Comparison Between Drug-Coated Balloon and Stents in Large De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis of RCT Data.

PURPOSE: Although a number of studies involving small-vessel de novo coronary disease showed clinical benefits of drug-coated balloons (DCB), the role of DCB in large vessel lesions is still unclear. METHODS: We searched main electronic databases for randomized controlled trials (RCTs) comparing DCB with stents for large vessel de novo coronary artery disease. The primary endpoint was major cardiovascular adverse events (MACE), composite cardiovascular death (CD), myocardial infarction (MI), or target lesion revascularization (TLR). RESULTS: This study included 7 RCTs with 770 participants. DCB were associated with a marked risk reduction in MACE [Risk Ratio (RR): 0.48; 95% confidence interval [CI]: 0.24 to 0.97; P = 0.04], TLR (RR: 0.53; 95% CI: 0.25 to 1.14; P = 0.10), and late lumen loss [standard mean difference (SMD): -0.57; 95% CI: -1.09 to -0.05; P = 0.03] as compared with stents. There is no significant difference in MI (RR: 0.58; 95% CI: 0.21 to 1.54; P = 0.27), CD (RR: 0.33; 95% CI: 0.06 to 1.78; P = 0.19), and minimal lumen diameter (SMD: -0.34; 95% CI: -0.72 to 0.05; P = 0.08) between groups. In subgroup analyses, the risk reduction of MACE persisted in patients with chronic coronary syndrome (RR: 0.25; 95% CI: 0.07 to 0.89; P = 0.03), and patients receiving DCB vs. bare metal stent (RR: 0.19; 95% CI: 0.05 to 0.73; P = 0.01). In addition, there was no significant difference between the DCB group and the drug eluting stent group for MACE (RR: 0.69; 95% CI: 0.30 to 1.60; P = 0.38). CONCLUSION: DCB may be an effective therapeutic option in patients with large vessel de novo coronary artery disease.

Drug-coated balloons versus drug-eluting stents for coronary de novo lesions in dialysis patients.

BACKGROUND: The aim of this study was to compare the efficacy of drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) angioplasty in the treatment of de novo coronary artery lesions in dialysis patients. METHOD: We retrospectively enrolled 400 consecutive dialysis patients with 464 coronary de novo lesions treated by DCB or DES from five participating institutions in Japan. The primary endpoint was target lesion revascularization (TLR) at 12 months. We performed serial coronary angiographic analysis. RESULTS: There were no significant differences in the rate of TLR between the groups in either crude or propensity score-matched analysis (DES 14.1% vs. DCB 14.7%, P = 0.864, DES 12.1% vs. 12.1%, P = 1.00). Target lesion thrombosis was not observed in the DCB group; however, stent thrombosis was observed in 7 patients (2.2%) in the DES group. The rate of binary restenosis was similar in both groups (DES, 20.9% vs. DCB, 22.8%; P = 0.749). The late lumen loss at follow-up was significantly greater in the DES group than in the DCB group (0.61 ± 0.76 mm vs 0.22 ± 0.48 mm; P < 0.001). Late lumen enlargement was observed in 38.6% of patients in the DCB group. CONCLUSION: The efficacy of DCB angioplasty for de novo coronary artery lesions in dialysis patients was similar to that of DES angioplasty in the real world. Drug-coated balloon angioplasty can be an acceptable treatment for de novo coronary artery lesions in dialysis patients.

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions.

BACKGROUND: Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes. METHODS: In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR). RESULTS: From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was -0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was -0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226). CONCLUSIONS: In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: a meta-analysis of clinical trials.

BACKGROUND: Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results. OBJECTIVE: This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions. METHODS: The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters >2.5 mm. RESULTS: Three RCTs and one non-RCT with a total of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with a standardized mean difference (SMD) of -0.07 (95% confidence interval [CI]: -0.31, 0.316; P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with a risk ratio (RR) of 1.17 (95% CI: 0.46, 2.95; P = 0.746). CONCLUSION: This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6-9 months after percutaneous coronary intervention in patients presenting with coronary artery disease.

