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- 幻灯介绍：
Direct Stenting Using the Sirolimus-Eluting Stent
Presented at
American College of Cardiology
Scientific Sessions 2004
Presented by Dr. Jeffrey W. Moses
DIRECT Trial
Endpoints (8 months):
In-lesion late loss
DIRECT Trial
Presented at ACC Scientific Sessions 2004
Patients matching those of the SIRIUS trial: de novo native coronary lesions requiring single-vessel treatment of lesions 2.5-3.5 mm in diameter and 15-30 mm in length
Non-randomized, multicenter
Direct Stenting
Sirolimus-eluting stents using direct stenting
n=225
Predilatation
Mandatory predilatation stent delivery strategy (from the Sirolimus-eluting stent arm of the SIRIUS trial)
n=533
Presented at ACC Scientific Sessions 2004
DIRECT Trial
%
There was no difference in 30-day major adverse cardiac events (MACE), myocardial infarction (MI), and target vessel failure. There was also no difference in six-month MACE or stent thrombosis occurrence at six months.
30-Day MACE
p=0.23
30-Day MI
p=0.27
30-Day Target Vessel Failure
p=0.20
6-Month MACE
p=0.21
6-Month
Stent Thrombosis
p=0.44
Presented at ACC Scientific Sessions 2004
DIRECT Trial
%
There was no difference in the primary endpoint of eight-month late loss in-stent or in-lesion. Binary restenosis rates were also similar in both groups. Similar results were observed in the subgroup of patients with small, medium, and large vessels, as well as diabetics.
Binary Restenosis In-Stent
p=0.80
Binary Restenosis
In-Lesion
p=0.30
Direct Stenting
Pre-dilatation
Direct Stenting
Pre-dilatation
Direct Stenting
Pre-dilatation
Direct Stenting
Pre-dilatation
8-Month Late
Loss In-Stent
p=NS
8-Month Late
Loss In-Lesion
p=NS
Among patients receiving sirolimus-eluting stents for treatment of single, de novo lesions, there was no difference in procedure success, MACE at six months, or late loss at eight months for direct stenting compared with historical controls of predilatation.
Other trials such as E-SIRIUS have reported on the subgroup of patients undergoing direct stenting versus predilatation with sirolimus-eluting stent, but the number of patients was relatively small (<100). While provocative, the trial has several limitations, most notably the nonrandomized design and the use of historical controls, which differed in several important practice patterns compared with the current trial population, such as a higher use of GP IIb/IIIa inhibitors, longer stent length, and higher maximum device pressure.
DIRECT Trial