Target Lesion Revascularization Rate Research Articles

Technical success, clinical efficacy, and insight into the causes of restenosis after the percutaneous coronary intervention of de novo coronary artery lesions using a paclitaxel-coated balloon with citrate ester excipient.

The aim of this all-comers registry study was to investigate the technical success, clinical efficacy, and safety of a drug-coated balloon (DCB) with paclitaxel combined with citrate ester excipient (CEE) in percutaneous coronary intervention (PCI) of de novo coronary lesions in an all-comers population. A total of 338 consecutive PCIs using the DCB (CEE)-only approach comprising 406 de novo lesions were included in the study. Technical success was determined by the successful delivery of the device and no need for bailout stenting. The mean follow-up time was 25 ± 12 months. The mean age of patients was 71 ± 11 years, and 48% had the acute coronary syndrome. A total of 55% of the patients were at risk of factor bleeding. The delivery of DCB was successful in 98% of cases. The overall technical success rate was 83%. Bailout stenting was used in 9% of lesions. Rotational atherectomy was used in 11% of cases before the DCB-only approach. The mean diameter of the DCBs used was 2.7 ± 0.5 mm and 38% of DCBs were large (≥3.0 mm). The 12-month MACE rates were 5.4 ± 1.7 and 18.3 ± 3.1% in stable CAD and in ACS, respectively. The respective target lesion revascularization (TLR) rates were 3.0 ± 1.3 and 8.5 ± 2.3%. Unacceptable acute recoil (>30%) was found in 74% of cases that needed repeat revascularization. No acute vessel closures occurred after DCB treatment. The DCB-only strategy using a paclitaxel-coated (CEE) device was technically feasible, safe, and effective in an all-comers population. Acute recoil was found as a significant cause of restenosis after the DCB-only strategy.

Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions

The study aimed to assess the 24-month safety and effectiveness of a new generation drug-coated balloon (DCB) (Elutax; AR Baltic Medical, Vilnius Lithuania-also marketed as Emperor in some European countries; Aachen Resonance, Germany, and AB Medica, Italy) for the treatment of patients with femoropopliteal lesions. From January 2019 to January 2020, DCB angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoropopliteal lesions (group A) and compared with a noncontemporary control group (group B) consisting of 71 patients (71 limbs) treated with plain old balloon angioplasty (POBA) between January 2017 and January 2018. Before performing the angioplasty, both groups underwent clinical examination, ultrasound evaluation, and computed tomography angiography to delineate subject clinical and baseline lesion characteristics. Primary end point was primary patency rate at 24 months. Secondary end points included clinically driven target lesion revascularization (CD-TLR), overall survival and limb salvage rates. In both groups technical success rate was 100% with bailout stenting performed in 16.9% (9/53) of lesions in group A, while stenting was necessary in 22.5% of lesions (16/71) in group B. Patients treated with Elutax exhibited lower 24-month restenosis/reocclusion rate and improved primary patency compared to those treated with POBA (restenosis/reocclusion rate: 9.4% vs. 25.3%, CI 95% 0.01-0.30, P=0.034; primary patency: 88.2% vs. 71.5%, log rank P=0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB versus 18.3% for POBA. No device or procedure-related deaths occurred, and no 30-day mortality was observed in either group. During the follow-up period, the limb salvage rate was 94.9% for A group and 92.1% for B group. All minor amputations occurred in limbs presented with chronic limb threatening ischemia (CLTI). Overall survival was 91.7% for group A and 89.4% for group B. Paclitaxel+Dextran DCB angioplasty proved safe and effective in managing chronic lesions of femoropopliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.

Protocol of the evolution study: A prospective, multicenter, observational study evaluating the effect and health economics of endovascular treatment in patients with moderate and severe calcification of femoropopliteal artery.

Peripheral artery disease with calcification is extremely prevalent in the elderly. Due to the calcification, it requires a different clinical approach than the more common arteriosclerosis obliterans of the lower extremity. The introduction of novel technologies such as the drug-coated balloon, directional atherectomy, supera and drug-eluting stent has improved the prognosis of these patients. This study will contribute to the development of higher-quality evidence-based medicine for clinical treatment by assessing the quality of life (QOL), clinical treatment effect, and health economics of patients with calcification. The Evolution study is designed as a prospective, multicenter, observational, real-world study. From January 2021 to December 2022, 600 patients with moderate to severe femoropopliteal artery calcification will be recruited from ten locations in China. After discharge, information on demographics, disease history, procedure details, imaging findings, and follow-up will be collected. Patients will undergo follow-up at 1, 6, 12, 18, and 24 months after operation. Technical success rate, vascular quality of life questionnaire, primary patency rate of the target lesion, clinically driven target lesion revascularization rate (CD-TLR), and health economics evaluation are all included as outcome measures. The Evolution study helps to investigate the clinical and financial results of various endovascular therapy modalities for patients with moderate and severe femoropopliteal artery calcification. These actual facts may help to harmonize therapy recommendations for peripheral artery disease. The study protocol was registered at www.clinicaltrials.gov (registration number: NCT04716361).

Provisional stenting with side branch rescue stenting is associated with increased 3-year target lesion failure in patients with acute coronary syndrome and coronary bifurcation lesions.

BackgroundProvisional stenting (PS) is the main treatment for a majority of coronary bifurcation lesion and includes PS with 1-stent and PS with 2-stent. However, the treatment difference between PS with 1-stent and with 2-stent remains unclear in patients with the acute coronary syndrome (ACS) and coronary bifurcation lesions.Materials and methodsOverall, 820 ACS patients with Medina 1,1,1 or 0,1,1 coronary bifurcation lesion who had completed 3-year follow-up were included and assigned to the PS with 1-stent (n = 519) or the PS with 2-stent (n = 301) according to the use of final stenting technique. The primary endpoint was the target lesion failure (TLF) at 3 years since stenting procedures.ResultsAt 3-year follow-up, TLF occurred in 85 (16.4%) patients in the PS with 1-stent group and 69 (22.9%) in the PS with 2-stent group (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.06–2.17, p = 0.021), mainly driven by a higher rate of target lesion revascularization (TLR) in the PS with 2-stent group (13.0% vs. 8.3%, HR 1.65, 95% CI 1.04–2.61, p = 0.033). Complex bifurcations, side branch (SB) pretreatment, intravascular imaging guidance, and hyperlipidemia were the four predictors for 3-year TLF. SB pretreatment was associated with increased 3-year TLR, leading to an extremely higher 3-year TLF.ConclusionProvisional with 2-stent for patients with ACS is associated with a higher rate of 3-year TLF, mainly due to increased requirement of revascularization. SB pretreatment should be avoided for simple bifurcation lesion.

Course of ankle-brachial-index 12 months after intravascular lithotripsy in calcified peripheral lesions

Abstract Background Intravascular lithotripsy (IVL) is a relatively novel treatment option for calcified lesions in peripheral artery disease. Little is known about the mid to long-term functional status of the patients and target lesion revascularization rate (TLR) after IVL only procedure. Purpose To evaluate the course of ankle-brachial-index (ABI) and to assess the rate of revascularization 1 year after intravascular lithotripsy performed on calcified peripheral lesions. Methods Between December 2018 and January 2021 IVL was performed on 61 limbs of 51 patients presenting with Rutherford classes 2–5. Ankle-brachial-index (ABI) was documented before the procedure as well as 1 day, 6 months and 1 year after the procedure within a single center real-life registry. Further endpoint was revascularization with PTA or peripheral bypass surgery. The vast majority of cases were done as IVL only procedure (58%) All procedures were done in upper leg/pelvic stenosis. Results ABI measurement after 12 months was done in 42 of 51 patients (82%). Three pts were missed due to media sclerosis. Due to loss of follow-up, ABI after 6 months could not be performed on 4/61 patients (7,8%) and 12-month-ABI in another 8/51 cases (15,6%). Initial baseline ABI of 0.6±0.26 before the procedure increased to 0.8±0.25 (p<0.0001) one day afterward. After 6 months, the ABI of 0.8±0.27 (n=49; p<0.0001) was still significantly improved compared to baseline. After 1 year, ABI with 0.7±0.22 was still improved, however not significantly different from baseline (Figure 1). Target lesion revascularization was needed in 7 patients (13%), 4 with subsequent IVL, 3 with PTA and 2 with peripheral bypass surgery. Conclusions In our large single center registry, IVL performed mainly as a stand-alone procedure was safe and effective even after a mid-term follow up. TLR was necessary in 13%, which is lower than in previous published IVL data (20,7% as in DISRUPT-PAD-II) [1]. ABI after 12 months improved but did maintain statistical significance, compared with other procedure like scoring balloon [2]. Funding Acknowledgement Type of funding sources: None.

