Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

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Randomised Controlled TrialEvidence: Moderate
50CEBM

The New England journal of medicine

Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI

BACKGROUND: Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) has been associated with increased stent optimization and reduced adverse events among patients with complex coronary-artery lesions, but adoption of this strategy in Western countries remains low. Although practice guidelines recommend intracoronary imaging for anatomically complex lesions, evidence from current European practice is limited. METHODS: In this investigator-initiated, international, open-label, randomized, controlled trial, we assigned patients undergoing complex PCI to either IVUS-guided PCI, performed with the use of prespecified stent-optimization criteria, or angiography-guided PCI. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization. RESULTS: Of the 2020 patients who underwent randomization, 1010 in the IVUS-guided PCI group and 1009 in the angiography-guided PCI group were included in the primary analysis. The mean age of the patients was 69 years, 79.4% were men, and 27.4% presented with an acute coronary syndrome. The mean procedure duration was 88.8 minutes with IVUS-guided PCI and 66.2 minutes with angiography-guided PCI. Dilation with balloon angioplasty after stent implantation was performed in 91.3% of the IVUS-guided PCI procedures and in 84.5% of the angiography-guided PCI procedures. At a median follow-up of 19.0 months (interquartile range, 15.2 to 23.4), target-vessel failure had occurred in 140 patients (13.9%) in the IVUS-guided PCI group and in 112 patients (11.1%) in the angiography-guided PCI group (hazard ratio, 1.25; 95% confidence interval, 0.97 to 1.60; P = 0.08). Procedural complications occurred in 11.3% of the IVUS-guided PCI procedures and in 10.2% of the angiography-guided PCI procedures. The frequency of adverse events appeared to be similar in the two groups. CONCLUSIONS: Among patients undergoing complex high-risk PCI, a strategy of routine IVUS-guided PCI performed with the use of prespecified stent-optimization criteria was not associated with a lower risk of target-vessel failure than angiography-guided PCI alone. (Funded by Boston Scientific; IVUS-CHIP ClinicalTrials.gov number, NCT04854070.).

13 June 2026

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Randomised Controlled TrialEvidence: Strong
80CEBM

Journal of the American Heart Association

Comparison of Intravascular Imaging-, Physiology-, or Angiography-Guided Approaches for Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis

BACKGROUND: Despite current guidelines recommending physiology- and intravascular imaging-guided percutaneous coronary intervention (PCI) in specific lesion subsets, angiography-guided PCI remains common in practice. The comparative effectiveness of these strategies remains uncertain. We aimed to compare clinical outcomes of PCI guided by intravascular imaging or physiological assessment versus conventional angiography. METHODS: We conducted a systematic review and network meta-analysis of randomized controlled trials, searching PubMed and EMBASE up to May 31, 2025. Eligible studies compared at least 2 of the following 6 guidance modalities in PCI: angiography, intravascular ultrasound (IVUS), optical coherence tomography/optical frequency domain imaging, fractional flow reserve, angiography-derived fractional flow reserve, and instantaneous wave-free ratio. The primary outcome was trial-defined major adverse cardiovascular events (MACEs). Hazard ratios (HRs) with 95% CIs were pooled using a frequentist random-effects network meta-analysis. Subgroup analyses assessed clinical presentation and guidance objectives such as decision making and procedural optimization. RESULTS: We identified 43 randomized controlled trials involving 39 291 patients. IVUS-guided PCI (HR, 0.69 [95% CI, 0.60-0.79]), optical coherence tomography/optical frequency domain imaging-guided PCI (HR, 0.75 [95% CI, 0.63-0.90]), and fractional flow reserve-guided PCI (HR, 0.81 [95% CI, 0.70-0.95]) were associated with a lower risk of MACEs compared with angiography-guided PCI. Furthermore, IVUS-guided PCI was associated with a lower risk of MACEs compared with instantaneous wave-free ratio-guided PCI (HR, 0.74 [95% CI, 0.55-1.00]). IVUS-guided PCI reduced the risk of MACE in both acute coronary syndrome and non-acute coronary syndrome patients. CONCLUSIONS: IVUS- and optical coherence tomography/optical frequency domain imaging-guided PCI were superior to angiography-guided PCI in reducing MACEs. Among the physiology-based approaches, only fractional flow reserve showed a clear benefit.

9 Apr 2026

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