Everolimus-eluting Stent Implantation Research Articles

One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes.

A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.

Deteriorative Effect of a Combination of Hypertriglyceridemia and Low High-Density Lipoprotein Cholesterolemia on Target Lesion Revascularization after Everolimus-Eluting Stent Implantation.

This study aimed to investigate the association between a combination of elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels and target lesion revascularization (TLR) following everolimus-eluting stent (EES) implantation. The adverse impact of clinical, lesion, and procedural characteristics on TLR in patients with elevated TG and reduced HDL-C levels was also assessed. We retrospectively collected data on 3,014 lesions from 2,022 consecutive patients, who underwent EES implantation at Koto Memorial Hospital. Atherogenic dyslipidemia (AD) is defined as a combination of non-fasting serum TG ≥ 175 mg/dL and HDL-C ＜40 mg/dL. AD was observed in 212 lesions in 139 (6.9%) patients. The cumulative incidence of clinically driven TLR was significantly higher in patients with AD than in those without AD (hazard ratio [HR] 2.31, 95% confidence interval [CI] 1.43-3.73, P=0.0006). Subgroup analysis showed that AD increased the risk of TLR with the implantation of small stents (≤ 2.75 mm). Multivariable Cox regression analysis showed that AD was an independent predictor of TLR in the small EES stratum (adjusted HR 3.00, 95% CI 1.53-5.93, P=0.004), whereas the incidence of TLR was similar in the non-small-EES stratum, irrespective of the presence or absence of AD. Patients with AD had a higher risk of TLR after EES implantation, and this risk was greater for lesions treated with small stents.

Relationship between Atherogenic Dyslipidemia and Target Lesion Revascularization Post Everolimus-Eluting Stent Implantation.

Relationship between Atherogenic Dyslipidemia and Target Lesion Revascularization Post Everolimus-Eluting Stent Implantation.

Abstract 17285: Impact of Baseline Yellow Plaque Assessed by Coronary Angioscopy on 11-month Vascular Response After Stent Implantation

Background: In-stent yellow plaque (YP) evaluated by coronary angioscopy (CAS) 1 year after stent implantation is associated with the future adverse cardiac event. However, the impact of baseline YP on vascular response has not been fully investigated. Methods: This was a sub-analysis of the Collaboraiton-1 study (multicenter, retrospective, observational study). A total of 88 lesions from 80 patients with chronic coronary syndrome who underwent percutaneous coronary intervention with polymer-free biolimus A9-coated stent or durable-polymer everolimus-eluting stent implantation were analyzed. Optical coherence tomography (OCT) and CAS were serially performed immediately and 11 months after stent implantation. YP was defined as the stented segment with yellow or intensive yellow color assessed by CAS. Neoatherosclerosis was defined as a lipid or calcified neointima assessed by OCT. Neointimal coverage (NIC) over the stent was classified into 4 grades by CAS: grade 0, stent struts fully visible; grade 1, stent struts bulging into the lumen, although covered; grade 2, stent struts embedded in the neointima, but translucently visible; and grade 3, stent struts fully embedded and invisible. OCT and CAS findings at 11 months were compared between the lesions with baseline YP (YP group) and those without YP (Non-YP group). Results: Baseline YP was detected in 37 lesions (42%). OCT findings at 11 months showed that the incidence of neoatherosclerosis was significantly higher in YP than Non-YP groups (11% versus 0%, P=0.028) and mean neointimal thickness tended to be lower (104±43 μm versus 120±48 μm, P=0.098). CAS finding at 11 months demonstrated that dominant and minimum NIC grades were significantly lower (Figure) and maximum yellow color grade was significantly higher in YP than Non-YP groups. Conclusions: Baseline YP affected the incidence of neoatherosclerosis as well as poor neointimal coverage at 11 months after stent implantation.

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Disease in Diabetics: The BEST Extended Follow-Up Study

BackgroundDiabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD). ObjectivesThis study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial. MethodsPatients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years). ResultsIn diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group. ConclusionsIn diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828)

Efficacy of Percutaneous Coronary Intervention With Synergy Stents in Patients Aged ≥75 Years: 1-Year Clinical Outcomes from the Synergy Elderly Registry

Data regarding the clinical outcomes of older patients after Synergy everolimus-eluting stent (S-EES) implantation are limited. This study investigated the 12-month clinical outcomes of older patients who underwent percutaneous coronary intervention with new-generation drug-eluting stents according to ischemic risks. This prospective multicenter study targeted patients aged ≥75years who underwent S-EES implantation. The primary and secondary end points included 12-month device-oriented composite end point (DOCE) (cardiovascular death, target vessel myocardial infarction, or target lesion revascularization) and major adverse cardiac and cerebrovascular events (MACCEs; all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis, or stroke), respectively. A stratified analysis was conducted according to high-ischemic risk (HIR), defined as complex coronary intervention (number of stents implanted ≥3, total stented length >60mm, chronic total occlusion, left main, or bifurcation), diabetes, or chronic kidney disease. In total, 650 enrolled patients aged ≥75years were categorized into HIR (n=425) and non-HIR groups (n=225). In the total population, the 1-year incidence of DOCEs was 2.5%. The rates of DOCEs were not significantly different between the HIR and the non-HIR groups, whereas the MACCE rate was higher in the HIR (9.4%) than the non-HIR group (4.9%, p=0.035), and the DOCE and MACCE components did not differ significantly in the occurrence between the groups. The independent predictors for the DOCEs or MACCEs included age, anemia, or left ventricular ejection fraction <40%. In conclusion, in older patients, S-EES implantation demonstrated favorable device-related outcomes, regardless of procedural complexity or co-morbidities. However, it requires careful attention because older patients with HIR are associated with worse clinical outcomes.

Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries)

There is limited data on new-generation stent outcomes in patients with previous coronary artery bypass graft (CABG) and the associated risk of gender and race/ethnicity is unclear. We investigated 1-year outcomes after platinum chromium everolimus-eluting stent implantation in a diverse population of men, women, and minorities with previous CABG pooled from the PLATINUM Diversity (NCT02240810) and PROMUS Element Plus (NCT01589978) registries. Our primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1-year post percutaneous coronary intervention (PCI). Secondary end points included all-cause death, MI, TVR, target vessel failure, and stent thrombosis. A total of 4,175 patients were included in the analysis, including 1,858 women (44.5%), 1,057 minorities (25.3%), and 662 (15.9%) with previous CABG. Patients with previous CABG were older, included more men and White patients, and had more co-morbidities compared with patients without previous CABG. At 1 year, patients with previous CABG had a higher risk of MACE (12.6% vs 7.5%, hazard ratio 1.70, 95% confidence interval 1.32 to 2.19, p<0.001) and end points, including death/MI, TVR, and target vessel failure. After multivariate adjustment, no differences were observed in MACE (adjusted hazard ratio 1.11, 95% confidence interval 0.82 to 1.49, p=0.506) or any secondary end points. No interaction was observed between previous CABG and gender or minority status. In conclusion, in a contemporary PCI population, patients with previous CABG remain at high risk for PCI because of their elevated risk profile. Previous CABG status was however not independently associated with worse outcomes after adjustment, nor was any interaction observed with gender or race/ethnicity.

Impact of Selection Preference on Longer-Term Outcomes between Bioresorbable Vascular Scaffold versus Everolimus-Eluting Stent for True Lumen Tracking-Recanalized Chronic Total Occlusion.

Creation of sizable subintima during intervention for chronic total occlusions (CTO) could lead to the key selection preference of metallic stents rather than bioresorbable vascular scaffolds (BVS) and then possibly deviate the outcome comparisons in real-world studies. By including recanalized CTO with true lumen tracking, we tested if any selection preference remained and compared the outcomes between everolimus-eluting stent (EES) and BVS implantation.Among 211 consecutive CTO interventions with true lumen tracking from August 2014 to April 2018 when BVS was available, we compared the clinical and interventional features between 28 patients with BVS and 77 patients with EES implantation. With propensity score matching and a median follow-up of 50.5 (37.3-60.3) months, we further assessed 25 patients with BVS and 25 with EES for target vessel failure (TVF: cardiac death, target vessel myocardial infarction, and target lesion revascularization).Multivariate analyses showed that BVS was still favored in the presence of LAD CTO (odds ratio (OR) = 3.4, 95% confidence interval (CI) = 1.0-11.7) and an average scaffold/stent size ≥ 3 mm (OR = 10.5, 95% CI = 3.0-37.3). EES was preferred for lesions with a J-CTO score ≥ 3 (OR = 19.3, 95% CI = 3.4-110.8) and multivessel intervention necessary at index procedure (OR = 11.3, 95% CI = 1.9-67.3). With matched comparisons, the TVF-free survival of EES was better than that of BVS for CTO recanalization (P = 0.049 by log-rank test) at long-term follow-up.Even with true lumen tracking techniques, selection bias remained substantial when determining either device for CTO implantation. The matched comparison of outcomes suggested the unfavorable longer-term impacts of the first generation of BVS on CTO lesions.

Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents

ObjectivesTo assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions. Material and methodsIn this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported. ResultsA total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported. ConclusionsThree years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention

BackgroundDiabetes was reported to be associated with an impaired response to clopidogrel. ObjectivesThe aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI). MethodsA subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year. ResultsThere were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; Pinteraction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; Pinteraction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; Pinteraction = 0.19). ConclusionsClopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)

The BEST trial is here - but is anyone listening?

The long-term outcome of the Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease trial has recently been published. This appraisal provides a critical evaluation of the main findings of the study.

Abstract 15084: One- versus Three-Month DAPT in Diabetic Patients With High Bleeding Risk Undergoing PCI: Results From the Xience Short DAPT Global Program

Introduction: In patients at high bleeding risk (HBR), a short dual antiplatelet therapy (DAPT) duration after coronary stenting has been associated with fewer bleeding events and preserved ischemic protection. Whether these effects are maintained in diabetic patients is unclear. Purpose: To assess the safety and efficacy of 1- versus 3-month DAPT after percutaneous coronary intervention (PCI) with stent implantation among HBR patients with or without diabetes. Methods: We included patients from three prospective, international, single-arm studies (XIENCE Short DAPT Program), which enrolled HBR patients successfully treated with a fluoropolymer-based cobalt-chromium everolimus-eluting stent (XIENCE, Abbott). Subjects were eligible for DAPT discontinuation at 1 month (XIENCE 28 USA and Global) or at 3 months (XIENCE 90), if free from ischemic events and adherent to DAPT. The primary endpoint was the composite of all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding. Outcomes were assessed between 1 and 12 months after index PCI using propensity score adjustment. Results: Out of 3,352 patients, 1,299 (38.8%) had diabetes. The rate of death or MI at 12 months was higher in diabetic than in non-diabetic patients (10.1% vs 6.6%) while the rate of BARC 2-5 bleeding was similar (9.5% vs 9.2%). A one v. three months of DAPT duration resulted in a borderline reduction in death or MI (adj. HR 0.70, 95% CI 0.47-1.05) in diabetic but not in non-diabetic patients (adj. HR 1.24, 95% CI 0.86-1.79; p-interaction=0.016) and fewer BARC 2-5 bleeding in both groups (adj. HR 0.67, 95% CI 0.45-1.01 and adj. HR 0.77, 95% CI 0.56-1.06, respectively; p-interaction=0.950). Conclusions: Among HBR patients undergoing everolimus-eluting stent implantation, diabetic patients derive important benefit in reducing death and MI and bleeding events from a one month compared with three-month DAPT duration.

