Bioresorbable vascular scaffolds may be implanted in more complex lesions, according to results from the BVS Expand Registry, published in JACC: Cardiovascular Interventions.
Cordula M. Felix, MD, of the Thoraxcenter in Rotterdam, the Netherlands, and colleagues initiated this prospective, single-center, single-arm study to evaluate the bioresorbable vascular scaffold system (Abosrb; Abbott Vascular) in more complex lesions (eg, calcified lesions, total occlusions, long lesions, and small vessels).
They recruited 249 patients with 335 lesions from September 2012 to January 2105. Patients were included if they presented with non-ST-segment elevation myocardial infarction (NSTEMI), stable or unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native, previously untreated, coronary artery.
Major adverse cardiac events (MACE) served as the primary end point, which was a composite of cardiac death, MI, and target lesion revascularization (TLR).
The mean lesion length was 22.16 ± 13.79 mm and the mean number of scaffolds per patient was 1.79 ± 1.15. There were American College of Cardiology/American Heart Association (ACC/AHA) classification type B2/C lesions present in 38% of patients, and invasive imaging was used in 39%.
The MACE rate was 6.8% at 18 months, and the rates of cardiac mortality, MI, and TLR were 1.8%, 5.2%, and 4.0%, respectively. Definite scaffold thrombosis occurred at a rate of 1.9%.
Researchers did find the following characteristics were associated with ≥2 times the increased MACE risk: male sex (hazard ratio [HR]: 4.079; P=.18), using >2 scaffolds or having >2 lesions (HR: 2.41; P=.19), underexpansion (HR: 2.25; P=.16), and age >65 years (HR: 2.11; P=.20).
In addition, the following characteristics were associated with ≥3 times the increased scaffold thrombosis risk: age >65 years (HR: 4.49; P=.19), long lesions (HR: 3.55; P=.27 for lesions of 20 mm and HR: 3.42; P=.22 for lesions of 33 mm), calcified lesions (HR: 3.55; P=.27), and reference vessel diameter ≤2.5 mm (HR: 3.26; P=.31).
“Taking into account the complexity of the treated lesions, the one-year MACE rate of 5.1% observed in the current registry is low and in line with previous trials using BVS [bioresorbable vascular scaffolds] in relatively simple lesions,” the authors noted.
Dr Felix and colleagues concluded that their study supports a more extensive use of bioresorbable vascular scaffolds as well as larger randomized trials comparing scaffolds with metal drug-eluting stents specifically in this patient setting.
Felix CM, Fam JM, Diletti R, et al. Mid-to-long-term clinical outcomes of patients treated with the everolimus-eluting bioresorbable vascular scaffold. The BVS Expand Registry. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2016.04.035.