Clinical and angiographic outcomes following percutaneous treatment of non-occlusive vs. chronically total occluded coronary lesions

Abstract Background Recent advancements in recanalization techniques, introduction of dedicated equipment and elaboration of systematic algorithmic approaches have significantly improved procedural success of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures. However, despite their undisputable merits in terms of procedural success, direct comparisons of mid-term clinical and angiographic outcomes following CTO and non-CTO-PCI are missing. Purpose The aim of this study was to assess the clinical and angiographic outcomes of patients undergoing successful CTO-PCI as compared to a propensity matched cohort of patients undergoing PCI of non-occlusive coronary lesions. Methods All consecutive patients undergoing successful CTO recanalization procedures at our center between 2015 and 2018 were included (N=453; 472 lesions). For matching purposes, all patients undergoing non-CTO-PCI present in our database were included (N=14733; 23458 lesions). A 1-to-1 nearest neighbour matching using baseline clinical and angiographic variables was performed to identify one patient undergoing non-CTO-PCI (N=453; 472 vessels) for each patient undergoing CTO-PCI (N=453; 472 vessels). Surveillance angiography was scheduled at 6–9 months and clinical follow-up was performed up to 12 months. The primary clinical endpoint of interest was the incidence of major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). The secondary angiographic endpoint was in-segment binary restenosis. Results Patients undergoing CTO-PCI displayed a tendency towards higher degrees of binary restenosis at surveillance angiography as compared to those undergoing non-CTO-PCI (CTO vs. non-CTO: 30.5% vs. 24.0%; P=0.058), despite not meeting statistical significance. Of note, the incidence of occlusive restenosis was low and comparable between groups (2.2% vs. 1.4%; P=0.603). At 12 months follow-up, MACE occurred in 83 patients (19.7%) in the CTO-PCI and 59 patients (14.1%) in the non-CTO-PCI group (hazard ratio [HR] = 1.44; 95% confidence interval [CI]: 1.03–2.01; P=0.033). TLR rates were significantly higher following CTO- as compared to non-CTO-PCI (17.2% vs. 10.3%; HR=1.72 [1.18–2.51], P=0.005). The incidence of all-cause death (2.6% vs. 3.3%; P=0.548) and MI (0.5% vs. 1.4%; P=0.177) was not significantly different between the groups. Conclusion In this large, propensity-matched comparison of clinical and angiographic outcomes following CTO- vs. non-CTO-PCI, we found CTO-PCI to be associated with a higher MACE rate at 12 months, primarily driven by significantly higher TLR rates. The incidence of occlusive restenosis was low and comparable between groups. Funding Acknowledgement Type of funding sources: None.

Great Safety and Efficacy of a New Drug-eluting-stent manufactured in a developing country at minimal cost: the VSTENT at 3 years follow-up