Comparison of Drug-Eluting Stent and Plain Old Balloon Angioplasty After Rotational Atherectomy in Severe Calcified and Large Coronary.

Drug-eluting stent (DES) is well known to be effective in severely calcified lesion after rotational atherectomy (ROTA). However, there are still some situations when stents should be avoided and plain old balloon angioplasty (POBA) should be the preferred option. The present study aims to explore whether POBA is comparably effective to DES in large and calcified coronary pretreated by ROTA in clinical outcomes.Consecutive patients treated for severely calcified lesions in the large (≥ 3 mm) coronary using ROTA + DES or ROTA + POBA were retrospectively analyzed. The major adverse cardiac events (MACE), including all-cause/cardiac death and target lesion revascularization (TLR) at 1 year and 2 years posttreatment, were compared between groups using the Cox regression analysis to identify independent predictors of TLR and MACE.The analysis included 285 cases in the ROTA + DES group and 47 cases in the ROTA + POBA group, without relevant differences in clinical baseline characteristics. Of note, lesion length was greater in the ROTA + DES group (37.2 versus 19.3 mm, P < 0.001); the ROTA + DES group had a higher rate of chronic total occlusion (CTO) lesions, with 8.4%, and the ROTA + POBA group had none. The inhospital/30-day mortality rate (5.3%, ROTA + DES; 6.4%, ROTA + POBA) and the 12- and 24-month all-cause/cardiac mortality rate (9.3%, ROTA + DES; 7.7%, ROTA + POBA) were not significantly different between the two groups. TLR rates were not significantly different between the two groups at 12 (4.6%, ROTA + DES; 4.3%, ROTA + POBA) and 24 (5.3%, ROTA + DES; 6.4%, ROTA + POBA) months.Outcomes were comparable for ROTA + DES and ROTA + POBA in severely calcified large coronary artery intervention with respect to midterm death or TLR rate, especially for short lesion of < 20 mm.

Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions.

OBJECTIVES: To assess the safety and efficacy of fractional flow reserve (FFR) guided paclitaxel-coated balloon (PCB) treatment for de novo coronary artery lesions. BACKGROUND: There is limited data on PCB treatment for de novo lesions especially of major epicardial coronary arteries. METHODS: Sixty-six patients with 67 de novo lesions who underwent successful plain old balloon angioplasty (POBA) were included. If POBA-FFR was favorable (≥ 0.85), PCB was applied and if POBA-FFR was <0.85, stent implantation was preferred over PCB. RESULTS: Forty-five lesions were treated with PCB (67.2%) and 22 lesions with stents (32.8%). Dual antiplatelet therapy duration was 6 weeks. Late luminal loss with PCB was significantly less than stent (0.05 ± 0.27 mm vs. 0.40 ± 0.54 mm, P = 0.022). The baseline FFR of target lesions was 0.69 ± 0.16 in PCB and 0.60 ± 0.11 in stent group (P = 0.015), however, the FFR at 9 months was not different between groups (0.85 ± 0.08 in PCB vs. 0.85 ± 0.05 in stent group, P = 0.973). At 1 year, one myocardial infarction and one target lesion revascularization related to in-stent restenosis were detected, both in the stent group. CONCLUSION: POBA-FFR-guided PCB treatment is safe and effective for de novo coronary lesions with good anatomical and physiological patency at mid-term follow-up. © 2015 Wiley Periodicals, Inc.

A Comparison of 2 Paclitaxel-Coated Balloon Systems in Treatment of De Novo Coronary Artery Lesions.

