Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

Merinopoulos, Ioannis; Gunawardena, Tharusha; Corballis, Natasha; Bhalraam, U; Gilbert, Tim; Maart, Clint; Richardson, Paul; Ryding, Alisdair; Sarev, Toomas; Sawh, Chris; Sulfi, Sreekumar; Wickramarachchi, Upul; Wistow, Trevor; Mohamed, Mohamed; Mamas, Mamas A.; Vassiliou, Vassilios; Eccleshall, Simon

doi:10.1007/s00392-022-02106-y

Cited by 15 publications

(12 citation statements)

References 18 publications

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“…We defined total cost as the sum of (1) procedural devices‐cost, (2) procedural staff‐cost, (3) post‐PCI hospital stay cost, and (4) antiplatelet regime cost. Previous work from our group demonstrated no difference between DCB‐only angioplasty and second generation DES in terms of all‐cause mortality and net cardiac events including unplanned TLR 3,4 . Therefore, for this work we did not estimate costs from subsequent cardiovascular‐related hospital admissions.…”

Section: Methodsmentioning

confidence: 98%

“…Previous work from our group demonstrated no difference between DCB-only angioplasty and second generation DES in terms of all-cause mortality and net cardiac events including unplanned TLR. 3,4 Therefore, for this work we did not estimate costs from subsequent cardiovascular-related hospital admissions. Every effort was made to identify how many devices were used for patients with multiple lesions.…”

Section: Methodsmentioning

confidence: 99%

“…1,2 Previous work from our group has demonstrated the safety and efficacy in terms of cardiovascular outcomes of DCB-only angioplasty as compared to second generation drug eluting stent (DES) in patients with STelevation myocardial infarction (STEMI), left main stem disease as well as stable angina due to de novo coronary artery disease of all vessel sizes. [3][4][5] Limited data suggest that DCB angioplasty for ISR is cost-effective compared to DES. 6 There is a lack of data regarding the cost-effectiveness of DCB-only angioplasty for de novo coronary artery disease as compared to second generation DES.…”

Section: Introductionmentioning

confidence: 99%

“…Its use is supported by guidelines for in‐stent restenosis (ISR) while randomized trials have demonstrated its efficacy for small vessel de novo disease 1,2 . Previous work from our group has demonstrated the safety and efficacy in terms of cardiovascular outcomes of DCB‐only angioplasty as compared to second generation drug eluting stent (DES) in patients with ST‐elevation myocardial infarction (STEMI), left main stem disease as well as stable angina due to de novo coronary artery disease of all vessel sizes 3–5 . Limited data suggest that DCB angioplasty for ISR is cost‐effective compared to DES 6 .…”

Section: Introductionmentioning

confidence: 99%

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Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease

Merinopoulos,

Gunawardena,

Corballis

et al. 2023

Cathet Cardio Intervent

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AimsWe aimed to perform a cost analysis of drug coated balloon (DCB)‐only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications.BackgroundDCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost‐effectiveness of DCB‐only angioplasty for treatment of de novo coronary artery disease as compared with second generation DES.MethodsWe compared total costs of patients treated with DCB or DES for first presentation of ST‐elevation myocardial infarction, non‐ST‐elevation myocardial infarction, or stable angina due to de novo disease between January 1, 2018 and November 15, 2019. We defined total cost as the sum of (1) procedural devices‐cost, (2) procedural staff‐cost, (3) post‐percutaneous coronary intervention hospital stay cost, and (4) antiplatelet regime cost. A cost minimization analysis was performed to compare the costs of DCB and DES.ResultsWe present 1952 all‐comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1236 lesions) treated with DES for de novo coronary artery disease. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 vs. £3143.98). However, the cost per lesion treated was calculated to be £15.51 cheaper in the DCB group (£3007.56 vs. £3023.07). The results were consistent irrespective of duration of long‐term antiplatelet medications.ConclusionWe have compared the cost‐effectiveness of DCB‐only angioplasty to DES‐angioplasty and showed that the per patient and per lesion results were not different and hence cost should not be implicated in the decision to choose DCB or DES.

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Section: Methodsmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease

Merinopoulos,

Gunawardena,

Corballis

et al. 2023

Cathet Cardio Intervent

Self Cite

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“…7 While DCB are an established treatment option for in-stent restenosis and small vessel disease, 8,9 few data are available regarding usage of DCB in large vessels and in combination with DES. [10][11][12][13] Usage of DCB alone or in combination with DES, as part of a hybrid approach, has been proposed to reduce stent burden and overcome the associated complications even in large vessels 13,14 ; however, clinical data supporting the safety and efficacy of such approach are scarce. The aim of the present study was to compare the clinical outcomes of a DCB-based treatment strategy for LAD revascularization, as compared with conventional DES-only PCI.…”

mentioning

confidence: 99%

Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery

Gitto,

Sticchi,

Chiarito

et al. 2023

Circ: Cardiovascular Interventions

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BACKGROUND: Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. METHODS: Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. RESULTS: We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40–82] versus 56 [46–66] mm; P =0.002), while longer DESs were implanted (38 [24–62] versus 56 [46–66] mm; P <0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P =0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20–1.27]; P =0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07–0.58]; P =0.003), mainly driven by less target lesion revascularization. CONCLUSIONS: A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.

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Use of sirolimus‐coated balloon in de novo coronary lesions; long‐term clinical outcomes from a multi‐center real‐world population

Basavarajaiah,

Sharma,

Sticchi

et al. 2024

Cathet Cardio Intervent

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BackgroundSirolimus‐coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long‐term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de‐novo lesions from a real‐world practice.AimsTo report long‐term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions.Methods and ResultsWe analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high‐volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE).During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty‐two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST‐segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions (20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67).During the median follow‐up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure.ConclusionsThe results from this long‐term follow‐up in a real‐world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

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Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice

Cited by 15 publications

References 18 publications

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease

Drug-Coated Balloon Angioplasty for De Novo Lesions on the Left Anterior Descending Artery

Use of sirolimus‐coated balloon in de novo coronary lesions; long‐term clinical outcomes from a multi‐center real‐world population

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