Target Lesion Thrombosis Research Articles

Drug-coated balloon versus drug-eluting stent revascularization in the treatment of de novo acute myocardial infarction

Abstract Objective To assess the efficacy and safety of a drug-coated balloon (DCB) revascularization on percutaneous coronary intervention (PCI) in patients with de novo acute myocardial infarction (AMI). Background Data on DCB-only treatment in the context of AMI are limited. Methods A total of 96 patients with de novo AMI successfully treated with DCB alone were retrospectively enrolled. Visual residual stenosis ≤ 30% without flow-limiting dissection was considered a satisfactory pre-balloon angioplasty and followed by DCB treatment. We compared it with 96 propensity-matched patients treated with second-generation drug-eluting stent (DES) from the PTRG-DES registry (n = 13,160 patients). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding (Bleeding Academic Research Consortium bleeding type 3 or greater) at 1 year. Results Baseline clinical characteristics were comparable between the groups. The mean device diameter was larger in DES group (2.7 ± 0.3 mm vs. 3.1 ± 0.4 mm, P < 0.001). No abrupt vessel closure requiring treatment occurred after treatment with DCB. The MACE was comparable in both groups (6.2% in DCB group vs. 7.3% in DES group, P = 0.790) at 1-year follow-up. Conclusions In de novo AMI patients, DCB-only treatment approach had comparable clinical outcomes at 1-year follow-up. DCB-only treatment may be a safe and effective alternative to DES in carefully selected patients who had satisfactory pre-dilation results.

Usage patterns and outcomes of drug coated ballons at a tertiary care center - a cohort analysis in 462 patients

Abstract Background The usage of drug coated ballons (DCB) in percutaneous coronary interventions (PCI) is rising. Initially applied in in-stent restenosis (ISR), wider clinical applications especially in de novo lesions (DNL) are discussed. Here we aim to assess the pattern of usage as well as the clinical and angiographic outcomes associated with DCB. Methods For this analysis we included all patients treated with DCB during PCI, at a tertiary care centre between 01/2015 and 12/2021. Cath lab results of all patients were screened to assess the DCB indication. Patients were followed up until 09/2022 to assess clinical as well as angiographic complications. Results A total of 7608 interventions were carried out between 2015 and 2021, in 462 (6.1%) a DCB was used. The median follow-up time were 3.1 years (IQR 1.6 to 4.4 years), the median age of our patient population was 66 (IQR 58-75) and 24.7% (n=114) were female. There were 92 of 462 (19.9%) cases including a DNL preparation, 335 (72.5%) cases treating an ISR, in 6 (1.3%) cases both, DNL and ISR were treated, and in 29 (6.3%) cases DCB were used for other reasons (e.g. pre-/ postdilatation in coronary stenting). The mean DCB inflation diameter was significantly higher in ISR with 3.50mm (IQR 3.0-3.5mm) compared to DNL with 2.50mm (2.00-2.50mm, p-value <0.001 ) While the number of DCBs used is rising over time (179 cases [38.7%] in 2015-2018, 283 cases [61.3%] in 2019-2021), the proportion of de novo lesions showed no significant difference (37/179 [20.7%] in 2015-2018, 61/282 [21.6%] in 2019-2021, p-value 0.806, Figure 1). Patients with DCB for ISR had significantly higher rates of arterial hypertension (ISR: 255 [76.1%], DNL: 57 [62.0%], both: 3 [50.0%], other: 20 [69.0%] p value 0.029), hyperlipidaemia (ISR: 228 [68.1%], DNL: 56 [60.9%], both: 2 [33.3%], other: 14 [48.3%], p value 0.041) and previous myocardial infarction (ISR: 231 [69.0%], DNL: 33 [35.9%], both: 2 [33.3%], other: 8 [27.6%], p-value <0.001). When analysing the outcomes, patients with DNL showed lower rates of acute myocardial infarction (8 [8.2%] vs 51 [15.0%]) as well as target lesion (6 [6.1%] vs 56 [16.5%]) and any revascularization (27 [27.6%] vs 122 [35.9%])%]), yet a higher rate of cardiovascular mortality (19 [5.6] vs 9 [9.2%]) during the follow up period compared to patients treated for ISR (Figure 2). Both groups showed a very low rate of target lesion thrombosis within 30 days after PCI (1 [1.0%] vs 1 [0.3%], p-value 0.745). Conclusions The use of DCB in PCIs is increasing, yet as we were able to emphasize with our data, they are primarily used in ISR as well as lesions with a small vessel diameter with favourable outcomes indicated by low event rates. Research should expand beyond small-vessel disease and ISR to assess safety and outcomes of DCB in DNL, larger vessels and bifurcation interventions with one stent to further assess its potential benefits in a wider field of indications.

