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A Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients With De Novo Lesions of the Native Coronary Arteries - GENESIS
Description:
The goal of this trial was to determine the safety and efficacy of a Conor reservoir-based CORIO (pimecrolimus-eluting) or SYMBIO (dual drug delivery of pimecrolimus- and paclitaxel-eluting) stent versus the CoStar control (paclitaxel-eluting) stent for the treatment of single de novo coronary lesions.
Hypothesis:
The CORIO and SYMBIO stents were noninferior to paclitaxel-eluting stents in reducing 6-month angiographic in-stent late lumen loss.
Study Design
Patients Screened: 375
Patients Enrolled: 248
Mean Follow Up: 6 months
Mean Patient Age: 62 years
Female: 23
Mean Ejection Fraction: 62.8%
Patient Populations:
• Single de novo native coronary artery lesions
• Reference vessel diameters: 2.5-3.5 mm
• Lesion length <25 mm
Primary Endpoints:
In-stent late loss at 6 months
Secondary Endpoints:
• Device, lesion, and procedural success
• MACE at 30 days, 6 months, and 1-5 years of follow-up
• In-segment late loss
• In-stent and in-segment minimal lumen diameter and binary restenosis
• % volume obstruction
• Late acquired stent malapposition
Drug/Procedures Used:
This was a single-blinded study in which patients were randomized 2:2:1 to the CORIO, SYMBIO, or CoStar control arm. Intravascular ultrasound was performed in the first 30 patients in each arm.
Concomitant Medications:
Dual antiplatelet therapy for 6 months
Principal Findings:
A total of 248 patients were enrolled, 100 to the CORIO arm, 101 to the SYMBIO arm, and 49 to the CoStar arm. There were 27% diabetics, about 29.8% of patients had undergone prior PCI, and 27.8% had unstable angina. The trial was suspended early for unclear reasons, but presumably because of a higher incidence rate in the CORIO arm compared with the CoStar arm.
Procedural success was 94%, 100%, and 100% for CORIO, SYMBIO, and CoStar, respectively.
Average lesion length was 14.5 mm; there were 26.7% bifurcation lesions. In-stent late loss, the primary endpoint, was 1.40 ± 0.67 mm, 0.96 ± 0.73 mm, and 0.58 ± 0.58 mm, whereas in-stent restenosis was 39.8%, 20.4%, and 7.1% for CORIO, SYMBIO, and CoStar, respectively. Six-month major adverse cardiac events (MACE) for the CORIO, SYMBIO, and CoStar arms were 39.0%, 14.4%, and 2.0%, respectively, driven predominantly by differences in the rates of target vessel revascularization (TVR) of 35.0%, 14.4%, and 2.0%, and of myocardial infarction (MI) of 8.0%, 1.0%, and 0%, respectively. Six-month rates of protocol-defined stent thrombosis were 2.0%, 1.0% and 0%, respectively.
Interpretation:
This is the first trial to study and successfully demonstrate dual drug delivery in the treatment of patients with coronary artery disease undergoing PCI. However, the incidence of in-stent restenosis and the need for TVR at 6 months were very high in patients treated with pimecrolimus. These high rates were mitigated to an extent in patients with concomitant paclitaxel-elution; however, the rates were lowest for the paclitaxel only-eluting stents. Further long-term data are necessary.
References:
Safety and Efficacy Outcomes of Dual Pimecrolimus/Paclitaxel Drug Delivery Versus Single Drug Delivery Using Conor Reservoir Technology: GENESIS Trial Six-Month Results. Presented by Dr. Stefan Verheye at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.
Verheye S, Agostoni P, Dawkins KD, et al. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) trial. JACC Cardiovasc Interv. 2009 Mar;2(3):205-14.
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