Zotarolimus-eluting Stent Implantation Research Articles

Long-term follow-up of contemporarydrug-eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial.

The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published. The aim of this subanalysis was to assess long-term performance of two contemporary drug-eluting stents (DES) in a diabetic population. In the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus-eluting stent (PP-ZES) or PF-AES. The primary endpoint was target-lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization. Clinical outcomes between discharge and 3 years follow-up were assessed. A total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP-ZES patients versus 10.0% in PF-AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP-ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF-AES arm (p = 0.036). In the insulin-dependent diabetic population, TLF occurred in 19.1% of PP-ZES patients versus 10.4% of PF-AES patients (p = 0.21). NACE occurred in 40.4% of PP-ZES patients versus 27.1% of PF-AES patients (p = 0.10). This subanalysis shows that the use of PF-AES results in similar clinical outcomes as compared to PP-ZES, yet some benefits of use of PF-AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.

In Vivo Assessment of In-Stent Restenosis After Resolute Zotarolimus-Eluting Stent Implantation: Multimodality Imaging with Directional Coronary Atherectomy.

In Vivo Assessment of In-Stent Restenosis After Resolute Zotarolimus-Eluting Stent Implantation: Multimodality Imaging with Directional Coronary Atherectomy.

766 Distal embolization protection systems. A rare complication

Abstract Aims The no reflow phenomenon is a not rare complication that occurs in up to 30% of patients with acute coronary syndrome undergoing myocardial reperfusion by percutaneous coronary intervention. The use of coronary artery thrombus aspiration or distal embolization protection systems has reduced the risk of distal embolization and no-reflow phenomenon. Methods and results We describe the case of a 77 year old female suffering from hypertension presented at our emergency department for inferior STEMI. An urgent coronary angiography was performed, showing a three-vessel coronary artery disease with right coronary artery sub-occluded in the middle segment (culprit lesion), with a voluminous endoluminal minus image, as intracoronary thrombosis. Before performing the coronary angioplasty, a Spider FX3 filter was placed on the distal segment of the right coronary artery; thrombus aspiration was performed, which was ineffective, then angioplasty and Zotarolimus eluting stent implantation in the mid segment of the right coronary artery. After stent implantation, an image of minus was highlighted inside the basket of the filter, as a migrated and incarcerated thrombotic formation; then, the filter was removed. During the removal of the filter, longitudinal crush of the distal portion of the stent is caused, with limitation of the downstream flow, in the absence of haemodynamic instability. The stent was recrossed with Fielder XT guidewire supported by Turnpike LP Microcatheter. Multiple dilations werenperformed with semi-compliant and non-compliant increasing-caliber balloons and then Zotarolimus eluting stent implantation, in partial overlap with the distal portion of the previously implanted stent, with TIMI flow 3. The echocardiogram showed a normal global systolic function, with alterations in regional kinetics. On the 6th day, angioplasty and Zotarolimus eluting stent implantation was performed on the mid-proximal segment of the left anterior descending artery. During the hospitalization the patient was stable and has been discharged in good condition on the ninth day. Conclusions The interest of this case is the evidence of a rare complication related to the use of distal embolization protection system, probably due to an incomplete closure of the filter before removal, due to the high amount of thrombotic material inside it. The rapid recrossing of the stent after the longitudinal crush, the angioplasty and the second stent implantation, led to a quick flow restoration, without haemodynamic and clinical consequences on the patient's outcome.

Clinical Impact of Lesion Complexity on 2-Year Outcomes After Zotarolimus-Eluting Stents Implantation.

The clinical efficacy and safety of second-generation drug-eluting stents in complex percutaneous coronary interventions (PCIs) are not well established. The clinical influence of the lesion complexity after PCI with zotarolimus-eluting stents (ZES) was evaluated. From a prospective multicenter observational study, a total of 926 patients that underwent successful PCIs with ZES were included. Complex PCIs were defined as patients with≥3 lesions treated, 3 vessels treated, severe calcified lesions, bifurcated lesions with 2 stents implanted, left main disease, chronic total occlusion lesions, and/or diffuse long (total stent length≥60mm) lesions and were compared to the noncomplex group. The primary outcome was incidence of target lesion failures at 2 years, defined as a composite of cardiac death, target lesion-myocardial infarctions, and target lesion revascularization. The patients were divided into complex PCI (n=249) and noncomplex (n=677) groups. In the complex PCI group, the 2-year risk of a target lesion failure was not significantly higher than in the noncomplex PCI group (4.8% vs 3.7%; adjusted hazard ratio: 1.373; 95% confidence interval: 0.689-2.738; P=0.367). The same trend was observed for all composites of the clinical outcomes. Older age and advanced chronic kidney disease were independent predictors for the primary outcome. Up to 2 years after a ZES implantation, the clinical outcomes did not differ according to lesion complexity.

3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis.

The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population. PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy. In this physician-initiated, multicenter, randomized, all-comers trial, patients undergoing percutaneous coronary intervention with implantation of DES were enrolled. Patients were stratified for diabetes and troponin status and randomized to implantation of a permanent-polymer zotarolimus-eluting stent (PP-ZES) or a PF-AES. Dual-antiplatelet therapy duration was 12months in troponin-positive patients and 1month in troponin-negative patients. A noninferiority analysis was conducted to compare the 2 arms regarding target lesion failure (TLF) between 1 and 3 years. A total of 1,491 patients were randomized and treated. In this landmark analysis, between 1- and 3-year follow-up, TLF occurred in 35 patients (4.9%) in the PP-ZES arm and 37 PF-AES patients (5.1%). Clinical noninferiority of the PF-AES was confirmed, with a risk difference of 0.2% (upper limit 1-sided 95% CI: 2.2%; Pnoninferiority=0.0031). ReCre8 (Randomized "All-Comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent) is the first randomized, multicenter trial with a head-to-head comparison of PP-ZES compared with PF-AES to investigate clinical outcomes of these new-generation DES in an all-comers population with long-term follow-up. On the basis of the present results, PF-AES are clinically noninferior to PP-ZES regarding TLF between 1 and 3 years. (Randomized "All-Comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent; NCT02328898).

Patients With High Bleeding Risk Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stent Implantation Treated With Short Dual Antiplatelet Therapy: A Recre8 Subanalysis

The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population.PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy.In this physician-initiated, multicenter, randomized, all-comers trial, patients undergoing percutaneous coronary intervention with implantation of DES were enrolled. Patients were stratified for diabetes and troponin status and randomized to implantation of a permanent-polymer zotarolimus-eluting stent (PP-ZES) or a PF-AES. Dual-antiplatelet therapy duration was 12 months in troponin-positive patients and 1 month in troponin-negative patients. A noninferiority analysis was conducted to compare the 2 arms regarding target lesion failure (TLF) between 1 and 3 years.A total of 1,491 patients were randomized and treated. In this landmark analysis, between 1- and 3-year follow-up, TLF occurred in 35 patients (4.9%) in the PP-ZES arm and 37 PF-AES patients (5.1%). Clinical noninferiority of the PF-AES was confirmed, with a risk difference of 0.2% (upper limit 1-sided 95% CI: 2.2%; Pnoninferiority = 0.0031).ReCre8 (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent) is the first randomized, multicenter trial with a head-to-head comparison of PP-ZES compared with PF-AES to investigate clinical outcomes of these new-generation DES in an all-comers population with long-term follow-up. On the basis of the present results, PF-AES are clinically noninferior to PP-ZES regarding TLF between 1 and 3 years. (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent; NCT02328898)

Comparison of the 9-Month Intrastent Condition and 30-Month Clinical Outcomes After Resolute Zotarolimus-Eluting Stent Implantation Between Standard-Duration and 1-Month Dual Antiplatelet Therapy Followed by Prasugrel Monotherapy.

Background: In this study we investigated the efficacy and safety of very short duration (1-month) dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy. In particular, we compared intrastent conditions using optical coherence tomography (OCT) after second-generation drug-eluting stent implantation between standard-duration and 1-month DAPT followed by prasugrel monotherapy.Methods and Results: Between May 2015 and February 2018, 120 consecutive patients who underwent elective Resolute zotarolimus-eluting stent implantation were enrolled and divided into those receiving standard-duration or 1-month (1M) DAPT followed by prasugrel monotherapy; 47 patients (n=55 stents) and 46 patients (n=54 stents) in the standard and 1M groups, respectively, completed the protocol. The primary endpoint was the prevalence of abnormal intrastent tissue at the 9-month examination, as observed by OCT. The secondary endpoint was the presence of composite adverse events, including all-cause death, myocardial infarction, stent thrombosis, target lesion and vessel revascularization, and major and minor bleeding. The prevalence of abnormal intrastent tissue was similar between the standard and 1M groups (1.6% vs. 1.5%, respectively; non-inferiority P<0.01). There was a tendency for fewer composite events in the 1M than standard group at the 30-month follow-up examination (28.3% vs. 44.7%, respectively; P=0.41).Conclusions: In conclusion, 1M DAPT followed by prasugrel monotherapy after second-generation drug-eluting stent implantation was not inferior to standard-duration DAPT in terms of intrastent thrombus formation and composite adverse events.

Efficacy of Zotarolimus-Eluting Stents in Treating Diabetic Coronary Lesions: An Optical Coherence Tomography Study.

Diabetes mellitus (DM) plays an important role in restenosis and late in-stent thrombosis (ST).The current study using optical coherence tomography (OCT) aims to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (ZES) treatment. OCT images of 90,212 struts and quantitative coronary angiography (QCA) in 62 patients (32 with DM and 30 without DM) with 69 de novo coronary lesions (34 DM and 35 non-DM) both after ZES implantation and 12 ± 1month angiographic follow-up were recorded. Patient characteristics, lesion characteristics, clinical outcomes, and OCT findings including neointimal thickness, coverage, malapposition, and intimal morphology were analyzed. Baseline patient characteristics and lesion characteristics data were similar between the two groups. Higher neointimal thickness (0.14 ± 0.09mm vs. 0.09 ± 0.04mm, p = 0.021), more neovascularization (3.03 ± 6.24 vs. 0.52 ± 1.87, p = 0.017) and higher incidence of layered signal pattern (12.19 ± 19.91% vs. 4.28 ± 9.02%, p = 0.049) were observed in diabetic lesions comparing with non-diabetic lesions. No differences were found in malapposition, uncovered percentage, and thrombus between the two groups (all p > 0.05). Occurrence of clinical adverse events was also similar during the follow-up period (p > 0.05). Although more neointimal proliferation and more neovascularization were found in diabetic coronary lesions whencompared with non-diabetic lesions, treatment with ZES showed similar stent malapposition rate at 1-year follow-up. The data indicated that ZES treatment could possibly beeffective in treating diabetic coronary lesions. ClinicalTrials.gov identifier, NCT01747356.

Impact of underlying plaque type on strut coverage in the early phase after drug-eluting stent implantation.

The aim of this study was to investigate whether the underlying plaque type affects the neointimal coverage after drug-eluting stent implantation. A total of 1793 struts in 22 zotarolimus-eluting stents were assessed using optical coherence tomography imaging within 3 months of implantation. Neointimal coverage was evaluated within 5 mm from each stent edge on cross-sectional optical coherence tomography images at every 1-mm interval. The percentage of struts covered by neointima was compared among the normal segment group, the fibrous plaque group, and the lipid plaque group on the basis of the underlying plaque type. The percentage of covered strut was significantly lower in the normal segment group than in the fibrous plaque group (35.9±30.2 vs. 57.1±31.0%, P<0.05) and the lipid plaque group (vs. 64.7±23.5%, P<0.01). The neointima was significantly thinner in the normal segment group than in the lipid plaque group (19.0±22.3 vs. 32.0±18.8 μm, P<0.01). The percentage of struts on the normal segment was significantly higher in cross-sections with a ratio of uncovered to total struts per section more than 0.3 than in cross-sections with a ratio up to 0.3 (32.4±31.7 vs. 19.5±33.8%, P<0.01). Struts on the normal segment were less covered and had thinner neointima than struts on the lipid plaque at the stent edge within 3 months after zotarolimus-eluting stent implantation. Caution should be exercised when implanting longer drug-eluting stents to achieve uniform strut coverage in the early phase.

Comparison of the 9-month intra-stent conditions and 2-year clinical outcomes after Resolute zotarolimus-eluting stent implantation between 3-month and standard dual antiplatelet therapy

BackgroundThe use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. Methods and resultsEighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. ConclusionThis OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs.

5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program

ObjectivesThe authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BackgroundIndividual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. MethodsThe RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. ResultsThe 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. ConclusionsIn the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions.

PurposeTo evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI).Materials and MethodsFrom three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions.ResultsFor 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion–related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423–0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160–35.206, p=0.033).ConclusionSex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program.

We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients. We compared long-term outcomes of STEMI patients undergoing primary angioplasty <12 hours from symptom onset who were randomised to the R-ZES (n=122) or the everolimus-eluting stent (EES, n=158) in the RESOLUTE All Comers Trial after propensity score adjustment. The five-year cumulative incidence of target lesion failure (TLF) was 7.6% versus 10.4% among patients treated with R-ZES versus EES, respectively, (adjusted p=0.304), and comprised clinically driven target lesion revascularisation (TLR, 2.5% versus 2.0%, adjusted p=0.766) and cardiac death/target vessel MI (5.1% versus 9.1%, adjusted p=0.123). The five-year cumulative incidence of stent thrombosis was 0.8% for R-ZES patients versus 1.3% for EES patients (adjusted p=0.868). In the RESOLUTE Global Clinical Trial Program, excluding RESOLUTE All Comers, the three-year cumulative incidence of TLF with R-ZES was 9.8% and comprised 7.0% clinically driven TLR and 4.5% cardiac death/target vessel MI. Patients with STEMI who received R-ZES had excellent long-term clinical outcomes which were similar to those of patients who received EES.

Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial).

At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients. Patients were eligible for this study if they were between 40 and 75 years old with in-stent restenosis >50% by quantitative coronary angiographic analysis in DES or within 5 mm of the stent edges with signs of ischaemia. Eligible patients (n = 304, 146 women and 158 men) were randomly assigned to receive either EES (158 patients) or ZES (146 patients). The primary endpoint of the study was to compare neointima volume between the EES and ZES groups at the 9-month follow-up IVUS. MACEs, including death, non-fatal MI, stent thrombosis and the need for repeated TLR within 3 years, were noted. The 9-month angiographic and IVUS follow-up showed no significant differences in late lumen loss (0.40 ± 0.56 vs. 0.45 ± 0.61 mm, P = 0.57, respectively) and neointima volume (0.51 ± 0.48 vs. 0.56 ± 0.54 mm3/1 mm, P = 0.47, respectively) in the EES and the ZES groups. Composite MACEs such as death, MI, stent thrombosis and TLR during 3-year follow-up were comparable between the two groups [15.8% (n = 25) in the EES group and 22.6% (n = 33) in the ZES group, P = 0.276], independent of de novo DES type, sex, age, body mass index, presence of diabetes, hypertension and dyslipidaemia. Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.

Duration of dual antiplatelet therapy after various drug-eluting stent implantation

ObjectiveTo evaluate efficacy and safety of long duration dual anti-platelet therapy i.e., >12months (L-DAPT) and short duration DAPT i.e., ≤12months (S-DAPT) after various drug-eluting stent (DES) implantation. MethodsWe searched Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to identify randomized controlled trials (RCTs) assessing the effect of L-DAPT versus S-DAPT after sirolimus-eluting (Cypher®); paclitaxel-eluting stents (Taxus®); zotarolimus-eluting (Endeavor®) and everolimus-eluting stents (Xience V®) implantation. Odds ratio (OR) and 95% confidence intervals (CI) were calculated using random-effects models. Subgroup analyses were performed comparing two second generation DES and for RCTs comparing S-DAPT and L-DAPT. ResultsWe included six RCTs that randomized 19,012 patients to S-DAPT versus L-DAPT (4638 in first generation DES; 14,374 in second generation DES; 8099 EES; 4876 in ZES). Compared with L-DAPT, S-DAPT was associated with a higher rate of myocardial infarction (MI) and stent thrombosis (ST) after first [2.65 (1.88, 3.73) and 3.85 (2.14–6.93) respectively] and a higher rate of MI after second generation DES [1.33 (1.06, 1.67)]. There were no significant differences in the rates of all cause mortality, cardiovascular (CV) mortality and stroke with L-DAPT and S-DAPT after implantation of first [0.97 (0.52, 1.81); 1.19 (0.52–2.70); and 1.12 (0.36–3.52) respectively] and second generation DES [0.93 (0.69, 1.25); 0.93 (0.63, 1.36); and 0.58 (0.19, 1.75), respectively]. On further analysis of type of second generation DES, S-DAPT continues to show a higher rate of MI and ST after EES implantation [1.54 (1.11, 2.13) and 2.68 (1.20–5.94) respectively]; however there was no significant difference in the rate of MI and ST with S-DAPT and L-DAPT after ZES implantation [1.07 (0.44, 2.61) and 1.11(0.39, 3.13), respectively]. Conclusion1) Compared with L-DAPT, S-DAPT was associated with a higher rate of MI without any significant difference in the rate of all cause mortality, CV mortality and stroke after first and second generation DES.2) Rate of ST was also higher with S-DAPT compared to L-DAPT after first generation DES implantation; however, it was not significantly different after second generation DES. 3) On further subgroup analysis of second-generation stent there was no significant difference in the rate of all cause mortality, CV mortality, MI, ST and stroke with S-DAPT and L-DAPT after ZES implantation. S-DAPT may be optimal for newer generation stents particularly ZES.

Abstract 14867: Duration of Dual Antiplatelet Therapy After Various Drug Eluting Stent Implantation

Objective: To evaluate efficacy and safety of long duration DAPT i.e., &gt; 12 months (L-DAPT) and short duration DAPT i.e., ≤ 12 months (S-DAPT) after various drug eluting stent (DES) implantation. Methods: We searched Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) to identify randomized controlled trials (RCTs) assessing the effect of L-DAPT versus S-DAPT after sirolimus-eluting (Cypher®); paclitaxel-eluting stents (Taxus®); zotarolimus-eluting (Endeavor®) and everolimus-eluting stents (Xience V®) implantation. Primary efficacy end points were stent thrombosis, target vessel revascularization (TVR), all cause mortality and cardiac mortality. Primary safety end points were major bleeding and stroke. Event rates were compared using a Forest plot of relative risk using a random effects model. Results: We included six RCTs that randomized 19,012 patients to S-DAPT versus L- DAPT (4638 first generation DES; 14,374 in second generation DES; 8099 EES; 4876 in ZES). Outcomes with S-DAPT and L-DAPT in various generations of DES stents are summarized in table below: Conclusion: Compared with L-DAPT, S-DAPT was associated with higher rate of myocardial infarction and stent thrombosis without any significant difference in the rate of all cause mortality, cardiac mortality and stroke after first and second generation DES. However, on subgroup analysis of second generation stent there was no significant difference in the rate of all cause mortality, cardiac mortality, myocardial infarction, stent thrombosis and stroke with S-DAPT and L-DAPT after ZES implantation. Shorter duration DAPT may be optimum for newer generation stents particularly ZES.

Duration of clopidogrel-based dual antiplatelet therapy and clinical outcomes after endeavor sprint zotarolimus-eluting stent implantation in patients presenting with acute coronary syndrome

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) remains controversial in patients with acute coronary syndrome (ACS). We sought to compare outcomes after the implantation of zotarolimus-eluting stent (ZES) between patients with ACS who received clopidogrel-based DAPT for >6months and those treated for ≤6months. MethodsFrom a registry of patients treated with ZESs between October 2005 and January 2010, 1740 patients with ACS were selected for the present analysis. Landmark analyses were performed for ACS patients who were event-free at 6months follow-up (n=1674). The primary outcome was a major adverse cardiac and cerebrovascular event (MACCE), including all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis, or stroke. We also performed adjustments for the baseline characteristics of patients, using their propensity-score matching (n=469 pairs). ResultsDuring a median follow-up of 22.5months, the rate of MACCE was 6.4% in patients with DAPT >6months (n=1140) and 4.7% in patients with DAPT ≤6months (n=534) (adjusted hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.61–1.82; p=0.86). After propensity-score matching, DAPT >6months was not found to be associated with a lower incidence of MACCE compared with DAPT ≤6months (adjusted HR 0.80, 95% CI 0.44–1.45, p=0.46). The rates of all-cause death or MI, TVR, stent thrombosis, and stroke also did not differ significantly between two groups. ConclusionDAPT for >6months do not seem to be associated with improved clinical outcomes in patients with ACS undergoing percutaneous coronary intervention (PCI) with ZES.

Thrombotic complications associated with early and late nonadherence to dual antiplatelet therapy.

This study sought to assess the frequency and clinical impact of dual antiplatelet therapy (DAPT) nonadherence. There are limited data on the impact of DAPT nonadherence during the first year after a second-generation drug-eluting stent placement. After successful Endeavor zotarolimus-eluting stent implantation, 2,265 patients were enrolled in a registry with limited exclusions and monitored during 12 months of prescribed DAPT. Predictors of any nonadherence (ANA) at 6 months were analyzed by multivariable analysis, and the association between ANA at 6 or 12 months with the endpoints of death, myocardial infarction, and stent thrombosis was assessed. The study population included 30% female patients, 34% with diabetes and 36% with acute coronary syndromes. ANA occurred in 208 patients (9.6%) before 6 months and 378 patients (18.5%) before 1 year. Major bleeding (odds ratio [OR]: 12.83, 95% confidence interval [CI]: 7.55 to 21.80, p < 0.001) was the only predictor of ANA at 6 months. In time-dependent analyses, ANA before 6 months was associated with an increased risk of death or myocardial infarction (7.6% vs. 3.0%, p < 0.001) and a numerical increase in stent thrombosis (2.0% vs. 0.9%, p = 0.12). After adjustment for baseline differences, ANA within 6 months remained associated with death or MI (OR: 1.95, 95% CI: 1.02 to 3.75). ANA occurring after 6 months did not increase the risk of subsequent ischemic events. DAPT ANA occurs frequently and is associated with increased risk for thrombotic complications if it occurs within the first 6 months. Major bleeding was a significant correlate of DAPT ANA within 6 months. (EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events; NCT01069003).

Impact of body mass index on long-term clinical outcomes after second-generation drug eluting stent implantation: Insights from the international global RESOLUTE program.

An increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents. Individual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up. Data from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile (≤ 25.95 kg/m(2) -Low or normal weight) 1,727 patients; II tertile (>25.95 ≤ 29.74 kg/m(2) -overweight) 1,695 patients, and III tertile (>29.74 kg/m(2) -obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI] = 0.89 [0.69, 1.14], P = 0.341; major adverse cardiac events (I-III tertile, HR [95% CI] = 0.90 [0.72, 1.14], P = 0.389; cardiac death (I-III tertile, HR [95% CI] = 1.20 [0.73, 1.99], P = 0.476); myocardial infarction (I-III tertile, HR [95% CI] = 0.86 [0.55, 1.35], P = 0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI] = 0.75 [0.53, 1.08], P = 0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI] = 0.98 [0.49, 1.99], P = 0.964. In the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions.

Efficacy and safety of limus-eluting versus paclitaxel-eluting coronary artery stents in patients with diabetes mellitus: A meta-analysis

Background/objectivesThe relative efficacy and safety of limus-eluting stent (LES) versus paclitaxel-eluting stent (PES) in DM patients remain unclear. MethodsThe PubMed, EMBASE, and Cochrane Central Register of Controlled Trials electronic databases were searched from January 2001 to December 2013. Clinical trials that performed head-to-head comparisons of LES versus PES implantation in patients with DM were considered for inclusion. ResultsThis meta-analysis included 28 clinical trials involving 23,678 patients: 9953 who underwent sirolimus-eluting stent (SES) implantation, 4209 underwent everolimus-eluting stent (EES) or zotarolimus-eluting stent (ZES) implantation, and 9516 underwent PES implantation. The short-term target lesion revascularization (TLR) rate was significantly lower after SES implantation than after PES implantation (3.6% vs 6.3%; odds ratio (OR): 0.659; P=0.014), but there were no significant differences in the rates of target vessel revascularization (TVR), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality, or major adverse cardiac events (MACE). There were no differences in the longer-term rates of TLR, TVR, ST, MI, all-cause mortality, or MACE between SES versus PES. Second-generation LES (EES or ZES) implantation resulted in lower rates of ST (2.1% vs 3.3%; OR: 0.586; P<0.001), MI (2.3% vs 4.1%; OR: 0.527; P=0.001), and MACE (8.0% vs 10.3%; OR: 0.796; P=0.007) than PES implantation. ConclusionsIn patients with DM, short- and longer-term MACE rates were similar after first-generation LES and PES implantation. The second-generation LES may be better than PES implantation in rates of ST, MI, and MACE.