De-novo Coronary Lesions Research Articles

Impact of Stent Size Selection on Acute and Long-Term Outcomes After Drug-Eluting Stent Implantation in De Novo Coronary Lesions.

Although significant undersizing often results in incomplete stent apposition or underexpansion, the possible impact of oversized stent implantation on arterial wall injury has not been systematically investigated with drug-eluting stents. The aim of this study was to investigate the impact of stent oversizing on acute and long-term outcomes after drug-eluting stents implantation in de novo coronary lesions. Serial (baseline and 6-12 months) coronary angiography and intravascular ultrasound were performed in 2931 lesions treated with drug-eluting stents (355 sirolimus, 846 paclitaxel, 1387 zotarolimus, and 343 everolimus). The percentage of stent oversizing to angiographic reference vessel diameter (RVD) was calculated as (nominal stent diameter-RVD)/RVD×100 (%). Clinical outcomes, including target lesion revascularization and stent thrombosis, were followed for 1 year. Overall, smaller preintervention RVD was associated with higher percentage of stent oversizing (P<0.001). The significant oversizing group underwent less post-dilatation (P=0.002) but achieved greater stent expansion (P<0.001) and less incomplete stent apposition (P<0.001) without increase of edge dissection after procedure. When stratified by vessel size and stent oversizing, progressive decreases of restenosis (P=0.002) and target lesion revascularization rates (P=0.007) were found in favor of larger vessel size and oversized stents. Stent thrombosis was observed the most in small RVD with low percentage of stent oversizing group among the subgroups (P=0.040). The positive impact of stent oversizing was documented on procedural and clinical outcomes. In particular, small vessels treated with smaller stents were associated with greater adverse events, suggesting that aggressive selection of larger stents, with appropriate attention to edge effects, may optimize long-term outcomes, even in drug-eluting stents implantation.

Role of optical coherence tomography guided percutaneous coronary intervention to assess stent malapposition in de-novo coronary lesions

Role of optical coherence tomography guided percutaneous coronary intervention to assess stent malapposition in de-novo coronary lesions

TCTAP A-044 Is Drug-eluting Balloon Highly Favorable in De Novo Coronary Lesions

Recently, a drug-eluting balloon (DEB) has emerged as a potential therapeutic option and has been widely adopted for treating in-stent restenosis. However, the benefits of DEB are still uncertain for de novo coronary lesions. From January 2010 through April 2016, 171 consecutive patients with de

TCT-481 A novel approach to treat de-novo coronary bifurcation lesion: results of the novel abluminal coated sirolimus eluting dedicated bifurcation stent in first 37 patients from the Bi-Siro study

TCT-481 A novel approach to treat de-novo coronary bifurcation lesion: results of the novel abluminal coated sirolimus eluting dedicated bifurcation stent in first 37 patients from the Bi-Siro study

Drug-eluting balloons in the treatment of de-novo coronary lesions: a meta-analysis of randomized-controlled trials.

The aim of this meta-analysis was to evaluate the efficacy of drug-eluting balloons (DEBs) plus bare-metal stents (BMS) for the treatment of de-novo coronary lesions. Eleven trials involving 1279 patients were included in this study. The main endpoints were as follows: late lumen loss (LLL), binary restenosis, stent thrombosis (ST), and major adverse cardiovascular events (MACEs). The definition of MACEs was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Compared with BMS alone, DEB plus BMS showed a lower risk for LLL (P=0.007) and MACEs (P=0.010). There were no significant differences in binary restenosis (P=0.212), ST (P=0.199), death (P=0.141), MI (P=0.439), and TLR (P=0.340). Compared with drug-eluting stents (DES), DEB plus BMS could increase the risk of LLL (P=0.002) and MACEs (P=0.026). The risks of binary restenosis (P=0.113), ST (P=0.832), death (P=0.115), MI (P=0.831), and TLR (P=0.111) were similar between DEB plus BMS and DES. DEB plus BMS was better than BMS alone in reducing LLL and MACEs, especially when dilatation was performed after stenting for de-novo coronary lesions, but it was inferior to DES. Therefore, the treatment strategy with DEB plus BMS should not be recommended for de-novo coronary lesions, except for patients who have contraindications for DES.

Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.

Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial

Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Biotronik AG.

TCT-555 Impact of Stent Size Selection on Acute and Long-Term Outcomes after Drug-Eluting Stent Implantation in De Novo Coronary Lesions

The advent of bioresorbable scaffolds is redrawing attention to accurate device size selection. While significant undersizing often results in incomplete strut apposition (ISA) or underexpansion, possible impact of oversized stent implantation on arterial wall injury has not been systematically

Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.

There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients. The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P(non-inf) < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38). Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.

Neointimal response to second-generation drug-eluting stents in diabetic patients with de-novo coronary lesions: intravascular ultrasound study.

The aim of this study was to evaluate the extent of neointimal response after the implantation of a second-generation drug-eluting stent, zotarolimus-eluting stent (ZES-ER, Endeavor Resolute) or everolimus-eluting stent (EES, Xience V), using intravascular ultrasound (IVUS) in diabetic patients. In all, 154 diabetic patients with de-novo coronary lesions were randomized to be implanted with a ZES-ER or EES, and the angiographic follow-up at 9 months combined with a complete IVUS study was available for 96 patients with 101 lesions. Baseline demographic and lesion parameters were similar in both groups at index percutaneous coronary intervention. On follow-up angiography, in-stent late lumen loss and minimal lumen diameter were not different between the two groups. On IVUS study, neointimal hyperplasia volume [median (interquartile range): ZES-ER vs. EES; 2.25 mm (0.57-6.25) vs. 1.59 mm (0.45-8.37), P=0.615] and in-stent percentage of volume obstruction [median (interquartile range): ZES-ER vs. EES; 1.16% (0.33-3.61) vs. 0.77% (0.29-4.01), P=0.615] showed similar results between the two groups. In diabetic patients, the second-generation drug-eluting stents, ZES-ER and EES, were comparable in inhibiting neointimal proliferation.

Switching types of drug-eluting stents does not prevent repeated in-stent restenosis in patients with coronary drug-eluting stent restenosis

ObjectivesWe treated patients experiencing drug-eluting stent (DES) restenosis with plain old balloon angioplasty (POBA), implantation of the same type of DES [homogeneous drug-eluting stent (HOMO-DES)], or implantation of a different type of DES [heterogeneous drug-eluting stent (HETERO-DES)], and compared the efficacy and safety of these procedures for the prevention of repeated in-stent restenosis (ISR).BackgroundIn patients with de-novo coronary lesions, DES implantation is associated with a markedly reduced restenosis rate as compared with that associated with a bare metal stent and POBA. However, the optimal management strategy for patients with DES ISR remains unknown.Patients and methodsWe identified 191 consecutive DES ISR lesions from 183 patients who required clinically driven revascularization and divided them into three groups according to the treatment: 38 lesions were treated with POBA, 38 with HOMO-DES, and 115 with HETERO-DES.ResultsThe incidence of target lesion revascularization (TLR) was 42.1% (16/38), 15.8% (6/38), and 16.5% (19/115) in the POBA, HOMO-DES, and HETERO-DES groups (POBA vs. HOMO, HETERO-DES; P=0.002, respectively). Multivariate analysis indicated that diabetes [odds ratio (OR), 3.4], hemodialysis (OR, 7.74), nonfocal ISR patterns (OR, 3.35), previous myocardial infarction (OR, 3.26), and POBA (OR, 8.84) were independent predictors of TLR.ConclusionA strategy involving repeated DES implantation was superior to POBA for preventing recurrent restenosis. Treatment with a different type or generation of DES does not appear to reduce the incidence of TLR. Moreover, we identified certain useful factors for facilitating appropriate and early triage in the patients with repeated DES ISR.

TCT-592 Lower Five Year Event Rates In The Genous Endothelial Progenitor Cell Capturing Stent Compared With A Drug Eluting Stent In De-novo Coronary Artery Lesions With A High-risk Of Restenosis; A Randomized Controlled Trial

TCT-592 Lower Five Year Event Rates In The Genous Endothelial Progenitor Cell Capturing Stent Compared With A Drug Eluting Stent In De-novo Coronary Artery Lesions With A High-risk Of Restenosis; A Randomized Controlled Trial

TCT-605 Safety and Efficacy of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent for the Treatment of De Novo Coronary Lesions: 2-Year Results from the Prospectively Patient-Level Pooled Analysis of the TARGET I and TARGET II Trials

Early reports revealed that a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (named target eluting technology) FIREHAWK (MicroPort Medical, Shanghai, China) was safe and effective in 1-year follow-up in a large cohort of patients from the TARGET clinical program. We

Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: The DEMONSTRATE study

BackgroundIt has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent (DES) implantation. We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3months, compared to Vision/Multilink8 Bare Metal Stent (BMS) at 1month. MethodsThe ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation (DEMONSTRATE) was a multicenter, randomized, parallel group study. Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 (19) or Vision/Multilink8 (19) stent placement at 6 OCT-experienced centers. Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of <30%, determined by OCT at 3 and 1months for Cre8 and Vision/Multilink8, respectively. Percentage of uncovered/malapposed stent struts, neointimal growth and thickness were the main secondary end-points. ResultsThe primary end-point of RUTTS score <30% occurred in 99.8% (899/901) of Cre8 struts and in 99.6% (1116/1121) of Vision/Multilink8 struts (difference 0.2, CI 95% −0.2 to 0.6, p for noninferiority <0.001). The percentage of uncovered/malapposed struts was comparable (0.36±0.64 vs. 0.12±0.24, p=0.145) in the two study groups, while both neointimal percentage area (8.46±5.29 vs. 19.84±15.93, p<0.001) and thickness (0.07±0.04 vs. 0.16±0.12, p<0.001) were significantly reduced by Cre8 stent. ConclusionsThe Cre8 DES at 3months has comparable strut coverage to Vision/Multilink8 BMS at 1month while preserving a greater efficacy in neo-intima formation reduction. Further studies to assess clinical implication of these Cre8 characteristics are warranted.

TCTAP A-167 Bioabsorbable Vascular Scaffolds (BVS) Eluting with Everolimus: for Percutaneous Coronary Intervention (PCI) of Patients with De-novo Coronary Artery Lesion: Our Experiences at Apollo Hospitals Dhaka

Aim of the study was to evaluate the primary procedural success of percutaneous coronary intervention (PCI) of de-novo coronary artery lesion by using BVS Absorb stents eluting with Everolimus. Total 16 patients were enrolled in this very preliminary study of BVS absorb. Among them, Male: 11 and

Bioabsorbable Vascular Scaffolds Eluting with Everolimus: for Percutaneous Coronary Intervention of Patients with de-novo Coronary Artery Lesion: Our Experiences at a Tertiary Hospital

Background: Aim of the study was to evaluate the primary procedural success of percutaneous coronary intervention (PCI) of de-novo coronary artery lesion by using Bioabsorbable Vascular Scaffold (BVS) ABSORB stents eluting Everolimus. Methods: Total 16 patients were enrolled in this very preliminary study of BVS absorb. Among them, Male: 11 and Female: 5. Total 20 stents were deployed. Mean age were for Male: 56 yrs, for Female: 60 yrs. Associated coronary artery disease (CAD) risk factors were Dyslipidemia, High Blood pressure, Diabetes Mellitus, Positive family history (FH) for CAD and Smoking. Patients were followed up clinically. Results: Among the study group; 13 (81%) were Dyslipidemic, 10(62.5%) were hypertensive; 6 (37.5%) patients were Diabetic, FH 3(18.75%), and 2(18%) were all male smoker. Female patients were more obese [Body Mass Index (BMI) M 25: F 27] and developed CAD in advance age. A common stented territory was for left anterior descending artery (LAD): 6 (37.5%), left circumflex artery (LCX) 5 (25%), right coronary artery (RCA) 6(37.5%). One patient had both LCX and LAD stenting. Total 3 patients had double/overlapping stent in RCA lesion. Territory wise distributions of BVS ABSORB stent were for LAD 6(30%), RCA 9 (45%), and LCX 5 (25%). There was no periprocedural or postprocedural complication. Conclusion: BVS ABSORB Everolimus eluting vascular scaffold showed favorable clinical outcome without any major cardiac events (acute or late stent thrombosis, MI or death) over a period of 9 month. Thus, BVS ABSORB would be favorable alternative to other available drug eluting metallic stents. DOI: http://dx.doi.org/10.3329/cardio.v6i2.18352 Cardiovasc. j. 2014; 6(2): 122-126

Impact of exercise-based cardiac rehabilitation on de novo coronary lesion in patients with drug eluting stent.

ObjectiveTo compare the rate of progression of de novo lesion between the cardiac rehabilitation (CR) and control groups.MethodsThis is a retrospective observational study. Patients who received drug-eluting stent (DES) due to acute coronary syndrome were included as subjects. The CR group received eight weeks of early CR program, and sustained a self-exercise program in the homes. The control group was instructed to exercise independently. Nine months after the first insertion of DES, we implemented follow-up coronary angiography, and compared the rate of progression of de novo lesion by quantitative angiographic measurement between the two groups.ResultsA total of 81 patients were recruited as subjects to CR group (n=32) or control group (n=49). At nine months, late luminal loss was 0.04±0.23 mm in the CR group and 0.00±0.31 mm in the control group (p=0.54, observed power=0.10). Late loss was -0.90%±9.53% in the CR group and 0.80%±11.15% in the control group (p=0.58, observed power=0.05). No target lesion revascularization procedures were needed in the CR group, while two in the control group (p=0.25). In the CR group, mean VO2max was significantly improved from 24.36±5.00 to 27.68±5.24 mL/kg/min (p<0.001).ConclusionWe could not observe a statistically significant difference in the progression rate of de novo lesion between the CR and control groups. Thus the current amount of nine months exercise-based CR program does not seem to have a distinct impact on the retardation of de novo coronary lesion in patients who received percutaneous coronary intervention with DES.

Attenuated plaque is associated with plaque prolapse accompanied by cardiac enzyme elevation after drug-eluting stent implantation

This study aimed to evaluate the relationship between grayscale intravascular ultrasound-attenuated plaque (AP) and poststenting plaque prolapse (PP) as well as their influence on creatine kinase-myocardial band (CK-MB) elevation after drug-eluting stent (DES) implantation. The relationship between baseline AP and poststenting PP and their impacts on percutaneous coronary intervention (PCI) are not well known. A total of 141 single, native, de-novo coronary lesions in 141 patients with normal pre-PCI CK-MB levels who underwent intravascular ultrasound before and after DES implantation were studied. AP was found in 72 (51.1%) lesions and PP occurred in 43 (30.5%) lesions. Baseline AP was associated with greater plaque area, lesion eccentricity, and positive remodeling, and was associated with higher frequency of poststenting PP (47.2 vs. 13.0%, P<0.001) as well as greater poststenting PP volume (2.2±1.3 vs. 1.9±1.1 mm, P=0.045). Elevated CK-MB levels were observed in 34 (24.1%) lesions and significantly more frequently in patients with baseline AP and poststenting PP than without both of these findings. Multivariate analysis indicated that AP with PP was the predictor of post-PCI CK-MB elevation. Baseline AP was associated with high-risk characteristics, higher frequency, and greater volume of poststenting PP accompanied by CK-MB elevation in patients with DES implantation.

TCT-596 Early Vascular Restoration following treatment of single de-novo coronary artery lesions with the DESolve Nx Novolimus Eluting Bioresorbable Coronary Scaffold System (NEBCSS) at 6 months: Insights from the Serial IVUS analysis of the pivotal, prospective, multicentre, DESolve NX Trial

The DESolve Bioresorbable Scaffold is a novel drug-eluting device combining a PLLA-based scaffold coated with a bioresorbable polylactide-based polymer and a potent anti-proliferative sirolimus metabolite, Novolimus. The drug dose is 5 mcg per mm of scaffold length. An early benefit with regard to

TCT-431 Angiographic Results of a novel Novolimus Eluting Bioresorbable Coronary Scaffold System (NEBCSS) for the treatment of single de-novo coronary artery lesions: 6 month Serial QCA analysis results from the pivotal, prospective, multicentre, DESolve NX Trial

By design, drug-eluting bioresorbable scaffolds have been developed as an alternative to metallic stents in order to provide temporary vascular scaffolding, prevent vessel recoil and inhibit late clinical events due to excessive neointimal hyperplasia formation including restenosis and lesion