3rd Generation Drug-eluting Stent Research Articles

Abstract 11766: Impact of Increasing Stent Length on Long-Term Clinical Outcomes Undergoing Intracoronary Imaging-Guided Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents

Background: While longer stent length of first-generation drug-eluting stents (DES) has been associated with stent-related adverse events, the association between stent length of new-generation DES and clinical outcomes remains controversial. Methods and Results: Consecutive 1403 patients including 2277 lesions who underwent intracoronary imaging-guided percutaneous coronary intervention with 2nd- and 3rd-generation DES were enrolled. Patients were divided into two groups according to total stent length (TSL), and followed up for major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction and target lesion revascularization (TLR) for patients. Lesions were divided into two groups according to TSL as well, and followed up for TLR and stent thrombosis. In the per patient analysis, long TSL group (TSL ≥ 32 mm, n = 703) had higher prevalence of diabetes (54.5% vs. 45.2%, P &lt 0.001), anemia (48.4% vs. 43.0%, P = 0.042), peripheral artery disease (&lt% vs. 10.6%, P = 0.003), multi-vessel disease (64.7% vs. 36.2%, P &lt 0.001) and chronic total occlusion (9.5% vs 3.4%, P 0.001) than short TSL group (TSL &lt 32 mm, n = 691). In the follow up period (mean of 1528 days), MACE and TLR were significantly higher in long TSL group than in short TSL group (P = 0.009 and P = 0.037, respectively). In the multivariate analysis after adjusting for confounding factors, the long TSL was an independent predictor of MACE and TLR (hazard ratio [HR] 1.59, P = 0.002 and HR 1.74, P = 0.047). In the per lesion analysis, Kaplan-Meier curve revealed that TLR was significantly higher in long TSL group (TSL ≥ 26 mm, n = 1160) than short TSL group (TSL < 26mm, n = 1117) (P = 0.017), while stent thrombosis was comparable between the two groups. In the multivariate analysis, TLR was an independent predictor of TLR (HR 1.62, P = 0.029). Conclusion: Longer stent length of new-generation DES was associated with MACE and TLR, but not with stent thrombosis.

Assessment of utility values and QALYs after primary PCI with DP-Xience and BP-Biomatrix stents.

BackgroundPrimary percutaneous coronary intervention (PPCI) is the recommended treatment in ST elevated myocardial infarction (STEMI). The determination of Quality of life (QoL) for various options of coronary revascularization is important for establishment of a comprehensive care plan. Studies of QoL in interventional cardiology are scarce. Our study has compared utility scores and quality adjusted life year (QALY) of 2nd and 3rd generation drug eluting stents (DES).MethodsAn observational cohort study was conducted to evaluate QoL and QALY using EQ-5D-5L questionnaire. Patients undergoing PPCI between July-Dec 2019 were evaluated after completion of one year of procedure.ResultsTotal 334 patients were evaluated, study population consisted of a greater number of males (87.13%) than females. Mean utility value was more in 3rd G Biomatrix stents; 0.829 ± 0.11 than 2nd G Xience stents; 0.794 ± 0.11 (p < 0.05). Visual analogue scale (VAS) value was also high in 3rd G DES (81.84 ± 8.29) as compared to 2nd G DES (77.81 ± 9.01); p< 0.05. A significant association was found between utility scores/VAS and age, DM, HTN, Current smoking, family history and CAD diagnosis. There was a gain of 0.035 QALY with the use of Biomatrix DES.ConclusionHealth related quality of life (HRQOL) is a leading support in the decision making of therapeutic interventions. Our study has found that Biodegradable polymer (BP) Biomatrix DES are superior to the Durable polymer (DP) Xience DES having better QoL and QALY.

Challenges of antithrombotic therapy in the management of cardiovascular disease in patients with inherited bleeding disorders: A single-centre experience.

Cardiovascular events in patients with inherited bleeding disorders are challenging to manage. The risk of bleeding secondary to antithrombotic treatment must be balanced against the risk of thrombosis secondary to haemostatic therapy. Patients with inherited bleeding disorders with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) or atrial fibrillation (AF) from a single centre (2010-2018) are included. A total of 11 patients undergoing CABG (n=3), PCI (n=5) or with AF (n=3) and a diagnosis of haemophilia A (n=8), haemophilia B (n=1), factor XI deficiency (n=1) and von Willebrand disease (n=1) managed by a multidisciplinary team are reported. In patients undergoing CABG, factor levels were normalized for 7-10days with trough levels of 70-80% with severe patients continuing high-dose factor prophylaxis (trough 20-30%) three weeks post-operatively with daily aspirin. In a patient with mild haemophilia A and an inhibitor, recombinant factor VIIa dosing was monitored with thromboelastometry. For PCI, a 3rd-generation drug-eluting stent with one month of dual antiplatelet therapy in addition to high-dose prophylaxis as needed was preferred. Patients with AF and severe haemophilia did not receive antithrombotic treatment, and a thrombin generation assay was used to guide heparin dosing in mild haemophilia. Our experience demonstrates the importance of interdisciplinary communication to identify strategies that decrease the risk of bleeding and thrombosis. The use of extended, increased intensity prophylaxis facilitated antiplatelet therapy. Global assays may help balance the intensity of haemostatic and antithrombotic treatment.

Differences in lesion characteristics and patient background associated with the medium-term clinical outcomes of bare-metal and first-, second- and third-generation drug-eluting stents

We investigated the lesion characteristics and patient background factors associated with the medium-term incidence of major adverse cardiac events (MACEs) for bare-metal stents (BMS) and 1st-, 2nd- and 3rd-generation drug-eluting stents (DES) using the PCI-Registry (FU-Registry). Between January 2003 and March 2016, 2967 cases/3508 lesions for which percutaneous coronary intervention was performed at Fukuoka University Hospital and related facilities were enrolled. Patients were divided into BMS and 1st-, 2nd- and 3rd-generation drug-eluting stent (DES) groups. The incidence of MACEs in the BMS group (26.2%) was significantly higher than those in the 1st, 2nd and 3rd DES groups (18.0%, 12.5%, and 11.0%, respectively). The incidence of MACEs in the BMS group was strongly associated with insulin use, hemodialysis, low high-density lipoprotein cholesterol, stent minimum lesion diameter, stent length, severe calcification and a small vessel diameter of less than 2.5mm. Some of these factors showed no association with MACEs among the drug-elution groups, and only hemodialysis, arteriosclerosis obliterans and severe calcification showed a strong correlation in the 2nd DES group. In the 3rd DES group, none of the factors considered were associated with MACEs. In conclusion, in stent implantation, the number of factors associated with MACEs has gradually decreased as the stent generation increased.

Design and Rational for a Prospective Randomized Study of Safety Outcomes Treated with Edoxaban in Patients with Stable Coronary Artery Disease and Atrial Fibrillation (PRAEDO AF Study)

Background: In non-valvular atrial fibrillation (NVAF) patients with coronary artery disease (CAD), using antiplatelet drugs in addition to anticoagulants for stroke prevention may further increase the bleeding risk. Several guidelines have recommended an oral anticoagulant (OAC) monotherapy in patients with stable CAD one year after percutaneous coronary intervention (PCI). When considering early neointima healing of current 3rd generation drug-eluting stents (DESs), the duration of the de-escalation from a single antiplatelet drug plus an OAC to an OAC alone therapy can be shortened by less than one year after PCI. The data on the clinical acceptability of short durations for de-escalation to an edoxaban monotherapy in those patients are still lacking. Methods: A multicenter, prospective, randomized, open-label, parallel group study has been established to investigate the safety outcomes of an edoxaban monotherapy in NVAF patients with stable CAD for over at least 6 months after PCI (PRAEDO AF study). From 7 institutions in Japan, approximately 200 participants will be randomized to receive either edoxaban monotherapy or edoxaban plus clopidogrel. All patients will be followed-up at least 1 year after enrollment. The primary endpoint is the percentage of serious bleeding complications and clinically significant bleeding combined events according to the ISTH criteria for edoxaban alone and edoxaban plus an antiplatelet agent. Conclusions: This will be the first study to assess the safety of edoxaban monotherapy in NVAF patients with stable CAD over 6 months after the 3rd generation DES and over 12 months after 1st or 2nd DES implantations.

IRREGULAR PROTRUSION IS CORRELATED WITH DEVELOPMENT OF NEOATHEROSCLEROSIS AFTER 2NDAND 3RDGENERATION DRUG-ELUTING STENT IMPLANTATION: OPTICAL COHERENCE TOMOGRAPHIC STUDY

We examined the correlation between irregular protrusion area and the 8-month development of the neoatherosclerosis after new generation drug-eluting stent (DES) implantation. We enrolled 117 consecutive patients (134 lesions) with 2nd and 3rd generation DES who received pre and post-stenting

P2689Irregular protrusion area is associated with incidence of cardiac events after implantation of new generation drug-eluting stents - optical coherence tomography study

Abstract Background Several studies using optical coherence tomography (OCT) have shown that the prevalence of irregular protrusion was associated with the incidence of adverse cardiac events. However, the correlation between cardiac events and protrusion area is not well investigated. Method One hundred twenty-nine consecutive patients with 138 clesions with 2nd and 3rd generation drug-eluting stents (DES) which had pre-stenting and post-stenting OCT imaging between April 2016 and April 2018 were evaluated. We compared baseline characteristics, procedure findings and OCT findings including minimum stent area, protrusion type and maximum protrusion area between target lesion revascularization (TLR) group and non-TLR group. Results TLR occurred in 12 (9.3%) in 129 patients. The baseline characteristics and procedure findings were similar between TLR group and non-TLR group. Univariate analysis revealed that maximum irregular protrusion area was significantly larger (0.51 [0.00–0.63] vs 0.00 [0.00–0.27], p=0.036) in TLR group than non-TLR group. Receiver operating characteristic curve analysis revealed that the suitable cutoff value of maximum irregular protrusion area were 0.43mm2 for TLR. In multivariate analysis using the parameters with p value&lt;0.10 determined by univariate analysis, maximum irregular protrusion (≥0.43mm2) and minimum stent area (MSA) were independently correlated with TLR (table). Odd's ratio (95% CI) P value Major irregular protrusion (≥0.43mm2) 17.3 (3.63–82.6) &lt;0.001 MSA 2.13 (1.15–3.93) 0.002 Conclusion Major irregular protrusion (&gt;0.43mm2) in post-stenting OCT findings may be a powerful predictor of TLR in the patients with new generation DES.

P686Cancer is not associated with increased cardiac and bleeding events after 2nd- and 3rd-generation drug-eluting stents implantation

Abstract Background Previous studies demonstrated the impact of concomitant cancer on the increased risk of adverse cardiac and bleeding events after percutaneous coronary intervention (PCI). However, the impact in this 2nd- and 3rd-generation drug-eluting stent (DES) era remains to be elucidated. Purpose To clarify the impact of cancer on clinical outcomes in patients after 2nd- or 3rd -generation DES implantation. Methods A total of 932 patients who underwent PCI with 2nd- or 3rd -generation DES were included. Patients who were diagnosed with cancer after PCI were excluded from the present cohort. The incidence of major adverse cardiac events (MACE) including cardiac death, myocardial infarction and target or non-target vessel revascularization, and bleeding events was compared between the patients with cancer or the history of treatment for cancer (cancer group, n=140) and the patients without cancer (no cancer group, n=792). Bleeding events were evaluated according to the Thrombolysis in Myocardial Infarction definition. Further comparisons were performed between the 2 groups (cancer group, n=126; no cancer group, n=252) after the adjustment of baseline clinical characteristics using 1:2 propensity score-matching analysis. Results The incidence of MACE at median 577 [340–1043] days after the PCI was comparable between the 2 groups in both unadjusted (15.0% vs. 15.0%, p=0.984) (Panel A) and adjusted cohorts (14.3 vs. 13.1%, p=0.796), although the incidence of all cause death in the cancer group was significantly greater than the no cancer group (15.1 vs. 9.5%, p=0.007, in the adjusted cohort). The increased risk of MACE was not observed in any types of cancer or treatment (Panel B). The incidence of bleeding events was also comparable between the 2 groups (4.0 vs. 2.0%, p=0.297, in the adjusted cohort). Conclusion The increased incidence of MACE and bleeding events in patients with cancer was not demonstrated after the 2nd- or 3rd-generation DES implantation. Further studies are required to clarify the safety and efficacy of PCI in patients with cancer.

Incidence, retrieval methods, and outcomes of intravascular ultrasound catheter stuck within an implanted stent: Systematic literature review

BackgroundThere have been no reviews regarding intravascular ultrasound (IVUS) catheter entrapment during percutaneous coronary intervention (PCI). This study investigated the incidence, retrieval methods, and outcomes of IVUS catheter stuck within implanted stents. MethodsBetween January 2015 and July 2018, a total of 794 consecutive patients underwent PCI for coronary artery disease. Among them, 705 patients underwent stent implantation using IVUS. The patients with IVUS catheter entrapment in an implanted stent were investigated. ResultsTen patients (1.4%) suffered from an IVUS catheter stuck in an implanted stent. Among them, 7 patients had very tortuous lesions while 5 patients had severely calcified lesions. Seven patients (70%) underwent placement of the 3rd generation drug-eluting stent (DES), and the stent diameters were ≤2.5mm among 8 patients (80%). Retrieval methods were the buddy wire technique, the double guide catheter technique, covering the exit port of IVUS catheter with a balloon catheter, and covering with GuideLiner® catheter (Vascular Solutions Inc., Minneapolis, MN, USA). On multivariable analysis, the predictors of IVUS catheter entrapment were tortuous lesion [odds ratio (OR), 8.21; 95% confidence interval (CI), 2.19–30.7; p=0.002], 3rd generation DES (OR, 5.31; 95% CI, 1.08–26.1; p=0.021), and stent diameter ≤2.5mm (OR, 6.31; 95% CI, 1.29–30.8; p=0.010). Furthermore, we identified 6 cases of IVUS catheter entrapment through a systematic literature review. ConclusionsThe IVUS catheter was almost stuck in tortuous lesions and the 3rd generation DES with a small diameter. We could successfully retrieve it in all cases using various retrieval techniques.

Successful retrieval of a dislodged Zotarolimus-eluting coronary stent in the ascending aorta

Coronary stent dislodgment or embolization is rare in the era of 3rd generation Drug Eluting Stents but is a challenging complication in interventional cardiology. Intracoronary embolization of the dislodged stent is associated with a high risk of coronary occlusion, due to thrombus formation and subsequent myocardial infarction. Furthermore, systemic embolization may cause severe cerebrovascular events. Nonsurgical retrieval options for this complication are being used with good results in most cases, but bailout cardiac surgery may be indicated if percutaneous retrieval attempts fail. We present here a case of dislodgement of a zotarolimus-eluting coronary stent during percutaneous coronary intervention and successful retrieval from the ascending aorta using a Amplatz goose neck microsnare.

Abstract 13165: Comparison of Strut Coverage at 2 Weeks After Second and Third Generation DES Implantation in Patients With STEMI

Background: Third generation drug-eluting stent (DES) is characterized by thinner strut and abluminal coating with bioabsorbable polymer, and in vitro studies has demonstrated earlier endothelialization than previous generation of DES. However, whether this holds true also in human coronary is unknown. Objective: Using optical coherence tomography (OCT), we compared strut coverage between 2 nd generation DES (XIENCE) and 3 rd generation DES (SYNERGY) at 2 weeks after stent implantation for ST-segment elevation myocardial infarction (STEMI). Methods: Twenty-four patients with STEMI who were underwent primary percutaneous coronary intervention with XIENCE (n=14) or SYNERGY (n=10) were enrolled in this study. Angiographic and OCT were conducted at just after and 2 weeks after stent implantation. Two independent analysts who were blind to the clinical and stent information analyzed all images. Results: A total of 4362 struts were analyzed in this OCT study. There was no difference between XIENCE and SYNERGY in percentage of malapposed struts (5.38% vs. 4.78%, p=0.81), percentage of residual thrombus (57.1% vs. 40.0%, p=0.43) and maximal thrombus area (0.20mm 2 vs. 0.15mm 2 , p=0.61). Percentage of strut coverage was significantly higher in SYNERGY than XIENCE (42.9% vs. 22.8%, p=0.0007). Conclusion: At 2 weeks after stent implantation for STEMI lesions, increased strut coverage was observed in SYNERGY than XIENCE, suggesting earlier vascular healing after SYNERGY implantation.

COMPARISON OF VASCULAR INFLAMMATION AND ENDOTHELIAL FUNCTION IN RESPONSE TO A NEW NOBORI AND CYPHER DRUG ELUTING STENTS IN PIG CORONARY ARTERIES

Background: Nobori is a 3rd generation Drug Eluting Stent (DES), designed to include drug eluting biodegradable polymer coated only abluminal side of the stent. The new features may differently impact inflammation and endothelium functions as compared to the currently marketed DES. At the present time, preclinical data on direct comparison of these DESs are not available. In this study, we examined vascular inflammation and endothelial function of the segments adjacent to the stent and histology of stented areas of Nobori and Cypher DES.