Systematic Review on Role of Drug Eluting Stent (DES) Versus Drug-Coated Balloon (DCB) in Small Vessel Coronary Artery Disease.

PURPOSE OF REVIEW: This review aims to explain the current advancements in the treatment modalities for small vessel coronary artery disease (SVCAD) and de novo lesions post-percutaneous coronary intervention (PCI), focusing on drug-coated stents (DES) and drug-coated balloons (DCB). Its goal is to address the lack of standards in the management of these lesions and to assess the potential of DCB as a preferential treatment strategy over DES in the long term. RECENT FINDINGS: Technological advancements have improved drug-eluting stents (DES) and drug-coated balloons (DCB) which offer a more promising avenue for managing SVCAD. According to new data, DCBs, initially recognized for their efficacy in preventing restenosis within three to five years of stent placement, may offer superior outcomes compared to DES in certain clinical scenarios. This review shows that DCBs have a favorable therapeutic profile in the treatment of SVCAD, and they could be considered as an alternative to DES. Although the initial data is compelling, definitive conclusions cannot be met without further large-scale, long-term clinical trials. The implication of these findings suggests a shift in the future of SVCAD management and requires additional research to substantiate the long-term benefits of DCB use in SVCAD. Should ongoing and future studies corroborate the current evidence, DCB could emerge as the standard of care for SVCAD, significantly influencing clinical practices and future research.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Sex-specific inequalities in the use of drug-coated balloons for small coronary artery disease: a report from the BASKET-SMALL 2 trial.

BACKGROUND AND OBJECTIVES: Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail. METHODS: In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months. RESULTS: Among 758 randomized patients, 382 were assigned to DCB (23% women) and 376 to DES (30% women). In general, women were older, had more often diabetes mellitus and renal insufficiency, and presented more often with an acute coronary syndrome, whereas men were more often smokers, had multivessel disease and a previous history of acute myocardial infarction, and received a treatment with a statin. After 3 years, the primary clinical end point was not significantly different between groups (13% women vs. 16% men, HR 0.82; 95% CI 0.52-1.30; p = 0.40). There was no interaction between sex and coronary intervention strategy regarding MACE at 36 months (10% women vs. 16% men in DCB, 16% women vs. 15% men in DES; pinteraction = 0.31). CONCLUSION: In small native coronary artery disease, there was no statistically significant effect of sex on the difference between DCB and DES regarding MACE up to 36 months. CLINICAL TRIAL REGISTRATION: URL: http://www. CLINICALTRIALS: gov . Unique identifier: NCT01574534. CAD coronary artery disease, MACE major adverse cardiovascular events, HR Hazard ratio, DCB drug-coated balloon, DES drug-eluting stent.

Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up.

BACKGROUND: Native vessel coronary artery disease represents 1 of the most attractive fields of application for drug-coated balloons (DCBs). To date, several devices have been compared with drug-eluting stents (DESs) in this setting with different outcomes. OBJECTIVES: The authors sought to compare the short- and long-term performance of the paclitaxel DCB with the everolimus-eluting stent in patients with de novo lesions in small coronary vessel disease. METHODS: PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) was an academic, international, investigator-driven, multicenter, open-label randomized clinical trial in which patients were allocated to a DCB (n = 118) or DES (n = 114). We previously reported the superiority of DCBs regarding in-lesion late lumen loss at 6 months. Herein we report the final 3-year clinical follow-up with the occurrence of major adverse cardiac events (MACEs), a composite of cardiac death, nonfatal myocardial infarction, target lesion revascularization, and its individual components. RESULTS: The 3-year clinical follow-up (median 1,101 days; IQR: 1,055-1,146 days) was available for 102 patients allocated to DCB and 101 to DES treatment. The cumulative rate of all-cause death (4% vs 3.9%; P = 0.98), cardiac death (1% vs 1.9%; P = 0.56), myocardial infarction (6.9% vs 2%; P = 0.14), and target lesion revascularization (14.8% vs 8.8%; P = 0.18) did not significantly differ between DCBs and DESs. MACEs and acute vessel occlusion occurred more frequently in the DES group (20.8% vs 10.8% [P = 0.046] and 4% vs 0% [P = 0.042], respectively). CONCLUSIONS: The long-term clinical follow-up of the PICCOLETO II randomized clinical trial shows a higher risk of MACEs in patients with de novo lesions in small vessel disease when they are treated with the current-generation DES compared with the new-generation paclitaxel DCB. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Clinical outcomes of percutaneous coronary intervention for de novo lesions in small coronary arteries: A systematic review and network meta-analysis.

Background: Percutaneous coronary intervention (PCI) has a well-established role in revascularization for coronary artery disease. We performed network meta-analysis to provide evidence on optimal intervention strategies for de novo lesions in small coronary arteries. Materials and methods: Enrolled studies were randomized clinical trials that compared different intervention strategies [balloon angioplasty (BA), biolimus-coated balloon (BCB), bare-metal stent (BMS), new-generation drug-eluting stent (New-DES), older generation sirolimus-eluting stent (Old-SES), paclitaxel-coated balloon (PCB), and paclitaxel-eluting stent (PES)] for de novo lesions in small coronary arteries. The primary outcome was major adverse cardiac events (MACE). Results: A total of 23 randomized clinical trials comparing seven intervention devices were analyzed. In terms of the primary outcome, New-DES was the intervention device with the best efficacy [surface under the cumulative ranking curve (SUCRA), 89.1%; mean rank, 1.7], and the Old-SES [risk ratio (RR), 1.09; 95% confidence interval (CI), 0.45-2.64] and PCB (RR, 1.40; 95% CI, 0.72-2.74) secondary to New-DES, but there was no statistically significant difference between these three intervention devices. All DES and PCB were superior to BMS and BA for MACE in both primary and sensitivity analysis. For secondary outcomes, there was no association between all-cause mortality and myocardial infarction (MI) with any intervention strategy, and additionally, the findings of target lesion revascularization (TLR) were similar to the primary outcomes. Conclusion: Paclitaxel-coated balloon yielded similar outcomes to New-DES for de novo lesions in small coronary arteries. Therefore, this network meta-analysis may provide potential support for PCB as a feasible, effective, and safe alternative intervention strategy for the revascularization of small coronary arteries. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/#recordDetails], identifier [CRD42022338433].

Optical coherence tomography-guided drug coated balloon in non-small de novo coronary artery lesions: a prospective clinical research.

PURPOSE: The combined use of drug coated balloon (DCB) and optical coherence tomography (OCT) for the treatment of non-small coronary de novo lesion remains to be evaluated. We investigated the safety and efficacy of OCT-guided DCB in non-small coronary de novo lesion patients with predilation of cutting balloon. METHODS: https://clinicaltrials.gov/, ClinicalTrials.gov Identifier: NCT04795144. This study was a prospective, and open-label study. We enrolled patients with non-small de novo lesions treated with OCT-guided DCB. The non-small de novo lesions indicated vessel lesions with a diameter ≥ 2.5 mm. The primary endpoints were the success rate of the procedure and the occurrence of target lesion revascularization. The secondary endpoints were myocardial infarction, cardiac death, and major adverse cardiac events (MACE) within 3 months after the procedure. RESULTS: At the Second Hospital of Jilin University, we enrolled 54 patients (54 lesions) with non-small de novo lesions who were treated with OCT-guided DCB from October 2018 to June 2019. A total of 52 patients were successfully treated with DCB-only strategy, while 2 patients turned to bailout stenting. A total of 21 patients had undergone angiography 3 months after the procedure with the late lumen loss of 0.24±0.57 mm. There was no statistically significant difference in minimal lumen diameter (MLD) between post-DCB and at 3-month angiographic follow-up (2.25±0.40 mm vs 2.04±0.54 mm; P = 0.110). Only 1 patient developed restenosis with the incidence of MACE rate of only 1.92% (n = 1). There was no significant difference in the stenosis of the lumen diameter of the target lesion vessel between 3 months after operation and immediately after operation. CONCLUSIONS: Our study showed that OCT-guided DCB with cutting balloon under guidance may be a novel approach in non-small de novo coronary artery disease.

