COMPARE-ABSORB: BVS noninferior to EES for TLF in high-risk patients

SAN DIEGO — In a population of high-risk patients, a bioresorbable vascular scaffold was noninferior to an everolimus-eluting stent for target lesion failure at 1 year, according to data presented at TCT 2018.

However, the BVS (Absorb, Abbott Vascular) was associated with higher rates of device thrombosis and target vessel MI compared with the EES (Xience, Abbott Vascular).

For the investigator-initiated COMPARE-ABSORB trial, researchers selected “a patient population which potentially might benefit the most by the vascular restoration therapy concept in the long term,” Pieter C. Smits, MD, PhD, FESC, director of the interventional cardiology and cardiac research departments at Maasstad Hospital in Rotterdam, the Netherlands, said during a press conference.

All of the 1,670 patients had high-risk characteristics for restenosis, defined as diabetes and/or multivessel disease with more than one de novo target lesion, or a complex de novo target lesion, defined as being at least 28 mm in length, in a small vessel, with a pre-existing total occlusion or a bifurcation, Smits said.

Pre-dilatation and post-dilatation were mandatory, and quantitative coronary angiography, IVUS or OCT was recommended to help place stents or scaffolds in target vessels less than 2.75 mm in reference vessel diameter.

Patients were randomly assigned to the BVS or the EES. The primary endpoint was noninferiority for TLF, defined as cardiac death, target vessel MI or clinically indicated target lesion revascularization, at 1 year. Smits said the investigators plan to follow the patients for 7 years.

At 1 year, the TLF rate was 4.2% for the EES and 5.1% for the BVS (difference, 0.9 percentage points; 95% CI, –1.2 to 3; HR = 1.24; 95% CI, 0.79-1.94; P for noninferiority < .001), Smits said.

The BVS group had higher 1-year rates of target vessel MI than the EES group (4% vs. 2.1%; HR = 1.96; 95% CI, 1.1-3.51), but not cardiac death (0.6% vs. 0.1%; HR = 4.87; 95% CI, 0.57-41.7) or clinically indicated TLR (2.4% vs. 2.7%; HR = 0.89; 95% CI, 0.48-1.62), according to the researchers.

Device thrombosis at 1 year was higher in the BVS group (2% vs. 0.6%; HR = 3.32; 95% CI, 1.22-8.99), Smits said, noting that in the BVS group, 56% of definite scaffold thrombosis cases occurred in patients with reference vessel diameter 2.75 mm or less, 76% of definite or probable scaffold thrombosis cases occurred within 10 days of the procedure and only one patient had scaffold thrombosis related to cessation of dual antiplatelet therapy.

“The target lesion failure rate in this high-risk population was for both devices impressively good, potentially due to the applied implantation protocol,” Smits said. – by Erik Swain

Reference:

Smits PC, et al. Late-Breaking Trials 5. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Disclosure: Smits reports he received institutional research grants from Abbott Vascular, St. Jude Medical and Terumo and speaker/consultant fees from Abbott Vascular, AstraZeneca, St. Jude Medical and Terumo.