Drug-eluting Stents Group Research Articles

Drug-Coated Balloon vs. Drug-Eluting Stents for De Novo Unprotected Left Main Stem Disease: The SPARTAN-LMS Study.

The objective of this study is to compare the outcomes of patients treated with drug-coated balloons (DCBs) or second-generation drug-eluting stents (DESs) for de novo unprotected left main stem (LMS) disease. Previous studies comparing the treatment of LMS disease suggest that the mortality for DES PCI is not worse than CABG. There are limited data from studies investigating the treatment of de novo LMS disease with DCB angioplasty. We compared the all-cause and cardiac mortality of patients treated with paclitaxel DCB to those with second-generation DES for de novo LMS disease from July 2014 to November 2019. Data were analysed using Kaplan-Meier analyses and propensity-matched analyses. A total of 148 patients were treated with either a DCB or DES strategy. There was no significant difference in all-cause mortality in the DCB group (19.5%) compared to the DES group (15.9%) (HR 1.42 [0.61-3.32], p = 0.42). Regarding cardiac mortality, 2 (4.9%) were recorded for the DCB group and 7 (6.5%) for the DES group (HR 1.21 [0.31-4.67], p = 0.786); for target vessel myocardial infarction, there were 0 (0%) for the DCB group and 7 (6.5%) for the DES group; and for target lesion revascularisation, there were 3 (7.3%) in the DCB group and 9 (8.3%) in the DES group (HR: 0.89 [0.24-3.30]). p = 0.86. These remained not significant after propensity score matching. We found no difference in the mortality outcomes with DCB angioplasty compared to second-generation DES, with a median follow-up of 33 months. DCB can therefore be regarded as a safe option in the treatment of LMS disease in suitable patients.

Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement

ObjectiveTo compare the results of endovascular treatment with drug-eluting stents (DES) and drug-coated balloons (DCB) in atherosclerotic lesions in the femoropopliteal artery, as well as to assess restenotic patterns. MethodsClinical data from 617 cases treated with DES or DCB for femoropopliteal diseases were analyzed in this multicenter, retrospective cohort study. From these, 290 DES and 145 DCB cases were extracted by propensity score matching. Outcomes investigated were 1- and 2-year primary patency, reintervention, and restenotic pattern and its impact on symptoms in each group. ResultsThe primary patency rates at 1 and 2 years in the DES group were superior to those in the DCB group (84.8% and 71.1% vs 81.3% and 66.6%, P = .043), whereas there was no significant difference in freedom from target lesion revascularization (91.6% and 82.6% vs 88.3% and 78.8%, P = .13). Compared with what was measured before the index procedures, exacerbated symptoms, rate of occlusion, and an increase in the occluded length at loss of patency were more frequent in the DES group than in the DCB group. The odds ratios were 3.53 (95% confidence interval, 1.31-9.49; P = .012), 3.61 (1.09-11.9; P = .036), and 3.82 (1.15-12.7; P = .029), respectively. On the other hand, the frequency of an increase in lesion length and requirement of target lesion revascularization were similar between the two groups. ConclusionsPrimary patency was significantly higher at 1 and 2 years in the DES than in the DCB group. However, DES were associated with exacerbated clinical symptoms and complicated lesion characteristics at the point of loss of patency.

A retrospective study from a single center to compare outcomes in 79 patients with in-stent restenosis treated with paclitaxel-coated balloon angioplasty or drug-eluting stent implantation

BackgroundDespite the recent progress made in drug-eluting stents (DESs), in-stent restenosis (ISR) is still a common complication of percutaneous coronary interventions. This retrospective study from a single center aimed to compare outcomes in 79 patients with ISR treated with paclitaxel-coated balloon (PCB) angioplasty or DES implantation.ResultsFrom January 2017 to December 2021, 83 ISR lesions from 79 patients were included. Thirty-two were treated with PCB and 51 treated with available DES in the catheterization laboratory. Baseline characteristics were similar in both groups. Mean time between index angioplasty and restenosis was 27 months with a minimum of 4 months and a maximum of 70 months. Concerning Mehran ISR angiographic classification, classes II and III were more likely treated with DES. Stenosis diameter and minimal lumen diameter (MLD) were similar in both groups. PCB used was significantly shorter than DES: Mean length was 19.75 ± 5.7 versus 22.1 ± 16.5 (p < 0.001), respectively. Angiographic results immediately after intervention were similar in both groups: In-segment MLD after the procedure was 2.5 ± 0.4 in the DES group and 2.26 ± 0.55 in the PCB group. A median follow-up of 20 months was achieved for 68 patients, and 11 were lost to follow-up. There was also no difference in both groups regarding free from events survival.ConclusionsThe findings from this study support recent international studies that have shown no significant differences between DES and PCB and in-stent restenosis. This suggests that PCB use is an option to consider in our local daily practice.

Drug-Coated Balloon vs. Drug-Eluting Stent in Acute Myocardial Infarction: A Systematic Review and Updated Meta-Analysis.

This study aimed to systematically review the evidence of drug-coated balloon used in the treatment of acute myocardial infarction and compared with using drug-eluting stent in terms of clinical and angiographic outcomes for a relatively long follow-up period. Electronic databases including PubMed, Embase, and the Cochrane Library were used to search for the information of each study. A total of 8 studies involving 1310 patients were included in this meta-analysis. During a median follow-up duration of 12 months (range 3-24 months), there were no statistical differences between the drug-coated balloon and drug-eluting stent group in terms of a major adverse cardiovascular event (odds ratio = 1.07; P =.75; 95% CI: 0.72-1.57), all-cause death (odds ratio = 1.01; P =.98; 95% CI = 0.56-1.82), cardiac death (odds ratio = 0.85, P =.65; 95% CI = 0.42-1.72), target lesion revascularization (odds ratio = 1.72; P =.09; 95% CI: 0.93-3.19), recurrent myocardial infarction (odds ratio = 0.89, P =.76; 95% CI: 0.44-1.83), and thrombotic event (odds ratio = 1.10; P =.90; 95% CI: 0.24-5.02). Drug-coated balloon was not linked with risk of late lumen loss compared with drug-eluting stent (mean difference = -0.06 mm; P =.42; 95% CI: -0.22-0.09 mm). However, there was a higher incidence of target vessel revascularization noted in the drug-coated balloon group compared with the drug-eluting stent group (odds ratio = 1.88; P =.02; 95% CI: 1.10-3.22). The subgroup analysis stratified by different study types and ethnicities showed there were no significant differences between the 2 groups. Using drug-coated balloon might serve as a potential alternative strategy for patients with acute myocardial infarction because of the similar clinical and angiographic outcomes compared with using drug-eluting stent; nevertheless, the issue of target vessel revascularization should be more focused on. Larger and more representative studies are needed in the future.

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.

Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III.

The PIONEER III trial showed the 12-month safety and efficacy of the Supreme drug-eluting stent (DES) vs the durable polymer everolimus-eluting stent. We sought to assess whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location. This subgroup analysis of the PIONEER III trial compared the characteristics and outcomes of patients recruited from North America, Europe, and Japan and the relative differences in patient outcomes according to the site recruitment volume. From October 2017 to July 2019, 1629 patients were recruited in North America (816, 50.1%), Europe (650, 39.9%), and Japan (163, 10%). Procedural success was achieved in 1556 of 1611 procedures (96.6%), with no difference by the geographic location. Target lesion failure at 12 months for combined groups was observed in 84 of 1629 patients (5.2%), with no significant geographic differences (4.7%, 6.5%, and 2.5%, respectively; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.15). Compared with those from high-recruiting sites, results from low-recruiting sites were similar for target lesion failure, major adverse cardiac events, stent thrombosis, and mortality, with a nonsignificant trend for higher rates of myocardial infarction. Despite regional differences in patient characteristics, the clinical outcomes between Supreme DES and durable polymer everolimus-eluting stent in the PIONEER III trial were not different, supporting the generalizability and robustness of the findings from this multicenter controlled trial.