Background: In percutaneous coronary intervention (PCI) of de novo lesions, drug-coated balloons (DCB) have been shown to be a promising strategy to improve clinical outcomes of patients with small vessel disease. Evidence of this strategy in PCI of de novo coronary lesions in a real-world setting is limited. The objective of this study was to compare the 12-month outcomes of 2 paclitaxel-coated balloon systems for the treatment of all de novo coronary artery lesions. Methods: All patients who were treated for de novo coronary artery stenosis with either SeQuent Please or In.Pact Falcon DCB at a single center from January 2014 to December 2018 were included. The primary end point was the composite of cardiac death, nonfatal myocardial infarction, and target vessel revascularization (3-point major adverse cardiovascular events) at 12 months. Results: A total of 496 patients with 623 lesions, of which 144 were treated with SeQuent Please and 352 were treated with In.Pact Falcon were included in the study. Baseline patient, lesion and procedural characteristics at baseline were similar between groups. At 12-month follow-up, 3-point major adverse cardiovascular event outcomes were similar (4.2% vs 2.3% respectively; P = .272). Deaths due to cardiovascular events were few and similar between groups (2.7% vs 1.1% respectively; P = .20). Conclusions: Both paclitaxel DCB systems have similar efficacy and safety outcomes, suggesting that both may be an appropriate treatment choice for patients with de novo lesions. However, a larger randomized controlled study is needed to confirm these findings.

Establishment of a Nomogram for Predicting the Suboptimal Angiographic Outcomes of Coronary De Novo Lesions Treated with Drug-Coated Balloons.

INTRODUCTION: Factors affecting the angiographic outcomes of coronary de novo lesions treated with drug-coated balloons (DCBs) have not been well illustrated. The aim of the study is to establish a nomogram for predicting the risk of suboptimal diameter stenosis (DS) at angiographic follow-up. METHODS: A retrospective analysis was performed on a cohort of patients who underwent DCB intervention for coronary de novo lesions with angiographic follow-up data. Multivariable logistic regression analysis was applied to determine the independent predictors of DS ≥ 30% at follow-up, and then a nomogram model was established and validated. RESULTS: A total of 196 patients (313 lesions) were divided into the suboptimal (DS ≥ 30%) and optimal (DS < 30%) DS groups according to quantitative coronary angiography (QCA) measurements of the target lesions at follow-up. Seven independent factors including calcified lesions, true bifurcation lesions, immediate lumen gain rate (iLG%) < 20%, immediate diameter stenosis (iDS) ≥ 30%, DCB diameter/reference vessel diameter ratio (DCB/RVD) < 1.0, DCB length and mild dissection were identified. The area under the curve (AUC) (95% CI) of the receiver-operating characteristic (ROC) curve of the nomogram was 0.738 (0.683, 0.794). After the internal validation, the AUC (95% CI) was 0.740 (0.685, 0.795). The Hosmer-Lemeshow goodness of fit (GOF) test (χ2 = 6.57, P = 0.766) and the calibration curve suggested a good predictive consistency of the nomogram. CONCLUSIONS: The well-calibrated nomogram could efficiently predict the suboptimal angiographic outcomes at follow-up. This model may be helpful to optimize lesion preparation to achieve optimal outcomes.

Favorable Vasomotor Function after Drug-Coated Balloon-Only Angioplasty of De Novo Native Coronary Artery Lesions.

Balloon-injured coronary segments are known to harbor abnormal vasomotion. We evaluated whether de novo coronary lesions treated using drug-coated balloon (DCB) are prone to vasospasm and how they respond to ergonovine and nitrate. Among 132 DCB angioplasty recipients followed, 89 patients underwent ergonovine provocation test at 6-9 months follow-up. Within-subject ergonovine- and nitrate-induced diameter changes were compared among three different sites: DCB-treated vs. angiographically normal vs. segment showing prominent vasoreactivity (spastic). No patient experienced clinically refractory vasospastic angina or symptom-driven revascularization during follow-up. Ergonovine induced vasospasm in seven patients; all were multifocal spasm either involving (n = 2) or rather sparing DCB-treated segments (n = 5). None showed focal spasm that exclusively involved DCB-treated lesions. Among 27 patients with vasospastic features, DCB-treated segments showed less vasoconstriction than spastic counterparts (p < 0.001). A total of 110 DCB-treated lesions were analyzed to assess vasomotor function. Vasomotor function, defined as a combined constrictor and dilator response, was comparable between DCB-treated and angiographically normal segments (p = 0.173), while significant differences were observed against spastic counterparts (p < 0.001). In our study, DCB-treated lesions were not particularly vulnerable to vasospasm and were found to have vasomotor function similar to angiographically normal segments, supporting safety of DCB-only strategy in treating de novo native coronary lesions.

Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo Lesions of Large Coronary Arteries.

Background and Objectives: Use of drug-coated balloon (DCB)-only strategy for revascularization of native large coronary artery lesions is on the rise. The long-term efficacy of this approach for bifurcation and non-bifurcation lesions remains unknown. We aim to assess the long-term clinical outcomes of DCB-only strategy for the treatment of de novo bifurcation and non-bifurcation lesions in large coronary arteries. Methods: This multicenter, prospective, observational study enrolled 119 patients with de novo coronary lesions in vessels ≥2.75 mm. The primary end point was the rate of clinically driven target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR). Patients were followed up for a median of 2 years. Results: Of 119 patients with 138 lesions, 66 patients (75 lesions) had bifurcation and 53 patients (63 lesions) had non-bifurcation lesions. Average reference vessel diameter was 3.1 ± 0.3 mm, and there was no difference in bifurcation and non-bifurcation group (3.0 ± 0.3 vs. 3.1 ± 0.3mm; p = 0.27). At 2-year follow-up, the TLF occurred in five (4.2%), TLR in four (3.4%), and target vessel revascularization (TVR) in five (4.2%) cases. The frequency of TLR and TVR was higher in the non-bifurcation group (p = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups (p = 0.17). The cumulative incidence of TLF (Kaplan-Meier estimates) was also not different in the two groups (log-rank p = 0.11). Conclusion: DCB-only strategy for de novo lesions in large coronary arteries appears to be safe and effective for both bifurcation and non-bifurcation lesions. Further randomized clinical trials are warranted to confirm the value of DCB-only strategy in de novo bifurcation lesions of large vessels.

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.

Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion.

Although drug-eluting stents (DES) have become the mainstay of percutaneous coronary intervention, late and very late stent thrombosis remains a concern. Drug-coated balloons (DCB) have the advantage of preserving the anti-restenotic benefits of DES while minimizing potential long-term safety concerns. Currently the two methods to ensure successful DCB treatment of a stenotic lesion are angiography or physiology-guided DCB application. This review will evaluate these two methods based on previous evidence and make suggestions on how to perform DCB treatment more efficiently and safely.

Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group.

Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration. Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.

Serial assessment of de novo coronary lesions after drug-coated balloon treatment analyzed by intravascular ultrasound: A comparison between acute coronary syndrome and stable angina pectoris.

BACKGROUND: This study aimed to assess the serial changes in de novo coronary lesions, including acute coronary syndrome (ACS), treated with a drug-coated balloon (DCB). METHODS: In this retrospective single-center study, the intravascular changes in patients with de novo lesions treated with DCB were evaluated with serial intravascular ultrasound (IVUS) pre-procedure, post-procedure, and at follow-up. A two-dimensional IVUS measurement was performed with slices at 1 mm intervals in the treated lesion. RESULTS: This study comprised 40 lesions, including 27 lesions with stable angina pectoris (SAP) and 13 ACS. IVUS showed that the median vessel and lumen area increased significantly from pre-procedure to post-procedure and from post-procedure to follow-up. The median plaque area decreased significantly from pre-procedure to post-procedure and follow-up. The IVUS between ACS and SAP demonstrated that the total vessel volume and the total lumen volume increased, and the total atheroma volume decreased significantly from pre- to follow-up in both groups. The percent change in the lumen area increased, and the plaque area decreased significantly in ACS compared to SAP from pre- to post-procedure and follow-up. CONCLUSION: The findings of this study suggest that DCB treatment for de novo coronary lesions in patients with ACS and SAP may maintain anatomical patency and increase lumen with positive vessel remodeling and regression of plaque.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study.

INTRODUCTION: Scoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty. METHODS: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292). RESULTS: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901). CONCLUSIONS: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute.

