Treatment of left main coronary artery stenosis with the STENTYS self-expandable drug-eluting stent - a pilot registry

Postepy Kardiol Interwencyjnej. 2014;10(4):226-30. doi: 10.5114/pwki.2014.46941. Epub 2014 Nov 17.

Abstract

Percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA) for revascularization after stenosis is still considered controversial therapy. Previous studies were performed with balloon-expandable drug-eluting stents (DES). Balloon-expandable stents presented a challenge because they were not able to adapt effectively to variation in the vessel lumen. There are limited data on LMCA therapy with self-expandable DES for treatment of medial and distal lesions. The advantages of a self-apposing stent are adaptation to vessel size, vessel tapering, stent sizing, and good apposition. This was a pilot study to determine safety and device success rate in patients with middle and distal LMCA stenosis treated with the STENTYS self-expanding coronary DES stent. The primary endpoints were device success, acute procedural success and in-hospital and 30-day MACE. Twenty-four patients were included. Median logistic EuroSCORE was 1.6% (1.1-2.6%). Median Syntax score was 20.0 (20.0-27.2) points. Significant stenosis according to the anatomical region was in the middle of the LMCA in 5 cases (21%) and the distal part in 19 (79%). Stent sizes used were: 3.0 × 3.5 mm in 9 (37.5%); 3.5 × 4.0 mm in 3 (12.5%); 3.5 × 4.5 mm in 12 (50%). Device success and acute procedural success were achieved in 23 patients (95.8%), with no edge dissection in any patient. In 1 patient the proximal end of the stent protruded into the aorta. In all patients during their hospitalization and 30-day follow-up there were no adverse events. The data compiled from this small, single-center pilot study suggest that the STENTYS self-expanding coronary stent may be a reasonable approach to treat lesions within the LMCA. These results warrant a larger future clinical trial.

Keywords: left main; percutaneous coronary intervention; self-expanding stent.