Long-term efficacy of drug-coated balloon-based treatment for de novo left anterior descending artery disease

Drug-coated balloons (DCB) are increasingly utilized in percutaneous coronary intervention (PCI), but their effectiveness in coronary artery disease (CAD) needs further exploration. This study investigates the efficacy and safety of a DCB-based strategy for de novo left anterior descending artery (LAD) disease. Patients with de novo LAD lesions treated with DCB alone or combined with drug-eluting stents (DES) and were retrospectively enrolled from 2010 to 2023 (n = 268). The comparator group consisted of patients treated with second-generation DES from a Korean multicenter registry (n = 4,147). The primary endpoint was three-year major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, target vessel revascularization, target lesion thrombosis, and major bleeding. In the DCB-based group (n = 268), 218 (81.3%) received DCB-only, while 50 (18.7%) underwent a hybrid approach. After propensity score-matching of 243 paired subjects, baseline characteristics were balanced. The DCB-based PCI reduced overall stent burden by 86.7% and significantly lowered the risk of MACE at three years compared to DES-only PCI (4.5% vs. 7.6%, HR 0.50, 95% CI 0.28–0.90; p = 0.020). The most significant reduction was in major bleeding. The DCB-based approach offers an alternative to DES-only strategy for LAD PCI by reducing three-year MACE risk, supporting its use in treating de novo CAD.

Comparative long-term efficacy and safety of two paclitaxel-coated balloons with different coating strategies for the treatment of drug-eluting coronary stent restenosis.

We previously showed non-inferiority of a low-dose paclitaxel-coated balloon (PCB) with citrate excipient (Agent PCB) as compared to normal-dose iopromide excipient (SeQuent Please PCB) in terms of angiographic and clinical endpoints at 12 months. The long-term clinical efficacy and safety of Agent PCB is not defined. 262 patients (323 DES-ISR lesions) were enrolled in this study and treated with either Agent PCB (125 patients, 151 lesions) in the ISAR-DESIRE 3a trial or with SeQuent Please PCB (137 patients, 172 lesions) in the setting of the randomized ISAR-DESIRE 3 trial with similar in- and exclusion criteria serving as historical control arm. The follow-up period was extended to 7 years. The efficacy and safety endpoints of this analysis were target-lesion revascularization (TLR), death, myocardial infarction (MI) and target lesion thrombosis (TLT) at 7 years. At 7 years, 206 patients (78.6%) were alive. The risks of TLR (hazard ratio [HR]: 1.29, 95% confidence interval [CI]: 0.87-1.90; p = 0.205), death (HR: 1.38, 95% CI: 0.82-2.35; p = 0.227), MI (HR: 1.10, 95% CI: 0.39-3.15; p = 0.852) and TLT (HR: 2.18, 95% CI: 0.20-24.10; p = 0.523) were comparable between Agent PCB and SeQuent PCB. Multivariate analysis showed comparable risks of TLR, death and MI between both PCB devices. In patients treated for DES-ISR by angioplasty with Agent PCB and SeQuent Please PCB, there was no statistically significant difference in TLR at 7 years. Randomized trials with standardized lesion preparation and long-term follow-up are warranted to further evaluate comparative efficacy of both devices. (ClinicalTrials. gov Identifier: NCT02367495).

Drug-eluting stent vs. Balloon angioplasty in patients with in-stent restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IntroductionIn-stent restenosis (ISR) is seen in up to 20% of cases and is the primary cause of percutaneous coronary intervention (PCI) failure. With the use of re-stenting with a drug-eluting stent (DES), plain old balloon angioplasty (BA) use is decreasing. We aim to compare the efficacy and safety profile of DES over BA in the management of ISR. MethodsElectronic databases were searched to identify all randomized controlled trials (RCTs) comparing DES to BA for coronary ISR. The mantel-Haenszel method with a random effects model was used to calculate pooled risk ratios (RR). ResultsFour trials comprising 912 patients (543 in DES and 369 in the BA group) were included in the final study. The mean follow-up was 45 months. DES was found to be superior with a lower requirement of target vessel revascularization (TVR) (RR: 0.45, 95% CI: 0.31–0.64, p-value <0.0001), and target lesion revascularization (TLR) (RR: 0.59, 95%CI: 0.44–0.78, p-value 0.0002) compared to BA. However, all-cause mortality, cardiovascular mortality, incidence of myocardial infarction (MI), and target lesion thrombosis were not different between the two intervention arms. ConclusionDES was found to be superior to BA for the management of coronary ISR with a reduction in the risk of TLR and TVR. No difference in mortality, risk of MI, or target lesion thrombosis was observed between the two interventions.

Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0-1.0 and 2.0; IQR: 1.0-3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0-38.0 mm and 42.0 mm; IQR: 28.0-67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions.

Drug-coated balloon: an effective alternative to stent strategy in small-vessel coronary artery disease-a meta-analysis.

Small-vessel coronary artery disease (CAD) is frequently observed in coronary angiography and linked to a higher risk of lesion failure and restenosis. Currently, treatment of small vessels is not standardized while having drug-eluting stents (DES) or drug-coated balloons (DCBs) as possible strategies. We aimed to conduct a meta-analytic approach to assess the effectiveness of treatment strategies and outcomes for small-vessel CAD. Comprehensive literature search was conducted using PubMed, Embase, MEDLINE, and Cochrane Library databases to identify studies reporting treatment strategies of small-vessel CAD with a reference diameter of ≤3.0 mm. Target lesion revascularization (TLR), target lesion thrombosis, all-cause death, myocardial infarction (MI), and major adverse cardiac events (MACE) were defined as clinical outcomes. Outcomes from single-arm and randomized studies based on measures by means of their corresponding 95% confidence intervals (CI) were compared using a meta-analytic approach. Statistical significance was assumed if CIs did not overlap. Thirty-seven eligible studies with a total of 31,835 patients with small-vessel CAD were included in the present analysis. Among those, 28,147 patients were treated with DES (24 studies) and 3,299 patients with DCB (18 studies). Common baseline characteristics were equally distributed in the different studies. TLR rate was 4% in both treatment strategies [0.04; 95% CI 0.03-0.05 (DES) vs. 0.03-0.07 (DCB)]. MI occurred in 3% of patients receiving DES and in 2% treated with DCB [0.03 (0.02-0.04) vs. 0.02 (0.01-0.03)]. All-cause mortality was 3% in the DES group [0.03 (0.02-0.05)] compared with 1% in the DCB group [0.01 (0.00-0.03)]. Approximately 9% of patients with DES developed MACE vs. 4% of patients with DCB [0.09 (0.07-0.10) vs. 0.04 (0.02-0.08)]. Meta-regression analysis did not show a significant impact of reference vessel diameter on outcomes. This large meta-analytic approach demonstrates similar clinical and angiographic results between treatment strategies with DES and DCB in small-vessel CAD. Therefore, DES may be waived in small coronary arteries when PCI is performed with DCB.

Comparison of 7-Year, Real-World Clinical Outcomes between Drug-Coated Balloon Angioplasty versus Drug-Eluting Stent Implantation in Patients with Drug-Eluting Stent In-Stent Restenosis.

There are no data available comparing the real-world, long-term clinical outcomes of drug-eluting balloon (DEB) angioplasty and drug-eluting stent (DES) implantation in DES in-stent restenosis (ISR) lesions. We aimed to compare the real-world, long-term data available between DEBs and DESs in DES-ISR lesions. We analyzed consecutive DES-ISR lesions (225 lesions from 205 patients; male: 66.3%; mean age: 62.4 years) treated with either DEB or DES. The primary endpoint was target lesion revascularization (TLR), and the primary safety endpoint was the lesion-oriented composite outcome (LOCO). The LOCO is composed of cardiac death, myocardial infarction, and target lesion thrombosis during follow-up. During the 7-year follow-up period, TLR did not differ significantly between the DEB (n = 108) and the DES groups (n = 117) (HR: 1.07; 95% CI: 0.59-1.93, p = 0.83). The LOCO was significantly lower in the DEB group compared to the DES group (HR: 0.40; 95% CI: 0.16-0.98, p = 0.04), which was mainly driven by the lower levels of myocardial infarction (HR: 0.24; 95% CI: 0.06-0.94, p = 0.04) and the absence of target lesion thrombosis in the DEB group (vs. DES group 6%, p = 0.02). Additionally, cardiac death was found to be similar between the DEB and DES groups (HR: 0.56; 95% CI: 0.18-1.75, p = 0.32). DEB angioplasty showed favorable safety with a similar efficacy to that of DES implantation in DES-ISR lesions during the long-term follow-up period.

Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease

BackgroundData on drug-coated balloon (DCB) treatment in the context of diabetes mellitus (DM) and multivessel coronary artery disease (CAD) are limited. We aimed to investigate the clinical impact of DCB-based revascularization on percutaneous coronary intervention (PCI) in patients with DM and multivessel CAD.MethodsA total of 254 patients with multivessel disease (104 patients with DM) successfully treated with DCB alone or combined with drug-eluting stent (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n = 13,160 patients) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years.ResultsThe DCB-based group was associated with a reduced risk of MACE in patients with DM (hazard ratio [HR] 0.19, 95% confidence interval [CI] 0.05–0.68, p = 0.003], but not in those without DM (HR 0.52, 95% CI 0.20–1.38, p = 0.167) at the 2-year follow-up. In patients with DM, the risk of cardiac death was lower in the DCB-based group than the DES-only group, but not in those without DM. In both patients with or without DM, the burdens of DES and small DES (less than 2.5 mm) used were lower in the DCB-based group than in the DES-only group.ConclusionsIn multivessel CAD, the clinical benefit of a DCB-based revascularization strategy appears to be more evident in patients with DM than in those without DM after 2 years of follow-up. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277)

Randomized Pilot Study to Compare DCB-Based versus DST-Based Strategies for the Treatment of True or Complex Coronary Bifurcation Lesions.

Dual stenting technique (DST) is still mandatory for some true bifurcation lesions (BLs), but drug-coated balloon (DCB) alone may offer a new optional treatment with the potential benefits of fewer implants. However, procedural safety presents a concern when using DCB-only to treat true BLs. This study sought to explore the safety and efficacy of the DCB-only strategy for the treatment of true BLs. Sixty patients with TBLs were randomly assigned to be treated by a DCB-based strategy or DST-based strategy. All patients received angiographic follow-up scheduled after one-year and staged clinical follow-up. The primary endpoint was the one-year late lumen loss (LLL) and cumulative major cardiac adverse events (MACEs) composed of cardiac death (CD), target vessel myocardial infarction (TVMI), target lesion thrombosis (TVT), or target vessel/lesion revascularization (TLR/TVR). The secondary endpoint was the one-year minimal lumen diameter (MLD), diameter stenosis percentage (DSP) or binary restenosis (BRS), and each MACE component. The baseline clinical and lesioncharacteristics were comparable with similar proportions (20.0% vs. 23.3%, p = 1.000) of the complex BLs between the two groups. At the one-year follow-up, LLL was significantly lower in the DCB-based group (main-vessel: 0.05 0.24 mm vs. 0.25 0.35 mm, p = 0.013; side-branch: -0.02 0.19 mm vs. 0.11 0.15 mm, p = 0.005). MLD, DSP and TLR/TVR were comparable between the groups. The one-year cumulative MACE, all driven by TLR/TVR (6.7% vs. 13.3%, p = 0.667), was low and similar without CD, TVMI or TVT in both groups. Compared to the DST strategy, the DCB- based strategy may be safe and effective in treatment of the selected true BLs. Clinical registration number is ChiCTR1900024914.

Long-Term Clinical Outcomes of Drug-Coated Balloon Treatment for De Novo Coronary Lesions.

Data are limited on the long-term efficacy and safety of drug-coated balloon (DCB) treatment in comparison to drug-eluting stent (DES) for de novo coronary lesions. We investigated the long-term clinical outcomes of DCB treatment in percutaneous coronary intervention (PCI) for de novo coronary lesions. A total of 103 patients scheduled for elective PCI for de novo non-small coronary lesions (≥2.5 mm) who were successfully treated with DCB alone were retrospectively compared with 103 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n=13160). All patients were followed for 5 years. The primary endpoint was major adverse cardiac events [MACE; cardiac death, myocardial infarction, stroke, target lesion thrombosis, target vessel revascularization (TVR), and major bleeding] at 5 years. At 5-year clinical follow-up, Kaplan-Meier estimates of the rate of MACE were significantly lower in the DCB group [2.9% vs. 10.7%; hazard ratio (HR): 0.26; 95% confidence interval (CI): 0.07-0.96; log-rank p=0.027]. There was a significantly lower incidence of TVR in the DCB group (1.0% vs. 7.8%; HR: 0.12; 95% CI: 0.01-0.98; long-rank p=0.015), and there was major bleeding only in the DES group (0.0% vs. 1.9%; log-rank p=0.156). At 5-year follow-up, DCB treatment was significantly associated with reduced incidences of MACE and TVR, compared with DES implantation, for de novo coronary lesions.

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

BackgroundThe 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.MethodWe 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.ResultsThere 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.ConclusionThe 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.

Use of drug-eluting stents in patients with critical limb ischemia and infrapopliteal arterial disease: a real-world single-center experience

BackgroundAlthough no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience. MethodsA total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates. ResultsOf the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively. ConclusionsThe clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.

Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons

ObjectiveTo evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions. MethodsThis was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences. ResultsWe included 6715 lesions treated with DCBs, 4483 SeQuent® Please (S-DCB), 1071 IN.PACT Falcon (I-DCB) and 1161 Pantera® Lux (P-DCB), in 5670 patients. The mean DCB diameter was 2.4 mm. Bailout stenting occurred in 6.7% of lesions. Angiographic success was 98.5%.The overall cumulative rate of restenosis was 5.5% (299 events). The risk for reported restenosis did not significantly differ between I-DCB vs S-DCB, adjusted hazard ratio (aHR) 0.96; 95% confidence interval (CI) 0.69–1.34, P-DCB vs S-DCB aHR 0.88; 95% CI 0.63–1.23 and I-DCB vs P-DCB aHR 1.10; 95% CI 0.72–1.68. The cumulative risk for TLT was 0.8% in all three DCBs. The risk for MACE or individual components of MACE did not differ between the three patient-groups. ConclusionIn de novo coronary lesions, we found comparable long-term efficacy with three currently available DCB brands. DCB angioplasty was feasible with low risk for long-term restenosis and TLT.

Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis

BackgroundIn patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). ObjectivesThis study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments — angioplasty with drug-coated balloon (DCB) and repeat stenting DES — in patients with BMS-and DES-ISR. MethodsThe DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. ResultsA total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. ConclusionsAt 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.

A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.

Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group. In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis. ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

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

ObjectivesThe 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). BackgroundNotwithstanding 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. MethodsThe 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. ResultsThe 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. ConclusionsBecause 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.

Clinical outcomes of SeQuent Please paclitaxel-coated balloons for de novo small coronary artery lesion in a Japanese multicenter post-approval registry.

Drug-coated balloon (DCB) angioplasty has emerged as an effective management strategy worldwide. In June 2016, DCB became available for the treatment of de novo small coronary lesions in Japan; however, there has been no multicenter analysis in a post-approval real-world clinical setting to date. The aim of this study was to evaluate the efficacy of DCB for de novo small coronary lesions based on a Japanese multicenter registry. From June 2016 to July 2017, a total of 111 lesions (102 patients) treated with DCB for de novo small coronary lesions were enrolled at six Japanese institutions. The primary endpoint was the rate of target lesion revascularization (TLR) at 12 months. Angiographic follow-up endpoints were binary restenosis and late lumen loss (LLL). Clinical follow-up data at 12 months were available for 106 lesions, excluding five lesions that required bailout stenting. The TLR rate was 5.7% (6/106 lesions). No cardiac death or target lesion thrombosis was observed. The binary restenosis rate was 14.4% and LLL was 0.0017 ± 0.37 mm. DCB angioplasty for de novo small coronary lesions in the real-world environment in Japan is effective with acceptable 12-month outcomes.

Efficacy of drug-coated balloon angioplasty in early versus late occurring drug-eluting stent restenosis: A pooled analysis from the randomized ISAR DESIRE 3 and DESIRE 4 trials.

Whether there exist differences concerning clinical outcomes between patients presenting with early versus late DES-ISR undergoing treatment with drug-coated balloons (DCB) remains a scientific knowledge gap. This is a pooled analysis including patients with DES-ISR assigned to treatment with DCB in the setting of the ISAR DESIRE 3 and 4 trials. Clinical outcomes were evaluated according to time of occurrence of ISR after DES implantation, in patients presenting with early (≤12 months) versus late DES-ISR (>12 months) undergoing treatment with DCB. The primary endpoint of this analysis was major adverse cardiac event (MACE), defined as the combined incidence of death, myocardial infarction and target lesion revascularization (TLR) at 12 months after DCB treatment. Secondary endpoints included the incidence of death, myocardial infarction, TLR and target lesion thrombosis at 12 months after DCB treatment. This analysis included 352 patients, 199 patients presented with early-ISR, 153 patients with late-ISR. Concerning the primary endpoint, patients with early-DES-ISR as compared those with late-DES-ISR showed significant higher risk (25.9% vs. 17.0%; p = .04). In a multivariate analysis including diabetic status, clinical presentation, previous coronary bypass graft and diameter stenosis after DCB-treatment, the adjusted hazard ratio showed significant higher risk for MACE of early-DES-ISR as compared to late-DES-ISR (HRadj = 1.8, [95% CI = 1.1-3.0], p = .02). Clinical outcome at 12 months after treatment of DES-ISR with DCB, showed significant higher clinical event rates in patients presenting with early DES restenosis, as compared with patients presenting with late DES restenosis.

Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study).

Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02-1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58-1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71-1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53-1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80-2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.