Long-Term Clinical Outcomes of New-Generation Drug-Eluting Stents in Coronary Artery Disease: A Real-World Observational Study.

BACKGROUND: Treating vessels with a very small reference vessel diameter (RVD) in coronary artery disease is challenging. OBJECTIVE: Long-term evaluation of new-generation drug-eluting stents (DESs) for the treatment of coronary lesions with different RVDs. METHODS: From April 2009 to March 2019, 780 patients who underwent single coronary stenting were divided into ≤ 2.25 (very small), 2.5-3.0 (small), and ≥ 3.5 mm (large) DES groups after 1:2:2 propensity score matching. The primary endpoint was target lesion failure (TLF), and the secondary endpoints were major adverse cardiac events (MACEs) and stent thrombosis (ST). RESULTS: During 3 years after new-generation DES implantation, TLF and MACE rates were significantly lower in the very small DES group. The risk of TLF was significantly lower in the very small DES group compared to the small DES group [very small vs. small: TLF, adjusted hazard ratio (HR) = 0.282, p = 0.040]. The risks of MACEs and all-cause mortality were significantly lower in the very small DES group compared to the small DES group (very small vs. small: MACEs, adjusted HR = 0.215, p = 0.001; all-cause mortality, adjusted HR = 0.181, p = 0.005). The cumulative incidence rates of TLF-free (log-rank test p = 0.001) and MACE-free (log-rank test p < 0.001) survival were significantly different among the groups, and the very small DES group had a high event-free survival rate. No cases of ST occurred in any group. CONCLUSIONS: Our results indicate that the use of new-generation DESs for treating coronary lesions in very small vessels is safe and effective.

Clinical outcomes of drug-eluting balloon for treatment of small coronary artery in patients with acute myocardial infarction.

There were good clinical outcomes of drug-eluting balloon (DEB) use in de novo lesions and in-stent restenosis (ISR) lesions. However, few studies focused on DEB use in patients with acute myocardial infarction (AMI). The aim of this study was to retrospective evaluate the efficacy of DEB for patients of AMI with de novo small coronary artery disease. Between March 2016 and March 2018, patients of AMI with de novo small coronary artery (reference diameter 2.0-2.8 mm) and received percutaneous coronary intervention (PCI) were enrolled. 268 patients were divided into DEB group (PCI with further DEB, n = 56) and drug-eluting stent (DES) group (PCI with further DES, n = 212). The primary endpoint was major adverse cardiac events (MACE; all-cause death, non-fatal myocardial infarction, target lesion revascularization and target vessel revascularization) at 24 months. A subset of patients underwent angiographic follow-up. Clinical characteristics were balanced in the two groups. Mean reference vessel diameter was similar between the DEB and DES groups (2.64 ± 0.17 mm vs 2.65 ± 0.14 mm, P = 0.625). The 24-month MACE rates were 17.5% in DEB group and 16.4% in DES group (P = 0.853). Stent thrombosis was seen in three patients (1.46%) in DES group. There was no vessel thrombosis noted in the DEB group. Angiographic follow-up was performed in 35.71% of DEB group and 27.25% of DES group. Late lumen loss was similar between the two groups (DEB 0.14 ± 0.13 mm, DES 0.19 ± 0.12 mm, P = 0.442). DEB is a reasonable strategy for AMI with small coronary artery. Compared with DES, DEB is an alternative strategy which had similar 24-month clinical outcomes.

Small vessel coronary artery disease: How small can we go with myocardial revascularization?

