New-generation Drug-eluting Stents Research Articles

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.

Antithrombotic regimens in patients with atrial fibrillation and coronary artery disease after percutaneous coronary intervention: A focused review

Atrial fibrillation and coronary artery disease are common comorbidities with increasing incidences worldwide. About 5–15% of atrial fibrillation patients will require coronary stenting at some point in their lives, which necessitates dual antiplatelet therapy with aspirin and a P2Y12 antagonist. Triple therapy refers to the clinical scenario in which a patient is prescribed aspirin, P2Y12 antagonist, and oral anticoagulant, usually in the setting of atrial fibrillation. Current guidelines on atrial fibrillation do not offer strong recommendations on triple therapy management. Furthermore, the optimal duration of dual antiplatelet therapy after percutaneous coronary intervention is evolving based on contemporary research and development of newer generation drug eluting stents, changing the necessary duration of triple therapy in patients with atrial fibrillation. This review will offer an in-depth survey of current guidelines, current evidence, and future studies regarding triple therapy in atrial fibrillation patients undergoing percutaneous coronary intervention.

Mapping intermediate degradation products of poly(lactic-co-glycolic acid) in vitro.

There is widespread interest in using absorbable polymers, such as poly(lactic-co-glycolic acid) (PLGA), as components in the design and manufacture of new-generation drug eluting stents (DES). PLGA undergoes hydrolysis to progressively degrade through intermediate chemical entities to simple organic acids that are ultimately absorbed by the human body. Understanding the composition and structure of these intermediate degradation products is critical not only to elucidate polymer degradation pathways accurately, but also to assess the safety and performance of absorbable cardiovascular implants. However, analytical approaches to determining the intermediate degradation products have yet to be established and evaluated in a standard or regulatory setting. Hence, we developed a methodology using electrospray ionization mass spectrometry to qualitatively and quantitatively describe intermediate degradation products generated in vitro from two PLGA formulations commonly used in DES. Furthermore, we assessed the temporal evolution of these degradation products using time-lapse experiments. Our data demonstrated that PLGA degradation products via heterogeneous cleavage of ester bonds are modulated by multiple intrinsic and environmental factors, including polymer chemical composition, degradants solubility in water, and polymer synthesis process. We anticipate the methodologies and outcomes presented in this work will elevate the mechanistic understanding of comprehensive degradation profiles of absorbable polymeric devices, and facilitate the design and regulation of cardiovascular implants by supporting the assessments of the associated biological response to degradation products. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1129-1137, 2018.

Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial

Objective: Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES). Methods: We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as “high-risk” if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%). Results: At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00). Conclusions: The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

Percutaneous intervention versus coronary artery bypass graft surgery in left main coronary artery stenosis: a systematic review and meta-analysis

BackgroundThe optimal revascularization technique in patients with left main coronary artery disease (CAD) remains controversial. We aimed to compare the long-term performance of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in treatment of left main CAD.MethodsPubMed, EMBASE, and the Cochrane Library were searched until November 16, 2016.ResultsSix randomized controlled trials and 22 matched observational studies including 22,487 patients and 90,167 patient-years of follow-up were included. PCI was associated with an overall higher risk for the major adverse cardiac and cerebrovascular events (hazard ratio (HR), 1.42; 95% confidence interval (CI), 1.14–1.77), mainly driven by higher rates of myocardial infarction (HR, 1.69; 95% CI, 1.22–2.34) and revascularization (HR, 2.80; 95% CI, 1.86–4.22). The overall risks for all-cause death (HR, 1.05; 95% CI, 0.93–1.20), cardiac death (HR, 1.05; 95% CI, 0.69–1.59), stroke (HR, 0.64; 95% CI, 0.33–1.24), and the composite safety endpoint of death, myocardial infarction, or stroke (HR, 1.06; 95% CI, 0.97–1.16) were similar between PCI and CABG. Stratified analysis based on stent types showed that the increased risk for myocardial infarction associated with PCI was only evident in patients with bare-metal stents or early-generation drug-eluting stents (DES), but not newer-generation DES. Stratified analyses based on study designs showed largely similar findings with the overall analyses, except for a significantly higher incidence of myocardial infarction in adjusted studies (HR, 2.01; 95% CI, 1.64–2.45) but a trend toward higher incidence in randomized trials (HR, 1.39; 95% CI, 0.85–2.27) associated with PCI.ConclusionsCompared with CABG, PCI with newer-generation DES might be a safe alternative revascularization strategy for treatment of left main CAD, but is associated with more repeat revascularization.

Bioresorbable Scaffold: The Emerging Reality and Future Directions.

In the era of drug-eluting stents, large-scale randomized trials and all-comer registries have shown excellent clinical results. However, even the latest-generation drug-eluting stent has not managed to address all the limitations of permanent metallic coronary stents, such as the risks of target lesion revascularization, neoatherosclerosis, preclusion of late lumen enlargement, and the lack of reactive vasomotion. Furthermore, the risk of very late stent, although substantially reduced with newer-generation drug-eluting stent, still remains. These problems were anticipated to be solved with the advent of fully biodegradable devices. Fully bioresorbable coronary scaffolds have been designed to function transiently to prevent acute recoil, but have retained the capability to inhibit neointimal proliferation by eluting immunosuppressive drugs. Nevertheless, long-term follow-up data of the leading bioresorbable scaffold (Absorb) are becoming available and have raised a concern about the relatively higher incidence of scaffold thrombosis. To reduce the rate of clinical events, improvements in the device, as well as implantation procedure, are being evaluated. This review will focus on the current CE-mark approved bioresorbable scaffolds, their basic characteristics, and clinical results. In addition, we summarize the current limitations of bioresorbable scaffold and their possible solutions.