Advantages of DES over BMS in Preventing the Risk of Myocardial Infarction, Ischemic Stroke, and Mortality in Various Populations

Backgrounds: Previous studies have demonstrated that drug-eluting stents (DESs) are more effective than bare metal stents (BMSs) in reducing the risk of myocardial infarction in the short term, but the long-term preventive benefits for myocardial infarction, ischemic stroke, and mortality are not clear. Objective: This study deeply analyzed the long-term (within 3 years) advantages of the use of DESs in preventing the risk of myocardial infarction, ischemic stroke, and mortality in various populations compared with those of using BMSs. Methods: This was a retrospective observational cohort study. We used the 2015-2019 claims data from Taiwan's National Health Insurance Research Database. Patients over the age of 18 who underwent coronary stent placement (both DESs and BMSs) for the first time in 2016 were included in the study population. Propensity-score matching was applied to increase the comparability of the DES and BMS groups. We used a Cox proportional hazard regression analysis to compare the effectiveness of DESs and BMSs in preventing myocardial infarction, ischemic stroke, and all-cause mortality. A subgroup analysis was also performed. Results: In total, 21,608 cases were included in this study. Overall, the risk of myocardial infarction (aHR = 0.82; 95% CI: 0.78-0.85), ischemic stroke (aHR = 0.88; 95% CI: 0.81-0.95), and mortality (aHR = 0.61; 95% CI: 0.57-0.65) in the DES group were significantly lower than those in the BMS group. However, in some special cases, the results were not statistically significant. In particular, in patients with obesity (aHR = 2.61; 95% CI: 1.20-5.69), the DES group appeared to have a significantly higher long-term intermediate ischemic risk than the BMS group. Conclusions and Relevance: In conclusion, although DESs were more effective than BMSs in reducing the risk of long-term myocardial infarction, ischemic stroke, and mortality, this study also found that, in some cases, the advantages of DESs over BMSs were not clearly observed.

Midterm safety and efficacy of elective drug-coated balloon angioplasty in comparison to drug-eluting stents for unrestrictive de novo coronary lesions: A single center retrospective study

BackgroundThe safety and efficacy of elective drug-coated balloon (DCB) angioplasty for unrestrictive de novo coronary stenosis in daily practice is not fully understood, especially in comparison to those of drug-eluting stents (DESs). MethodsA total of 588 consecutive de novo coronary stenotic lesions electively and successfully treated with either DCB (n = 275) or DESs (n = 313) between January 2016 and December 2019 at our medical center were included. The primary safety endpoint was the incidence of target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization. The secondary angiographic efficacy endpoint was angiographic restenosis frequency, defined as a follow-up percent diameter stenosis of >50. The endpoints were compared after baseline adjustment using propensity score matching. In addition, the frequency and predictors of late lumen enlargement (LLE), defined as minus late luminal loss, were examined in 201 crude angiographic follow-up lesions after DCB angioplasty. ResultsA total of 31 baseline parameters were adjusted to analyze 177 lesions in each group. The TLF frequencies (DCB group: 9.6 % during a mean observational interval of 789 ± 488 days vs. DES group: 10.2 %, 846 ± 484 days, p = 0.202) and cumulative TLF-free ratios of both groups were not significantly different (p = 0.892, log-rank test). The angiographic restenosis frequency in the DCB group (6.3 %, n = 128) was not significantly different from that of the DES group (10.1 %, n = 100, p = 0.593). LLE was observed in 45.3 % of entire lesions, and a type-A dissection was a significant predictor of LLE among 23 variables (odds ratio: 3.02, 95 % CI: 1.31–6.95, p = 0.010). ConclusionsThe present single-center retrospective study revealed statistically equivalent midterm clinical safety and angiographic efficacy among both elective DCB angioplasty and DESs placements in the treatment of unrestrictive de novo coronary lesions. In our daily practice environment, LLE was achieved in approximately half after DCB angioplasty.

