[Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial].
BACKGROUND
Increased thrombogenicity and smooth muscle cell proliferative response induced by the metal struts compromise the advantages of coronary stenting. The objective of this randomized, multicenter study was to ascertain whether a reduced strut thickness of a stent is associated with improved follow-up angiographic and clinical results.


RESULTS
The study covered 651 patients with stenosis in the native coronary arteries > 2.8 mm in diameter. They were randomly assigned to receive 1 of 2 commercially available stents of comparable design but different thickness: 326 patients to the thin-strut stent (strut thickness of 50 microm) and 325 patients to the thicker-strut stent (strut thickness of 140 microm). The primary end point was the angiographic restenosis (> or = 50% diameter luminal stenosis at follow-up angiography). The secondary end points were the incidence of reinterventions due to restenosis-induced ischemia and the total rate of death and myocardial infarctions at 1 year (a combined end point). The incidence of angiographic restenosis was 15.0% in the thin-strut group and 25.8% in the thick-strut group (relative risk, 0.58; 95% CI, 0.39 to 0.87; p = 0.003). Clinical restenosis was also significantly reduced. Reinterventions were made in 8.6% of the thin-strut patients and in 13.8% of the thick-strut patients (relative risk, 0.62; 95% CI, 0.39 to 0.99; p = 0.03). No difference was observed in the combined 1-year rate of death and myocardial infarction.


CONCLUSIONS
The use of a thin-strut device is associated with a significant reduction of angiographic and clinical restenosis after coronary artery stenting. These findings may have relevant implications for the currently most widely used percutaneous coronary intervention.
Adnan
A
Kastrati
Julinda
J
Mehilli
Josef
J
Dirschinger
Franz
F
Dotzer
Helmut
H
Schuhlen
Franz-Josef
FJ
Neumann
Martin
M
Fleckenstein
Conrad
C
Pfafferott
Melchior
M
Seyfarth
Albert
A
Schomig
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D003331:Coronary Vessels / Q000503:physiopathology; D004867:Equipment Design / Q000592:standards; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D019233:Retreatment / Q000379:methods / Q000706:statistics & numerical data; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects / Q000592:standards / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome