Impact of PCI versus optimal medical therapy on quality of life in patients with chronic total occlusions: NOBLE-CTO randomized controlled trial
M M Brochner, J J Siig, M K Christensen, P Soegaard, S Riahi, A Lismanis, K Grikis, D Sondore, E O Fosse, T Steigen, B Raungaard, J G Rasmussen, T Zaremba, L Thuensen, A EftekhariAbstract
Background
There are no definitive randomized trials demonstrating prognostic benefit of chronic total occlusion percutaneous intervention (CTO-PCI) and prior studies have been neutral due to lack of power and high cross-over rates. The main anticipated gain is therefore symptomatic relief and better quality of life. Given the complexity of CTO-PCI more data is needed.
Purpose
To evaluate the impact of CTO-PCI on quality of life and major adverse cerebrovascular and cardiac events (MACCE).
Methods
The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion (NOBLE-CTO, NCT03392415), multicenter, multinational randomized trial, ran from June 2018 to August 2025.
Patients eligible for CTO-PCI with a vessel diameter ≥ 3.0 mm were offered enrollment. Main exclusion criteria were life expectancy <1 year, dialysis and inability to undergo cardiac magnetic resonance imaging.
Patients were randomly assigned to optimal medical therapy (OMT) or PCI. Following inclusion, Seattle Angina Questionnaire (SAQ) was recorded at baseline and at 6 months. Subsequently, the OMT group was offered cross-over.
Endpoints were change in SAQ and MACCE (all-cause mortality, myocardial infarction, revascularization, stroke and transitory cerebral ischemia). Premature ending of the trial due to slow inclusion gave power to evaluate SAQ only.
Results
Baseline characteristics were similar between groups. Of 247 patients included for analysis, 123 received PCI, and 124 OMT. Mean age was 66.8 years (±8.9), 205 (83.0%) were male, 180 (72.9%) were smokers, 207 (83.8%) had hypercholesterolemia, 184 (71.0%) hypertension and 20 (22.7%) diabetes mellitus. 122 (49.4%) patients had a history of PCI, and 11 (4.5%) coronary artery bypass grafting. 143 (57.9%) had multivessel disease. In 147 (60.7%) the index lesion was RCA, 52 (21.5%) LAD and 43 (17.8%) CX. Mean left ventricular ejection fraction was 50.8% (±14.6%).
Mean follow-up at time of analyses (30-09-2025) was 4.35 years with a combined 1073.94 patient years of follow-up. 17 (13.7%) of OMT patients chose PCI after 6 months.
In both arms SAQ increased significantly during follow-up, without any difference between arms. In patients with an initial Quality of Life Score <60, a larger increase in Angina Frequency Score (PCIΔ25.76 vs OMTΔ20.62, p=0.008), Quality of Life Score (PCIΔ39.41 vs OMTΔ28.76, p=0.01) and Treatment Satisfaction Score (PCIΔ2.48 vs OMTΔ0.89, p=0.026) was found among patients who underwent PCI (Figure 1). In patients with a CCS >1 at enrolment a larger increase in Quality of Life Score (PCIΔ22.8 vs OMTΔ14.68, p=0.007) and Treatment Satisfaction Score (PCIΔ2.74 vs OMTΔ1.88, p=0.043) among patients who underwent PCI, was observed (Figure 2).
Conclusion
This randomized trial showed that both CTO-PCI and OMT have equally good effect on quality of life. In patients with poor baseline quality of life, CTO-PCI was superior. There was no difference in MACCE between groups.Figure 1For image description, please refer to the figure legend and surrounding text.Figure 2For image description, please refer to the figure legend and surrounding text.