First- Versus New-Generation Drug-Eluting Stents in Patients With Heart Transplant With Cardiac Allograft Vasculopathy

Although several studies have previously reported on the efficacy of percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) in heart transplant patients with cardiac allograft vasculopathy, few data regarding new-generation DES are currently available. We sought to compare the efficacy of new-generation versus first-generation DES in 90 consecutive patients with heart transplant (113 de novo coronary lesions) who underwent urgent or elective PCI with first-generation (28 patients) or new-generation (62 patients) DES. For each patient, the severity of cardiac allograft vasculopathy and postprocedural extent of revascularization were quantified calculating baseline and residual SYNTAX score, respectively. The primary end point was a composite of major adverse cardiac events-myocardial infarction, cardiovascular death, or target vessel revascularization-at 3years. Overall, the median baseline SYNTAX score was 8 (5 to 15), and a total number of stents per patient of 1.6 ± 0.9 was implanted. Post-PCI residual SYNTAX score was 1.5 (0 to 4), with 13 patients having a score >8. At 3 years, the Kaplan-Meier estimate of freedom from major adverse cardiac events was 64%, with no differences between first-generation and new-generation DES groups (log-rank test p=0.269). Nevertheless, patients treated with new-generation DES experienced a lower rate of target vessel revascularization (15% vs 31%, log-rank test p=0.058). In the multivariate Cox regression analysis, a post-PCI residual SYNTAX score >8 (hazard ratio 2.37, confidence interval 0.98 to 5.73, p=0.054) was identified as an independent predictor of the primary end point.

Primary percutaneous coronary intervention in CAD patients: A comparison of major adverse cardiovascular events of second- and third-generation drug-eluting stents.

Background: Biodegradable polymer (BP) drug-eluting stents (DES) have been introduced as a novel solution to the problems of durable polymer (DP) stents. In Pakistan, very few studies are available for the treatment intervention in post-primary percutaneous coronary intervention (PPCI) patients. Our study will compare the major adverse cardiovascular events (MACEs) and their predictors in patients with coronary artery disease (CAD) undergoing PPCI with second- or third-generation DES. Methodology: An observational, retrospective, cohort study was carried out on CAD patients undergoing PPCI with either second- (DP-XIENCE Prime/XIENCE Xpedition) or third-generation (BP-BioMatrix NeoFlex/BioMatrix Alpha) DES. MACEs were assessed after 1year of PPCI procedure in 341 patients and screened as per inclusion/exclusion criteria (167 in the second-generation group and 174 in the third-generation group). Results: The number of male patients (86.2%) was more than female patients in our study population. MACEs were reported in 4.19% patients after 1year duration, and the percentage of MACEs was more in the second-generation DES group (4.77%) than in the third-generation group (3.44%); however, statistical analysis has not found any significant difference (p = 0.534). The rate of myocardial infarction (1.19% vs. 0.57%) and stent thrombosis (1.8% vs. 1.15%) was more in the second-generation DES group. However, restenosis (1.19% vs. 1.15%) and cardiac death (0.59% vs. 0.57%) were almost same in both groups. A significant association was found between MACEs and diabetes mellitus (p = 0.025), hypertension (p = 0.035), smoking (p = 0.008), and a family history of CAD (p = 0.018). Conclusion: BP-BioMatrix and DP-XIENCE DES have comparable clinical outcomes. Findings of the current study will assist the policy makers and healthcare providers in the rationalization of scarce resources and evidence-based patient care. However, longer follow-up studies are required for convincing results.

