I-LOVE-IT 2: Biodegradable Polymer SES as Effective as Durable Polymer SES in All-Comers
A novel biodegradable sirolimus-eluting stent (SES) is noninferior to a durable polymer SES at 1 year in real-world patients, according to data from the randomized I-LOVE-IT 2 trial that were presented at TCT 2014 and published simultaneously in JACC: Cardiovascular Interventions. However, researchers advised that it remains to be seen whether the new device can reduce the risk of stent thrombosis.
With minimal exclusion criteria, Bo Xu, MD, of Fu Wai Hospital, Beijing, China, randomly assigned patients 2:1 to receive biodegradable polymer SES (Tivoli, Essen Tech; n=1,860) or durable polymer SES (Firebird 2, Microport; n=930), both with similar cobalt chromium platforms, at 32 centers across China. Within the biodegradable polymer SES group, patients were also randomized to receive 6 or 12 months of dual antiplatelet therapy.
At 1 year, the biodegradable polymer SES proved noninferior to the durable polymer SES for the primary endpoint of target lesion failure (TLF; cardiac death, target vessel MI or clinically indicated target lesion revascularization), and the two devices were similar for each of the component endpoints (see Figure). Rates of definite/probable stent thrombosis were low and equivalent between groups at 0.4% for biodegradable polymer and 0.6% for durable polymer SES (P=.55).
Multivariate Cox regression analysis revealed four independent predictors of TLF at 1 year: emergent PCI for acute MI (HR 2.45; 95% CI 1.43-4.19; P=.001), baseline SYNTAX score (HR 1.02; 95% CI 1.01-1.04; P=.002), total stent length per patient (HR 1.00; 95% CI 1.00-1.01; P=.003) and unsuccessful lesion (HR 4.32; 95% CI 1.87-9.96; P=.0006).
“The present I-LOVE-IT 2 trial has demonstrated that [the biodegradable polymer] SES is noninferior in terms of efficacy to [the durable polymer] SES in clinical practice,” Xu said during his presentation. “Whether [the biodegradable polymer device] improves safety with respect to lowering stent thrombosis incidence compared with [the durable polymer device] remains to be shown in longer-term follow-up of this trial or in future studies.”
According to the paper, research aimed at achieving better safety for biodegradable polymer devices needs to focus both on reducing the thickness of stent struts and polymer.
Enrollment criteria
Patients included in the trial had at least one de novo coronary lesion with diameter stenosis ≥70% in a vessel, with a reference diameter between 2.5 mm and 4 mm. Complete revascularization was required within 30 days among patients with multivessel disease. Exclusion criteria included restenotic lesions, stent implantation within 1 year, and left ventricular ejection fraction <40%.
Disclosures:
Xu reports no relevant conflict of interest.
Comments