Original Title: Clinical outcomes following “off-label” versus “established” indication of bioresorbable scaffolds for treatment of coronary artery disease in a real-world population.

Reference: Tadashi Miyazaki, et al EuroIntervention 2016;11:475-478.

Courtesy of Dr. Carlos Fava.

Bioresorbable scaffolds (BSB) have shown their benefit in different studies, but there is little information available on “off label” indications in the real world.

The study analyzed 189 patients with 260 lesions receiving BSB; only 21 (11.1%) were “on-label” indications and 168 (88.9%) with 225 lesions were “off-label” indications. The device used was the everolimus eluting scaffold Absorb (Abbott Vascular).

Patients in the “off-label” group were more often diabetic (28.6% vs 4.8%; p=0.03), with higher SYNTAX score (16.9 vs. 11.5; p=0.01), more lesions B2/C (54.3% vs. 80%; p=0.002), longer lesions (28 mm. vs. 13 mm p=0.01) and bigger number of implanted stents (1.17 vs. 1.59; p=<0.001).

Bifurcation lesions were similar in both groups. 4.4% of rotational atherectomy was used in the “off-label” patients to prepare the lesion.

While in hospital, there were no differences in MACE combined events, with an only event in the “off label” group due to a thrombus in the scaffold two hours post procedure.

At one year, neither were there differences in target vessel revascularization or target lesion failure. Two patients “off-label” presented stent thrombosis and received emergency PCI with second generation DES.

Conclusion

In the real world, 88.9% of patients received BSB with an “off-label” indication. “Off-label” indication of BSB seems to be associated to an acceptable evolution considering the complexity of the analyzed group.

Editorial Comment

This analysis shows that BSB assessed in real world patients with complex lesions offer a very good performance compared to second generation DES.

Courtesy of Dr. Carlos Fava. Interventional Cardiologist. Favaloro Foundation – Buenos Aires, Argentina.