2nd Generation Drug-eluting Stent Implantation Research Articles

Long-term outcomes in high-bleeding risk patients undergoing PCI for acute coronary syndromes: results from a large single-center pci registry

Abstract Introduction Current clinical guidelines recommend prolonged dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). However, an extended DAPT duration in high-bleeding risk (HBR) patients amplifies the risk of post procedural complications. Hence, clinicians often face the dilemma of prolonging DAPT duration to prevent recurrent ischaemic events at the expense of increasing the incidence of bleeding in high-risk patients. The actual incidence of ischaemic and bleeding events in this particular population is not well elucidated. Purpose To evaluate one-year ischemic and bleeding outcomes following PCI for ACS in a real-world HBR population as defined by the Academic Research Consortium (ARC) consensus document. Methods We included all patients who presented with ACS to a high-volume single PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent implantation. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the recent ARC-HBR consensus. The outcomes of interest were major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), and target lesion revascularization (TLR), and major bleeding events, including both peri-procedural and post-discharge bleeding. All outcomes were assessed at 1-year follow-up. The Kaplan-Meier method was used for time-to-event analyses. Results Out of 6,097 ACS patients included in this analysis, 2,717 (44.6%) fulfilled the ARC-HBR definition. Compared to non-HBR group, HBR patients were more frequently female, older, more likely to have cardiovascular risk factors (e.g., diabetes, hypertension, and hyperlipidemia) and complex coronary artery disease (e.g., multi-vessel disease, bifurcation lesions, and calcification). The 1-year incidence of MACE was significantly higher in HBR patients (16.3% vs. 8.1%, HR 2.16, 95% CI [1.81–2.59], p<0.001) (Figure 1A). This finding was driven by higher rates of all-cause death and MI (Figure 1B). The 1-year incidence of major bleeding was also significantly higher in HBR patients compared to non-HBR (11.1% vs. 3.1%, HR: 3.92, 95% CI 3.10–4.95; p<0.001). Conclusions HBR patients undergoing PCI for ACS are not only subject to bleeding complications but are also at an increased risk for ischemic events and all-cause mortality. Figure 1 Funding Acknowledgement Type of funding source: None

Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation.

Determining the optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important clinical issue. We evaluated the effects of ischemia (by DAPT score) and bleeding (by PRECISE-DAPT score), as well as the impact of DAPT duration, on clinical outcomes. From pooled analysis of four randomized clinical trials, 5131 patients undergoing second-generation DES implantation were randomized to short-duration (n=2575; ≤ 6months) or standard-duration (n = 2556; ≥ 12months) DAPT groups. This population was further divided into four subgroups according to PRECISE-DAPT (high bleeding risk ≥ 25) and DAPT (high ischemic risk ≥ 2) scores. Net clinical outcomes (1.3% vs. 1.3%; p = 0.89) and ischemic events (5.0% vs. 4.5%; p = 0.44) did not differ between the two duration groups, although bleeding events were more frequent in patients with standard-duration DAPT (0.4% vs. 0.9%; p = 0.04). Standard-duration DAPT was associated with fewer ischemic events (6.9% vs. 4.0%; p = 0.02) and no increase in bleeding events only among patients at low bleeding risk and high ischemic risk. The other groups show no differences in net clinical outcomes, ischemic events, or bleeding events according to DAPT duration. Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12months after second-generation DES implantation. However, standard-duration DAPT reduced ischemic events without increasing bleeding events among patients at low bleeding and high ischemic risk. When determining DAPT duration, considering both ischemic and bleeding risk can help optimize patient benefits. EXCELLENT (NCT00698607), RESET (NCT01145079), IVUS-XPL (NCT01308281), OPTIMA-C (NCT03056118).

P974Efficacy of plaque debulking for bifurcated or ostial lesion by directional coronary atherectomy before 2nd generation drug eluting stent (PERFECT2)

Abstract Objectives We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) before 2nd generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. Background Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting used. Methods Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-2nd generation DES plaque debulking with a novel DCA was conducted. All patients were scheduled to perform a follow up (9–12 months) angiography (coronary angiography or coronary computed tomography). The primary end point was the target vessel failure (TVF) at follow-up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. Results A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all without any major procedure-related event and only 1 case needed complex stenting. TVF rate at 9–12 months follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at ostial of main-branch in 3cases. No death, no coronary artery bypass grafting, and no myocardial infarction were reported in the patients within the first year. Figure1 Conclusion DCA before 2nd generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions. Acknowledgement/Funding None

