Knowledge gaps in revascularization strategies in the setting of type II myocardial infarction: A common clinical dilemma in contemporary practices.

BackgroundModern contemporary percutaneous coronary intervention (PCI) techniques with drug-eluting stents (DES) have high procedural success rates in chronic total occlusion (CTO) but with a high prevalence of repeat revascularization. The use of drug-coated balloons (DCBs) in CTO is an alternative treatment strategy. The evidence for DCBs in CTO is, therefore, of interest, and we provide a structured and comprehensive review of the evidence available in terms of the use of DCBs in CTO, including de novo and in-stent (IS) CTO lesions.ObjectivesWe conducted a systematic review and meta-analysis on the use of DCBs in the management of coronary CTO.MethodsElectronic databases (PubMed, Embase and Ovid) were systematically searched from inception to April 2024 for DCB CTO studies. A meta-analysis was undertaken using a random-effects inverse-variance method due to heterogeneity. The primary outcome is target lesion revascularization (TLR). Secondary outcomes are major adverse cardiac events (MACE) as a composite of target lesion revascularization (TLR), cardiac death (CD), and any myocardial infarction (MI) including procedural and non-procedural MI, target vessel revascularization (TVR), angiographic outcomes such as late lumen loss (LLL), binary restenosis, and reocclusion.ResultsA total of 10 studies consisting of 1,695 patients were systematically reviewed. This showed that late luminal changes in terms of lumen gain and minimal lumen loss were consistently seen in CTO cohorts 7–12 months after DCB treatment. Five studies were included for meta-analysis with 1,474 patients. There were no significant differences in TLR between treatment strategies such as DCB, DES, and hybrid (DES + DCB) in both de novo and IS-CTO populations as follows: DCB vs DES [OR, 0.71; 95% CI 0.49–1.02], DCB vs DES in IS-CTO [OR, 0.78; 95% CI 0.45–1.34], DCB vs Hybrid [OR, 0.96; 95% CI 0.39–1.43], and hybrid vs DES [OR, 0.76; 95% CI 0.15–3.84]. Similar findings were seen with the MACE outcome. A sensitivity analysis showed no difference between the above-mentioned groups in terms of MI, CD, and TVR.ConclusionThe limited initial evidence on DCB in coronary CTO-PCI suggests a safe and effective alternative treatment strategy and suggests RCTs are, therefore, required.Graphical Supplementary InformationThe online version contains supplementary material available at 10.1007/s00392-025-02639-y.

Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease

Purpose To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization. Materials and Methods The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016–2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). Results Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure. Conclusion DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Femoropopliteal In-Stent Restenosis.

Background:Type 2 myocardial infarction is caused by myocardial oxygen supply-demand imbalance, and its diagnosis is increasingly common with the advent of high-sensitivity cardiac troponin assays. Although this diagnosis is associated with poor outcomes, widespread uncertainty and confusion remain among clinicians as to how to investigate and manage this heterogeneous group of patients with type 2 myocardial infarction.Methods:In a prospective cohort study, 8064 consecutive patients with increased cardiac troponin concentrations were screened to identify patients with type 2 myocardial infarction. We excluded patients with frailty or renal or hepatic failure. All study participants underwent coronary (invasive or computed tomography angiography) and cardiac (magnetic resonance or echocardiography) imaging, and the underlying causes of infarction were independently adjudicated. The primary outcome was the prevalence of coronary artery disease.Results:In 100 patients with a provisional diagnosis of type 2 myocardial infarction (median age, 65 years [interquartile range, 55–74 years]; 43% women), coronary and cardiac imaging reclassified the diagnosis in 7 patients: type 1 or 4b myocardial infarction in 5 and acute myocardial injury in 2 patients. In those with type 2 myocardial infarction, median cardiac troponin I concentrations were 195 ng/L (interquartile range, 62–760 ng/L) at presentation and 1165 ng/L (interquartile range, 277–3782 ng/L) on repeat testing. The prevalence of coronary artery disease was 68% (63 of 93), which was obstructive in 30% (28 of 93). Infarct-pattern late gadolinium enhancement or regional wall motion abnormalities were observed in 42% (39 of 93), and left ventricular systolic dysfunction was seen in 34% (32 of 93). Only 10 patients had both normal coronary and normal cardiac imaging. Coronary artery disease and left ventricular systolic dysfunction were previously unrecognized in 60% (38 of 63) and 84% (27 of 32), respectively, with only 33% (21 of 63) and 19% (6 of 32) on evidence-based treatments.Conclusions:Systematic coronary and cardiac imaging of patients with type 2 myocardial infarction identified coronary artery disease in two-thirds and left ventricular systolic dysfunction in one-third of patients. Unrecognized and untreated coronary or cardiac disease is seen in most patients with type 2 myocardial infarction, presenting opportunities for initiation of evidence-based treatments with major potential to improve clinical outcomes.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03338504.

