Stent restenosis study

Fischman DL, Leon MB, Bairn DS, et al., for the Stent Restenosis Study Investigators. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994 331 496-501. 

Vascular stenting has become a common procedure during percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) procedures because it has been found to reduce restenosis (Narins et al., 1998). In both the STRESS (Stent Restenosis Study) and BENESTENT... 

Zairis MN, Ambrose JA, Manousakis SJ, et al. The impact of plasma levels of C-reactive protein, lipoprotein (a) and homocysteine on the long-term prognosis after successful coronary stenting the Global evaluation of new events and restenosis after stent implantation study. J Am Coll Cardiol 2002 40 1375-1382. 

In a study by Bartunek et al. [134], 35 patients were infused with AC 133 bone marrow cells after AMI. The mean dose was 12.6 million cells, and the mean infusion was 11.4 days after the index event. At 4-month follow-up, treated patients had an improved mean LVEF but higher rates of stent restenosis, stent reocclusion, and de novo coronary artery lesions than did the controls. 

The ERASER Investigators, Acute platelet inhibition with abcix-imab does not reduce in-stent restenosis (ERASER study). Circulation 1999 100 799,... 

Hoffmann R, Mintz GS, Dussaillant GR, et al. Patterns and mechanisms of in-stent restenosis a serial intravascular ultrasound study. Circulation 1996 94 1247-1254. 

Waksman R, Ajani AE, Pichard AD, et al, Oral Rapamune to Inhibit Restenosis study, Oral rapamycin to inhibit restenosis after stenting of de novo coronary lesions the Oral Rapamune to Inhibit Restenosis (ORBIT) study, J Am Coll Cardiol 2004 44 1386-1392. 

First, there was a consistent benefit in clinical and angiographic binary restenosis data. As we can see in Table 2, in-stent restenosis of the two pilot studies, which comprised only de novo lesions, angiographic restenosis was in only a single digit of restenosis, with a late loss of around 0.6 mm. All these numbers represent, compared to the average restenosis rate of control arm from the more recent DES trials, a reduction of 81 % of in-stent restenosis and a 42% reduction of late loss, and also represent a reduction of 90% of MACCE. 

Among these 76 patients, 109 bare-coronary stents were deployed in 103 de novo lesions in an equal number of major native epicardial vessels. Patients with in-stent restenosis, bifurcation lesions, vein graft lesions, lesion length of >0.20 mm, acute myocardial infarction in the previous 72 hours, poor left ventricular function (ejection fraction <35%), renal failure defined as creatinine concentration of >2 mg, or under immunosuppressive treatment were excluded from the study. 

Chaves AJ, Sousa AG, Mattos L, etal, Pilot study with an intensified oral sirolimus regimen for the prevention of in-stent restenosis in de novo lesions, Catheter Cardiovasc Interv 2005 66 535-540. 

Commeau (155) (ISR II study) 2005 BX Velocity Polyethyl methacrylate Human coronary art (In-stent restenosis) Sirolimus 1,4 xg/mm2 ... 

Waksman R, Cheneau E, Ajani AE, et al. Intracoronary radiation therapy improves the clinical and angiographic outcomes of diffuse in-stent restenotic lesions results of the Washington Radiation for In-Stent Restenosis Trial for Long Lesions (Long WRIST) Studies. Circulation 2003 107 1744. 

The data suggest that the Biod/VV s/o Batimastat OC Stent is safe during the period of drug elution from the stent (pharmacokinetic studies have shown that 94% of the batimastat will have eluted from the PC coating after one month). The final 30 days results suggest that the presence of the batimastat in the coating is not associated with an increased occurrence of MACE or serious adverse events, therefore, the Biod/VYs/o Batimastat OC Stent is safe in the short term for use in patients. However, the long-term (six months) data demonstrate that the Biod/VYs/o Batimastat OC Stent has no additional beneficial effect on restenosis (Table 6). 

Based on these data, we conducted a study to determine the effects of a l7(3-estradiol-eluting stent on neointimal formation in a high-injury porcine coronary model (29). Our study showed that l7(3-estradiol-eluting PC-coated stents (Abbott/ Biocompatibles) were associated with a 40% reduction in neointimal formation without affecting endothelial regeneration. This approach could have a potential clinical benefit in the prevention and treatment of in-stent restenosis. 

The first clinical study was the RAVEL trial, which showed that no cases of restenosis were observed with the DES, but 26.6% of BMS cases suffered from restenosis [31]. A 3 year follow-up of the RAVEL study showed sustained clinical benefits [35], during which another set of trials called the SIRIUS study compared the safety and efficacy of the sirolimus eluting stent with two smaller studies that were performed in Europe (E-SIRIUS) and Canada (C-SIRIUS) [36-39]. The combined results showed a reduction in in-stent restenosis from 38.5% (BMS) to 3.1% (sirolimus eluting stent). 

---