BACKGROUND: To evaluate the efficacy of paclitaxel-coated balloons (SeQuent Please®) for large de novo coronary lesions with diameters greater than 2.8 mm. METHODS: We performed a retrospective study of 527 consecutive patients with 595 de novo lesions (222 lesions) that comprised the large vessel disease (LVD) group, with a reference diameter (RD) ≥ 2.8 mm; the other 373 lesions comprised the small vessel disease (SVD) group, with a RD < 2.8 mm who received drug-coated balloon (DCB) angioplasty at the Beijing Hospital, Beijing, China. Sixty-eight patients with 91 lesions, including 45 LVD lesions, underwent coronary angiography at an average 10.7 months after DCB intervention. Clinical characteristics were recorded, and coronary angiograms were analysed with Quantitative Coronary Angiography (QCA) software. RESULTS: The patients in the LVD group were much younger than those in the small vessel group (61.7 ± 11.3 vs. 63.8 ± 11.7, P = 0.003), and fewer LVD patients had diabetes (27.0 vs. 57.8%, P = 0.001), three-vessel disease (37.5 vs. 52.6%, P = 0.003) and complex lesions (37.8 vs. 48.8%, P = 0.009) than those in the SVD group. Lesion preparations for LVD were more complicated than for SVD, such as 40.1% of lesions required the additional use of a cutting or scoring balloon (P = 0.004), and 21.2% lesions required non-compliant (NC) balloons (P < 0.001). Coronary dissections occurred in 63(28.3%) lesions in the LVD group but bail-out drug-eluting stent (DES) implantation was required only in one lesion (0.5%), which were both comparable with those in the SVD group. The success rate of DCB intervention was quite high and also similar in the LVD group and SVD group (99.5 vs. 99.7%, P > 0.05). QCA analysis showed that the follow-up minimal lumen diameter (MLD) was significantly increased compared with the MLD immediately post angioplasty both in the SVD group (1.75 ± 0.48 vs. 1.58 ± 0.31 mm, P = 0.008) and the LVD group (2.26 ± 0.66 vs. 2.09 ± 0.40 mm, P = 0.067). At an average of 10.1 months of clinical follow-up, the major adverse cardiovascular event (MACE) rate was 0% in the LVD group and 1.4% in the SVD group, with target lesion revascularization (TLR) rates of 0% and 1.1%, respectively. No death was observed in either group. CONCLUSIONS: DCB for de novo coronary lesions with diameters greater than 2.8 mm was as safe and effective as for small vessel lesions, suggesting that the DCB-only strategy is also feasible in large de novo lesions intervention.

Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels.

BACKGROUND: A drug-coated balloon (DCB) has been designed as a new device for the treatment of coronary artery disease. The data regarding DCB-treated lesions in large coronary artery are limited. The purpose of our study was to explore the effectiveness and safety of DCB in large coronary artery. METHODS: We prospectively analyzed all patients treated with DCB in de novo lesions consistent with inclusion criteria between May 2015 and April 2017. The observed outcomes included target lesion revascularization (TLR), myocardial infarction, cardiac death and non-cardiac death, and major adverse cardiac events (MACE). RESULTS: There were 92 patients including 94 coronary de novo lesions treated in all. The most often utilized DCB diameters were 3.0 mm (41.5%) and 3.5 mm (39.4%). Two acute closures occurred in hospital. Six bailout drug-eluting stents were used in the percutaneous coronary interventions (6.4%). Quantitative coronary angiography measurement at follow-up showed late lumen loss was -0.02 ± 0.49 mm. The TLR rate and overall MACE rates were 4.3% and 4.3% during the follow-up period in the whole patient population, respectively. CONCLUSIONS: Our study showed that the "DCB only" strategy is safe and efficient in large vessel lesions of patients whose predilation achieved an acceptable result.

Comparison of fractional flow reserve and angiographic characteristics after balloon angioplasty in de novo coronary lesions.

