TCT-425 Real-World Experience with Absorb(tm) Bioresorbable Scaffold Technology - Early Australian Registry Results (original) (raw)
2013, Journal of the American College of Cardiology
Background: Bioresorbable vascular scaffolds have been available on the European market since November 2011. The first experience in a real-world setting is being documented in the ASSURE registry (NCT01583608). The registry aims to investigate the safety, efficacy and performance of the everolimus-eluting, bioresorbable vascular scaffold (BVS, ABSORBÔ, Abbott Vascular Inc., Santa Clara, CA) over a period of 3 years. Methods: Consecutive patients with de novo native coronary artery disease were treated with BVS at 6 German centers and included in the prospective, observational registry. Acute and 6-months outcomes of equal weight were device success, procedural success, cardiac death, myocardial infarction, ischemia driven target lesion revascularization and target vessel failure or revascularization. Angiographic parameters were assessed at baseline and post procedure. Results: A total of 183 patients (63.5 AE 9.3 years, 79.8% male) were enrolled from April 2012 to March 2013 and 198 lesions were treated. Eligibility criteria for ABSORB A/B would have been met in 16% and for ABSORB EXTEND in 70% of the patients. Acute device success was achieved in 194 (98%) lesions and acute procedural success in all patients. No cardiac death or myocardial infarction occurred and no target lesion revascularization was necessary during hospital stay. Median lesion length was 14.5 mm (5-84 mm) with 85 (42.9%) lesions > 20 mm. 31 (15.7%) lesions were moderately or heavily calcified, 6 (3%) lesions were tightly angulated and 6 (3%) lesions involved a side branch ! 2 mm in diameter. Diameter stenosis was 77.9% at baseline and 4.8% post PCI on average. In 11 (5.6%) lesions diameter of stenosis was ! 99%. The reference vessel diameter of 32 (16.2%) lesions was 2.5 mm. In 30 (15.2%) lesions > 1 BVS was implanted and in 11 patients > 1 target vessel was treated. Bailout with a drug eluting stent was necessary in 3 (1.5%) lesions. Conclusions: Acute results for safety, efficacy and performance of BVS for de novo coronary artery disease in all day clinical practice are promising. Angiographic core lab results will be obtained by June 2013 and clinical 6-months results by September 2013. TCT-422 Malapposition is observed more frequently and to a greater degree in fibrocalcific plaques during bioresorbable vascular scaffold implantation
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