The Elusive Late Benefit of Biodegradable Polymer Drug-Eluting Stents
Bibliographic record
Abstract
Article, see p 325 D rug eluting stents (DES), the standard-of-care stents in contemporary percutaneous coronary intervention, significantly reduce the risk of restenosis in comparison with bare metal stents (BMS).However, first-generation durable polymer (DP) DES were associated with high rates of very late (>1 year) events such as restenosis, stent thrombosis, and neoatherosclerosis, events attributed to a persistent inflammation/hypersensitivity reaction to the polymer. 1 The solutions to this polymer-related problem proceeded in 3 directions: (1) development of more biocompatible DP that reduces inflammation and promotes faster healing; (2) development of biodegradable (BP) polymer that biodegrades after drug elution, leaving behind a BMS-like stent; and (3) development of polymer-free DES where the drug is delivered without a polymer and is therefore a BMS-like stent.The clinical gains from improvement in the polymer-related aspects of stent design have been apparent.The second-generation DP-DES have lower risk of restenosis, stent thrombosis, myocardial infarction (MI), and death in comparison with BMS or first-generation DP-DES. 2,3Despite these excellent results with the second-generation DP-DES, major adverse cardiovascular events continue to accrue beyond 1 year at a steady rate.This has been attributed to continued low-grade peri-strut inflammation and promotion of neoatherosclerosis with the second-generation DP-DES.As such, BP-DES were touted as the future of DES technology. 4linical trials of BP-DES showed lower restenosis and stent thrombosis in comparison with the first-generation DP-DES, although the results have been variable. 2However, the more important question has been the comparison of BP-DES with the second-generation DP-DES.Cumulative data from meta-analyses of randomized trials suggest, at best, the noninferiority of BP-DES in comparison with second-generation DP-DES. 5Given the short duration of these trials, many have posited that the benefits of BP-DES will be seen at longer duration of follow-up after the polymer fully biodegrades (over months to years depending on the polymer). 6he 10-year outcomes of the ISAR-Test 4 trial (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) in the current issue of Circulation 7 provide further insights into this question.The ISAR-Test 4 trial enrolled 2603 patients with coronary artery disease who were randomly assigned 2:1:1 to the Yukon Choice PC stent (a BP-DES coated on the abluminal surface of a stent [87 µm thick] with a unique microporous surface) versus the Xience stent (a second-generation DP-DES [81 µm thick]) versus the Cypher stent (a first-generation DP-DES [140 µm thick]).The trial showed noninferiority of the BP-DES in comparison with DP-DES at 1 year and concluded that "the results provide a framework for testing the potential clinical advantage of BP-DES over the medium to longterm." 6At 10 years follow-up, the second-generation DP-DES, and the BP-DES,
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".