Author + information
- Antonio De Miguel Castro1,
- Etelberto Hernandez2,
- Victor Jimenez Diaz1,
- Alberto Ortiz Saez3,
- Guillermo Bastos Fernández1,
- Saleta Fernández Barbeira4,
- Ivan Gomez-Blazquez5,
- Jose Baz1 and
- Andres Iñiguez2
There is large information regarding the clinical results of Absorb bioresorbable vascular scaffold (Abbott Vascular) in selective patients included in randomized clinical trials. However, there are limited data on efficacy and safety of Absorb scaffold in non-selective patients treated with this device in daily clinical practice.
Single-center, prospective, observational study. Patients revascularized with Absorb scaffold in standard clinical practice entered into an all-comers design. The primary end point was a composite of cardiac death, myocardial infarction or stroke after 2-years follow-up. Data for patients with in-scaffold restenosis and/or thrombosis were collected.
242 patients were included (january 2012 - march 2016). 202 patients completed 2 years follow-up. Characteristics of the patients at baseline: mean age 58,5 years, male 78,7%, hypertension 54,5%, dyslipidemia 68,8%, diabetes mellitus 26,2%, previous myocardial infarction 25,5%, previous percutaneous coronary intervention 41,1%, previous bypass surgery 3,5%, mean ejection fraction 56,35%. Indication for percutaneous coronary intervention: ST-segment elevation myocardial infarction 22,3%, non-ST-segment elevation myocardial infarction 22,3%, unstable angina 12,4%, stable angina and/or documented ischemia 41,1%. Radial access 98,5%. The success of coronary angioplasty was 100%. Clinical events after 2 years follow-up are reported in attached table.
|Clinical events after 2 years follow-up|
|Composite of cardiac death, myocardial infarction or stroke||11 (5,5%)|
|Death from any cause - Cardiac||9 (4,5%) 5 (2,5%)|
|Stroke - Ischemic - Hemorrhagic||2 (1,0%) 1 (0,5%) 1 (0,5%)|
|All myocardial infarction - Non Q-wave - Q-wave - Fatal||6 (3,0%) 3 (1,5%) 3 (1,5%) 1 (0,5%)|
|Definitive scaffold thrombosis||6 (3,0%)|
In our single-center observational study, the incidence of clinical events, restenosis and definitive scaffold thrombosis after 2 years follow-up is concordant with those reported in large randomized clinical trials. Our results support the efficacy and safety of Absorb scaffold in non-selective patients treated with this device in daily clinical practice.
CORONARY: Stents: Bioresorbable Vascular Scaffolds