P2688A novel risk factor of stent restenosis after drug-eluting stent implantation; Involvement of triglyceride deposit cardiomyovasculopathy, coronary atherosclerosis with triglyceride deposition

Abstract Background Triglyceride deposit cardiomyovasculopathy (TGCV) is a novel disease concept characterized by the excessive accumulation of triglyceride in cardiomyocytes and vascular smooth muscle cells, leading to coronary artery disease (CAD), heart failure, and arrhythmia. However, it is rarely known whether TGCV contributes to the increased risk of vascular failure after drug eluting stent (DES) implantation. Purpose The aim of this study was to evaluate vascular failure after 2nd generation DES implantation in patients with TGCV. Methods Among 637 consecutive patients suspected of having CAD who underwent both coronary angiography and iodine-123-β-methyliodophenyl-pentadecanoic acid (BMIPP) scintigraphy between 2010 and 2018, we analyzed the data from 92 patients who met the inclusion criteria (shown in Table and Figure). Ninety-two patients were allocated to the presence (TGCV group, 11 patients) or absence (control group, 81 patients) of TGCV. All of 92 patients were implanted 2nd generation DES and underwent planned follow up coronary angiography. Control patients were diagnosed of diabetes mellitus. Binary restenosis (ISR), defined as angiographic luminal diameter ≥50% by quantitative coronary angiography, target lesion revascularization (TLR), In-stent late loss and restenosis morphology were assessed in 23 stents of TGCV group and 120 stents of control group. Results There were no significant differences in baseline characteristics between the two groups except for the prevalence of hypertension. In-stent late loss was greater in TGCV than in control (0.45 (−0.04 to 3.33) vs. 0.15 (−0.18 to 2.75), p=0.ehz748.10067), resulting in greater incidence of ISR and TLR in TGCV than in control (34.8% vs. 10.0%, p=0.0017; 21.7% vs. 6.7%, p=0.021, respectively). On multivariable logistic regression analysis, TGCV was found to be a significant and independent predictor for ISR after 2nd generation DES implantation. Regarding restenosis morphology, diffuse and occlusive pattern of ISR, were more frequently observed in TGCV than control (87.5% and 33.3%, Fisher's exact test p=0.028). Table 1.The 4th edition diagnostic criteria for TGCV Items Clinical findings 2 points I) BMIPP scintigraphy Wash-Out Rare <10% II) Diffuse narrowng coronary arteries 1 point III) Jordans anomaly in peripheral blood smear IV) Diabetes Decision 4 points or more → Definite TGCV Figure 1 Conclusion Patients with TGCV showed the greater incidence of vascular failure even after 2nd generation DES implantation, contributing to the novel risk factor for coronary intervention even in the 2nd DES era.

Association of Subclinical Intrastent Thrombus Detected 9 Months After Implantation of 2nd-Generation Drug-Eluting Stent With Future Major Adverse Cardiac Events ― A Coronary Angioscopic Study ―

Detection of yellow plaques (YP) by coronary angioscopy (CAS) 1 year after 1st-generation drug-eluting stent (DES) implantation has been related to future coronary events. However, the association between CAS findings and clinical outcomes following 2nd-generation DES implantation has not been investigated. Methods and Results: This study included a total of 248 2nd-generation DES in 179 patients, who were examined by CAS 9±2 months after implantation. Angioscopic evaluation included dominant neointimal coverage (NIC) grade, heterogeneity of NIC, presences of YP and intrastent thrombus. The outcome measure was major adverse cardiac events (MACE) defined as a composite of cardiac death, acute myocardial infarction and any coronary revascularization. The association between the CAS findings and MACE was evaluated using the Kaplan-Meier method. A Cox proportional hazards model was used to assess the predictors of MACE. The mean follow-up duration was 1,367±843 days. Dominant NIC grade (P=0.98), heterogeneity of NIC (P=0.20) and YP (P=0.53) were not associated with the incidence of MACE. However, intrastent thrombus was significantly associated with MACE (P=0.033). Intrastent thrombus (adjusted hazard ratio: 2.22; 95% confidence interval [CI]: 1.12-4.39), acute coronary syndrome (2.83; 95% CI: 1.42-5.67) and B2/C lesion (2.13; CI: 1.12-4.05) were independent predictors of MACE. Subclinical intrastent thrombus observed by CAS at 9 months after 2nd-generation DES implantation was independently associated with poor clinical outcome.

Effect of diabetes mellitus on long-term outcomes after repeat drug-eluting stent implantation for in-stent restenosis

BackgroundWhether diabetes mellitus (DM) is a predictor of long-term adverse clinical outcomes after repeat drug eluting stent (DES) implantation for DES in-stent restenosis (ISR) remains controversial. We sought to evaluate the effect of DM on the long-term clinical outcomes in patients undergoing repeat DES implantation for DES-ISR lesions.MethodsIn the present study, 254 patients with DES-ISR were divided into DM or non-DM groups according to the presence or absence of DM. All patients received repeat 2nd generation DES implantation for DES-ISR. The occurrences of major adverse cardiac events (MACEs) over a 2-year follow-up period were compared between the two groups. MACEs were defined as cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). MACE free survival was investigated with Kaplan-Meier curve analysis. Cox regression analysis was used to identify factors associated with MACEs.ResultsBaseline clinical characteristics were similar between groups, except for the prevalence of early restenosis (lower) in the DM group. Differences in angiographic and procedural characteristics were not significant between groups. The rates of 2-year MACE (30.9 vs. 26.0%; P = 0.453) and TLR (24.7 vs. 19.7%; P = 0.411) were similar between groups. MACE-free survival and TLR-free survival were also similar between groups (P = 0.441 and P = 0.807). Subgroup analysis suggested a significant difference in the MACE (39.0 vs.15.3%, P < 0.001) and TLR occurrence (30.5 vs.8.2%, P < 0.001) and TLR-free survival (lower in early subgroup, P < 0.001) between early and late occurrence of ISR in the non-DM group of patients but not in the DM group. After adjustment for all significant clinical variables, Cox regression analysis indicated that DM was not associated with MACEs (hazard ratio [HR] 1.531, 95% confidence interval [CI] 0.882-2.658, P =0.130). Non-focal type ISR and early ISR were predictors of MACEs (HR 2.671, 95% CI 1.468-4.858,P = 0.001; HR 4.703, 95% CI 2.725-8.117, P < 0.001, respectively).ConclusionsPatients with DM have similar 2-year clinical outcomes to patients without DM when repeat 2nd generation DES was used for treatment of DES-ISR. DM is not the predictor of long-term prognosis in patients undergoing repeat 2nd generation DES for DES-ISR.

Frequency and predictors of bleeding events after 2nd generation drug-eluting stent implantation differ depending on time after implantation

BackgroundAntiplatelet therapy is required after drug-eluting stent (DES) implantation, but bleeding events occur unexpectedly. We aimed to assess whether bleeding event predictors after 2nd generation DES (2nd DES) implantation differed by time after implantation. MethodsWe studied 1912 consecutive patients who underwent successful 2nd DES implantation (70±10 years, 72% male). Bleeding events were recorded as early (≤1 year) and late (>1 year). Major bleeding events were defined as a composite of type 5, 3, and 2 bleeding in the Bleeding Academic Research Consortium criteria. Predictors were assessed using a Cox proportional hazard model. ResultsBleeding event rates were 3.3%, 5.1%, and 6.7% at 1, 2, and 3 years, respectively, with the highest 1-year rate in year 1 (p<0.001). Cause and severity of bleeding events were similar between early and late bleeding events. Prior history of gastrointestinal bleeding, non-steroidal anti-inflammatory drug use, and triple antithrombotic therapy [adjusted risk ratio (RR): 3.68, 3.21, 4.57, respectively; p<0.01] were independent predictors of early bleeding events. Age >80 years and severe renal dysfunction (adjusted RR: 2.27, 2.02, respectively; p<0.01) were independent predictors of late bleeding events. Survival rate was significantly lower in patients with bleeding events compared with patients without bleeding events (82.4% vs 90.1%; p<0.001). ConclusionFrequency and predictors of bleeding events after 2nd DES implantation differ by time after implantation. Treatment strategies corresponding to individual patients are required.

TCTAP A-025 Efficacy of Long 2nd Generation Drug-Eluting Stent Implantation from Healthy to Healthy Segment Under Intravascular Ultrasound Guidance in Acute Myocardial Infarction

TCTAP A-025 Efficacy of Long 2nd Generation Drug-Eluting Stent Implantation from Healthy to Healthy Segment Under Intravascular Ultrasound Guidance in Acute Myocardial Infarction

TCT-342 Impact of Daily Glucose Fluctuation on Vessel Healing after 2nd Generation Drug-eluting Stent Implantation Assessed by Continuous Glucose Monitoring and Optical Coherence Tomography

Several investigations revealed that daily glucose fluctuation has adverse effects on endothelial cells. Moreover, we reported that it may have an independent contributing factor on coronary plaque vulnerability. Little is known, however, about its impact on neointimal growth after stenting in

Optical coherence tomography analysis of the stent strut and prediction of resolved strut malapposition at 3 months after 2nd-generation drug-eluting stent implantation.

Our objective was to clarify whether thrombogenic problems with stent struts are resolved at 3months after 2nd-generation drug-eluting stent implantation. Twenty-one patients with stable angina pectoris having 28 (22 zotarolimus-eluting, 6 everolimus-eluting) stents with optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were evaluated. Stent strut coverage and malapposition were evaluated by OCT immediately after PCI and at 3-month follow-up. Acute strut malapposition was observed in 26 out of 28 analyzed stents (92.9%). At 3-month follow-up, 7 (26.9%) of those 26 stents with strut malapposition were completely resolved, and the mean percentages of uncovered struts and malapposed struts were 8.3 and 2.0% when analyzed by each individual stent. When analyzing a total of 30,060 struts, 807 struts (2.7%) demonstrated acute strut malapposition. Among these, 219 struts (27.1%) demonstrated persistent strut malapposition. On the basis of receiver-operating characteristic curve analysis, a strut-to-vessel (S-V) distance≤160µm on post-stenting OCT images was the corresponding cutoff point for resolved malapposed struts (sensitivity 78.1%, specificity 62.8%, area under the curve 0.758). The S-V distance of persistent malapposed struts on post-stenting OCT images was longer than that of resolved malapposed struts (235±112 vs. 176±93µm, p<0.01). At 3months after PCI, the prevalence rates of uncovered and malapposed struts were relatively low in 2nd-generation drug-eluting stent. Our results suggest that OCT-guide PCI with an S-V distance≤160µm may be recommended especially in patients with planed short-term DAPT.

Impact of Insulin Resistance on Neointimal Tissue Proliferation after 2nd-Generation Drug-Eluting Stent Implantation.

Percutaneous coronary intervention is established as an effective treatment for patients with ischemic heart disease; in particular, drug-eluting stent implantation is known to suppress in-stent restenosis. Diabetes mellitus is an independent risk factor for restenosis, so reducing insulin resistance is being studied as a new treatment approach. In this prospective study, we sought to clarify the factors associated with in-stent restenosis after percutaneous coronary intervention, and we evaluated the homeostasis model assessment of insulin resistance (HOMA-IR) index as a predictor of restenosis. We enrolled 136 consecutive patients who underwent elective percutaneous coronary intervention at our hospital from February 2010 through April 2013. All were implanted with a 2nd-generation drug-eluting stent. We distributed the patients in accordance with their HOMA-IR index values into insulin-resistant Group P (HOMA-IR, ≥2.5; n=77) and noninsulin-resistant Group N (HOMA-IR, <2.5; n=59). Before and immediately after stenting, we measured reference diameter, minimal lumen diameter, and percentage of stenosis, and after 8 months we measured the last 2 factors and late lumen loss, all by means of quantitative coronary angiography. After 8 months, the mean minimal lumen diameter was smaller in Group P than that in Group N (1.85 ± 1.02 vs 2.37 ± 0.66 mm; P=0.037), and the mean late lumen loss was larger (0.4 ± 0.48 vs 0.16 ± 0.21 mm; P=0.025). These results suggest that insulin resistance affects neointimal tissue proliferation after 2nd-generation drug-eluting stent implantation.

COMPARISON OF PROTECTIVE EFFECT OF ANGIOTENSIN II RECEPTOR BLOCKER AND CALCIUM CHANNEL BLOCKER FOR ENDOTHELIAL VASOMOTOR FUNCTION AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION

Although previous studies demonstrated protective effect of angiotensin II receptor blockers (ARB) for endothelial function after drug-eluting stent (DES) implantation, little is known whether ARB are effective after 2nd generation DES implantation. A total of 40 hypertensive patients with stable