Prospective, Randomized Evaluation of Sirolimus-Eluting Coronary Stents With Fixed-Wire and Rapid-Exchange Delivery Systems and a Novel Bioresorbable Drug Carrier - OPTIMIZE IDE
Contribution To Literature:
The OPTIMIZE IDE trial failed to show that the Svelte drug-eluting stent was noninferior to a control drug-eluting stent at preventing target lesion failure.
The goal of the OPTIMIZE IDE trial was to evaluate a drug-eluting stent/fixed-wire device compared with a conventional rapid exchange drug-eluting stent among patients undergoing percutaneous coronary intervention (PCI).
Patients undergoing primary PCI were randomized to the Svelte drug-eluting stent group (n = 827) versus control drug-eluting stent (n = 812). After randomization, operators in the Svelte drug-eluting stent group could choose between the Svelte IDE or the Svelte Rx device. The Svelte is designed to facilitate transradial access with direct stenting.
- Total number of enrollees: 1,639
- Duration of follow-up: 12 months
- Mean patient age: 66 years
- Percentage female: 29%
- Percentage with diabetes: 31%
- ≤3 native coronary artery lesions in ≤2 major epicardial vessels
- Objective ischemia
- Reference vessel diameter ≥2.25 mm to ≤4.0 mm
- Lesion length ≤34 mm
- % diameter stenosis ≥50 to <100%
- Angulation ≤90◦
- Mild to moderate calcium density
- Left main, chronic total occlusion, saphenous vein graft, in-stent restenosis or ST-segment elevation myocardial infarction (STEMI)
- Planned cardiac intervention (for example, TAVR)
- Need for anticoagulation
Other salient features/characteristics:
- Transradial approach: 78%
- Direct stent strategy: 95%
- Post-dilatation: 52%
- Mean reference vessel diameter: 2.8 mm
- Mean lesion length: 14 mm
The primary outcome, 12-month target lesion failure, defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization, occurred in 10.3% of the Svelte group compared with 9.5% of the control group (p for noninferiority = not significant).
- Target lesion revascularization: 1.9% of the Svelte group compared with 1.5% of the control group (p = 0.57)
- Target vessel MI: 8.2% of the Svelte group compared with 9.3% of the control group (p = 0.49)
- Stent thrombosis at 12 months: 0.38% of the Svelte group compared with 0.51% of the control group (p = 0.72)
Among patients undergoing PCI, the Svelte drug-eluting stent did not meet the threshold for noninferiority with respect to the composite outcome of target lesion failure.
Presented by Dr. Dean Kereiakes at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 17, 2020.
Keywords: Constriction, Pathologic, Death, Sudden, Cardiac, Dilatation, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Sirolimus, Stents, TCT20, Thrombosis, Transcatheter Cardiovascular Therapeutics
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