Dual antiplatelet therapy for 1 versus 3 months in high bleeding risk patients with or without oral anticoagulant therapy after coronary stenting

Abstract Background A short DAPT duration after coronary stenting has been associated with similar ischemic outcomes and fewer bleeding complications in patients at high bleeding risk (HBR). Whether these effects are preserved irrespective of concomitant oral anticoagulant (OAC) therapy remains unclear. Purpose To evaluate the safety and efficacy of 1-month versus 3-month DAPT among HBR patients with or without indication to OAC therapy who undergo cobalt-chromium everolimus-eluting stent implantation. Methods The XIENCE Short DAPT Program comprises three prospective, international, single-arm studies evaluating 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT in HBR patients who had undergone successful everolimus-eluting XIENCE stent implantation. OAC therapy at discharge was a study inclusion criterion. Subjects were eligible to discontinue DAPT at 1 or 3 months if free from ischemic events and adherent to DAPT. The primary endpoint was the composite of all-cause death or any myocardial infarction (MI). The major secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2–5 bleeding. In this exploratory analysis, HBR patients on 1-month DAPT were compared with those on 3-month DAPT according to the presence of background OAC therapy. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI using propensity-score (PS) adjustment. Results A total of 3,364 patients, 1,392 on 1-month DAPT and 1,972 on 3-month DAPT, were eligible for the analyses. Patients on OAC therapy (n=1424, 42.3%) were younger, more often male and of white race, and with a lower prevalence of other HBR criteria such as chronic kidney disease and anemia. The incidence of death or MI at 12 months was similar between the two groups (8.0% vs 7.9%) while BARC 2–5 bleeding was higher in OAC patients (12.2% vs 7.2%). After PS adjustment, 1-month DAPT, compared with 3-month DAPT, did not increase the 1-year risk of death or MI in both OAC (adjHR 0.71, 95% CI 0.47–1.08) and non-OAC patients (adjHR 1.24, 95% CI 0.88–1.75; p-interaction = 0.11). The risk of BARC 2–5 bleeding was consistently reduced in both OAC (adjHR 0.71, 95% CI 0.51–1.00) and non-OAC patients (adjHR 0.77, 95% CI 0.53–1.11; p-interaction = 0.69). Conclusions Among HBR patients undergoing everolimus-eluting stent implantation, 1-month DAPT compared with 3-month DAPT was associated with similar ischemic outcomes and reduced bleeding, regardless of concomitant OAC therapy. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Abbott

Comparison of 6-Month and Prolonged Dual Antiplatelet Therapy after Percutaneous Coronary Intervention with Biodegradable Polymer Everolimus-Eluting Stent.

Background The optimal duration of dual antiplatelet therapy (DAPT) after biodegradable-polymer (BP) everolimus-eluting stent (EES) implantation remains uncertain. Methods This study analyzed 793 patients who underwent percutaneous coronary intervention (PCI) with BP-EES in 10 cardiovascular centers in Korea between July 2016 and January 2018. Using the prescription data at 6 months post-PCI, we divided these patients into two groups, namely, short-DAPT and prolonged-DAPT groups, which underwent DAPT for 6 and > 6 months of PCI, respectively. The primary endpoint, which included mortality, myocardial infarction, or target-vessel revascularization at 2 years, was compared by propensity score (PS) matching between the two groups. Results Out of the 793 patients, 283 matched pairs were identified by PS matching. Out of this matched population, 405 (71.6%) patients had an acute coronary syndrome. The primary endpoint did not differ in 2 years between the short-DAPT and prolonged-DAPT groups (7.5% vs. 8.3%; hazard ratio, 0.87; 95% confidential interval, 0.47–1.60; P = 0.648). Likewise, no difference was found regarding mortality, cardiac mortality, myocardial infarction, target-lesion failure, target-vessel failure, and bleeding events defined by the Bleeding Academic Research Consortium and Thrombolysis In the Myocardial Infarction classification. Meanwhile, one patient in the short-DAPT group had definite stent thrombosis at 364 days post-PCI. Subgroup analysis showed that several anatomical and procedural factors were not significantly related to DAPT duration. Most patients (77.4%) in both groups were prescribed clopidogrel at discharge. Conclusions In real-world patients undergoing PCI with BP-EES, the ischemic and bleeding endpoints demonstrated no difference between 6-month and prolonged (>6 months) DAPT.

Vascular Response After Everolimus-Eluting Stent in Acute Myocardial Infarction Caused by Calcified Nodule.

Patients with acute myocardial infarction (AMI) caused by calcified nodules (CN) have worse clinical outcomes following primary percutaneous coronary intervention (PCI). This study investigated the late vascular response after everolimus-eluting stent (EES) implantation assessed by optical coherence tomography (OCT) in patients with AMI caused by CN, by comparing with plaque rupture (PR) and plaque erosion (PE).Methods and Results: Based on the OCT findings in AMI culprit lesions before PCI, a total of 141 patients were categorized into 3 groups (PR, PE, or CN), and the OCT findings immediately and 10 months after PCI were compared. The frequency of PR, PE, and CN was 85 (60%), 45 (32%), and 11 patients (8%), respectively. In the 10-month follow-up OCT, the frequency of lesions with uncovered struts and lesions with malapposed struts were highest in the CN group, followed by the PR and PE groups (82% vs. 52% vs. 40%, P=0.042 and 73% vs. 26% vs. 16%, P<0.001, respectively). The incidence of intra-stent thrombus, re-appearance of CN within the stent, and target lesion revascularization were higher in the CN group compared with the PR and PE groups (36% vs. 9% vs. 7%, P=0.028; 27% vs. 0% vs. 0%, P<0.001; and 18% vs. 2% vs. 2%, P=0.024, respectively). Late arterial healing response at 10 months after EES implantation in the CN was worse compared with PR and PE in patients with AMI.

Vascular healing in high-bleeding-risk patients at 3-month after everolimus-eluting stent versus biolimus A9-coated stent implantation: insights from analysis of optical coherence tomography and coronary angioscopy.

The prevalence of high-bleeding-risk (HBR) patients who undergo coronary stenting has been reported as 20-40%. This study sought to assess vascular healing in HBR patients by coronary angioscopy (CAS) and optical coherence tomography (OCT). We prospectively analyzed 38 HBR patients with coronary artery disease who successfully underwent everolimus-eluting stent (EES) implantation (20 patients, 23 lesions) or drug-coated stent (DCS) implantation (18 patients, 18 lesions). Follow-up coronary angiography, CAS, and OCT were planned at 3months after the procedure. The clinical characteristics and inclusion criteria of HBR were comparable between groups. CAS analysis showed that mean yellow color grade was significantly higher with EES than with DCS (1.33 [1.0, 1.67] vs. 1.0 [0.67, 1.5]; P = 0.04). In contrast, OCT analysis demonstrated that most struts in both groups were well-apposed struts with neointimal coverage (93.9% each; P = 1.00), and percentages of the mean neointimal area were comparable between EES and DCS (4.4 ± 3.5mm2 vs. 4.5 ± 4.1mm2; P = 0.91). The frequency of uncovered struts was significantly lower with EES than with DCS (2.4% vs. 5.3%; P < 0.001), whereas the frequency of malapposed struts was significantly higher with EES than with DCS (3.5% vs. 0.8%; P < 0.001). During follow-up, no stent thrombosis or major bleeding complications were encountered in either group. Among HBR patients, both EES and DCS demonstrated good vascular healing at 3-month follow-up with some different features in CAS and OCT assessments.

Impact of statin therapy on late target lesion revascularization after everolimus-eluting stent implantation according to pre-interventional vessel remodeling and vessel size of treated lesion

