Treatment Of Small Vessel Disease Research Articles

Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial)

The Dissolve drug-coated balloons (DCBs) is a new-generation DCB coated with paclitaxel of balloon surface, with midchain triglyceride excipient. Although the use of DCBs is a promising technique, little is known about the the clinical efficacy of the novel Dissolve DCB in coronary small vessel disease. This study was a prospective, randomized, multicenter, noninferiority trial comparing the Dissolve DCB with the Resolute drug-eluting stent (DES) in patients with a reference vessel diameter ≥2.25 and ≤2.75mm. Patients with a reference vessel diameter ≥2.00 and <2.25mm were enrolled in the very small vessel registry. The angiographic and clinical follow-up were planned at 9months and 1year in all patients, respectively. The primary end point was 9-month in-segment percentage diameter stenosis. A total of 247 patients with small vessel disease from 10 Chinese sites were included (Dissolve DCB, n=118; Resolute DES, n=129); 30 patients were treated with the DCB in the very small vessel cohort. The 9-month in-segment percentage diameter stenosis was 31.2 ± 2.0% with Dissolve DCB versus 26.1 ± 2.1% with Resolute DES; the 1-sided 97.5% upper confidence limit of the difference was 10.3% (p for noninferiority=0.0002). At 12months, the DCB and DES groups were associated with similar rates of target lesion failure (8.5% vs 6.1%, p=0.28) and major adverse cardiac and cerebrovascular events (20.9% vs 13.6%, p=0.12). In conclusion, the Dissolve DCB was noninferior to the Resolute DES for the primary end point of 9-month in-segment percentage diameter stenosis in this multicenter, head-to-head, randomized trial (a safety and efficacy study of Dissolve In Treatment Of Coronary Small Vessel Disease; NCT03376646).

Small-vessel Coronary Angioplasty – Past, Present, and Future

Small-vessel disease (SVD) is an important subset of the population with coronary artery disease which may account for up to 30–70% according to different series. The challenges of SVD interventions are first to detect the true small-vessel size along with the true length of the lesion by intravascular imaging, then to decide about the interventional strategies as there is difficulty in delivering the stent to the lesion, dissections, under expansions of the stent during percutaneous coronary intervention with increased incidence of restenosis, and need for revascularization on the long term as well. Special attention is to be paid to this subset of patients of SVD as the treatment strategies need to be improvised than simple balloon dilatation or stenting with drug-eluting stents. At present, drug-coated or eluting balloon emerging as an improvised strategy for treating these patients with intravascular imaging. This article concentrates on the latest updates in SVD treatment.

Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study

BackgroundImmediate and long-term functional outcomes after percutaneous treatment of small vessel disease (SVD) with drug-coated balloon (DCB) versus drug-eluting stent (DES) remain unknown. The study sought to investigate whether treatment of de novo SVD with DCB yields similar functional results compared with DES, as judged with angiography-based quantitative flow ratio (QFR).Methods and resultsQFR was measured at pre-procedural, post-procedural and 9-month angiography in all available subjects from the non-inferiority RESTORE SVD China trial, in which patients were randomized to Restore DCB (n = 116) or Resolute DES (n = 114) study arms. Primary outcome of this analysis was 9-month QFR. Pre-procedural, post-procedural and 9-month QFR was performed in 84.8% (195/230), 83.0% (191/230) and 93.8% (181/193) cases, respectively. At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12). Both 9-month QFR and the QFR difference between post-procedure and 9-month follow-up were correlated with angiographic percentage of diameter stenosis and late loss, and predictive of 2-year clinical outcome.ConclusionsTreatment of coronary SVD with DCB resulted in similar 9-month functional results compared with DES. This study provides evidences to the value of QFR as a mean of evaluating device performance after coronary revascularization.Clinical trial registrationURL: https://www.clinicaltrials.gov; ClinicalTrial.gov: Identifier: NCT02946307.

Clinical Features and Experimental Models of Cerebral Small Vessel Disease.

