Project description:Stenting for severely calcified lesions has a higher risk of stent restenosis or stent failure than stenting for lesions without calcification, and stenting for complex lesions including ostial or bifurcation lesions sometimes causes plaque shift which leads to side branch occlusion. A calcified nodule (CN) is considered one of the culprits for stable angina or acute coronary syndrome. However, the optimal strategy for this lesion is not well clarified. We report a patient who presented stable angina with a CN at the ostial left circumflex artery. In this case, pretreatment with excimer laser coronary atherectomy (ELCA) and scoring balloon dilatation followed by drug-coated balloon (DCB) dilatation successfully prevented plaque shift caused by stenting in the acute phase. In addition, it also maintained the patency in the late phase. Furthermore, we observed the CN lesions at preprocedural, postprocedural, and late phase by optical coherence tomography. ELCA, which has a unique debulking technique, and scoring balloon dilatation followed by DCB dilatation might offer an alternative treatment for ostial CN lesions instead of stenting. 〈Learning objective: The optimal strategy for severely calcified lesions with calcified nodule is controversial because the prevalence of calcified nodule is rare and stent failure is more common in calcified lesions. In particular, regarding a calcified nodule located in ostial left circumflex coronary artery lesion, excimer laser coronary atherectomy and scoring balloon dilatation followed by drug-coated balloon may give an alternative treatment to avoid stenting.〉.
Project description:PurposeWe aimed to investigate the serial change of the side-branch ostial area (SBOA) depended on the wire-position before Kissing-balloon inflation (KBI) in the single-stent strategy for bifurcation lesions separately in the left main coronary artery (LMCA) and in non-LMCA.MethodsPatients who underwent a single-stent KBI for a bifurcation lesion and had OCT images at the timing of the rewiring, at the post-procedure, and at the 9-month follow-up were extracted from the 3D-OCT Bifurcation Registry, which is a multicenter-prospective registry of patients with a percutaneous coronary intervention for a bifurcation lesion under OCT guidance. The SBOA was measured by dedicated software, and the rewiring position at the side-branch ostium after crossover stenting was assessed by three-dimensional-optical coherence tomography (3D-OCT). The optimal rewiring was defined as link-free-type and distal rewiring. The relationship between the optimal rewiring and the serial change of the SBOA was investigated separately in LMCA and non-LMCA cases.ResultsWe examined 75 bifurcation lesions (LMCA, n = 35; non-LMCA, n = 40). The serial changes of the SBOA with the optimal rewiring were not significantly different regardless of LMCA and non-LMCA (LMCA:3.96 to 3.73 mm2, p = 0.38; non-LMCA:2.16 to 2.21 mm2, p = 0.98), whereas the serial changes of the SBOA with the sub-optimal rewiring were significantly reduced (LMCA:6.75 to 5.54 mm2, p = 0.013; non-LMCA:2.28 mm2 to 2.09 mm2, p = 0.024). There was no significant difference in clinical events between the optimal and sub-optimal rewiring group regardless of the LMCA and non-LMCA.ConclusionThe side-branch ostial area dilated with the optimal rewiring position in a bifurcation lesion treated with single crossover stenting and kissing-balloon inflation was preserved regardless of whether the bifurcation was in the LMCA or a non-LMCA.
Project description:Background Although clinical trials have reported favorable outcomes after drug-coated balloon (DCB) therapy for femoropopliteal lesions, their real-world performance and predictors have not been well evaluated. This study aimed to elucidate 1-year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1-year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow-up of 14.2 months, 811 patients experienced restenosis. The Kaplan-Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1-year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low-dose DCB, and residual stenosis. Conclusions The 1-year clinical outcomes after DCB use for femoropopliteal lesions in real-world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.
Project description:IntroductionScoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.MethodsWe studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).ResultsA total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).ConclusionsThe routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.
