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Published on: March 15, 2022
Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn: the ARGENTO study: a prospective,
Salvatore Cassese1, Gennaro Galasso, Alessandro Sciahbasi
1Department of Clinical Medicine, Cardiovascular Science and Immunology, Federico II University of Naples, Naples, Italy.
Insights
Genous Bio-engineered R stent (GRS) implantation is safe and effective for patients undergoing percutaneous coronary intervention (PCI) who may not tolerate long-term dual antiplatelet therapy (DAT). Study findings show no significant difference in major adverse cardiac events regardless of DAT duration (≤15 days or >15 days).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Percutaneous coronary intervention (PCI) often requires long-term dual antiplatelet therapy (DAT).
- Patients with low compliance to long-term DAT pose a clinical challenge.
- The Genous Bio-engineered R stent (GRS) offers a potential solution for this patient group.
Purpose of the Study:
- To evaluate the safety and efficacy of GRS in patients undergoing PCI with anticipated low compliance to DAT.
- To compare outcomes between patients receiving ≤15-day DAT and >15-day DAT after GRS implantation.
Main Methods:
- Prospective enrollment of 384 patients undergoing single- or multivessel PCI with GRS implantation.
- Exclusion criteria included recent revascularization, statin allergy, or prior antibody therapy.
- Evaluation of major adverse cardiac events (MACE), cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) at follow-up.
Main Results:
- At a mean follow-up of 22.8 months, MACE occurred in 8.6% of patients.
- Rates of cardiac death (3.4%), MI (3.4%), TVR (4.7%), and overall ST (2.3%) were reported.
- No significant differences in MACE or ST were observed between the ≤15-day and >15-day DAT groups.
Conclusions:
- GRS implantation appears to be a safe and effective strategy for patients undergoing PCI with low anticipated compliance to long-term DAT.
- The duration of DAT (≤15 days or >15 days) did not independently predict MACE in this cohort.
- GRS may offer a viable treatment option, mitigating concerns associated with prolonged antiplatelet therapy.
Background:
To investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤ 15-day or >15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn--ARGENTO study).
Methods:
Consecutive patients without ≤ 12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated.
Results:
Between March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8 ± 13.6 months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤ 15-day and >15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer-Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history, <45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57-6.80, p=0.27) was not independent risk factor for MACEs.
Conclusions:
In consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤ 15 days or >15 days).
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