Abstract 9859: Randomized Comparison of Bare Metal Stents Plus Colchicine vs Drug Eluting Stents: Preliminary Analysis of the Orca Trial (Oral Colchicine in Argentina)

Background: The use of colchicine has been associated with reduction of adverse cardiac events in patients with coronary artery disease (CAD). The role of this drug after percutaneous coronary intervention (PCI) with bare metal stents (BMS) has not been evaluated against isolated PCI with drug eluting stents (DES). Aim: The study was designed to test an improved cost-effectiveness with BMS plus colchicine (group BMS+C) compared to DES alone (group DES), provided its noninferiority in terms of major adverse cardiac events (MACE) at 1 year. Methods: This is a prospective, multicenter, randomized controlled trial performed in 4 centers. The trial has been registered at clinicaltrials.gov (NCT04382443). Study protocol and informed consent have been approved by an Independent Ethical and Review Board Committee and were presented to Argentina National regulatory authorities for Health, Technology and Medications. Patients in the BMS+C group received 0.5mg oral doses twice a day of colchicine for 3 months. Outpatient visits were scheduled at 1, 3, 6 and 12 months as well as at 3 and 5 years. Primary endpoints were to compare cost-effectiveness and MACE defined as composite of death, myocardial infarction (MI), cerebrovascular accident and ischemia-driven target vessel revascularization. Results: During February 2020 to April 2022, 412 patients with clinically indicated PCI were randomized in the study. Because 2 patients with COVID 19 at the time of randomization were excluded, the final study population was composed of 410 patients (205 patients in each group). Baseline demographic and angiographic characteristics were well balanced diabetes 19.5% vs 21.4%, Acute Coronary Syndromes 78% vs 75%, ST elevation MI 23% vs 21% multiple vessel CAD 44% vs 46%, culprit left anterior descending artery 58% vs 57.8%, peripheral vascular disease 3.4% in BMS+C and DES groups respectively.2.9% of patients in BMS+C didn’t complete the treatment for side effects (diarrhea). Presently, patients were follow at mean of 381 days ( range 45 to 839),1 -year follow-up was completed in 61%. Conclusion: A 3-month treatment with colchicine after PCI with BMS was feasible and safe. Final 1-year clinical outcomes and cost-effectiveness results will be available at the time of presentation.

Drug-coated balloon in the treatment of coronary left main true bifurcation lesion: A patient-level propensity-matched analysis.

An increasing body of evidence suggests that drug-coated balloon (DCB) angioplasty represents a valuable option for revascularization in selected patients with coronary bifurcation disease. However, there remains a paucity of real-world observational evidence on the efficacy of DCB in left main (LM) true bifurcation lesion. We compared clinical and angiographic outcomes of hybrid [DCB + drug-eluting stent (DES)] versus DES-only strategy (provisional stenting or two-stent strategies) in de novo LM true bifurcated lesions. The primary endpoint was the 2-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (CD-TLR). A routine 1-year angiographic follow-up was scheduled. Propensity-score matching was utilized to assemble a cohort of patients with similar baseline characteristics. Among 1077 eligible patients, 199 who received DCB treatment and 398 who were assigned to DES therapy had similar propensity scores and were included in the analysis. TLF within 2 years occurred in 13 patients (7.56%) assigned to DCB group, and 52 patients (14.36%) assigned to DES group (odds ratio: 0.487; 95% confidence interval: 0.258-0.922; P = 0.025; Log-rank P = 0.024). Compared with the DES group, the DCB group resulted in a lower rate of CD-TLR (2.91% vs. 9.42%; P = 0.007). Cardiac death, TVMI, all-cause mortality, and stent thrombosis were comparable between both groups. Patients treated with DES-only were associated with a higher late lumen loss (0.42 ± 0.62 mm vs. 0.13 ± 0.42 mm, P < 0.001) compared with the DCB group at 1 year. In sensitivity analysis, the DCB group also presented a lower incidence of TLF, CD-TLR and stent thrombosis both compared to the two-stent strategy and compared to provisional stenting (Ps < 0.05). The 2-year results of PCI utilizing DCB for LM true bifurcation lesions are superior to employing DES alone in terms of safety and effectiveness.

Long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: PARADE II study.

