A randomized trial comparing the hand-mounted JoStent with the premounted Multi-Link Duet stent in patients with coronary artery disease.
The objective of this multicenter randomized study was to compare the angiographic and clinical results achieved 1 year after coronary placement of two stent models: the hand-mounted JoStent and the premounted Multi-Link Duet stent. We included 505 patients who were randomly assigned to receive either the hand-mounted JoStent (n = 252) or the premounted Multi-Link Duet stent (n = 253). The primary endpoint of the study, late lumen loss, measured 1.12 mm in the JoStent group and 1.17 mm in the Multi-Link Duet group. These values were statistically equivalent (P = 0.02 from the equivalence test). No significant difference was observed in the incidence of restenosis, 24.2% in the JoStent and 25.2% in the Multi-Link Duet stent group, and target vessel revascularization, 13.9% in the JoStent and 15.4% in the Multi-Link Duet patients. In conclusion, the hand-mounted JoStent and the premounted Multi-Link Duet stent enable excellent procedural success rates and equally favorable 1-year angiographic and clinical outcomes.
Mehilli
J
J
Deutsches Herzzentrum, Munich, Germany.
Kastrati
A
A
Dirschinger
J
J
Dotzer
F
F
Schühlen
H
H
Fleckenstein
M
M
Neumann
F J
FJ
Schömig
A
A
D000368:Aged; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000601:surgery*; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome