Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds

作者：Woehrle Jochen; Naber Christoph; Schmitz Thomas; Schwencke Carsten; Frey Norbert; Butter Christian; Brachmann Johannes; Ingwersen Maja; Drabik Anna; Markovic Sinisa; Mathey Detlef G^*

来源：Eurointervention, 2015, 11(2): 149-156.

DOI：10.4244/EIJY14M12_10

• bioresorbable vascular scaffold
• coronary artery disease
• percutaneous coronary intervention

Aims: Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting.
Methods and results: Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54 +/- 0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5 +/- 0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis.
Conclusions: One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.

• 出版日期2015-6