Project description:IntroductionThere is limited evidence regarding the effectiveness of drug-coated balloon (DCB) angioplasty in the percutaneous treatment of complex de novo ostial coronary lesions. This study primarily aimed to explore the feasibility and safety of this innovative approach for ostial lesions in the left anterior descending artery (LAD).MethodsPatients treated with paclitaxel DCB or second-generation drug-eluting stents (DES) were retrospectively enrolled from two large centers. The primary endpoints were major adverse cardiovascular events (MACE), including cardiovascular death, target lesion revascularization (TLR), target vessel revascularization, and recurrent myocardial infarction related to target artery occlusion. Cox regression analysis was used to identify risk factors for MACE, and propensity score matching was performed to minimize selection bias.ResultsA total of 388 patients were included; among them, 52 were treated with paclitaxel DCB, and 336 with DES for ostial LAD lesions. Using propensity score matching, 49 patients were treated with DCB-only and 49 with the DES strategy. The average follow-up time was 12 months; subsequently, a non-significant decrease in MACE rate was observed in the DCB-only angioplasty treatment group (MACE: 6 vs. 6%, p = 1.0; TLR: 2 vs. 4%, p = 0.56). Cox regression analysis indicated that DCB-only angioplasty was not an independent risk factor for adverse events after adjusting for confounding risk factors (hazard ratio: 1.713, p = 0.43).ConclusionThe use of the DCB-only approach is an innovative and optional strategy in the treatment of isolated ostial LAD disease. A further randomized trial is of necessity to confirm the feasibility and safety of drug-coated balloon-only angioplasty for LAD de novo ostial lesions.
Project description:AimsAn 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.MethodsThe 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.ResultsAmong 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).ConclusionThe 2-year results of PCI utilizing DCB for LM true bifurcation lesions are superior to employing DES alone in terms of safety and effectiveness.
Project description:In patients with ostial coronary stents protruding into the aorta, there is concern for stent injury while undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THV). An 82-year-old male with history of symptomatic aortic stenosis, heart failure, and coronary artery disease with multiple interventions to right coronary artery (RCA) and a history of stent fracture requiring stent-in-stent placement one year previously, was evaluated for TAVR. His ostial RCA stent was protruding into the aorta at the level of sinotubular junction, with ostial stent to aortic wall (SAW) distance of 25.2 mm. There was concern for balloon inflation during TAVR leading to stent injury. The RCA was cannulated with a 6 French JR4 guide and wired with 0.014' coronary wire. Appropriately sized noncompliant balloon was advanced into RCA. Under rapid pacing, the coronary balloon was inflated across the RCA ostium followed by simultaneous deployment of THV. Intravascular imaging of the ostial RCA stent revealed no stent fracture. SAW distance is important to determine the possibility of balloon-induced stent injury during valve deployment. In cases where an ostial stent may interact with balloon inflation, kissing-balloon inflation may be performed to prevent stent injury.Learning objectiveIn patients with ostial coronary stents protruding into the aorta, stent to aortic wall distance is important to determine the possibility of balloon-induced stent injury during balloon-expandable transcatheter heart valve deployment. Kissing-balloon inflation may be performed to prevent stent injury.
Project description:There is currently no consensus regarding the optimum treatment strategy for an isolated side branch lesion. The usefulness of a side branch stenting technique with a balloon crushing the segment protruding into the main vessel has been reported; however, there remain concerns about malapposition of crushed stent struts and a consequent risk of stent thrombosis. We herein report a case with a diagonal branch lesion that was successfully treated with this technique. Follow-up optical coherence tomography clearly revealed that the protruding stent struts in the main vessel were crushed and covered almost completely. Our findings may support the feasibility of this treatment in the mid-term period. <Learning objective: There is currently no consensus regarding the optimum treatment strategy for an isolated side branch lesion. In the present case, we successfully treated an isolated diagonal branch lesion using a side branch stenting technique with a balloon crushing the segment protruding into the main vessel. Good neointimal coverage of a crushed stent segment protruding into the main vessel by follow-up optical coherence tomography may support the feasibility of this treatment in the mid-term period.>.
Project description:PURPOSE:The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty. METHODS:In the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months. RESULTS:A total of 171 patients (69?±?8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI -?0.04 to 1.3], p?=?0.06 and -?0.3 per 10 years [95% CI -?0.5 to 0.01], p?=?0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p?=?0.01 and OR 0.1 [95% CI 0.01 to 0.6], p?=?0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: -?0.1 per 10 mm [95% CI -?0.1 to -?0.03], p?=?0.001 and -?0.1 [95% CI -?1.7 to -?0.1], p?=?0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p?=?0.04). CONCLUSION:DCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.
Project description:Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear. Objective: To examine the effect of DCB in side branch protection for de novo CBL. Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed. Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P < 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P > 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P > 0.05). Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].