Difference in clinical target lesion revascularization between a silicon carbide-coated and an uncoated thin strut bare-metal stent: the PRO-Vision study.

BACKGROUND

Bare-metal stents trigger a foreign body reaction, resulting in neointima formation and restenosis. Silicon carbide (SiC) coating shields the metal from circulating blood and vessel wall, both potential sources of neointima smooth muscle cells.

METHODS

We investigated whether SiC-coated stents (PRO-Kinetic) have lower clinical target lesion revascularization (TLR) rates than do uncoated bare-metal stents (Vision). Stents were implanted in 2731 patients during 2 consecutive 18-month periods. Clinical TLR was evaluated at 1 year.

RESULTS

In the PRO-Kinetic group, TLR was significantly higher (9.0% vs 5.6%; unadjusted odds ratio, 1.61; 95% confidence interval [CI], 1.24-2.08; P < 0.001) compared with the Vision group. After adjustment for postintervention minimal luminal diameter (adjusted odds ratio [AOR], 0.56; 95% CI, 0.42-0.73), total implanted stent length (AOR, 1.01; 95% CI, 1.00-1.02), non-ST-segment elevation myocardial infarction or unstable angina at initial presentation (AOR, 1.89; 95% CI, 1.41-2.54), and triple vessel stenting (AOR, 2.68; 95% CI, 1.02-7.05), the use of PRO-Kinetic stents remained an independent predictor for revascularization (AOR, 1.57; 95% CI, 1.18-2.10; P = 0.002). Because strut thickness is lower in 2.0- to 3.0-mm PRO-Kinetic stents, a subgroup analysis (n = 2382 lesions) was performed. Even in this subgroup, PRO-Kinetic implantation proved an independent predictor of TLR (AOR, 1.62; 95% CI, 1.17-2.23; P = 0.003).

CONCLUSION

In contrast to theoretical expectations, the SiC-coated PRO-Kinetic stent was associated with greater target lesion revascularization rates at 1 year compared with the uncoated Vision stent.