Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial.
OBJECTIVES
This study sought to demonstrate the 5-year clinical and functional multislice computed tomography angiographic results after implantation of the fully resorbable everolimus-eluting scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California).


BACKGROUND
Multimodality imaging of the first-in-humans trial using a ABSORB BVS scaffold demonstrated at 2 years the bioresorption of the device while preventing restenosis. However, the long-term safety and efficacy of this therapy remain to be documented.


METHODS
In the ABSORB cohort A trial (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation), 30 patients with a single de novo coronary artery lesion were treated with the fully resorbable everolimus-eluting Absorb scaffold at 4 centers. As an optional investigation in 3 of the 4 centers, the patients underwent multislice computed tomography (MSCT) angiography at 18 months and 5 years. Acquired MSCT data were analyzed at an independent core laboratory (Cardialysis, Rotterdam, the Netherlands) for quantitative analysis of lumen dimensions and was further processed for calculation of fractional flow reserve (FFR) at another independent core laboratory (Heart Flow, Redwood City, California).


RESULTS
Five-year clinical follow-up is available for 29 patients. One patient withdrew consent after 6 months, but the vital status of this patient remains available. At 46 days, 1 patient experienced a single episode of chest pain and underwent a target lesion revascularization with a slight troponin increase after the procedure. At 5 years, the ischemia-driven major adverse cardiac event rate of 3.4% remained unchanged. Clopidogrel was discontinued in all but 1 patient. Scaffold thrombosis was not observed in any patient. Two noncardiac deaths were reported, 1 caused by duodenal perforation and the other from Hodgkin's disease. At 5 years, 18 patients underwent MSCT angiography. All scaffolds were patent, with a median minimal lumen area of 3.25 mm(2) (interquartile range: 2.20 to 4.30). Noninvasive FFR analysis was feasible in 13 of 18 scans, which yielded a median distal FFR of 0.86 (interquartile range: 0.82 to 0.94).


CONCLUSIONS
The low event rate at 5 years suggests sustained safety after the implantation of a fully bioresorbable Absorb everolimus-eluting scaffold. Noninvasive assessment of the coronary artery with an option of functional assessment could be an alternative to invasive imaging after treatment of coronary narrowing with such a polymeric bioresorbable scaffold. (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation [ABSORB]; NCT00300131).
['Onuma|Yoshinobu|Y|', 'Dudek|Dariusz|D|', 'Thuesen|Leif|L|', 'Webster|Mark|M|', 'Nieman|Koen|K|', 'Garcia-Garcia|Hector M|HM|', 'Ormiston|John A|JA|', 'Serruys|Patrick W|PW|']
D000368:Aged D001672:Biocompatible Materials D002317:Cardiovascular Agents D017023:Coronary Angiography D003324:Coronary Artery Disease D023903:Coronary Restenosis D003328:Coronary Thrombosis D003331:Coronary Vessels D054855:Drug-Eluting Stents D005060:Europe D000068338:Everolimus D005260:Female D053805:Fractional Flow Reserve, Myocardial D006801:Humans D008297:Male D008875:Middle Aged D061330:Multidetector Computed Tomography D009520:New Zealand D062645:Percutaneous Coronary Intervention D011237:Predictive Value of Tests D011446:Prospective Studies D011474:Prosthesis Design D020123:Sirolimus D013997:Time Factors D016896:Treatment Outcome
multislice computed tomography computed tomography MSCT fractional flow reserve FFR target lesion revascularization ischemia-driven interquartile range bioresorbable scaffold CT FFR(CT) ID IQR IVUS MACE MI OCT PDLLA PLLA QCA TLR TVR everolimus intravascular ultrasound major adverse cardiac event(s) myocardial infarction noninvasive fractional flow reserve according to multislice computed tomography noninvasive functional assessment optical coherence tomography poly-d,l-lactide poly-l-lactide quantitative coronary angiography target vessel revascularization