The issue of small coronary artery atherosclerosis represents an intriguing aspect of coronary artery disease, which is related with higher rates of peri- and post-procedural complications and impaired long-term outcome. This problem is further complicated by the unclear definition of small coronary vessel. Recent randomized controlled trials have provided new data on possible novel interventional treatment of small coronary vessels with drug-coated balloons instead of traditional new-generation drug-eluting stent implantation. Also, the conservative management represents a therapeutic option in light of the results of the recent ISCHEMIA trial. The current article provides an overview of the most appropriate definition, interventional management, and prognosis of small coronary artery atherosclerosis.

Distal anastomosis support for bypass grafting for the small posterior descending artery / 中华胸心血管外科杂志

Objective:To describe a distal anastomosis support (DAS) technique, and retrospectively investigate the effect of DAS on the mid-term graft patency of patient with small posterior descending artery.Methods:Between January and December 2016, 100 patients with triple-vessel disease and small PDA who continuously underwent off-pump coronary artery bypass grafting (OPCABG) (OPCABG group, n=50) and OPCABG with DAS for anastomosis of PDA grafted by saphenous vein (SVG) (OPCABG+ DAS group, n=50) were evaluated retrospectively. The dynamic changes of electrocardiogram and TnI level were observed within 48h after the surgery. All patients came back to follow-up visit 6th, 12th, 24th and 36th postoperative month. The primary endpoint was the graft failure (FitzGibbon B or O) of SVG-PDA on the follow-up CTA.Results:There was no death during the operation. There was no acute inferior wall myocardial infarction confirmed by electrocardiogram. Peak TnI within 48h of surgery was 0.74(0.98)ng/ml vs. 0.92(1.29)ng/ml, P>0.05, and the number of patients with peak TnI≥70×ULN was 3(6%, 3/50) vs.5(10%, 5/50), P>0.05. There was no postoperative death, and all the patients were discharged 5-15 days postoperatively. We found significantly improved cumulative graft patency in OPCABG+ DAS group at 36 months after operation [85.7%(42/49) vs. 68.0%(34/50), P<0.05). In multivariate logistic regression analysis, PDA with atherosclerotic lesions ( OR=6.513, 95% CI: 1.279-33.180, P=0.024), and peak TnI≥70×ULN within 48 h of surgery ( OR=5.948, 95% CI: 1.128-31.368, P=0.036) were independent predictors of graft failure, whereas concomitant DAS ( OR=0.222, 95% CI: 0.069-0.713, P=0.011) was significant protective factor. Conclusion:Concomitant DAS conferred superior mid-term patency of SVG-PDA in patients with small PDA. Adding the DAS procedure to OPCABG may be a promising surgical option for small PDA with atherosclerotic lesions.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

OBJECTIVES: This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. BACKGROUND: Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. METHODS: The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months. RESULTS: Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm. CONCLUSIONS: In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report.

OBJECTIVES: The aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES). BACKGROUND: Notwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established. METHODS: The study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction. RESULTS: The study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score-adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups. CONCLUSIONS: Because of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels.

Valves of the small coronary veins in porcine hearts.

The aim of the study was to investigate the existence of valves in small peripheral coronary veins of porcine hearts. The study was performed on 20 porcine hearts using standard histological methods. The veins in the subepicardial and intramyocardial regions of the anterior and posterior parts of the interventricular septum and in the wall of the right atrium were studied. Valves were present in intramyocardial veins (diameter of 75-180 µm), in the veins located just beneath the external surface of the myocardium (diameter 120-170 µm) and in the terminal segments of the ventricular veins (diameter 250 µm) opening into the stems of the anterior interventricular vein and middle cardiac vein. Valves were also recorded in most veins of the subepicardial space. The described rich presence of valves in the small coronary veins may contribute to a better comprehension of their hemodynamic properties. These findings may also help to improve the understanding of the efficacy of retrograde application of medications, a novel technique in cardiology and cardiac surgery.

Small-vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus-eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post-Approval studies.

OBJECTIVE: We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. BACKGROUND: There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. METHODS: We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. RESULTS: We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. CONCLUSION: In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Clinical Outcomes of Drug-Coated Balloons in Coronary Artery Disease Unsuitable for Drug-Eluting Stent Implantation.

