Routine CCTA at 6 months after left main PCI did not significantly reduce the composite primary endpoint compared to standard care (11.9% vs 12.5%; HR 0.97; 95% CI 0.76-1.23; P=0.80).
RCT (n=606)
Open-label
1:1
Yes
Effect estimate: HR 0.97 (95% CI 0.76-1.23)
Absolute Event Rate: 11.9% vs 12.5%
p-value: p=0.80
BACKGROUND: The clinical benefit of routine coronary computed tomography angiography (CCTA) after percutaneous coronary intervention (PCI) for unprotected left main (LM) disease is uncertain. OBJECTIVES: The authors evaluated whether CCTA-guided follow-up improves clinical outcomes vs symptoms- or ischemia-driven care after LM PCI. METHODS: PULSE was a prospective, multicenter, open-label randomized trial. A total of 606 patients treated with second-generation drug-eluting stents were enrolled (October 2019 to September 2024) and randomized 1:1 to CCTA at 6 months (experimental) or standard care (control). The primary endpoint was a composite of all-cause death, spontaneous myocardial infarction (MI), unstable angina, or definite or probable stent thrombosis at 18 months. Secondary endpoints included target-lesion revascularization (TLR) and each primary endpoint component. RESULTS: CCTA was completed in 272/303 experimental patients (89.8%) after a median of 200 days (IQR: 181-270 days). The primary endpoint occurred in 36/303 experimental patients vs 38/303 control patients (11.9% vs 12.5%; HR: 0.97; 95% CI: 0.76-1.23; P = 0.80). Compared with the control arm, the CCTA arm showed a reduced risk of spontaneous MI (0.9% vs 4.9%; HR: 0.26; 95% CI: 0.07-0.91; P = 0.004) and an increased risk of imaging-triggered TLR (4.9% vs 0.3%; HR: 7.7; 95% CI: 1.70-33.7; P = 0.001), whereas clinically driven TLR rates were similar (5.3% vs 7.2%; HR: 0.74; 95% CI: 0.38-1.41; P = 0.32). CONCLUSIONS: Routine CCTA after LM PCI did not reduce the composite primary endpoint, but was associated with fewer spontaneous MIs and more imaging-triggered revascularizations. Future trials to clarify its value in complex anatomic subsets appear to be warranted. (Angiographic Control vs Ischemia-Driven Management of Patients Treated With PCI on Left Main With Drug-Eluting Stents PULSE; NCT04144881).
D’Ascenzo et al. (Sun,) conducted a rct in Unprotected left main disease after percutaneous coronary intervention (n=606). Routine coronary computed tomography angiography (CCTA) vs. Standard care (symptoms- or ischemia-driven care) was evaluated on Composite of all-cause death, spontaneous myocardial infarction, unstable angina, or definite or probable stent thrombosis at 18 months (HR 0.97, 95% CI 0.76-1.23, p=0.80). Routine CCTA at 6 months after left main PCI did not significantly reduce the composite primary endpoint compared to standard care (11.9% vs 12.5%; HR 0.97; 95% CI 0.76-1.23; P=0.80).