AI Article Synopsis
- The study evaluates the performance of the SeQuent® crystalline sirolimus-coated balloon (SCB) in treating coronary artery disease and in-stent restenosis (ISR), suggesting it features a sustained release of the drug compared to traditional options like paclitaxel-coated balloons.
- Data from 126 patients were analyzed from the SIROOP registry over a two-year period, with outcomes measuring major adverse cardiovascular events (MACE), revascularization, and myocardial infarction; results showed a high procedural success rate and low MACE occurrence.
- The findings indicate promising results for the SCB in managing complex coronary lesions, but further research with randomized trials is necessary to confirm these outcomes.
Article Abstract
Background: There is mounting data supporting the use of drug-coated balloons (DCB) not only for treatment of in-stent restenosis (ISR), but also in native coronary artery disease. So far, paclitaxel-coated balloons represented the mainstay DCBs. The SeQuent® crystalline sirolimus-coated balloon (SCB) (B.Braun Medical Inc, Germany) represents a novel DCB, which allows a sustained release of the limus-drug. We evaluated its performance in an all-comer cohort, including complex coronary lesions.
Methods: Consecutive patients treated with the SeQuent® SCB were analyzed from the prospective SIROOP registry (NCT04988685). We assessed clinical outcomes, including major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiovascular death. Angiograms and outcomes were independently adjudicated.
Results: From March 2021 to March 2023, we enrolled 126 patients and lesions, of which 100 (79%) treated using a "DCB-only" strategy and 26 (21%) with a hybrid approach (DES + DCB). The mean age was 68 ± 10 years, 48 (38%) patients had an acute coronary syndrome. Regarding lesion characteristics, ISR was treated in 27 (21%), 11 (9%) underwent CTO-PCI and 59 (47%) of the vessels were moderate to severe calcified. Procedural success rate was 100%. At a median follow-up time of 12.7 (IQR 12; 14.2) months, MACE occurred in 5 patients (4.3%). No acute vessel closure was observed.
Conclusions: Our data indicates promising outcomes following treatment with this novel crystalline SCB in an all-comer cohort with complex coronary lesions. These results require further investigation with randomized trials.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10896972 | PMC |
| http://dx.doi.org/10.3389/fcvm.2024.1316580 | DOI Listing |
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