Search

There is a growing trend of patients with significant comorbidities among those referred for percutaneous coronary intervention (PCI). Consequently, the number of patients undergoing complex high risk indicated PCI (CHIP) is rising. CHIP patients frequently present with factors predisposing to extensive drug-eluting stent (DES) implantation, such as bifurcation and/or heavily calcified coronary lesions, which exposes them to the risks associated with an increased stent burden. The drug-coated balloon (DCB) may overcome some of the limitations of DES, either through a hybrid strategy (DCB and DES combined) or as a leave-nothing-behind strategy (DCB-only). As such, there is a growing interest in extending the application of DCB to the CHIP population. The present review provides an outline of the available evidence on DCB use in CHIP patients, which comprise the elderly, comorbid, and patients with complex coronary anatomy. Although the majority of available data are observational, most studies support a lower threshold for the use of DCBs, particularly when multiple CHIP factors coexist within a single patient. In patients with comorbidities which predispose to bleeding events (such as increasing age, diabetes mellitus, and hemodialysis) DCBs may encourage shorter dual antiplatelet therapy duration-although randomized trials are currently lacking. Further, DCBs may simplify PCI in bifurcation lesions and chronic total coronary occlusions by reducing total stent length, and allow for late lumen enlargement when used in a hybrid fashion. In conclusion, DCBs pose a viable therapeutic option in CHIP patients, either as a complement to DES or as stand-alone therapy in selected cases., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines., (© 2022. Higher Education Press.)

Objectives: At least 1 month of dual antiplatelet therapy is required after coronary stenting. The aim of this all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) with single antiplatelet treatment (SAPT)., Methods: Between 2011 and 2020, 232 PCIs were performed in 172 patients using the DCB-only strategy and discharged with SAPT., Results: The mean age of the patients was 75 ± 11 years and 59% were male. The clinical presentation was stable coronary artery disease (CAD) in 42% of the patients and acute coronary syndrome (ACS) in 58%. The lesions were mainly de novo (96%). The majority (58%) of treated lesions were in large coronary arteries (≥3.0 mm). Most (87%) of the patients were at high bleeding risk (HBR) with at least one major or two minor Academic Research Consortium (ARC) risk factors for bleeding. Periprocedural DAPT was used in 49% of the patients. The 12-month major adverse cardiac events (MACE, the composition of cardiovascular death, nonfatal myocardial infarction, and target-lesion revascularization) rate was 1.4% in stable CAD and 7.1% in ACS. The 12-month all-cause mortality after DBC only + SAPT strategy was 4.1% in stable CAD and 12.1% in ACS. The rate of ischemia-driven target lesion revascularisation (TLR) was 0% in stable CAD and 3.0% in ACS at 12 months. The 12-month rate of significant bleeding (BARC type 2-5) was 10.5%. There were no acute or subacute vessel closures., Conclusions: Despite the aged patient population with comorbidities, the TLR, MACE, and bleeding rates were low with DCB-only PCI combined with SAPT. This novel approach could reduce the post-PCI bleeding risk in patients with CAD and HBR compared to stenting., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries., Methods: This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events., Results: Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78-5.36]; P <0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P =0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51-2.62]; P =0.719 versus non-HBR, 0.96 [0.62-1.49]; P =0.863)., Conclusions: DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT01574534.

Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no "class effect" of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Ischemic heart diseases are the main cause of death worldwide, therefore secondary prevention and treatment of coronary artery disease (CAD) are highly significant for public health and mortality. The objective of this study is to evaluate LDL cholesterol (LDL-C) levels as outcomes of secondary prevention of CAD in Finland up to 24 months after being diagnosed with acute coronary syndrome (ACS). This retrospective analysis of patients with ACS was conducted in two areas of Finland that have a combined population of 400,000., Methods: The data used in the study covered all outpatient visits, inpatient episodes, prescriptions and LDL-C results for ACS patients during 2011-2015. To evaluate the outcome of the prevention, three separate measurements of patients' LDL-C levels were considered: baseline, first follow-up and final follow-up. The factors associated with reaching treatment goal were identified using logistic regression analysis., Results: 32% of ACS patients achieved the treatment goal (LDL-C <1.8 mmol/l) at the end of the 24-month follow-up period, but 21% of patients fluctuated between being on and above target., Conclusion: Two thirds of CAD patients with ACS and on statin therapy do not achieve LDL-C treatment target recommended by the guidelines. Since LDL-C levels fluctuate in the follow-up, a low level during the first 12 months after the acute event does not guarantee the maintenance of the results in the long term. Hence, LDL-C levels should be monitored at least on an yearly basis on follow-ups, and treatment adapted accordingly., Competing Interests: Declaration of competing interest The study was partly funded by Amgen Ltd., who provided funds for the work of RL, AT, MN and FH and covered the cost of data retrieval. TL has received a small consulting fee from Amgen in 2014 for providing expertise in defining the data collection criteria and organizing data collection in North Karelia. The supporting source had no involvement in the conduct of the study or access to the data. The authors had full access to the study data., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population., Methods: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546., Findings: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group., Interpretations: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future., Funding: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: The aim of this single center all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) in de novo lesions including large proximal coronary arteries., Methods: A total of 487 PCIs were performed using paclitaxel-coated DCB in 562 de novo lesions with the possibility for bailout stenting in a patient population presenting with stable coronary artery disease (CAD) or acute coronary syndrome (ACS). Half of the patients had at least one risk factor for bleeding. All of the treated lesions were de novo and 60% of DCBs used were ≥ 3.0 mm in diameter. The median follow-up time was 18 months for MACE and 60 months for survival., Results: The total mortality after DBC only strategy was 2.3 and 9.3% at 12 months in stable CAD and ACS, respectively. The 12-month MACE rate was 7.1 and 12% in stable CAD and ACS. The rate of ischemia-driven target lesion revascularization was only 1.4% in stable CAD and 2.8% after ACS at 12 months. Median duration of DAPT was one month. The 12 month rate of significant bleeding (Bleeding Academic Research Consortium types 2-5) was 5.9%. Acute vessel closure occurred only in one case (0.2%) after DCB treatment. Bailout stenting was used in 12% of lesions., Conclusions: PCI using DCB-only strategy with the possibility for provisional stenting is a safe and efficient in de novo coronary artery lesions in both stable CAD and ACS. This strategy may be useful especially in patients with high bleeding risk., (© 2018 Wiley Periodicals, Inc.)

Objectives: We investigated the safety and efficacy of PCI using drug-coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding., Background: DCB has been effective in the treatment of in-stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation., Methods: 82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow-up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month., Results: MACE (the composite of cardiovascular death, ischemia-driven target-lesion revascularization [TLR] or non-fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia-driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months., Conclusions: This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant., (© 2017, Wiley Periodicals, Inc.)

Members of the vascular endothelial growth factor (VEGF) family are among the most powerful modulators of vascular biology. They regulate vasculogenesis, angiogenesis, and vascular maintenance during embryogenesis and in adults. Because of their profound effects on blood vessels, VEGFs have received much attention regarding their potential therapeutic use in cardiovascular medicine, especially for therapeutic vascular growth in myocardial and peripheral ischemia. However, completed randomized controlled VEGF trials have not provided convincing evidence of clinical efficacy. On the other hand, recent preclinical proangiogenic VEGF studies have given insight, and anti-VEGF studies have shown that the disturbance of vascular homeostasis by blocking VEGF-A may lead to endothelial dysfunction and adverse vascular effects. Excess VEGF-A may contribute to neovascularization of atherosclerotic lesions but, currently, there is no evidence that transient overexpression by gene transfer could lead to plaque destabilization. Here, we review the biology and effects of VEGFs as well as the current status of clinical applications and future perspectives of the therapeutic use of VEGFs in cardiovascular medicine.