Heart (British Cardiac Society) · 2006
Steroid-eluting stents in patients with acute coronary syndrome: the dexamethasone eluting stent Italian registry.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ribichini Flavio, Tomai Fabrizio, Paloscia Leonardo, Di Sciascio Germano, Carosio Giuseppe, Romano Michele, Verna Edoardo, Galli Mario, Tamburino Corrado, De Cesare Nicoletta, Pirisi Raimondo, Piscione Federico, Lanteri Giorgio, Ferrero Valeria, Vassanelli Corrado, DESIRE investigators
Аннотация
OBJECTIVE: To assess immediate and mid-term clinical and angiographic outcomes of the dexamethasone drug-eluting stent (D-DES) in patients with acute coronary syndrome (ACS).
PATIENTS AND METHODS: A prospective, nationwide, controlled, registry. Inflammation plays a key role in ACS, and the anti-inflammatory effects of local elution of dexamethasone in unstable plaques may represent a valid therapeutic approach. All patients had ACS on admission (n = 332). 81.5% of the patients had unstable angina and 18.5% had non-ST elevation myocardial infarction (MI). 47% had ST-T segment changes, 59% had troponin elevation, 77% had elevated C-reactive protein levels and 48% had intermediate-high Thrombolysis in Myocardial Infarction risk score. Patients were treated according to an early invasive approach with 420 D-DES in 387 coronary lesions. Primary end point was the cumulative incidence of death, MI and ischaemia-driven target vessel revascularisation (TVR) at 6 months.
RESULTS: At 30 days, 2 (0.6%) patients died, and sub-acute stent thrombosis occurred in 2 patients. At 6 months, 328 (98.8%) patients were controlled, 3 (0.9%) patients had died, 7 (2.1%) had MI and 28 (8.5%) underwent ischaemia-driven TVR. Therefore, the primary end point occurred in 11.5% of patients. At multivariate analysis, multi-vessel coronary artery disease (odds ratio (OR) = 2.16, 95% CI = 1.47 to 3.17, p = 0.0001) and vessel diameter < or =2.75 mm (OR = 1.64, 95% CI = 1.08 to 2.49, p = 0.02) were independent predictors of 6-month clinical events. Global angiographic restenosis rate was 33.3%.
CONCLUSION: This is the first large, multicentre analysis of the clinical and angiographic outcomes obtained with D-DES implanted in ACS. D-DES offers a low rate of clinical events at 6 months, but has no anti-restenosis effect.
PATIENTS AND METHODS: A prospective, nationwide, controlled, registry. Inflammation plays a key role in ACS, and the anti-inflammatory effects of local elution of dexamethasone in unstable plaques may represent a valid therapeutic approach. All patients had ACS on admission (n = 332). 81.5% of the patients had unstable angina and 18.5% had non-ST elevation myocardial infarction (MI). 47% had ST-T segment changes, 59% had troponin elevation, 77% had elevated C-reactive protein levels and 48% had intermediate-high Thrombolysis in Myocardial Infarction risk score. Patients were treated according to an early invasive approach with 420 D-DES in 387 coronary lesions. Primary end point was the cumulative incidence of death, MI and ischaemia-driven target vessel revascularisation (TVR) at 6 months.
RESULTS: At 30 days, 2 (0.6%) patients died, and sub-acute stent thrombosis occurred in 2 patients. At 6 months, 328 (98.8%) patients were controlled, 3 (0.9%) patients had died, 7 (2.1%) had MI and 28 (8.5%) underwent ischaemia-driven TVR. Therefore, the primary end point occurred in 11.5% of patients. At multivariate analysis, multi-vessel coronary artery disease (odds ratio (OR) = 2.16, 95% CI = 1.47 to 3.17, p = 0.0001) and vessel diameter < or =2.75 mm (OR = 1.64, 95% CI = 1.08 to 2.49, p = 0.02) were independent predictors of 6-month clinical events. Global angiographic restenosis rate was 33.3%.
CONCLUSION: This is the first large, multicentre analysis of the clinical and angiographic outcomes obtained with D-DES implanted in ACS. D-DES offers a low rate of clinical events at 6 months, but has no anti-restenosis effect.