Lesion characteristics determined by angiography after balloon angioplasty such as residual dimeter stenosis (DS) or dissection type has been used to determine the treatment method of drug-coated balloon (DCB) or metal stent for de novo coronary lesions. The aim of this study is to identify angiographic and functional mismatch using residual DS, dissection type and fractional flow reserve (FFR). Baseline and post-balloon parameters were obtained from 151 patients with 167 lesions. Angiographically significant parameters after balloon angioplasty are residual DS > 30% or dissection type C or more. Post-balloon FFR cutoff value of 0.75 was used to define functionally significant lesions. The weak correlation was found between residual DS and post-balloon FFR (r =  - 0.317, p < 0.001). There were 68.7% of mismatch population (residual DS > 30% and post-balloon FFR ≥ 0.75) and 7.1% of reverse mismatch population (residual DS ≤ 30% and post-balloon FFR < 0.75). All reverse mismatch lesions were found in left anterior descending artery. There was no correlation between dissection severity and post-balloon FFR (p = 0.654). In high post-balloon FFR group, long-term clinical outcomes showed no difference between DCB and stent groups with (p = 0.788) or without (p = 0.426) the adjustment of lesion characteristics. There were high frequencies of mismatch between angiographic lesion characteristics and FFR values after balloon angioplasty. Post-balloon FFR measurements may be safe and effective compared to angiography-guided treatment if DCB only treatment is considered.

Paclitaxel-coated balloon treatment for functionally nonsignificant residual coronary lesions after balloon angioplasty.

There is limited data on the efficacy of paclitaxel-coated balloon (PCB) compared to stents for de novo coronary lesions. The purpose of this study was to compare the efficacy of PCB treatment with stent implantation for de novo coronary lesions after successful plain old balloon angioplasty (POBA) guided by fractional flow reserve (FFR). In 200 patients scheduled for elective percutaneous coronary intervention (PCI) for de novo lesions, FFR was measured after POBA (POBA-FFR). If POBA-FFR was ≥ 0.75, patients were treated with PCB (PCB group, n = 78) or stent (Stent group, n = 73). If POBA-FFR was < 0.75, stent was implanted as planned (Reference group, n = 42). The primary endpoint was late lumen loss at 9 months and the secondary endpoint was adverse cardiac events (cardiac death, myocardial infarction, target lesion thrombosis, or repeat revascularization) at 12 months follow-up. There was no between-group differences in the POBA-FFR (0.87 ± 0.05 in PCB, 0.89 ± 0.06 in stent, p = 0.101). At 9 months, late lumen loss was significantly lower in the PCB group compared to the Stent group (0.05 ± 0.33 vs. 0.59 ± 0.76 mm, p < 0.001). Adverse cardiac events were not different between the PCB, Stent and Reference groups (2.6, 5.5, and 9.5% respectively; p = 0.430 for PCB vs. Stent group; p = 0.229 for the reference vs. both other groups). PCB treatment guided by POBA-FFR showed excellent 9 months angiographic and functional results, as well as comparable 12 months clinical outcomes, compared with stent implantation for de novo coronary lesions.

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review.

Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used in coronary de novo lesions, either as part of a DEB-only strategy or in combination with another device, mainly a bare metal stent (BMS). By searching Pubmed and Embase we were able to identify 52 relevant studies, differing in design, intervention, and clinical setting, including patients with small vessel disease, bifurcation lesions, complex long lesions, acute myocardial infarction, diabetes mellitus, and elderly. In 23 studies, a DEB was combined with a BMS, 25 studies used a DEB-only strategy with only provisional BMS implantation, and four studies combined a DEB with a drug-eluting stent (DES). In the vast majority of studies, DEB in combination with BMS does not seem to improve clinical or angiographic outcome compared with DES, whereas a DEB-only strategy seems promising, especially when predilatation and geographical mismatch are taken into account. A lower risk of recurrent thrombosis with DEB compared with DES is not evident from the current studies. In conclusion, the main indication for DEB seems to be small vessel disease, especially in clinical scenarios in which a contraindication to dual antiplatelet therapy exists. The main approach should be a DEB-only strategy with only provisional bailout stenting, which has shown interesting results in different clinical scenarios. In general, larger randomized controlled studies with prolonged follow-up comparing DEB with best in class DES are warranted. Technical developments of DEBs including the use of different drugs might potentially improve the efficacy of such treatment.