The efficacy of spot stenting using drug-eluting stents (DES) for the treatment of long femoropopliteal (FP) lesion is unknown. This study aimed to compare clinical outcomes of long full coverage vs. spot coverage with DES for long FP artery disease. This multicenter randomized trial compared long DES vs. spot DES for FP lesions longer than 150 mm. All lesions were treated with paclitaxel-eluting stents (Zilver PTX). The primary endpoint was primary patency at 12 months. The study was terminated early after an interim analysis. A total of 103 patients (55 in the long DES group; 48 in the spot DES group) were eligible for analysis. There were no significant differences in baseline and lesion characteristics between groups. Total stent length was longer in the long DES group than in the spot DES group (225.6 ± 67.2 vs. 131.3 ± 48.7 mm, p < 0.001). Technical success was achieved in all patients. There was a trend toward a higher primary patency rate at 12 months in the long DES group than in the spot DES group (87.5% vs. 67.5%, p = 0.120). The rate of survival free from target lesion revascularization was significantly higher in the long DES group than in the spot DES group (91.7% vs. 72.0%, p = 0.044). In multivariate Cox regression analysis, spot DES [hazard ratio (HR) 2.42, 95% confidence interval (CI) 1.14-5.12, p = 0.021] and postdilation (HR 0.27, 95% CI 0.09-0.79, p = 0.018) were identified as independent predictors for loss of patency at 12 months post-procedure. Long DES were more effective than spot DES for treating long FP lesions. Clinicaltrials.gov, identifier: NCT02701881.

Percutaneous coronary intervention in patients with cancer using bare metal stents compared to drug-eluting stents.

Management of coronary artery disease (CAD) is unique and challenging in cancer patients. However, little is known about the outcomes of using BMS or DES in these patients. This study aimed to compare the outcomes of percutaneous coronary intervention (PCI) in cancer patients who were treated with bare metal stents (BMS) vs. drug-eluting stents (DES). We identified cancer patients who underwent PCI using BMS or DES between 2013 and 2020. Outcomes of interest were overall survival (OS) and the number of revascularizations. The Kaplan-Meier method was used to estimate the survival probability. Multivariate Cox regression models were utilized to compare OS between BMS and DES. We included 346 cancer patients who underwent PCI with a median follow-up of 34.1 months (95% CI, 28.4-38.7). Among these, 42 patients were treated with BMS (12.1%) and 304 with DES (87.9%). Age and gender were similar between the BMS and DES groups (p = 0.09 and 0.93, respectively). DES use was more frequent in the white race, while black patients had more BMS (p = 0.03). The use of DES was more common in patients with NSTEMI (p = 0.03). The median survival was 46 months (95% CI, 34-66). There was no significant difference in the number of revascularizations between the BMS and DES groups (p = 0.43). There was no significant difference in OS between the BMS and DES groups in multivariate analysis (p = 0.26). In addition, independent predictors for worse survival included age > 65 years, BMI ≤ 25 g/m2, hemoglobin level ≤ 12 g/dL, and initial presentation with NSTEMI. In our study, several revascularizations and survival were similar between cancer patients with CAD treated with BMS and DES. This finding suggests that DES use is not associated with an increased risk for stent thrombosis, and as cancer survival improves, there may be a more significant role for DES.

Outcomes of drug coated balloon only angioplasty for stable angina in routine clinical practice

