Fabrizio D'Ascenzo, Enrico Cerrato, Ovidio De Filippo, Luca Gaido, Alfonso Franzè, Mario Iannaccone, Wojciech Wańha, Andrea Santarelli, Vincenzo Guiducci, Umberto Barbero, Carlos Fernandez Pereira, Marco Gatti, Matteo Tebaldi, Massimo Giammaria, Giacomo Boccuzzi, Wojciech Wojakowski, Gianluca di Pietro, Roberto Placido, Sebastiano Gili, Alessandro Depaoli, Giuseppe Biondi Zoccai, Francesco Tomassini, Francesco Bruno, Daniela Zugna, Riccardo Faletti, Simone Biscaglia, Serena Caglioni, Ferdinando Varbella, Gaetano Maria de Ferrari, Gianluca Campo
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引用次数: 0
Abstract
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]).
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