2nd Generation Drug-eluting Stent Research Articles

Development and Validation of an Ischemic and Bleeding Risk Evaluation Tool in East Asian Patients Receiving Percutaneous Coronary Intervention.

The ischemic/bleeding risk of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is still uncertain. We sought to develop a tool to predict ischemic and bleeding events in East Asians receiving 2nd generation drug-eluting stents (DESs) PCI. A pooled cohort of 13,172 East Asian patients receiving PCI with 2nd generation DES (the Grand DES cohort) was analyzed to develop a scoring system. A net score was calculated by subtracting the bleeding score from the ischemic score. External validation was performed in the HOST-ASSURE and NIPPON trials. Among the total population, ischemic and bleeding events occurred in 195 patients (1.5%) and 166 patients (1.3%), respectively. The score to predict ischemic events included previous myocardial infarction (MI) or PCI, presentation as acute MI, anemia, stent diameter < 3 mm, and total stent length of ≥30 mm, while that for bleeding events included older age, low creatinine clearance, and anemia. C-statistics of the ischemic and bleeding model was 0.708 and 0.665, respectively. Patients with a net score of ≥1 had a higher ischemic risk compared with bleeding risk, and patients with a net score of ≤-1 had a higher bleeding risk compared with ischemic risk. The validation cohort showed a C-statistic of 0.647 for ischemic events and 0.633 for bleeding events. We developed a tool to predict ischemic and bleeding events in East Asian patients received PCI with 2nd generation DES. This system can be used to assess clinical event risks, and to determine the adequate duration of DAPT in East Asians.

TEMPORAL TRENDS IN STENT COVERAGE OF BIORESORBABLE POLYMER AND DURABLE POLYMER DRUG-ELUTING STENTS: A META-ANALYSIS OF STRUT-LEVEL OPTICAL COHERENCE TOMOGRAPHY DATA

Delayed strut coverage is an important risk factor for stent thrombosis. The endothelialization rate of bioresorbable polymer drug-eluting stents (BP DES) may be better compared to durable polymer 2nd generation drug eluting stents (DP DES). We pooled data from all optical coherence tomography (OCT

Different Neoatherosclerosis Patterns in Drug-Eluting- and Bare-Metal Stent Restenosis - Optical Coherence Tomography Study.

There are few reports about the differences between drug-eluting stents (DES) and bare metal stents (BMS) in neoatherosclerosis associated with in-stent restenosis (ISR), so we compared the frequency and characteristics of neoatherosclerosis with ISR evaluated by optical coherence tomography (OCT) in the present study. Methods and Results: Between March 2009 and November 2016, 98 consecutive patients with ISR who underwent diagnostic OCT were enrolled: 34 patients had a BMS, 34 had a 1st-generation DES, and 30 had a 2nd-generation DES. Neoatherosclerosis was defined as a lipid neointima (including a thin-cap fibroatheroma [TCFA] neointima, defined as a fibroatheroma with a fibrous cap <65 µm) or calcified neointima. As a result, lipid neointima, TCFA neointima and calcified neointima were detected in 39.8%, 14.3%, and 5.1%, respectively, of all patients. The frequency of neoatherosclerosis was significantly greater with DES than BMS (48.4% vs. 23.5%, P=0.018). The minimum fibrous cap thickness was significantly thicker with DES than BMS (110.3±41.1 µm vs. 62.5±17.1 µm, P<0.001). In addition, longitudinal extension of neoatherosclerosis in the stented segment was less with DES than BMS (20.2±15.1% vs. 71.8±27.1%, respectively, P=0.001). OCT imaging demonstrated that neoatherosclerosis with ISR was more frequent with DES than BMS and its pattern exhibited a more focal and thick fibrous cap as compared with BMS.

TCT-190 Comparison of Mid-term Clinical Outcomes between Optimal Frequency Domain Imaging-guided and Intravascular Ultrasound-guided Percutaneous Coronary Intervention with 2nd Generation Drug Eluting Stents in Stable Angina Pectoris

TCT-190 Comparison of Mid-term Clinical Outcomes between Optimal Frequency Domain Imaging-guided and Intravascular Ultrasound-guided Percutaneous Coronary Intervention with 2nd Generation Drug Eluting Stents in Stable Angina Pectoris

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. 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.

P4566Predictors for angiographic edge restenosis of 2nd generation drug-eluting stents: Integrated angiographic analyses from the post-marketing surveillance studies of everolimus-eluting stents in Japan

P4566Predictors for angiographic edge restenosis of 2nd generation drug-eluting stents: Integrated angiographic analyses from the post-marketing surveillance studies of everolimus-eluting stents in Japan

Obesity paradox in the era of percutaneous coronary intervention with 2nd-generation drug-eluting stents: an analysis of a multicenter PCI registry.

Being overweight has been identified as independent risk factors for coronary artery disease. However, overweight patients have been reported frequently to have better mortality outcomes, and there is little data showing they are at a disadvantage regarding secondary prevention of cardiovascular events. We analyzed the influence of being overweight (defined as body mass index > 25kg/m2) on adverse events in patients who underwent everolimus-eluting stent (EES) implantation using a multicenter registry with a maximum follow-up of 3years. Propensity score matching was done for adjusting baseline characteristics. We defined primary end points as major adverse cardiac and cerebrovascular events (MACCE: a composite of mortality from all causes, nonfatal myocardial infarction, and nonfatal stroke) and "MACCE excluding non-cardiac mortality". Other adverse events were analyzed as key secondary end points. Out of 1918 patients, 450 pairs were obtained through propensity score matching. Overweight patients were superior to non-overweight patients regarding MACCE (event rates: 8.2 vs. 13.8% in overweight vs. non-overweight, respectively; log-rank p = 0.009) and "MACCE excluding non-cardiac mortality" (5.9 vs. 10.1%, p = 0.03). On secondary end points, not only did overweight patients have significantly fewer major bleeding events (2.2 vs. 4.8%, p = 0.02), but they also had smaller adverse event rates for almost all such events; the differences were not statistically significant. Overweight patients had better outcomes for MACCE, even on excluding non-cardiac mortalities. No result was supportive of an evident advantage to non-overweight EES-implanted patients in terms of secondary prevention of cardiovascular events.

TCTAP A-003 Prognosis and Predictors of Lesion Failure After Left Main Bifurcation Intervention: Pooled Analysis of Korean Multicenter Drug-eluting Stent Cohort

There is a paucity of data regarding optimal percutaneous coronary intervention (PCI) strategy for left main (LM) bifurcation lesion and its prognostic predictors in 2nd generation drug-eluting stent (DES) era. Patient-level pooled analyses of five nationwide DES registries were performed with

Comparison of drug eluting stents (DESs) and bare metal stents (BMSs) with STEMI: who received BMS in the era of 2nd generation DES?

BackgroundThe aim of this study was to analyze the indications for using bare metal stents (BMSs) in hospitalizations with ST segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). MethodsThe study cohorts were identified from the National Inpatient Sample database from 2010–2014 using appropriate, International Classification of Diseases, 9th Revision, Clinical Modification, diagnostic and procedural codes. ResultsA total of 123,487 hospitalizations were identified for this study. Drug eluting stent (DES) use demonstrated lower in-hospital mortality (5.8% vs. 3.3%, P = < 0.01) and other in-hospital outcomes, thus resulting in lower hospitalization stay. Higher age, black race, greater comorbidity burden, inferior wall myocardial infarction, and the use of mechanical circulatory devices were all associated with BMS use. ConclusionDES was the preferred standard of care in the era of 2nd generation DES; however, BMSs were used in hospitalizations with high-risk procedures and multiple risk factors.

Two-Year Outcomes and Predictors of Target Lesion Revascularization for Non-Left Main Coronary Bifurcation Lesions Following Two-Stent Strategy With 2nd-Generation Drug-Eluting Stents.

Data on outcomes of non-left main coronary bifurcation lesions treated with the 2-stent strategy using 2nd-generation drug-eluting stents (DES) are insufficient.Methods and Results:The 2-year outcomes and predictors of target lesion revascularization (TLR) in 356 patients with 364 non-left main coronary bifurcation lesions treated with the 2-stent strategy using 2nd-generation DES were retrospectively evaluated. The primary outcome measure was defined as TLR. The median follow-up duration was 3.6 years (interquartile range, 2.7-4.9 years). A 2-year clinical follow-up was achieved in 99.2%. The 2-year cumulative incidence of TLR was 9.2%. Multiple stents implanted in either the main branch (adjusted odds ratio [OR] 3.01; 95% confidence interval [CI]: 1.37-6.62; P=0.006) or the side branch (adjusted OR 4.55; 95% CI: 1.99-10.4; P<0.001) and the culprit in the left anterior descending artery and its diagonal branch (adjusted OR 0.33; 95% CI: 0.15-0.75: P=0.008) were independent predictors of TLR within 2 years. The 2-year outcomes for the 2-stent strategy using 2nd-generation DES in non-left main coronary bifurcation lesions were acceptable. Coronary bifurcation location in the left anterior descending artery and its diagonal branch is protective against TLR, whereas multiple stents implanted in either the main branch or the side branch was associated with TLR.

Complete Versus Culprit-Only Revascularization for ST-Segment Elevation Myocardial Infarction and Multivessel Disease in the 2nd Generation Drug-Eluting Stent Era: Data from the INTERSTELLAR Registry.

Background and ObjectivesWe aimed to compare outcomes of complete revascularization (CR) versus culprit-only revascularization for ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) in the 2nd generation drug-eluting stent (DES) era.MethodsFrom 2009 to 2014, patients with STEMI and MVD, who underwent primary percutaneous coronary intervention (PCI) using a 2nd generation DES for culprit lesions were enrolled. CR was defined as PCI for a non-infarct-related artery during the index admission. Major adverse cardiovascular event (MACE) was defined as cardiovascular (CV) death, non-fatal myocardial infarction, target lesion revascularization, or heart failure during the follow-up year.ResultsIn total, 705 MVD patients were suitable for the analysis, of whom 286 (41%) underwent culprit-only PCI and 419 (59%) underwent CR during the index admission. The incidence of MACE was 11.5% in the CR group versus 18.5% in the culprit-only group (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.37–0.86; p<0.01; adjusted HR, 0.64; 95% CI, 0.40–0.99; p=0.04). The CR group revealed a significantly lower incidence of CV death (7.2% vs. 12.9%; HR, 0.51; 95% CI, 0.31–0.86; p=0.01 and adjusted HR, 0.57; 95% CI; 0.32–0.97; p=0.03, respectively).ConclusionsCR was associated with better outcomes including reductions in MACE and CV death at 1 year of follow-up compared with culprit-only PCI in the 2nd generation DES era.

Efficacy and safety of dual antiplatelet therapy after coronary stenting in patients with chronic kidney disease

We compared efficacy and safety of short- (3 or 6 months) versus long-term (≥12 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation, according to the presence of chronic kidney disease (CKD). Patient-level pooled analysis was performed with 7242 patients (87.2% with 2nd generation DES) from 5 randomized controlled trials. In both CKD (1273 patients) and non-CKD (5969 patients) population, the rates of patient-oriented composite outcomes at 1-year (POCO, all-cause death, any myocardial infarction [MI], stroke and TIMI major bleeding) were not different between the short- and long-term DAPT (hazard ratio [HR] 1.19, 95% confidence interval [CI] 0.76-1.86, P=.449 in CKD population; HR 1.14, 95% CI 0.83-1.56, P=.434 in non-CKD population). The rates of coronary thrombotic events (any MI and definite/probable stent thrombosis) also did not differ between short- and long-term DAPT in either CKD or non-CKD population. As for bleeding events, long-term DAPT increased the TIMI major bleeding (HR 2.91, 95% CI 1.31-6.48, P=.009) in non-CKD population. The similar trend was observed with long-term DAPT in CKD population. But it did not reach statistical significance (HR 3.15, 95% CI 0.64-15.63, P=.160). The rates of POCO and coronary thrombotic events were significantly higher in patients with CKD compared with those without CKD, which were not affected by short- or long-term DAPT. Higher bleeding incidence by long-term DAPT was only observed in non-CKD patients but not in CKD patients. Further large scale studies are warranted to confirm our findings.

TCT-802 Impact of diabetes mellitus on 1-year outcomes of Absorb Bioresorbable vascular scaffold vs. Everolimus-eluting Metallic stent: a propensity matched Analysis of COMPARE II, RAI and MAASSTAD-ABSORB Prospective Registries

Diabetes mellitus (DM) is associated with increased risk of subsequent events after PCI. To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in this setting, we aimed to compare the 1-year outcomes of Absorb BVS versus 2nd generation drug eluting stents (DES) by pooling diabetic

TCT-621 Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation in acute coronary syndrome: pooled-analysis of 3 randomization studies

To evaluate whether short-term (6 months) dual anti-platelet therapy (DAPT) would be non-inferior to long-term (≥ 12 months) DAPT in terms of clinical efficacy and safety after 2nd generation drug-eluting stents implantation in patients with acute coronary syndrome (ACS). From Pooled analyses

TCT-300 Five-Year Major Clinical Outcomes between First-versus Second-Generation Drug-Eluting Stents in Coronary Chronic Total Occlusions: Propensity Score Matched Analysis

There is limited long-term clinical outcome data comparing 1st- versus 2nd-generation drug-eluting stents (DESs) in patients with coronary chronic total occlusion (CTO) who underwent successful percutaneous coronary intervention (PCI). We investigated the 5-year major clinical outcomes of 1st-

Everolimus eluting stent vs first generation drug-eluting stent in primary angioplasty: A pooled patient-level meta-analysis of randomized trials