Abstract Introduction The recent BASKETSMALL2 trial demonstrated safety and efficacy of drug coated balloon (DCB) angioplasty for de novo small vessel disease. Registry data have demonstrated that DCB angioplasty is safe; however, the majority of these studies are limited due to long recruitment time and small number of patients with DCB compared to drug eluting stents (DES). Our aim was to investigate if DCB-only strategy is safe to incorporate in routine clinical practice. Methods We identified all patients treated for stable angina and de novo disease in our institution from January 2015 till November 2019. During that period an equivalent number of patients were treated with DCB-only or DES-only strategy on a yearly basis. The primary endpoint was all cause mortality. The secondary endpoints were cardiovascular mortality, acute coronary syndrome (ACS), ischaemic stroke, major bleeding and target lesion revascularisation (TLR). Data were obtained from the hospital episodes statistics from NHS digital. Clinical and angiographic data were collected from our prospectively collated database and supplemented from electronic records as required. All angiograms were reviewed to confirm accuracy of angiographic data and determine TLR. On multivariable COX regression analysis (Table 1) age, frailty and hypercholesterolaemia were the only independent predictors of all cause mortality. Results A total of 1302 patients were identified. HES data were not obtained for 65 patients who had opted-out, therefore 1237 were included in the analysis; 544 were treated with DCB and 693 with DES. The average age for the DCB-group was 67.9±10.2 years old (79% male); while for the DES group it was 67.9±9.7 years old (78.1% male). The average follow up was 1339±514 days and 1354±527 days for the DCB and DES group respectively. Table 1 shows the differences between the groups in terms of clinical and angiographic characteristics. The DES group had more patients with history of COPD (6.3% vs 3%; p=0.01) and larger average vessel diameter (3.46±0.58 vs 3.09±0.53mm; p&amp;lt;0.001). The DCB group had more patients with true bifurcation disease and TIMI 0 or 1 pre-PCI (11.6% vs 8.1%; p=0.04) and TIMI 0 or 1 pre-PCI (11.7% vs 6.6%; p=0.001). Furthermore, more than 70% of patients in the DCB group had vessel diameter ≥3mm indicating that large vessels were treated. The all cause mortality was 35 (6.4%) and 59 (8.5%) for the DCB and DES group respectively. Kaplan Meier estimator plot did not show a significant difference between the groups. There was no difference between the groups in any of the secondary endpoints (cardiovascular mortality, ACS, stroke, major bleeding and TLR). Conclusion Our real world data from a large, contemporary cohort of stable angina patients, including predominantly large vessels, demonstrate that DCB only angioplasty is safe compared to DES in terms of all major cardiovascular endpoints including TLR. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): B Braun - investigator initiated research

Stents versus bypass surgery: 3-year mortality risk of patients with coronary interventions aged 50+ in Germany

ObjectivesDue to demographic aging, the prevalence of coronary artery disease (CAD) is expected to increase in the future, resulting in a growing demand for stent and bypass interventions. This study aims to investigate the mortality risk of patients following conventional coronary artery bypass grafting (CABG) or endovascular procedure by the implantation of bare-metal stents (BMS) or drug-eluting stents (DES).MethodsBased on a random sample of 250,000 members of Germany’s largest health insurance ‘Allgemeine Ortskrankenkassen’ (AOK) from 2004 to 2015, incident CAD patients were analyzed by Cox Proportional-Hazard models. Risk adjustment was made for sex, age, other cardiac diseases, non-cardiovascular comorbidities and years since intervention. Due to later admission of DES and thus a shorter observation time, mortality was examined for 3 years since the intervention.ResultsBMS represented the most frequent procedure (48%). We found similar proportions of CABG (19%) and DES interventions (23%). After risk adjustment, the models showed a 21% (p = 0.004) lower mortality risk of patients with DES and also a 21% (p = 0.002) lower mortality risk of CABG patients compared to persons with BMS.ConclusionBased on a large-scale dataset, our study demonstrated survival advantages of CABG and DES interventions over BMS, with no differences between the DES and CABG groups. The results help to assess the risks of coronary interventions. Aspects of quality of life, severity of postoperative physical limitations, duration of rehabilitation, patients’ preferences, and aspects of cost-effectiveness for hospitals and society should be further considered.Graphical abstract

Long-term outcomes of drug-coated balloons in patients with diffuse coronary lesions.

