Abstract:Background: Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES).
Conclusions:The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone… Show more
“…The use of DCBs is associated with positive vessel remodeling, vascular healing inducing late lumen enlargement, and plaque reduction and stabilization . A disadvantage to using DCB is the possibility of suboptimal results in some patients secondary to persistent residual stenosis and dissections, necessitating bailout stenting …”
Section: Discussionsupporting
confidence: 89%
“…15,41 A disadvantage to using DCB is the possibility of suboptimal results in some patients secondary to persistent residual stenosis and dissections, necessitating bailout stenting. 42 Our results showed similar angiographic and long-term clinical outcomes with DCB versus DES in treating small-vessel de novo CAD, and better outcomes when compared with BA alone. The outcomes remained comparable when DCB was compared only to newergeneration DES.…”
Background
Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study.
Objectives
To assess the outcomes of DCB in the treatment of SVD compared with the standard of care.
Methods
We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD.
Results
Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty.
Conclusion
The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.
“…The use of DCBs is associated with positive vessel remodeling, vascular healing inducing late lumen enlargement, and plaque reduction and stabilization . A disadvantage to using DCB is the possibility of suboptimal results in some patients secondary to persistent residual stenosis and dissections, necessitating bailout stenting …”
Section: Discussionsupporting
confidence: 89%
“…15,41 A disadvantage to using DCB is the possibility of suboptimal results in some patients secondary to persistent residual stenosis and dissections, necessitating bailout stenting. 42 Our results showed similar angiographic and long-term clinical outcomes with DCB versus DES in treating small-vessel de novo CAD, and better outcomes when compared with BA alone. The outcomes remained comparable when DCB was compared only to newergeneration DES.…”
Background
Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study.
Objectives
To assess the outcomes of DCB in the treatment of SVD compared with the standard of care.
Methods
We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD.
Results
Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty.
Conclusion
The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.
“…In the past decade, a tremendous effort has been made to develop alternative strategies to overcome the limitations of the increased metal length implanted in the coronary arteries. One of the most studied alternatives are drug-coated balloons (DCB), which have the ability to homogeneously transfer drugs to the vessel wall without the need for prosthesis implantation 5 . The encouraging results in terms of safety and efficacy of DCB reported for in-stent restenosis (ISR) and small vessel disease (SVD) have led to continuous work in refining their still unclear role in native large coronary arteries.…”
Continuous advances in the field of interventional cardiology have led to the development of drug-coated balloons (DCB). These represent a promising device for overcoming the well-known limitations of traditional metallic stents, which are associated with a persistent yearly increased risk of adverse events. This technology has the ability to homogeneously transfer the drug into the vessel wall in the absence of a permanent prosthesis implanted in the coronary vessel.Robust data support the use of DCB for the treatment of in-stent restenosis, but there is also currently growing evidence from long-term follow-up of large randomised clinical trials regarding the use of these devices in other scenarios, such as de novo small and large vessel disease, complex bifurcations, and diffuse coronary disease. Other critical clinical settings such as diabetes mellitus, high bleeding risk patients and acute coronary syndromes could be approached in the upcoming future by using DCB, alone or as part of a blended strategy in combination with drug-eluting stents.There have been important scientific and technical advances in the DCB field in recent years. The purpose of this paper is to review the most current data regarding the use of DCB, including the mid-and long-term follow-up reports on the safety and efficacy of this novel strategy in different clinical and angiographic scenarios.
Percutaneous coronary intervention of small-vessel coronary artery disease (SVD) remains challenging due to difficulties with device delivery and high restenosis rate, even with the use of newer-generation drug-eluting stents. Drug-coated balloons represent an attractive emerging percutaneous coronary intervention option in patients with SVD. Potential advantages of drug-coated balloons in SVD include enhanced deliverability because of their small profile, avoidance of foreign-body implantation, and shorter duration of dual antiplatelet therapy.
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