Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease

Her, Ae-Young; Shin, Eun‐Seok; Kim, Sunwon; Kim, Bitna; Kim, Tae Hyun; Sohn, Chang-Bae; Choi, Byung Joo; Park, Yongwhi; Cho, Jung Rae; Jeong, Young‐Hoon

doi:10.1186/s12933-023-01853-0

Cited by 6 publications

(3 citation statements)

References 30 publications

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“…The improvement in coronary blood flow before DCB application was achieved through adequate pre-dilatation to induce dissection and facilitate homogenous drug delivery. Aside from attaining optimal lesion preparation by either non- or semi-compliant balloon or usage of non-compliant or scoring/cutting balloon as predilatation balloon and atherectomy in more complex lesions (i.e., calcified lesions), additional IVI such as IVUS and OCT is recommended ( 5 , 21 ). Moreover, satisfactory balloon angioplasty pre-DCB implantation results are usually achieved with a vessel ratio of 0.8–1.0, which is more likely to be precise using imaging.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty

Undarsa,

Saboe,

Tiksnadi

et al. 2024

Front. Cardiovasc. Med.

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BackgroundConcerns regarding restenosis after treatment with drug-coated balloons (DCB) remain. We aimed to identify the incidence of target lesion revascularization (TLR) and explore clinical, procedural, and other factors influencing it.MethodsSingle-center retrospective analysis of a prospective cohort PCI registry study included 80 patients (100 lesions) who underwent successful DCB angioplasty between January 2020 and October 2023 and follow-up angiography within 2 years of either planned or unplanned reason. Incidence and factors associated with TLR were analyzed.ResultsAngiographic evaluation was conducted within a median of 151 days (interquartile range: 109 days). During index procedure, 54% were complex lesions. Intravascular imaging (IVI) was performed in 80% of lesions. TLR occurred in 11% of the lesions and was less frequent in the IVI group compared to the angiography-alone group [6.3 vs. 54.5%; odds ratio: 0.156, 95% confidence interval (CI): 0.042–0.580; p = 0.002]. No association was found between baseline and lesion characteristics, lesion complexity, plaque morphology, pre-dilatation procedure balloon type, maximal inflation pressure, or length of DCB between the groups (p > 0.05). Multivariate analysis revealed that IVI utilization was independently associated with a lower TLR rate (adjusted odds ratio: 0.116, 95% CI: 0.020–0.669; p = 0.016).ConclusionIn DCB angioplasty, only IVI use exhibited a significant difference in the TLR rate among baseline lesion characteristics and lesion preparation and was independently associated with a lower TLR rate.

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Section: Discussionmentioning

confidence: 99%

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty

Undarsa,

Saboe,

Tiksnadi

et al. 2024

Front. Cardiovasc. Med.

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“…This poses challenges in selecting an appropriate stent size and length to cover the entire lesion. Consequently, there is a potential for geographical miss during PCI, leading to an increased risk of ISR development [16,17]. Pathological studies have indicated that calcified atherosclerotic lesions can be classified into microcalcification and macrocalcification.…”

Section: Discussionmentioning

confidence: 99%

Clinical Predictors for In-Stent Restenosis in Patients with Coronary Artery Disease Receiving Coronary Stent Implantation

