Comparison of restenosis rates of two coronary stent systems with different active coating

Abstract AR

Background & Objectives .: Angiographic restenosis has been reported in 50% of patients within 6 months after balloon angioplasty.

Although stent implantation has been shown to reduce restenosis as compared with percutaneous transluminal coronary angioplasty, in-stent restenosis (ISR) still occurs in 10-30% of the patients.

Drug-eluting stents containing the immunosuppressive agent rapamycin and the anti-mitotic agent paclitaxel have shown encouraging reductions in restenosis in de novo lesions, and possibly in in-stent restenosis lesions.

The goal of this study was to compare the restenosis rates in two coronary stent systems using rapamycin and paclitaxel.

Methodt: This observational study was conducted in the Cardiology Department at the Essen University Hospital, Germany.

A total of 106 consecutive patients received either rapamycin eluting stents (n=54) or paclitaxel stents (n=52) and underwent angiographic follow-up between August 2002 and February 2004.

All the patients received a daily dose of 100 mg aspirin indefinitely and 300 mg clopidogrel as a loading dose before the intervention and a daily dose of 75 mg for 6 months after the intervention.

The primary endpoint was diameter stenosis percentage at follow-up.

The secondary angiographic endpoints included late loss, binary restenosis, and minimal lumen diameter at follow-up.

The secondary clinical endpoints included the incidence of death, the need for bypass surgery or intervention to treat restenosis of the target lesions, myocardial infarction (Q wave or non Q wave), target vessel revascularization, and target lesion revascularization.

Results: The diameter stenosis (DS%) at follow-up with the rapamycin eluting stent was 25.11+ 18.24% vs.

25.90±21.23% for the paclitaxel stent;P=0.83.

Minimal lumen diameter at follow- rapamycin stent vs.

2.34+0.72 mm for the paclitaxel stent, P=0.57.

Binary restenosis was detected in 7 patients (12.9%) in the rapamycin group compared with 8 patients (15.3%) in the paclitaxel group (P=0.65).

Late loss was similar between the two groups.

No patients in either group suffered from M (Q wave or non Q wave) during follow-up.

The incidence of death was 0% in the both groups.

Coronary bypass surgery was not performed on any patient in the two groups.

Target lesion revascularization and target vessel revascularization were similar in the two groups.

Conclusion: In this observational study, we did not observe significant differences between the rapamycin-coated stent and the paclitaxel-coated stent in terms of follow-up angiographic parameters as well as clinical events.