BackgroundDrug-coated balloons (DCB), alone or in combination with drug-eluting stents (DES), may be used to treat diffuse coronary lesions. We aimed to explore the efficacy and safety of DCB in patients with diffuse coronary lesions.MethodsConsecutive patients with diffuse coronary lesions (lesion length > 25 mm) who underwent DCB and/or DES between January 2015 and December 2019 were included in this prospective, observational, multicenter study. The DCB group included 355 patients (360 lesions), of which 142 patients (143 lesions, 39.7%) received the DCB-only strategy and 213 patients (217 lesions, 60.3%) received the hybrid strategy (DCB combined with DES). The DES group included 672 patients (831 lesions) treated with DES alone. Target lesion revascularization (TLR) during 3-year follow-up was the primary outcome of interest. The secondary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, and target vessel revascularization.ResultsThe two groups had comparable baseline clinical and lesion characteristics. Lesion length was similar (43.52 ± 16.46 mm vs. 44.87 ± 15.80 mm, P = 0.181), but the stent length in the DCB group was significantly shorter (24.02 ± 23.62 mm vs. 51.89 ± 15.81 mm, P < 0.001). Ten lesions (2.8%) in the DCB group received bailout stents. Over 3 years of follow-up, no significant difference in TLR incidence between the groups (7.3 vs. 8.3%, log-rank P = 0.636) was observed. Incidence of MACE also did not differ significantly (11.3 vs. 13.7%, log-rank P = 0.324). No thrombosis events occurred in the DCB group, while four patients (0.6%) in the DES group experienced stent thrombosis (log-rank P = 0.193). Moreover, similar TLR and MACE rates were observed between DCB-only and hybrid strategies (TLR: 6.4 vs. 8.0%, log-rank P = 0.651; MACE: 11.4 vs. 11.2%, log-rank P = 0.884).ConclusionLong-term outcomes show that the efficacy and safety of the DCB strategy (DCB alone or combined with DES) are similar to those of DES alone in diffuse coronary lesions. These findings suggest that this strategy is a promising alternative for select patients with diffuse coronary lesions.

Bioresorbable scaffolds vs. drug-eluting stents on short- and mid-term target lesion outcomes in patients after PCI: A systematic review and meta-analysis

BackgroundWhile current concerns about bioresorbable scaffolds (BRS) are centered on late or very late scaffold thrombosis, less attention had been paid to short- and mid-term clinical outcomes. This review aimed to compare the short- and mid-term outcomes between BRS and drug-eluting stents (DES).MethodsA systematic review of randomized controlled trials (RCTs) that compared BRS vs. DES was conducted by searching PubMed, Cochrane Library, Web of Science, CNKI, WanFang, and VIP databases from inception until 19 April 2022 (language limited to English or Chinese). The primary outcome was target lesion failure (TLF) within 12 months, defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TVMI), and cardiac death. The secondary outcomes were in-stent diameter stenosis (DS%) provided by intraluminal imaging.ResultsA total of 13 studies were eligible and were included in this review (N = 9,702 patients). The follow-up duration ranged from 6 months to 1 year. A significantly higher rate of TLF [RR, 1.22, 95% CI (1.03, 1.44)] driven by the higher rate of TVMI [RR, 1.39, 95% CI (1.09, 1.76)] was observed in the BRS group than in the DES group. The risk of TLR and cardiac death was similar between the groups. Also, compared with the DES group, the BRS group had a significantly higher in-stent DS% within 1 year [MD = 5.23, 95%CI (3.43, 7.04); I2 = 97%; p < 0.00001].ConclusionBioresorbable scaffolds were associated with an increased risk of target lesion failure within 1 year as compared with DES, driven by the increased rates of target vessel myocardial infarction. Also, the in-stent DS% seemed to be higher with BRS. Therefore, BRS was inferior to DES in terms of target lesion outcomes at short- or mid-term follow-up.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=327966, PROSPERO (CRD42022327966).

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease.

The objective is to assess the performance of the Eluvia polymer coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in patients with femoropopliteal arterial disease. This is a retrospective, single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and December 2019 were included. Primary measure outcome of this analysis was the overall mortality. The PTX specific mortality, the primary patency, the amputation free survival (AFS), and the target lesion revascularization (TLR) rates were additionally evaluated. A total of 124 patients were treated by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In both groups the majority presented with lifestyle limiting claudication (BMS: 84% vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 4.02, p = 0.67) did not differ significantly between the two platforms. No significant difference was observed regarding the 24 months primary patency rate (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox regression analysis revealed a higher mortality risk among patients with chronic limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). In this cohort, the use of the Eluvia DES did not increase the risk for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack of statin therapy at baseline were associated with a higher risk for death.

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.