Low restenosis rate of the NIR coronary stent: results of the Danish multicenter stent study (DANSTENT)--a randomized trial comparing a first-generation stent with a second-generation stent.
BACKGROUND
Larger studies evaluating the angiographic results of second-generation stents are scarce. The objectives of this study were to assess current standards of angiographic and clinical outcomes after implantation of the second-generation stainless steel stent, NIR (Medinol Ltd, Tel Aviv, Israel), and to compare the outcomes with those of the first-generation Palmaz-Schatz (PS) stent (Johnson & Johnson, Warren, NJ).


METHODS
Patients having coronary artery lesions that could be covered by a stent of 15 mm in length were randomly assigned to receive the NIR or the PS. Procedural success, 6-month angiographic findings, and 1-year clinical outcomes were determined.


RESULTS
In 424 patients included in the study, the overall procedural success rate was high (NIR 98%, PS 99%, P =.90). Follow-up angiography was conducted in 91% of the patients. The overall rate of angiographic restenosis was low in both groups (NIR 9.9%, PS 12.6%, P =.35). We found a low restenosis rate in vessels with a minimal lumen diameter >3.1 mm after the procedure, particularly in the NIR group (<6%). The rate of target lesion revascularization after 1 year did not differ (NIR 12%, PS 10%, P =.47).


CONCLUSIONS
The angiographic and clinical outcomes after implantation of the second-generation stainless steel stent were not significantly better than those of the first-generation stent. The low restenosis rates, particularly in patients with the largest minimal lumen diameters after stent implantation, warrants circumspection when planning the evaluation of newer stent technologies that aim to further reduce coronary restenosis.
Jørgensen
Erik
E
Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen, Denmark. erikj@rh.dk
Kelbaek
Henning
H
Helqvist
Steffen
S
Jensen
Gunnar V H
GV
Saunamäki
Kari
K
Kastrup
Jens
J
Madsen
Jan Kyst
JK
Kløvgaard
Lene
L
Thuesen
Leif
L
Villadsen
Anton
A
van Weert
Anton W M
AW
Reiber
Johan H C
JH
D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000628:therapy; D000789:Angina, Unstable / Q000000981:diagnostic imaging / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D003718:Denmark; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D016017:Odds Ratio; D015607:Stents