Observational studyHerz2019
Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6‑month vs. 12‑month dual-antiplatelet therapy (DAPT).
Observational study in Herz, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02629575 (Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Pooled it
- Percutaneous Coronary Interventions with Sirolimus-Eluting Alex Plus Stents in Patients with or without Diabetes: 4-Year Results.Journal of cardiovascular development and disease · 2024Article
- Impact of diabetes mellitus on the early-phase arterial healing after drug-eluting stent implantation.Cardiovascular diabetology · 2020Observational
- Duration of Dual Antiplatelet Therapy and Late Stent Thrombosis Following Percutaneous Coronary Intervention with Second-Generation Drug-Eluting Stents: A Simple Meta-Analysis of Randomized Controlled Trials.Advances in therapy · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DES). Defining the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation is still under debate. The objective of this subgroup analysis of the all-comers ISAR 2000 registry was to assess the safety and efficacy of a short DAPT (<6 month) versus a longer DAPT (>6 month) in patients with diabetes electively treated with the polymer-free sirolimus-coated ultrathin strut drug-eluting stent (PF-SES).
methodsPatients who received the PF-SES were investigated in a multicenter all-comers observational study. The primary endpoint was the 9‑month target lesion revascularization (TLR) rate, whereas secondary endpoints included the 9‑month major adverse cardiac event (MACE) and procedural success rates.
resultsIn all, 167 patients were treated with DAPT for ≤6 months (S-DAPT group) and 350 patients underwent DAPT treatment for 12 months (L-DAPT group). There was no significant difference in the overall MACE rate (4.6% vs. 3.1%, p = 0.441), the 9‑month accumulated stent thrombosis rates (0.8% vs. 0.3%, p = 0.51), or the accumulated rate of bleeding complications (5.3% vs. 3.4%, p = 0.341).
conclusionPF-SES are safe and effective in daily clinical routine with low rates of TLR and MACE in patients with diabetes and stable disease. Our data suggest that extending the duration of DAPT beyond 6 months does not improve MACE or TLR at 9 months in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.