Cerebral small vessel disease (SVD) refers to a group of disease conditions affecting the cerebral small vessels, which include the small arteries, arterioles, capillaries, and postcapillary venules in the brain. SVD is the primary cause of vascular cognitive impairment and gait disturbances in aged people. There are several types of SVD, though arteriolosclerosis, which is mainly associated with hypertension, aging, and diabetes mellitus, and cerebral amyloid angiopathy (CAA) comprise most SVD cases. The pathology of arteriolosclerosis-induced SVD is characterized by fibrinoid necrosis and lipohyalinosis, while CAA-associated SVD is characterized by progressive deposition of amyloid beta (Aβ) protein in the cerebral vessels. Brain magnetic resonance imaging (MRI) has been used for examination of SVD lesions; typical lesions are characterized by white matter hyperintensity, lacunar infarcts, enlargement of perivascular spaces (EPVS), microbleeds, cortical superficial siderosis (cSS), and cortical microinfarcts. The microvascular changes that occur in the small vessels are difficult to identify clearly; however, these consequent image findings can represent the SVD. There are two main strategies for prevention and treatment of SVD, i.e., pharmacotherapy and lifestyle modification. In this review, we discuss clinical features of SVD, experimental models replicating SVD, and treatments to further understand the pathological and clinical features of SVD.

Drug-coated Balloons for Small Coronary Vessel Interventions: A Literature Review.

Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.

Current concepts about small vessel disease

Small vessel disease is a very common pathological process, which plays a key role in the development of stroke and cognitive impairment and, at the same time, affects other organs. The search for optimal drugs for prevention and treatment of small vessel disease has been continuing. The results of new studies enable further development of new treatment strategies. Currently, the drugs with neurotrophic properties become more and more important.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial

ObjectivesThe aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BackgroundHigher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)–only strategy is effective in de novo SVD is not yet established. MethodsIn the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. ResultsBetween August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). ConclusionsIn this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307)

TCT-264 Sirolimus Coated Balloon in The Treatment of Small Vessel Disease: Long Term Follow-up From The Indian Nanolute Registry

Percutaneous coronary intervention (PCI) with drug eluting stent (DES) in small vessel disease (SVD) is the standard of care with target lesion revascularization (TLR) ranging between 6-9%. Recently, drug coated balloon has been used to treat de-novo SVD with promising results. We sought to assess

Analysis of the effect of folic acid combined with mecobalamin in the treatment of cerebral small vessel disease with hyperhomocysteinemia

Objective To investigate the clinical effect of folic acid combined with methylcobalamin in the treatment of cerebral small vessel disease with hyperhomocysteinemia. Methods From January 2015 to December 2016, 78 patients who were diagnosed cerebral small vessel disease with high homocysteinemia(Hcy) and also associated with vascular mild cognitive impairment in the Second People's Hospital of Liaocheng were selected as the research objects, and they were randomly divided into control group and observation group, with 39 cases in each group.The control group was given routine treatment, and the observation group was treated with folic acid combined with mecobalamin on the bassis treatment of the control group.The levels of The Hcy, vitamin B12, folic acid and the Alzheimer's disease assessment scale-cognitive subscale(ADAS-cog) scores before and after treatment for 3 and 6 months were compared between the two groups. Results Before treatment, there was no statistically significant difference in the level of plasma Hcy between the two groups(t=0.34, P=0.74). There was no statistically significant difference in the level of plasma Hcy of the control group between before and after 3 and 6 months treatment(t=0.36, 1.30, all P>0.05). The plasma Hcy level in the observation group after 3 and 6 months treatment[(19.98±3.65)mol/L, (14.96±3.54)mol/L] were significantly lower than that before treatment[(26.38±2.95)mol/L](t=8.52, 15.48, all P 0.05). There was no statistically significant difference in the levels of vitamin B12 and folic acid of the control group between before and after 3 and 6 months treatment(all P>0.05). The vitamin B12 and folic acid levels in the observation group after 3 and 6 month treatment were significantly higher than those before treatment(all P 0.05). There was no statistically significant difference in the ADAS-cog scale score of the control group between before and after 3 and 6 months treatment(all P>0.05). The scores of ADAS-cog scale in the observation group after 3 and 6 months treatment[(12.05±2.13)points, (10.24±2.84)points] were significantly lower than that before treatment[(15.07±3.56)points](t=4.55, 6.62, all P<0.05), which were also significantly lower than that in the control group(all P<0.05). Conclusion Folic acid combined with methylcobalamin in the treatment of cerebral small vessel disease with hyperhomocysteinemia can significantly reduce the Hcy, vitamin B12 and folic acid levels, which can help to relieve the vascular cognitive impairment, so it is worthy of promotion and application. Key words: Basal ganglia cerebrovascular disease; Hyperhomocysteinemia; Folic acid; Mecobalamin

Pay attention to the role of blood pressure variability in the pathogenesis, prevention and treatment of cerebral small vessel disease

Pay attention to the role of blood pressure variability in the pathogenesis, prevention and treatment of cerebral small vessel disease

“Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon” Is the Target Lesion the Culprit One?

“Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon” Is the Target Lesion the Culprit One?

TCT-516 Bioresorbable Vascular Scaffolds for the Treatment of Small Vessel Disease: Results from a 3-Center Italian Experience

TCT-516 Bioresorbable Vascular Scaffolds for the Treatment of Small Vessel Disease: Results from a 3-Center Italian Experience

Book Review: “Cerebral Small Vessel Disease”. What’s the Big Deal about Small Vessels?

Book Review: “Cerebral Small Vessel Disease”. What’s the Big Deal about Small Vessels?

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study

Background/objectivesA prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. MethodsA total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. ResultsTwo-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6months, 1year and 2years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). ConclusionsOur results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Spotlight on the September 30 Issue

The additive total small-vessel disease (SVD) burden score is associated with lacunar stroke and represents the effect. This result suggests that smoking and hypertension are preventable risk factors and that this burden score should be used in research and clinical practice to capture the overall consequences of SVD. See p. 1228 From editorialists Jickling & Chen: “As the scale is refined, the hope is that a comprehensive evaluation of cerebral SVD will improve our understanding and treatment of SVD, and ultimately improve brain health.” See p. 1224 Multifeature analysis was performed using MRI metrics obtained at 3T, focusing …

Safety and effectiveness of drug-eluting stents versus bare-metal stents in elderly patients with small coronary vessel disease

Drug-eluting stents (DES) are more effective than bare-metal stents (BMS) in small coronary vessel disease. Whether this is true in elderly patients, it is unclear, as frailty and a high rate of comorbidities could increase the rate of DES-related complications. To assess procedural and long-term clinical outcomes of elderly patients with small vessel disease treated with DES or BMS. Consecutive elderly patients (≥ 75 years old) treated with stenting of native small coronary arteries (reference vessel diameter and implanted stent<3mm) were recruited during 2004-2008. Procedural and long-term clinical outcomes were compared between patients treated with BMS and DES. Propensity score-adjusted logistic regression analysis was performed to account for potential selection bias. Among 293 patients (175 BMS, 118 DES), peri-procedural myocardial infarction (12 [7%] vs. 5 [4%]; P=0.35) and blood transfusions (3 [2%] vs. 0; P=0.08) were not significantly different between the BMS and DES groups. Clinical follow-up (96% of patients, median [interquartile range] follow-up 3.5 [2.4] years) showed significantly lower adjusted major adverse cardiac events (hazard ratio [HR] 0.42, 95% confidence interval [CI] 0.24-0.72; P=0.002) and target vessel revascularization (TVR) (HR 0.33, 95% CI 0.14-0.76; P=0.009) in the DES group. No significant differences were observed between the groups in terms of death, myocardial infarction, stent thrombosis or bleeding. In this retrospective, non-randomized analysis of the treatment of small vessel disease in elderly patients, DES were as safe and more effective than BMS with a significant reduction in TVR.

A randomized multicentre study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: The BELLO (Balloon Elution and Late Loss Optimization) study

Objectives: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel eluting stents (PES) for the reduction of restenosis in small vessels. Background: DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de-novo disease. Methods: BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicentre trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary end-points were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. Results: Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter<2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference −0.21; 95% CI: −0.34 to −0.09; p noninferiority < 0.001; p superiority = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (8.9% vs. 14.1%; p = 0.25), target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (7.8% vs. 13.2%; p = 0.77). Conclusions: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES.

A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels: The BELLO (Balloon Elution and Late Loss Optimization) Study

The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease. BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected]. Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).

TCT-289: Treatment of small vessel disease (

TCT-289: Treatment of small vessel disease (<2.5mm) with a Placlitaxel Eluting Balloon: 6 months Outcomes of the Spanish Multicenter Registry

AS-236: Short and Midterm Results of the Paclitaxel-Eluting Balloon for the Treatment of Small Vessel Disease (

AS-236: Short and Midterm Results of the Paclitaxel-Eluting Balloon for the Treatment of Small Vessel Disease (<2.5 mm): Insights from the Spanish Dior Multicenter Registry