Circulation: Cardiovascular Interventions最新文献

Background: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR.

Methods: We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter.

Results: From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes.

Conclusions: In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES.

Registration: URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42024598433.

Background: The Minima Stent System is the first stent designed, tested, and Food and Drug Administration-approved for use in neonates, infants, and children. Our objective was to evaluate the safety and efficacy of Minima implantation for pulmonary artery stenosis (PAS) and coarctation of the aorta (CoA).

Methods: Multicenter, single-arm, prospective, nonrandomized trial. Primary end points included stenosis relief, freedom from device-related serious adverse events or surgical intervention through 6 months, and maintenance of vessel lumen diameter on computed tomography or catheter angiography at 6 months.

Results: Forty-two patients (21 PAS, 15 recurrent CoA, and 6 native CoA) underwent Minima implantation at a median age and weight of 9 (range, 0.4-112) months and 7.8 (3.4-28.3) kg. Implantation was successful in 41 (97.6%) and resulted in a median increase in minimal vessel diameter of 131% (46%-483%) and reduction in median pressure gradients from 25 (0-63) to 0 (0-6; P<0.001) mm Hg in patients with CoA. Two acute PAS stent embolizations occurred; both stents were secured in the contralateral PA, and one was treated with an additional Minima stent. Seven patients with CoA, all under 6 kg, experienced transient femoral artery thrombosis. At 6 months, there were no explants or device-related serious adverse events. Luminal diameter was maintained at 89% (59%-137%) of the implant diameter. During a median follow-up of 596 (412-979) days, 13 (31%; 7 CoA and 6 PAS) patients underwent planned stent expansion without complications.

Conclusions: The Minima system is safe and effective for treating PAS and CoA in infants and small pediatric patients. Luminal patency was preserved, and planned reinterventions for somatic growth seem well-tolerated in early follow-up.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05086016.

Background: In the randomized EBC MAIN trial (European Bifurcation Club Left Main Coronary Stent), target lesion revascularization at 3 years poststenting of left main (LM) bifurcations was more frequent with upfront dual-stenting compared with the stepwise provisional approach. Restenosis location and its relation to stent technique are poorly characterized. The aim of this study was to investigate restenosis location after LM bifurcation stenting, and the impact of stent implantation technique.

Methods: Patients from the EBC MAIN trial who underwent target lesion revascularization during the 3-year follow-up had restenosis location assessed by the core laboratory. Restenosis was defined as ≥50% lesion diameter stenosis.

Results: Among 48 patients with target lesion revascularization (mean age 70.3±10.6 years, 72.9% men), 31 were randomized to and treated with upfront dual-stenting, while 17 were randomized to the stepwise provisional technique, of whom 4 had dual-stent implantation. The treatment groups therefore comprised 35 dual-stented and 13 single-stented patients. The commonest pattern of subsequent restenosis was isolated ostial circumflex restenosis (58% of patients), regardless of dual- or single-stent implantation. The ostial circumflex was the culprit lesion for target lesion revascularization in 34 (71%) patients overall (dual- versus single-stented patients: 77% versus 54%; P=0.115). During the 3-year follow-up, the mean % diameter stenosis at the circumflex ostium was similar after dual- versus single-stent implantation (64.6% versus 60.5%, coefficient, -0.12 [95% CI, -0.46 to 0.22]; P=0.473). Single stenting from LM to the circumflex artery was associated with worse subsequent mean % diameter stenosis in the ostium of the left anterior descending artery versus single stenting from LM- left anterior descending (49.8% versus 19.8%, coefficient, 0.57 [95% CI, 0.003-1.13]; P=0.049).

Conclusions: The circumflex ostium is the commonest site requiring revascularization after LM bifurcation stenting, irrespective of whether 1 or 2 stents were deployed. Strategies are needed to improve the long-term success of percutaneous coronary intervention to the circumflex artery ostium.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02497014.

Ischemic heart disease is the leading cause of heart failure with reduced ejection fraction in the developed world. An evolution of background medical therapy over the past decade has spurred improvement in symptoms and a reduction in morbidity and mortality with ischemic cardiomyopathy. However, there is still ongoing debate about the role and impact of revascularization. Much of the societal guidance regarding revascularization with coronary artery bypass grafting in ischemic cardiomyopathy comes from the STICH trial (Surgical Treatment for Ischemic Heart Failure) which predates improvements in medical therapy. More recently, the REVIVED-BCIS2 trial (Revascularization for Ischemic Ventricular Dysfunction-British Cardiovascular Intervention Society) failed to show a benefit of percutaneous coronary intervention on heart failure hospitalization and mortality in ischemic cardiomyopathy over contemporary medical therapy alone. Yet, there are outstanding questions regarding the role and modality of revascularization required to improve outcomes. We review current data and future directions in the management of ischemic cardiomyopathy and the potential role of revascularization.

Background: There were no previous studies comparing aspirin with clopidogrel on top of oral anticoagulation (OAC) within 1 year after percutaneous coronary intervention when dual therapy with OAC and clopidogrel was recommended.

Methods: We conducted a subgroup analysis stratified by OAC in the 1-year follow-up of the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared 1-month dual antiplatelet therapy followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This subgroup analysis compared aspirin with clopidogrel in patients with or without OAC by the 30-day landmark analysis. The coprimary end points were the cardiovascular (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke), and bleeding end points (Bleeding Academic Research Consortium 3 or 5).

Results: In the 30-day landmark analysis (N=5809), there were 788 patients (13.6%) with OAC at discharge. Regardless of OAC, the incidence rates beyond 30 days up to 1 year were similar between the aspirin and clopidogrel groups for cardiovascular end point (OAC: 3.7% versus 3.9%, hazard ratio, 0.92 [95% CI, 0.44-1.93]; no OAC: 3.7% versus 3.6%; hazard ratio, 1.03 [95% CI, 0.77-1.38]; P interaction=0.78) and for bleeding end point (OAC: 3.5% versus 4.2%, hazard ratio, 0.82 [95% CI, 0.39-1.73]; no OAC 1.5% versus 1.4%, hazard ratio, 1.07 [95% CI, 0.66-1.72]; P interaction=0.57).

Conclusions: Aspirin compared with clopidogrel was associated with similar cardiovascular and bleeding outcomes beyond 30 days and up to 1 year after percutaneous coronary intervention regardless of OAC at discharge.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.