M. Galli et al., Acute and mid-term results of phosphorylcholine-coated stents in primary coronary stenting for acute myocardial infarction, CATHET C IN, 53(2), 2001, pp. 182-187
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-e
xpandable stent, laser etched from a 316 L stainless steel tube. This devic
e is coated with phosphorylcholine, a synthetic, hemocompatible phospholipi
d polymer that has been shown in experimental studies to reduce platelet an
d protein adhesion to the surface of the metal. One hundred consecutive pat
ients within 24 hr of symptoms of onset of acute MI, treated with primary P
ICA, were enrolled. After PICA, stenting was attempted in all eligible lesi
ons (reference diameter greater than or equal to 2.5 mm; no bend lesion > 4
5 degrees). Poststenting regimens contained ticlopidine (500 mg/day) and as
pirin (325 mg/day) and 6-12 hr of heparin infusion. Procedural success (TIM
I greater than or equal to II and residual stenosis < 30%) was obtained in
70/74 cases (95%). TIMI grade III was restored in 90% of cases. In the pati
ent group with procedural success (70 cases), 70 BiodivYsio stents were pla
ced. 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 wa
s reported. Two in-hospital major adverse cardiac events (MACE) were report
ed due to a nontreated left main disease that required coronary artery bypa
ss 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 remaini
ng 6%. Primary stenting with phosphorylcholine-coated stent leads to excell
ent short- and mid-term clinical outcomes and is associated with a restenos
is rate of 12%. (C) 2001 Wiley-Liss, Inc.