OBJECTIVE: The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia.
METHODS: BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups.
RESULTS: A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p = .0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p = .0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups.
CONCLUSIONS: Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation.
BACKGROUND: NCT02276313.

BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI.
METHODS: Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions.
RESULTS: Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group.
CONCLUSIONS: SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.

UNASSIGNED: Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed.
UNASSIGNED: This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death.
UNASSIGNED: A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05).
UNASSIGNED: This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group.
CONCLUSIONS: One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

BACKGROUND: Drug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions.
METHODS: Patients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics.
RESULTS: For focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39-1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40-1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29-0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19-0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26-0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15-0.54; p < 0.001).
CONCLUSIONS: The clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.

暂无摘要。

OBJECTIVE: Residual dissection is a concern in endovascular treatment with a DCB, and there is limited knowledge of hemodynamics at a dissection lesion. Therefore, the objective of this study is to evaluate the mean pressure gradient (MPG) and fractional flow reserve (FFR) at a residual dissection after DCB angioplasty for the superficial femoral artery (SFA).
METHODS: A total of 59 cases with residual SFA dissection treated with DCB angioplasty at a single center were analyzed retrospectively. The dissection was classified into 6 types (A-F). The primary endpoints were MPG and FFR at a residual dissection lesion after DCB angioplasty, using evaluation with a pressure wire.
RESULTS: The median lesion length was 70 (40-130) mm with 24% popliteal involvement, and 11 cases (18%) had chronic total occlusion. A completion angiogram revealed dissection of types A (n = 33, 56%), B (n = 18, 31%), C (n = 7, 12%), and D (n = 1, 2%). The median MPGs in type A, B, and C cases were 0 (0-2), 0 (0-4), and 3 (0-6) mmHg, with a significant lower in type C cases than in type A cases (A vs C, P = .021). The median FFRs in type A, B, and C cases of 1.0 (.98-1.00), 1.0 (.96-1.00), and .98 (.95-1.00) did not differ significantly among dissection types (A vs B, P = .86; A vs C, P = .055; B vs C, P = .15).
CONCLUSIONS: This is the first report of hemodynamics at a SFA dissection. The results suggest that low-grade dissection (types A or B) does not affect MPG and FFR at a SFA lesion. This indicates that a bailout stent may be unnecessary for patients with dissection of types A or B. A further investigation is needed to determine whether a scaffold is required for a SFA lesion with type C dissection.

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

UNASSIGNED: The role of atherectomy in treating femoropopliteal disease has been evolving rapidly. However, the clinical efficacy and safety of adjunctive atherectomy to percutaneous balloon angioplasty (BA) (plain balloon and drug-coated BA) remains controversial. We sought to perform a meta-analysis comparing atherectomy plus balloon angioplasty (ABA) versus BA alone in treating femoropopliteal disease.
UNASSIGNED: We searched PubMed, Cochrane Central Register of Clinical Trials, EMBASE, and ClinicalTrials.gov (from inception through January 10, 2022) for studies comparing ABA versus BA for femoropopliteal disease. We used a random-effects model to calculate risk ratio (RR) with 95% CIs. Target lesion revascularization (TLR), primary patency, and bailout stenting were the primary outcomes.
UNASSIGNED: Nine studies with 699 patients were included (4 randomized and 5 retrospective studies). Compared to BA alone, the ABA group showed a significant decrease in TLR driven by nonrandomized studies (RR 0.59; 95% CI, 0.40-0.85; P = .005) and bailout stenting (RR, 0.32; 95% CI, 0.21-0.48; P < .0001). There was no significant difference in TLR when the analysis was performed including only randomized trials. There was no significant difference in the primary patency between the 2 groups (RR, 1.04; 95% CI, 0.95-1.14; P = .37).
UNASSIGNED: Data from randomized trials suggest that compared with BA alone, the combination of atherectomy and BA showed no difference in TLR or primary patency. In observational studies, TLR and bailout stenting were reduced in ABA group but there was no difference in primary patency. Further studies are needed to investigate the clinical outcomes of atherectomy combined with BA in femoropopliteal lesions compared with BA alone.

UNASSIGNED: Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients treated with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). The present study evaluates primary patency after 1 and 2 years in this randomized population.
UNASSIGNED: The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries treated with IVL (n = 153) or PTA (n = 153) prior to DCB treatment or stenting. The powered secondary effectiveness endpoint was primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization plus freedom from restenosis determined by duplex ultrasound. Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency.
UNASSIGNED: Primary patency at 1 year was significantly greater in the IVL arm (80.5% vs 68.0%, P = .017). The requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, P < .0001). Freedom from clinically driven target lesion revascularization (IVL: 95.7% vs PTA: 98.3%, P = .94) and restenosis rates (IVL: 90.0% vs PTA: 88.8%, P = .48) were similar between the 2 groups at 1 year. At 2 years, primary patency remained significantly greater in the IVL arm (70.3% vs 51.3%, P = .003).
UNASSIGNED: The Disrupt PAD III RCT secondary endpoint of superior 1-year primary patency was achieved, confirming the consistent safety and effectiveness of IVL followed by DCB treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.

暂无摘要。