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

• Published in: Catheterization and cardiovascular interventions 2001-06, Vol.53 (2), p.182-187
• Main Authors: Galli, Mario, Sommariva, Luigi, Prati, Francesco, Zerboni, Santino, Politi, Alessandro, Bonatti, Roberto, Mameli, Stefano, Butti, Elena, Pagano, Alberto, Ferrari, Giovann
• Format: Article
• Language: English
• Subjects: acute myocardial infarction; Aged; Angioplasty, Balloon, Coronary; Biological and medical sciences; clinical experience; coated coronary stent; Coronary Vessels - surgery; Diseases of the cardiovascular system; Endpoint Determination; Female; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - surgery; Myocardial Infarction - therapy; Phosphorylcholine; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.1145

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 ≥ 2.5 mm; no bend lesion > 45°). Poststenting regimens contained ticlopidine (500 mg/day) and aspirin (325 mg/day) and 6–12 hr of heparin infusion. Procedural success (TIMI ≥ 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%. Cathet Cardiovasc Intervent 2001;53:182–187. © 2001 Wiley‐Liss, Inc.