Clinical evidence demonstrating the impact of statins for preventing late target lesion revascularization (TLR) after newer-generation drug-eluting stent implantation and differences in the effect of statins on late TLR according to pre-interventional vessel remodeling and vessel size is limited. We retrospectively evaluated 1193 de novo lesions in 720 patients who underwent everolimus-eluting stent implantation using intravascular ultrasound from January 2010 to December 2012. The primary endpoint was late TLR. Lesions were divided into the statin group (n = 825) and non-statin group (n = 368). The incidence of late TLR was significantly lower in the statin than non-statin group (1.7% vs. 5.2%, respectively; p = 0.001), and within the statin group, it was significantly lower in the follow-up low-density lipoprotein cholesterol (LDL-C) < 100 than ≥ 100 mg/dL level subgroup (1.0% vs. 3.6%, respectively; p = 0.006). Furthermore, in positive remodeling lesions and non-small vessel size lesions, the incidence of late TLR was significantly lower in the statin than non-statin group (1.6% vs. 8.5% and 1.3% vs. 5.3%, respectively; p = 0.001 and p = 0.004). Lowering the LDL-C level using statins was more effective for preventing late TLR after everolimus-eluting stent implantation. Evaluating pre-interventional vessel remodeling patterns and vessel size might be helpful to stratify lesions at high risk of late TLR.

Vascular Injury After Stenting - Insights of Systemic Mechanisms of Vascular Repair.

The role of circulating progenitor cells (CPC) in vascular repair following everolimus-eluting stent (EES) implantation is largely unknown. The aim of the study was to investigate the relationship between temporal variation in CPC levels following EES implantation and the degree of peri-procedural vascular damage, and stent healing, as measured by optical coherence tomography (OCT).Methods and Results: CPC populations (CD133+/KDR+/CD45low) included patients with stable coronary artery disease undergoing stent implantation, and were evaluated using a flow cytometry technique both at baseline and at 1 week. OCT evaluation was performed immediately post-implantation to quantify the stent-related injury and at a 9-month follow up to assess the mid-term vascular response. Twenty patients (mean age 66±9 years; 80% male) with EES-treated stenoses (n=24) were included in this study. Vascular injury score was associated with the 1-week increase of CD133+/KDR+/CD45low (β 0.28 [95% CI 0.15; 0.41]; P<0.001) and with maximum neointimal thickness at a 9-month follow up (β 0.008 [95% CI 0.0004; 0.002]; P=0.04). Inverse relationships between numbers of uncoated and apposed struts for the 9-month and the 1-week delta values of CD133+/KDR+/CD45low (β -12.53 [95% CI -22.17; -2.90]; P=0.011), were also found. The extent of vessel wall injury influences early changes in the levels of CPC and had an effect on mid-term vascular healing after EES implantation. Early CPC mobilisation was associated with mid-term strut coverage.

External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI

BackgroundAlthough randomized trials have established that coronary artery bypass grafting (CABG) is, on average, the most effective revascularization strategy compared with percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease (MVD), individual patients differ in many characteristics that can affect the benefits and harms of treatment. The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus) score was developed to predict different outcomes with CABG vs PCI on the basis of 8 patient characteristics and the smoking-treatment interaction. ObjectivesThis study aimed to assess the ability of the 5-year major adverse cardiovascular event (MACE) model to predict treatment benefit of CABG vs PCI in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. MethodsThis study identified 702 patients with diabetes and MVD to mirror the FREEDOM participants. Discrimination was assessed by C-index, and calibration was assessed by calibration plots in the PCI and CABG arms, respectively. The ability of the FREEDOM score to predict treatment benefit of CABG vs PCI was assessed. ResultsOverall, CABG was associated with a lower rate of 5-year MACE compared with PCI (12.4% vs 20.3%; log-rank P = 0.021) irrespective of a history of smoking (Pinteraction = 0.975). Both discrimination and calibration were helpful in the PCI arm (C-index: 0.69; slope: 0.96, intercept: −0.24), but moderate in the CABG arm (C-index: 0.61; slope: 0.61; intercept: −0.53). The FREEDOM score showed some heterogeneity of treatment benefit. ConclusionsThe FREEDOM score could identify some heterogeneity of treatment benefit of CABG vs PCI for 5-year MACE. Until further prospective validations are performed, these results should be taken into consideration when using the FREEDOM score in patients with diabetes and MVD. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972) (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease [BEST]; NCT00997828) (Future Revascularization Evaluation in Patients with Diabetes Mellitus [FREEDOM]; NCT00086450)

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.