Randomized comparison of GR-II stent and Palmaz-Schatz stent for elective treatment of coronary stenoses.
BACKGROUND
This prospective multicenter randomized clinical trial was designed to evaluate the long-term angiographic and clinical outcomes of elective treatment with the GR-II stent compared with the Palmaz-Schatz (PS) stent in patients with coronary stenoses.


RESULTS
Seven hundred fifty-five patients with myocardial ischemia and de novo native coronary stenoses in 3- to 4-mm vessels were randomly assigned to the PS (375 patients) or the GR-II stent (380 patients). The primary end point was 12-month target lesion revascularization (TLR)-free survival. Angiography was performed at baseline and at follow-up in the first 300 consecutive patients to assess the frequency of angiographic restenosis. Procedure success was 98.5% for the GR-II stent and 99.4% for the PS stent (P:=0.19). At 30 days, patients assigned to the GR-II stent had a higher stent thrombosis rate (3.9% versus 0.3% for PS stent, P:<0.001) and TLR rate (3.9% versus 0.5% for PS stent, P:<0.001). The GR-II group had a higher follow-up restenosis frequency (47.3% versus 20.6% for the PS group, P:<0.001) and a lower 12-month TLR-free survival rate (71.7% versus 83.9% for the PS group, P:<0. 001). Multivariate logistic regression analysis identified a smaller final stent minimal lumen diameter (odds ratio [OR] 2.49, 95% CI 1. 56 to 3.98; P:<0.001), diabetes mellitus (OR 2.14, 95% CI 1.42 to 3. 22; P:<0.001), and use of the GR-II stent (OR 1.78, 95% CI 1.20 to 2. 64; P:<0.01) as independent determinants of 12-month TLR.


CONCLUSIONS
On the basis of these long-term follow-up data, we conclude that use of the GR-II stent should be limited to the acute treatment of abrupt or threatened closure after failed conventional balloon angioplasty procedures.
Lansky
A J
AJ
Lenox Hill Hospital, New York, NY, USA.
Roubin
G S
GS
O'Shaughnessy
C D
CD
Moore
P B
PB
Dean
L S
LS
Raizner
A E
AE
Safian
R D
RD
Zidar
J P
JP
Kerr
J L
JL
Popma
J J
JJ
Mehran
R
R
Kuntz
R E
RE
Leon
M B
MB
D000704:Analysis of Variance; D017023:Coronary Angiography; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology*; D048909:Diabetes Complications; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012044:Regression Analysis; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome