| Title |
The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) Angiographic Results and 1-Year Clinical Outcomes
|
|---|---|
| Published in |
JACC: Cardiovascular Interventions, September 2017
|
| DOI | 10.1016/j.jcin.2017.06.021 |
| Pubmed ID | |
| Authors |
Stefan Verheye, Mathias Vrolix, Indulis Kumsars, Andrejs Erglis, Dace Sondore, Pierfrancesco Agostoni, Kristoff Cornelis, Luc Janssens, Michael Maeng, Ton Slagboom, Giovanni Amoroso, Lisette Okkels Jensen, Juan F. Granada, Pieter Stella |
| Abstract |
The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. |
X Demographics
The data shown below were collected from the profiles of 32 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 11 | 34% |
| Spain | 3 | 9% |
| Venezuela, Bolivarian Republic of | 2 | 6% |
| Colombia | 2 | 6% |
| Netherlands | 1 | 3% |
| Mexico | 1 | 3% |
| Croatia | 1 | 3% |
| Australia | 1 | 3% |
| Unknown | 10 | 31% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 22 | 69% |
| Scientists | 5 | 16% |
| Practitioners (doctors, other healthcare professionals) | 3 | 9% |
| Science communicators (journalists, bloggers, editors) | 2 | 6% |
Mendeley readers
The data shown below were compiled from readership statistics for 55 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 55 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 9 | 16% |
| Student > Master | 5 | 9% |
| Other | 4 | 7% |
| Student > Bachelor | 3 | 5% |
| Lecturer | 2 | 4% |
| Other | 6 | 11% |
| Unknown | 26 | 47% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 20 | 36% |
| Chemical Engineering | 2 | 4% |
| Nursing and Health Professions | 2 | 4% |
| Mathematics | 1 | 2% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
| Other | 2 | 4% |
| Unknown | 27 | 49% |
Attention Score in Context
This research output has an Altmetric Attention Score of 83. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 11 December 2019.
All research outputs
#513,255
of 25,382,440 outputs
Outputs from JACC: Cardiovascular Interventions
#96
of 4,032 outputs
Outputs of similar age
#10,840
of 328,531 outputs
Outputs of similar age from JACC: Cardiovascular Interventions
#2
of 88 outputs
Altmetric has tracked 25,382,440 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 97th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
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