Total revascularization of coronary disease at the time of primary percutaneous coronary intervention.

Femoropopliteal (FP) Tosaka class III in-stent restenosis (ISR) lesions remain a significant clinical problem and optimal revascularization management including the use of drug-coated balloon (DCB) and debulking devices has the potential to improve the outcomes for these patients. To compare clinical outcomes of debulking plus DCB with DCB alone in Tosaka III FP-ISR treatment in a Chinese population. This was a single-center retrospective study of patients who underwent endovascular interventions of debulking plus DCB or DCB alone for Tosaka III FP-ISR lesions. One-year primary patency was the main outcome. Other outcome measures are 12-month freedom from clinical-driven target lesion revascularization (f-CD-TLR), technical success rate, and periprocedural complications. A total of 80 patients with Tosaka III FP-ISR were included; 39 were treated with debulking plus DCB, among whom 22 were treated with laser atherectomy (LA) plus DCB and 17 were treated with rotational atherectomy (RA) plus DCB. 41 were treated with DCB alone. 12-month primary patency was significantly different between the debulking + DCB and DCB groups (87.2% vs. 65.9%, p = 0.039). in the subgroup comparison, no significant difference was found between the LA + DCB and RA + DCB groups (86.4% vs. 88.2%, p = 0.842). There were also no significant differences in the group and subgroup comparison of 12-month f-CD-TLR, technical success rate, and periprocedural complications. In this small preliminary experience, combined treatment with debulking and DCB angioplasty is correlated with better outcomes in 1-year primary patency for Tosaka III FP-ISR lesions.

Background In acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) is the standard treatment for revascularization. Stent apposition and sizing remain a significant challenge in ACS as vasospasm often complicates PCI.The use of drug-coated balloon (DCB) has emerged as a compelling alternative, avoiding the risk of mispositioned stents. There are a variety of DCB available differing in their drug type, coating technology and balloon design, but there is limited data comparing different types of DCB for ACS. Purpose We aimed to compare a paclitaxel-coated balloon using urea as excipient (the Study DCB) with other contemporary used DCB (Other DCB) for patients presenting with ACS. Methods We conducted a nationwide observational cohort study by using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). All patients in Sweden undergoing PCI are included in SCAAR. For this analysis, SCAAR was used to identify patients presenting with ACS and treated with DCB in Sweden between 2nd of August 2021 – 16th of May 2024. DCB used less than 100 times during the study period were excluded as were patients treated with use of different types of DCB during the same procedure. A separate analysis was used to assess outcome for solely patients presenting with ST-segment elevation myocardial infarction (STEMI). Outcome was assessed with Kaplan-Meier estimates and multivariable Cox proportional regression analysis. Results For this study, 1097 patients undergoing PCI using the study DCB and 3066 patients with Other DCB were included. The mean age in the study DCB group and Other DCB group was 71.0 vs 72.9 years, 75.6% vs 76.7% were male, 45.5% vs 49.1% had a previous myocardial infarction and 52.9% vs 50.2% had left main disease and/or multivessel disease on angiography. For the Study DCB and Other DCB respectively, the most common indication was NSTEMI (61.2% vs 60.3%) followed by unstable angina (20.4% vs 18.1%) and STEMI (18.4% vs 21.6%). After a 2-year follow-up, for the Study DCB and Other DCB respectively, the event rate of all-cause mortality was 8.7% vs 9.4%, myocardial infarction was 7.3% vs 9.2%, new revascularization with PCI was 17.0% vs 15.8%, target lesion definite thrombosis was 1.2% vs 1.6%, target lesion revascularization was 10.1% vs 9.9% and target vessel revascularization was 13.8% vs 12.8%. No statistically significant difference was observed after adjusting for confounders. For STEMI patients, the results were in line with the ACS analysis, showing similar outcome for the Study DCB and Other DCB. Conclusion In this comprehensive nationwide analysis investigating the use of DCB in ACS and STEMI, the Study DCB was associated with a similar outcome compared to other, contemporary DCB. These results are important for clinicians who are considering DCB in in ACS where evidence is limited to date.Figure 1.ACS outcome Figure 2.STEMI outcome

The optimal treatment for dysfunctional dialysis access between drug-coated balloon angioplasty (DCBA) and plain balloon angioplasty (PBA), including standard balloon angioplasty (SBA) and high-pressure balloon angioplasty (HPBA), remains unclear. This study aims to compare the efficacy and safety of DCBA and PBA. A systematic review was conducted to identify randomized controlled trials (RCTs) comparing DCBA and PBA. Outcomes included target lesion primary patency (TLPP), access circuit primary patency (ACPP), target lesion revascularization (TLR), technical success, and all-cause mortality. A meta-analysis with a priori subgroup analysis (ie, DCBA vs HPBA and DCBA vs SBA) was performed using a random-effects model to calculate risk ratios (RRs) and 95% confidence intervals (CIs). Twenty-five RCTs with a total of 2838 patients were included. DCBA showed higher TLPP at 6 months (RR: 1.27, 95% CI: 1.12-1.43, p<0.001) and 12 months (RR: 1.28, 95% CI: 1.13-1.45, p<0.001) than PBA. ACPP was also superior with DCBA at 6 months (RR: 1.25, 95% CI: 1.04-1.40, p=0.002) and 12 months (RR: 1.42, 95% CI: 1.23-1.65, p<0.001). However, no significant difference was found between DCBA and HPBA for TLPP (RR: 1.49, 95% CI: 0.83-2.67, p=0.181) and ACPP (RR: 1.30, 95% CI: 0.92-1.84, p=0.133) at 12 months. TLR was lower with DCBA at 6 months (RR: 0.60, 95% CI: 0.35-0.80, p=0.003) and 12 months (RR: 0.79, 95% CI: 0.68-0.93, p=0.005). No significant difference in the technical success rate and all-cause mortality was observed. DCBA improves TLPP and ACPP and reduces the TLR rate compared to PBA. However, it shows no significant advantage over HPBA in terms of TLPP and ACPP at 12 months. The technical success rate and all-cause mortality were similar between the 2 approaches.Clinical ImpactThis meta-analysis highlights the differential effectiveness of drug-coated balloon angioplasty (DCBA) compared with standard balloon angioplasty (SBA) and high-pressure balloon angioplasty (HPBA) in dysfunctional dialysis access. DCBA significantly improves primary patency and reduces revascularization rates compared to SBA, supporting its clinical utility. However, no clear advantage was found over HPBA at 12 months. These results suggest that while DCBA offers benefits over SBA, its added value over HPBA remains uncertain. Clinicians should consider individual patient factors and access characteristics when selecting the optimal angioplasty strategy.

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts. This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment (n = 2) and residual stenosis of > 30% (n = 2). On successful pre-dilation with a 7mm conventional balloon, patients were randomized to undergo either a 7mm drug-coated balloon (n = 94) or conventional balloon angioplasty (n = 92). The primary out-come measure was target lesion primary patency at 3 and 6months. The secondary out-come measures included target lesion primary patency at 12months and access circuit primary patency at 6 and 12months, clinical and technical success rates, and 12-month mortality differences between the groups. The target lesion primary patency and access circuit patency rates at 3 and 6months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3months) was significantly higher in the drug-coated balloon group (p = 0.002). Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.

Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans

Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated BalloonsVersus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACTSFA II Trial.

BackgroundType 4C myocardial infarction (MI) is a special type of myocardial infarction related to restenosis without thrombosis. There is a lack of relevant data on this new classification of acute MI (AMI). This study set out to examine the prognosis and treatment of type 4C MI in patients with non-ST-segment elevation MI (NSTEMI).MethodsWith reference to the NSTEMI cohort study database, we enrolled 1,032 cases of type 1 MI and 42 cases of type 4C MI from the period January 01, 2018 to August 31, 2018. All cases were followed up for 1 year. The outcome was major cardiovascular adverse events (including all-cause deaths, nonfatal MI, heart failure necessitating hospitalization, uncontrollable angina pectoris, and revascularization of the target vessels). Risk ratios (RR) were calculated using the generalized linear model. Cox multivariate analysis was performed to analyze the prognostic effects of drug-coated balloon (DCB) angioplasty or drug-eluting stent (DES) implantation in patients with type 4C MI.ResultsCompared with type 1 MI, type 4C MI was associated with a higher incidence of major adverse cardiovascular events (MACEs) [21.43% vs. 5.14%; adjusted RR: 3.725, 95% confidence interval (CI): 1.937–7.164]. Type 4C MI also showed a higher 1-year mortality rate than type 1 MI (7.14% vs. 1.55%; unadjusted RR: 4.607, 95% CI: 1.395–15.212). However, after adjusting for covariates, no statistical difference was noted (adjusted RR: 2.515, 95% CI: 0.768–8.233). Multiple adjustments to the Cox multivariate models revealed that neither DCB nor DES affected the clinical outcomes.ConclusionsType 4C MI has a poorer prognosis than type 1 MI. DCB angioplasty and DES implantation show similar efficacy in the treatment of type 4C MI.

Cardiovascular Risk Across Myocardial Injury and Infarction Categories Using the Universal Definition: An Individual Patient-Level Data Meta-Analysis.