BACKGROUND: The aim of this study was to investigate whether drug-coated balloon (DCB) treatment is effective for de novo coronary lesions that are unsuitable for drug-eluting stent (DES) implantation.Methods and Results:This retrospective study included 118 de novo lesions that were not suitable for DES implantation. Of the lesions, 40% was treated because of very small vessel disease. Patients with planned non-cardiac surgery and at high bleeding risk were 3% and 19%, respectively, and lesions that easily develop stent fracture comprised 26%. Clinically driven target lesion revascularization (TLR) was the primary endpoint. The rate of suboptimal lesion preparation before DCB treatment was set as the secondary endpoint. Optimal lesion preparation was defined as acquisition of Thrombolysis in Myocardial Infarction flow grade 3, minor coronary dissection, and residual stenosis ≤30%. The rate of suboptimal lesion preparation was 2.5% and 3 patients needed bail-out stenting. Accordingly, 115 patients were treated with a DCB. Clinically driven TLR had occurred in 8 patients (7.0%) at the 8-month follow-up. The presence of chronic total occlusion was identified as an independent predictor for TLR (odds 11.57; 95% confidence interval, 1.38-135.54; P=0.02). CONCLUSIONS: For lesions that are unsuitable for stent implantation, stent-less intervention using a DCB should be considered initially. The present study also highlighted that lesion preparation is key to a successful DCB strategy.

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.

Novel paclitaxel-coated scoring ballon for de novo complex coronary lesions-first report.

Drug-coated balloons (DCB) are being used for in-stent restenosis treatment and there is some preliminary experience in other coronary settings, including small vessels and side branches. Scoring balloons (SB) are a useful tool for the preparation of fibro-calcific lesions. Because of the controlled micro-dissections that SB induce, it has been hypothesized that they may have a role in helping paclitaxel deliverability inside the vessel wall. The AngioSculpt®X (Spectranetics) is a novel paclitaxel-coated SB with encouraging preliminary data for the treatment of in-stent restenosis. We here describe our first experience treating two de novo coronary lesions with angiographic follow up.

Initial and late efficacy of everolimus-eluting stents for small and non-small coronary lesions from evaluating delayed late loss study.

The aim of the present study was to evaluate the long-term outcomes at 2 years in patients in whom everolimus-eluting stents (EESs) were implanted in small and non-small vessels. A small vessel is an important risk factor for restenosis with BMSs, even in the first generation DESs. The 690 patients with 690 lesions implanted with an EES were enrolled and divided into two groups by vessel reference diameter (RD): >2.5 mm for non-small vessels (Non-S-group) and ≤2.5 mm for small vessels (S-group). Two years later, the 365 patients with no restenosis at 8 months who underwent angiography were enrolled into the late catch-up study. At the initial 8-month follow-up, the rates of restenosis and target lesion revascularization (TLR) of both groups were not significantly different (restenosis 3.9 vs 6.5%, p = 0.17; TLR 3.9 vs 6.5%, p = 0.17). At the late 2-year follow-up, there were no significant differences in the late loss (0.36 ± 0.66 vs 0.34 ± 0.50 mm, p = 0.14), net gain (1.50 ± 0.75 vs 1.26 ± 0.60 mm, p = 0.39), late catch-up restenosis rate (5.1 vs 3.4%, p = 0.38), TLR (4.9 vs 2.7%, p = 0.40), and delayed late loss (0.14 ± 0.58 vs 0.15 ± 0.49 mm, p = 0.10) between both groups. There is no correlation between delayed late loss and RD in all patients(r = -0.009) and in AMI patients (r = -0.004). These results demonstrate that the initial and late catch-up restenosis rates of small coronary vessels with EES placement were excellent, the same as for non-small coronary vessels. We suggest that involvement of small coronary arteries may not be a risk factor for restenosis and results of stenting for small coronary arteries with EES placement were excellent.