Abstract Background In the care patients with coronary artery disease, a new drug-eluting stent, the VSTENT, covered with sirolimus was designed and manufactured in a developing country at minimal cost. Beside the clinical concern, from an engineering perspective, the questions were: Was this stent flexible? What was its radial strength? Did this stent brace itself against the wall with a strong strut network? What was the cell size and design? Methods From 6.2019 to 8.2020, 150 patients from 5 hospitals underwent PCI with a new VSTENT in 212 lesions. At the index PCI (D1), a subgroup of 61 patients (40%) was preselected to undergo additional imaging procedures including intravascular ultrasound (IVUS=41) or optical coherence tomography (OCT=20). All patients were followed-up clinically every month for one year. At 6 months (D180) they underwent digital subtraction angiography (DSA=143) or a second IVUS or OCT for the intravascular subgroup. The rate of invasive imaging follow-up was 95% for DSA, 92% for IVUS and 95% for OCT. The rate of major adverse cardiovascular events (MACE: mortality, in-stent restenosis (ISR), Target lesion revascularization (TLR) and data on radial strength, longitudinal flexibility, expansion and coverage were calculated. Results In all patients, the technical success was 100% (successful balloon inflation, complete stent expansion, uneventful balloon removal). The VSTENTs were deployed in arteries of all sizes: small with diameter (D) = 2.5mm in 11.3%, D= 2.75mm in 24.1%, and in large arteries D= or >3mm in 66.6% of patients. The stent length varied from 15–38mm with 80% >20mm. 92% had good apposition as evidenced by OCT or IVUS. There was no acute in-stent thrombus, no loss of side branch and no perforation. There was one cardiac arrest with successful resuscitation. The bench and angiographic data on radial strength, longitudinal flexibility, expansion and coverage were excellent In Figure 1, The VSTENT design has open cells in the middle and closed cell at both distal segments. This design of mixed closed and open cell increases the radial strength at both ends while preventing the diametric difference (dog-boning effect) In Figure 2, after deployment of a VSTENT, the size of the open cell design in the middle of the stent is approximately 3.40 mm2 while the size of the distal closed cells design is 1.7 mm2. At 6 months, the rate of angiographic ISR inside the stent and within the 5 mm from the two ends was 3.5%. The rate of late lumen loss was 0.8mm in the in-stent segment and 0.07mm within 5mm of the two ends. The composite MACE was 4.7% with 1 mortality (0.7%) and 4 TLRs. At 36 months follow-up, only one TLR was reported. Conclusions At 3 years follow-up, the rate of angiographic ISR and TLR of the VSTENT was low. The data on radial strength, longitudinal flexibility, expansion and coverage were excellent. The VSTENT could be an affordable choice for interventional cardiology service in developing countries. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): United Healthcare

Prevalence and outcomes of stent thrombosis with in-stent calcified nodules: substudy from the REAL-ST registry.

The relationship between in-stent calcified nodules (IS-CN) and second-generation drug-eluting stent (G2-DES) stent thrombosis (ST) remains uncertain. We aimed to evaluate the prevalence, clinical demographic and long-term clinical outcomes after G2-DES ST with IS-CN. The prespecified substudy of the REAL-ST registry (a retrospective, multicentre registry of patients with definite ST after first- and G2-DES implantation) enrolled patients who experienced definite G2-DES ST and who underwent pre-intervention intravascular ultrasound imaging at index ST events. IS-CN was observed in 15 out of 118 (13%) definite G2-DES ST cases. The multiple logistic regression model demonstrated that haemodialysis (odds ratio [OR] 12.27, 95% confidence interval [CI]: 1.56-94.54; p=0.02), proximal or mid-right coronary artery lesions (OR 12.79, 95% CI: 1.78-92.13; p=0.01) and severe calcification (OR 13.01, 95% CI: 1.18-142.94; p=0.04) were independently associated with ST with IS-CN. The cumulative 5-year incidence of target lesion revascularisation (TLR) after ST was significantly higher in the IS-CN group than in the non-IS-CN group (p=0.02). Independent predictors of TLR after the index ST events were female sex (hazard ratio [HR] 3.05, 95% CI: 1.20-7.74; p=0.02), diabetes mellitus (HR 3.26, 95% CI: 1.26-8.41; p=0.01) and IS-CN (HR 3.07, 95% CI: 1.16-8.14; p=0.02). IS-CN may be one of the underlying mechanisms of G2-DES ST. Notably, IS-CN was associated with a higher TLR rate after the index ST events, suggesting the need for careful clinical follow-up of ST patients with IS-CN.

Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial

BackgroundSo far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies. ObjectivesThe aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. MethodsWithin a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes. ResultsAt 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups. ConclusionsThe 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543)

A method of assessing peripheral stent abrasiveness under cyclic deformations experienced during limb movement

Poor outcomes of peripheral arterial disease stenting are often attributed to the inability of stents to accommodate the complex biomechanics of the flexed lower limb. Abrasion damage caused by rubbing of the stent against the artery wall during limb movement plays a significant role in reconstruction failure but has not been characterized. Our goals were to develop a method of assessing the abrasiveness of peripheral nitinol stents and apply it to several commercial devices. Misago, AbsolutePro, Innova, Zilver, SmartControl, SmartFlex, and Supera stents were deployed inside electrospun nanofibrillar tubes with femoropopliteal artery-mimicking mechanical properties and subjected to cyclic axial compression (25%), bending (90°), and torsion (26°/cm) equivalent to five life-years of severe limb flexions. Abrasion was assessed using an abrasion damage score (ADS, range 1–7) for each deformation mode. Misago produced the least abrasion and no stent fractures (ADS 3). Innova caused small abrasion under compression and torsion but large damage under bending (ADS 7). Supera performed well under bending and compression but caused damage under torsion (ADS 8). AbsolutePro produced significant abrasion under bending and compression but less damage under torsion (ADS 12). Zilver fractured under all three deformations and severely abraded the tube under bending and compression (ADS 15). SmartControl and SmartFlex fractured under all three deformations and produced significant abrasion due to strut penetration (ADS 20 and 21). ADS strongly correlated with clinical 12-month primary patency and target lesion revascularization rates, and the described method of assessing peripheral stent abrasiveness can guide device selection and development. Statement of significancePoor outcomes of peripheral arterial disease stenting are related to the inability of stents to accommodate the complex biomechanics of the flexed lower limb. Abrasion damage caused by rubbing of the stent against the artery wall during limb movement plays a significant role in reconstruction failure but has not been characterized. Our study presents the first attempt at assessing peripheral stent abrasiveness, and the proposed method is applied to compare the abrasion damage caused by Misago, AbsolutePro, Innova, Zilver, SmartControl, SmartFlex, and Supera peripheral stents using artery-mimicking synthetic tubes and cyclic deformations equivalent to five life-years of severe limb flexions. The abrasion damage caused by stents strongly correlates with their clinical 12-month primary patency and target lesion revascularization rates, and the described methodology can be used as a cost-effective and controlled way of assessing stent performance, which can guide device selection and development.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns)

Purpose: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. Materials and Methods: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. Results: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). Conclusions: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. Clinical Impact Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

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.

Incidence and Predictors of Outcome in the Treatment of In-Stent Restenosis with Drug-Eluting Balloons, a Real-Life Single-Centre Study.

Objectives To determine the one-year and five-year occurrence and prognosticators of major adverse cardiac events (MACE: composition of all-cause death, myocardial infarction, target vessel revascularization, and vessel thrombosis), mortality, and target lesion revascularization (TLR) in patients with in-stent restenosis (ISR) treated with drug-eluting balloons (DEBs). Background DEBs have become an emerging therapeutic option for ISR. We report the results of a single-center retrospective study on the treatment of ISR with DEB. Methods 94 consecutive patients with ISR treated with the paclitaxel-eluting balloon were retrospectively studied between August 2011 and December 2019. Results The one-year MACE rate was 11.8%, and the five-year MACE rate was 39.8%. The one-year mortality was 5.3%, and the five-year mortality rate was 21.5%. The one-year TLR rate was 4.3%, and the five-year rate was 18.7%. The univariable-Cox proportional hazard models for TLR showed lesion length, and the number of DEBs per vessel is associated with adverse outcomes with H.R. of 1.038 (1.007–1.069) and 4.7 (1.6–13.8), respectively. Conclusion Our data indicate that at one year, DEBs provide an effective alternative to stenting for in-stent restenosis. Our five-year data, representing one of the longest-term follow-ups of DEB use, demonstrate high rates of MACE. The high five-year MACE reflects all-cause mortality in a high-risk population. This is offset by a reasonable five-year rate of TLR, indicating that DEB provides both short-term and long-term benefits in ISR.

Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

Response to pre-dilatation with POBA can predict target lesion revascularization after DCB angioplasty for de novo small coronary artery lesions.

ObjectiveTo assess the determinants of target lesion revascularization (TLR) after drug-coated balloon (DCB) angioplasty for de novo small coronary artery lesions.MethodsThis retrospective study enrolled consecutive lesions from patients that were in a stable condition and had undergone successful DCB treatment for de novo small coronary artery lesions. The study endpoint was TLR and major adverse cardiac events at 12 months.ResultsA total of 68 patients with 83 lesions were enrolled in the study. Of these, 11 (13.3%) lesions required TLR. Mean ± SD pre-dilatation balloon diameters were similar in the non-TLR (2.33 ± 0.72 mm) and TLR (2.18 ± 0.36 mm) groups. A comparison of the two groups showed that post/pre-lumen area ratio during pre-dilatation (%) by plain old balloon angioplasty (POBA) was significantly and negatively associated with TLR and the optimal cut-off point was 170%. Cox proportional hazard and multivariate regression analyses showed that post/pre-lumen area ratio was the only independent predictor of TLR (hazard ratio 0.9318; 95% confidence interval 0.9001, 0.9645).ConclusionGreater pre-dilatation using POBA, assessed as the post/pre-lumen area ratio, may be independently associated with a lower 12-month TLR rate in patients undergoing DCB angioplasty for de novo small coronary lesions.

Phoenix atherectomy for patients with peripheral artery disease.

Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD). We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients. Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed. A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK) segments (32%). Complex TASC C/D lesions and moderate to severe calcifications (PACSS score ≥2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (hazard ratio [HR] 3.7; p<0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03). The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates. DRKS00016708.

Predictors and outcomes of ischemia-driven target lesion revascularization in deferred lesion based on fractional flow reserve: a multi-center retrospective cohort study.

BackgroundFractional flow reserve (FFR) has become the gold standard for diagnosing ischemia in angiographically intermediate epicardial coronary artery stenosis. This study investigated the clinical outcomes and predictors of revascularization deferral based on FFR.MethodsIn this retrospective cohort study, we assessed 474 lesions (440 patients) where revascularization was deferred based on the FFR value. Minimum lumen diameter and %-diameter stenosis were measured. Calcification was graded as none, mild, moderate, or heavy. The synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) score I was also determined. The primary outcome was ischemia-driven target lesion revascularization (TLR) in deferred lesions within 3 years. Patients were also assigned into two groups based on FFR value.ResultsThe average age of the patients was 69.7±10.4 years. The average FFR value was 0.86±0.05. Stable angina pectoris was noted in 298 (67.7%) cases, and in-stent restenosis (ISR) was present in 28 (5.9%). The average SYNTAX score was 7.2±4.2. The 3-year ischemia-driven TLR was 18 lesions (3.8%). Cox proportional hazard model revealed that the SYNTAX score and ISR were independent predictors for TLR in deferred lesions [hazard ratio (HR) =1.10, 95% confidential interval (CI): 1.01–1.19, P=0.03; HR =6.33; 95% CI: 2.25–17.8, P<0.01, respectively]. The deferral group, with a low FFR value, tended to have higher TLR rates than other groups.ConclusionsLesions with lower FFR values were associated with a higher incidence of ischemia-driven TLR than those with higher FFR values. SYNTAX score and ISR were predictors for ischemia-driven TLR at 3 years in the deferred lesions.

Meta-Analysis of Provisional Versus Systematic Double-Stenting Strategy for Left Main Bifurcation Lesions

ObjectiveWe sought to compare the clinical outcomes with provisional versus double-stenting strategy for left main (LM) bifurcation percutaneous coronary intervention (PCI). BackgroundDespite two recent randomized controlled trials (RCTs) and several observational reports, the optimal LM bifurcation PCI technique remains controversial. MethodsPubMed, Cochrane Central Register of Controlled-Trials (CENTRAL), Clinicaltrials.gov, International Clinical Trial Registry Platform were leveraged for studies comparing PCI bifurcation techniques for LM coronary lesions using second-generation drug eluting stents (DES). The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes of interest were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), target vessel or lesion revascularization, and stent thrombosis. ResultsTwo RCTs and 10 observational studies with 7105 patients were included. Median follow-up duration was 42 months (IQR: 25.7). Double stenting was associated with a trend towards higher incidence of MACE (odds ratio [OR] 1.20; 95 % confidence interval [CI] 0.94 to 1.53) compared with provisional stenting. This was mainly driven by higher rates of target lesion revascularization (TLR) (OR 1.50; 95 % CI 1.07 to 2.11). There were no statistically significant differences in the incidence of all-cause mortality, cardiovascular mortality, MI, or stent thrombosis. On subgroup analysis according to the study type, provisional stenting was associated with lower MACE and TLR in observational studies, but not in RCTs. ConclusionFor LM bifurcation PCI using second-generation DES, a provisional stenting strategy was associated with a trend towards lower incidence of MACE driven by statistically significant lower rates of TLR, compared with systematic double stenting. These differences were primarily driven by observational studies. Further RCTs are warranted to confirm these findings.

Mid-term outcome of de novo lesions vs. in stent restenosis treated by intravascular lithotripsy procedures: Insights from the French Shock Initiative

BackgroundIntravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion. MethodsProspective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately. ResultsA total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group. ConclusionsIn this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted.