Safety and efficacy of the Essential Pro paclitaxel drug-eluting balloon for the treatment of coronary in-stent restenosis
Bibliographic record
Abstract
Introduction and objectives: Drug-eluting balloons (DEB) are an established treatment option for in-stent restenosis (ISR). This study aimed to assess the safety and efficacy of a novel DEB in patients with ISR. Methods: This prospective, single-center study enrolled a consecutive cohort of patients diagnosed with ISR who underwent coronary angioplasty with a new second-generation paclitaxel-eluting balloon. The 3 main endpoints were myocardial infarction, target lesion revascularization, and target vessel revascularization. Baseline variables were collected, including patient and procedure characteristics. Follow-up data were collected through medical records or telephone contact. Results: The study included 160 consecutive patients with 206 treated lesions (mean age, 71.4 ± 14.9 years, 15.5% women) undergoing percutaneous coronary intervention with DEB for ISR. A total of 53.3% of patients had acute coronary syndrome. The average diameter of the treated vessel was 3.10 ± 0.7 mm. The DEB used had a mean diameter of 3.1 ± 0.6 mm and a mean length of 23.1 ± 6.8 mm. Predilatation was performed in 98% of the lesions, and a noncompliant balloon was used in 80%. Intracoronary imaging was used in 24% of cases. At the end of the procedure, 98.5% of patients had Thrombolysis in Myocardial Infarction flow grade 3, residual stenosis was > 30% in 3.4%, and dissection occurred in 1.4%. Bail-out stenting was required in 4.8% of patients. Mortality was nil during follow-up (maximum 768 days). The incidence of myocardial infarction, target lesion revascularization, and target vessel revascularization were 5.4% (95%CI, 0.69-10.1), 8.4% (95%CI, 0-17.8), and 14.2% (95%CI, 3.61-24.78), respectively. Conclusions: In this cohort of patients with ISR treated with DEB, we observed a low rate of adverse events in both the short- and mid-term. These results support the safety and efficacy of this new generation of DEB for treating ISR.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".