Pathological findings after third- and second-generation everolimus-eluting stent implantations in coronary arteries from autopsy cases and an atherosclerotic porcine model

Migita, Suguru; Kitano, Daisuke; Li, Yuxin; Kōyama, Yutaka; Shimodai-Yamada, Sayaka; Ōnishi, Akira; Fuchimoto, Daiichiro; Suzuki, Shunichi; Nakamura, Yoshiyuki; Matsuyama, Taka‐aki; Hirota, Seiichi; Sakuma, Masashi; Tsujimoto, Masahiko; Hirayama, Atsushi; Okumura, Yasuo; Hao, Hiroyuki

doi:10.1038/s41598-021-85740-2

Cited by 2 publications

(1 citation statement)

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“…In our study, only 1 type of drug-eluting stent, the SYNERGY stent, was used in the PCI to avoid difficulties in interpretation of the results from different stent types. Pathologically, third-generation drug-eluting stents have been reported to be superior to the second-generation ones in animal models and autopsy samples . However, to our knowledge, no clinical data yet support the superiority of specific types of drug-eluting stents over others for early discontinuation of DAPT after PCI …”

Section: Discussionmentioning

confidence: 95%

P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent

Min,

Kang,

Cho

et al. 2024

JAMA Netw Open

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ImportanceP2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent.ObjectiveTo investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent.Design, Setting, and ParticipantsThe Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled.InterventionsPatients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693).Main Outcomes and MeasuresThe primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%.ResultsOf the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, −0.93 [1-sided 95% CI, −2.64 to 0.77] percentage points; P &lt; .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, −0.49 [95% CI, −2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, −0.60 [95% CI, −1.33 to 0.12] percentage points; P = .10).Conclusions and RelevanceIn patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations.Trial RegistrationClinicalTrials.gov Identifier: NCT03447379

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Section: Discussionmentioning

confidence: 95%