Acute and mid-term results of phosphorylcholine-coated stents in primary coronary stenting for acute myocardial infarction.

The aim of this pilot study was to evaluate the safety and efficacy of the BiodivYsio phosphorylcholine-coated stent in the primary treatment of acute myocardial infarction. The BiodivYsio stent (Biocompatible) is a balloon-expandable stent, laser etched from a 316 L stainless steel tube. This device is coated with phosphorylcholine, a synthetic, hemocompatible phospholipid polymer that has been shown in experimental studies to reduce platelet and protein adhesion to the surface of the metal. One hundred consecutive patients within 24 hr of symptoms of onset of acute MI, treated with primary PTCA, were enrolled. After PTCA, stenting was attempted in all eligible lesions (reference diameter > or = 2.5 mm; no bend lesion > 45 degrees ). Poststenting regimens contained ticlopidine (500 mg/day) and aspirin (325 mg/day) and 6-12 hr of heparin infusion. Procedural success (TIMI > or = II and residual stenosis < 30%) was obtained in 70/74 cases (95%). TIMI grade III was restored in 90% of cases. In the patient group with procedural success (70 cases), 70 BiodivYsio stents were placed. After stenting, diameter stenosis decreased from 96% +/- 11% to 22% +/- 12% (P < 0.01) and minimal luminal diameter increased from 0.13 +/- 0.29 to 2.47 +/- 0.43 (P < 0.01). Nominal stent diameter was between 3.0 and 4.0 mm (mean, 3.5 +/- 0.4 mm). Stent length was between 11 and 28 mm (mean, 17 +/- 4.5 mm). Clinical follow-up was obtained in all patients; angiographic follow-up was performed in 65/70 (93%). No acute or subacute thrombosis was reported. Two in-hospital major adverse cardiac events (MACE) were reported due to a nontreated left main disease that required coronary artery bypass graft (CABG) surgery. At follow-up, MACE were found in 9 of 68 patients (13%), target lesion revascularization (TLR) in 6%, and CABG in the remaining 6%. Primary stenting with phosphorylcholine-coated stent leads to excellent short- and mid-term clinical outcomes and is associated with a restenosis rate of 12%.