Yuki Katagiri1, Giovanni Luigi De Maria2, Norihiro Kogame1, Ply Chichareon1, Kuniaki Takahashi1, Chun Chin Chang3, Rodrigo Modolo1, Simon Walsh4, Manel Sabate5, Justin Davies6, Maciej Lesiak7, Raul Moreno8, Ignacio Cruz-Gonzalez9, Nick E J West10, Jan J Piek1, Joanna J Wykrzykowska1, Vasim Farooq11, Javier Escaned12, Adrian P Banning2, Yoshinobu Onuma3, Patrick W Serruys13. 1. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 2. Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom. 3. ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands. 4. Department of Cardiology, Belfast Health & Social Care Trust, Belfast, United Kingdom. 5. Thorax Institute, Hospital Clinic I Provincial de Barcelona, Barcelona, Spain. 6. Department of Cardiology, Imperial College London, London, United Kingdom. 7. 1st Department of Cardiology, University of Medical Sciences, Poznañ, Poland. 8. Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain. 9. Department of Cardiology, Hospital Universitario de Salamanca, Salamanca, Spain. 10. Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom. 11. Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, United Kingdom. 12. Hospital Cliinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain. 13. NHLI, Imperial College London, London, United Kingdom.
Abstract
OBJECTIVES: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD). BACKGROUND: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD. METHODS: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. RESULTS: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2 , intermediate tercile: 5.0-6.7 mm2 , and largest tercile: >6.7 mm2 ). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post-procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR. CONCLUSIONS: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years.
OBJECTIVES: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD). BACKGROUND: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD. METHODS: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. RESULTS: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2 , intermediate tercile: 5.0-6.7 mm2 , and largest tercile: >6.7 mm2 ). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post-procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR. CONCLUSIONS: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years.