BackgroundSeveral concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES) especially among STEMI patients. Newer generation DES has demonstrated to reduce ST at mid-term follow-up.Therefore, the aim of the present study is to perform an individual patient's data meta-analysis of trials comparing 1st generation DES vs. 2nd generation DES (everolimus-eluting stent, EES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. MethodsWe performed a formal search of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2010 to June 2016. We included all completed randomized trials comparing 1st vs. EES for patient presenting with STEMI. ResultsIndividual patients data were obtained from 3 trials, including a total of 1581 patients (686 or 43.4% randomized to 1st generation DES and 895 or 56.4% randomized to EES). At long-term follow-up (1584±588days), EES did not significantly reduce mortality (7.8.% vs 11.7%, HR [95%CI]=0.77 [0.52, 1.13], p=0.18, pheterogeneity=0.93), cardiac mortality (6.2% vs 7.6%, HR [95%CI]=0.90 [0.56, 1.44], p=0.65, pheterogeneity=0.85), and reinfarction (8.1% versus 11.2%, respectively; HR [95%CI]=0.74 [0.51, 1.07], p=0.11, pheterogeneity=0.52). However, EES significantly reduced the occurrence of ST (3.4% versus 6.1% respectively, HR [95%CI]=0.56 [0.32, 0.97], p=0.04, pheterogeneity=0.42) and target vessel revascularization (TVR) (14.2% versus 20.1%; HR [95%CI]=0.63 [0.42, 0.96], p=0.03, pheterogeneity=0.55). Landmark analysis showed more consistent benefits in ST with EES within 1year, whereas benefits in TVR were mostly observed later than 1year. ConclusionsThe present pooled patient-level meta-analysis demonstrates that among STEMI patients undergoing primary PCI, EES as compared to 1st generation DES is associated with a significant reduction in ST and TVR at long-term follow-up.

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.

Bioresorbable Vascular Scaffolds - Are We Facing a Time of Crisis or One of Breakthrough?

Current 2nd-generation drug-eluting stents (DES) have dramatically improved clinical outcomes after percutaneous coronary intervention for coronary artery disease. However, DES implantation has major long-term limitations related to the permanent presence of foreign material in the coronary artery. Bioresorbable vascular scaffolds (BVS) were designed to overcome this limitation of permanent metal-based DES. However, because of immature manufacturing technology, BVS have several drawbacks, such as the thicker strut, poor deliverability, poor radio-opacity, poor radial strength, and cumbersome procedure to meet the principle of PSP (Preparation, Sizing, and Post-dilatation). Initial studies indicated that BVS outcomes were non-inferior to those of current DES and recent follow-up data of trials have revealed an additional critical drawback, higher rate of scaffold thrombosis, on the top of the existing limitations of BVS. Thus attention must be paid to the appropriate BVS-specific implantation protocols (i.e., PSP), as well as adequate intensity and duration of dual antiplatelet therapy. In any case, current BVS need further technical evolution to replace current metallic DES in routine clinical use.

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.

Mechanical abnormalities associated with first- and second-generation drug-eluting stent thrombosis analyzed by optical coherence tomography in the national PESTO French registry

Background and objectivesDES thrombosis may be triggered by different mechanisms that are difficult to identify by angiography alone. This work aimed to investigate and compare the characteristics of stent thrombosis (ST) between 1st- and 2nd-generation drug-eluting stents (DES) among a large cohort of patients explored by optical coherence tomography (OCT). Methods and resultsThe PESTO study was a prospective national registry involving 29 French catheterization facilities. Patients with acute coronary syndromes were prospectively screened for presence of definite ST and analyzed by OCT after culprit lesion deocclusion.The analysis involved 71 subjects including 34 patients with 1st-generation DES (DES1G) and 35 patients with 2nd-generation DES (DES2G). Most patients (80%) presented with very late stent thrombosis. The median time between initial PCI and ST was longer in DES1G than DES2G patients (3.8 [2.6–6.5] years vs. 1.1 [0.04–2.3] years, p<0.0001). OCT identified an underlying morphological abnormality in 96% of the cases. Significant malapposition was the main abnormality observed either in DES1G (26%) or DES2G patients (35%). Ruptured neoatherosclerotic lesions were more frequently observed with DES1G than with DES2G (26% vs. 3%, p=0.008). There was no significant difference in percentage of malapposed struts and uncovered struts between groups. ConclusionsIn this registry, DES thrombosis mainly occurred ≥1year after initial PCI. OCT identified a mechanical abnormality in the vast majority of the cases. Similar causes were observed between DES1G and DES2G, but neoatherosclerotic lesions were more common in DES1G.