, 95% CrI: 1.15-1.46), stent thrombosis (adjusted HR 1.76, 95% CrI: 1.49-2.14), target lesion or vessel revascularisation (adjusted HR 1.99, 95% CrI: 1.58-2.50), and stroke (adjusted HR 1.21, 95% CrI: 1.03-1.42). The posterior probability of a higher risk associated with complex versus non-complex PCI was >99% for all study outcomes. Except for stroke (which was low certainty), the certainty of evidence was moderate to high for all other outcomes. Secondary analysis, including unadjusted risk estimates, provided consistent results. CONCLUSIONS: Patients undergoing complex PCI have an increased risk of both ischaemic and bleeding events compared with patients undergoing non-complex PCI (PROSPERO: CRD420250656254).

References

  1. 1.Piccolo, R., Vitale, A. P., Laino, A., Franzone, A., Cirillo, P., Di Serafino, L., Bardi, L., Spaccarotella, C. A. M., & Esposito, G. (2026). Ischaemic and bleeding events after complex versus non-complex PCI: a systematic review and meta-analysis. EuroIntervention. https://doi.org/10.4244/EIJ-D-25-01204
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