Yuan¹,

Wu²,

Hwang³

et al. 2023

Preprint

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Background Coronary artery disease (CAD) is a widely recognized cardiovascular disease that is considered the leading cause of death worldwide, affecting people on a global scale. Percutaneous coronary intervention (PCI), which involves procedures such as balloon angioplasty or stenting, plays an important role in opening blocked arteries and minimizing damage to the cardiac muscle. While the use of drug-eluting stents (DESs) has significantly reduced the occurrence of coronary restenosis, the problem of in-stent restenosis (ISR) continues to pose a significant clinical challenge. Gaining a deeper understanding of the clinical predictors associated with ISR is vital for early detection and appropriate treatment. Hence, this study aimed to evaluate the clinical predictors of ISR specifically in Taiwanese patients. Methods We conducted a single-center, retrospective case-control study, enrolling 517 CAD patients undergoing previous coronary stenting and stable angina with positive stress test or acute coronary syndrome (ACS) during follow-up between January 2019 and December 2022 at National Taiwan University Hospital. The patients were categorized into two groups: the ISR group, consisting of individuals who received drug-coated balloon (DCB) treatment (n=177), and the non-ISR group, comprising patients who did not receive DCB treatment (n=340). To gather relevant data, we meticulously reviewed the medical records and analyzed the findings from coronary angiography to assess the clinical characteristics of the patients. Results Patients with three-vessel disease (3VD) exhibited a higher prevalence of underlying diseases and were more likely to be taking aspirin and clopidogrel. Moreover, our analysis revealed that age (adjusted odds ratio [aOR] 1.02, 95% confidence interval [CI] 1.00 - 1.04, p = 0.037) and the presence of 3VD (adjusted odds ratio [aOR] 2.15, 95% confidence interval [CI] 1.03 - 4.46, p = 0.039) were significantly associated with an increased risk of coronary ISR. Conclusions Older age and 3VD were the independent predictors of coronary ISR in CAD patients receiving coronary stent implantation.

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“…Upon reaching the target lesion, the expansion of DCB can rapidly deliver antiproliferative drugs into the arterial wall through a lipophilic matrix during angioplasty without the necessity of implanting a scaffold [ 7 ]. This feature of DCB has the potential to minimize the negative effects associated with stent-related maladaptive biologic response [ 8 ]. Currently, the management of in-stent restenosis (ISR) by DCB is considered a Class IA recommendation [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design

Gao,

He,

Liu

et al. 2024

BMC Cardiovasc Disord

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Background Percutaneous coronary intervention (PCI) with primary stenting, which stands for stent implantation regardless of obtaining satisfactory results with balloon angioplasty, has superseded conventional plain old balloon angioplasty with provisional stenting. With drug-coated balloon (DCB), primary DCB angioplasty with provisional stenting has shown non-inferiority to primary stenting for de novo coronary small vessel disease. However, the long-term efficacy and safety of such a strategy to the primary stenting on clinical endpoints in de novo lesions without vessel diameter restrictions remain uncertain. Study design The REC-CAGEFREE I is an investigator-initiated, multicenter, randomized, open-label trial aimed to enroll 2270 patients with acute or chronic coronary syndrome from 43 interventional cardiology centers in China to evaluate the non-inferiority of primary paclitaxel-coated balloons angioplasty to primary stenting for the treatment of de novo, non-complex lesions without vessel diameter restrictions. Patients who fulfill all the inclusion and exclusion criteria and have achieved a successful lesion pre-dilatation will be randomly assigned to the two arms in a 1:1 ratio. Protocol-guided DCB angioplasty and bailout stenting after unsatisfactory angioplasty are mandatory in the primary DCB angioplasty group. The second-generation sirolimus-eluting stent will be used as a bailout stent in the primary DCB angioplasty group and the treatment device in the primary stenting group. The primary endpoint is the incidence of Device-oriented Composite Endpoint (DoCE) within 24 months after randomization, including cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization. Discussion The ongoing REC-CAGEFREE I trial is the first randomized trial with a clinical endpoint to assess the efficacy and safety of primary DCB angioplasty for the treatment of de novo, non-complex lesions without vessel diameter restrictions. If non-inferiority is shown, PCI with primary DCB angioplasty could be an alternative treatment option to primary stenting. Trial registration Registered on clinicaltrial.gov (NCT04561739).

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Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease

Cited by 6 publications

References 30 publications

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty

Factors influencing coronary artery target lesion revascularization after drug-coated balloon angioplasty

Clinical Predictors for In-Stent Restenosis in Patients with Coronary Artery Disease Receiving Coronary Stent Implantation

Drug-coated balloon angioplasty with provisional stenting versus primary stenting for the treatment of de novo coronary artery lesions: REC-CAGEFREE I trial rationale and design

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