Meta-Analysis Comparing Coronary Artery Bypass Grafting to Drug-Eluting Stents and to Medical Therapy Alone for Left Main Coronary Artery Disease

Historically, coronary artery bypass graft (CABG) surgery has been the standard revascularization method for unprotected left main coronary artery (LMCA) disease. Over the last decade, several randomized controlled trials (RCTs) have shown favorable results for percutaneous coronary intervention (PCI) with drug-eluting stent (DES) compared with CABG; however, no RCT has been conducted directly comparing DESs with medical therapy alone (MTA). Furthermore, the 2 most recently reported larger RCTs, using new-generation DESs reached somewhat conflicting conclusions comparing the 2 revascularization strategies. Therefore, we performed a traditional pairwise meta-analysis and Bayesian network meta-analysis to compare the efficacies of the 3 currently available treatment strategies (MTA, CABG, and DES) for unprotected LMCA disease. Scientific databases and websites were searched to find RCTs. Data from 8 trials including 4,850 patients were analyzed. Overall PCI increased the risk of major adverse cardiac and cerebrovascular events (MACCEs) driven by increased rate of revascularization compared with CABG, but no differences in all-cause mortality, cardiac mortality, and recurrent myocardial infarction were found. However, early (i.e., within 30days) PCI decreased the risk of MACCEs and stroke compared with CABG. In the mixed-treatment comparison models, both CABG and DESs were associated with better survival compared with MTA, but no difference was found between them. In conclusion, in patients with unprotected LMCA disease, PCI with DESs yields similar all-cause and cardiac mortalities compared with CABG. Furthermore, CABG increases early (i.e., within 30days) MACCE rates, driven by an increased risk of stroke. Over longer durations, PCI increases MACCE ratesbecause of increased recurrent revascularization.

Does the new generation of drug-eluting stents render bare metal stents obsolete?

The development of bare metal coronary stents revolutionized the treatment of coronary artery disease by reducing rates of acute vessel closure and restenosis associated with balloon angioplasty. However, bare metal stents (BMS) resulted in high rates of restenosis and led to the development of drug-eluting stents (DES). Those first-generation DES were followed by successive generations of DES that included improvements, such as biodegradable and more biocompatible polymers. Despite the superiority of the current DES compared to BMS, a subset of patients still receives BMS. The following paper reviews the literature comparing the safety and efficacy of newer generation DES to BMS in such patients and ultimately challenges the use of BMS in contemporary current DES era.

Meta-Analysis of Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Coronary Narrowing

Patients with unprotected left main coronary artery (ULMCA) disease are increasingly treated with percutaneous coronary intervention (PCI) using new-generation drug-eluting stents (DES); however, the benefits of DES compared with coronary artery bypass grafting (CABG) in ULMCA remain controversial. This meta-analysis evaluated the effects of PCI with DES compared with CABG for the treatment of ULMCA stenosis. Databases were searched through November 30, 2016. Randomized controlled trials (RCTs) comparing DES with PCI versus CABG for ULMCA stenosis were identified. We calculated summary odds ratios (ORs) and 95% CIs with the random-effects model. The primary outcome was major adverse cardiovascular events, defined as a composite of death from any cause, stroke, or myocardial infarction (MI). The analysis included 4,612 patients from 5 RCTs. Compared with CABG, patients assigned to PCI had a similar rate of major adverse cardiovascular events (OR 1.06, 95% CI 0.79 to 1.43), all-cause mortality (OR 1.03, 95% CI 0.79 to 1.35), cardiovascular death (OR 1.03, 95% CI 0.73 to 1.45), stroke (OR 0.81, 95% CI 0.38 to 1.76), and MI (OR 1.47, 95% CI 0.87 to 2.47). The risk of any repeat revascularization was significantly greater in the PCI group than that in the CABG group (OR 1.85, 95% CI 1.53 to 2.24). In conclusion, our meta-analysis of RCTs suggest that PCI with DESresults in comparable mortality, stroke, and MI compared with CABG for revascularization of ULMCA stenosis, with PCI associated with higher rates of repeat revascularization.

Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients

Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. To assess 5-year safety and efficacy of 2 newer-generation DESs in randomized participants with non-ST-elevation acute coronary syndromes or stable angina and to evaluate long-term outcomes of nonenrolled eligible patients treated with the same DESs. The TWENTE (Real-World Endeavor Resolute vs Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated, patient-blinded, randomized, comparative DES trial that enrolled patients from June 18, 2008, to August 26, 2010. Most patients had non-ST-elevation acute coronary syndromes and complex lesions. Of all 1709 eligible patients, 1391 (81.4%) were treated in the TWENTE trial with zotarolimus-eluting (ZES, n = 697) or everolimus-eluting (EES, n = 694) cobalt-chromium stents. The remaining 318 eligible patients (18.6%) were not enrolled but underwent nonrandomized treatment with the same DESs. Data were analyzed from August 26, 2015, to October 11, 2016. Event rates (percentages) were derived from log-rank analysis and may differ from straightforward calculation (nominator/denominator). The 5-year follow-up of the TWENTE participants was prespecified in the trial protocol; that of the nonenrolled participants was ad hoc. Target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Of 1709 eligible participants, 1233 (72.1%) were men, 476 (27.9%) were women, and mean (SD) age was 64.6 (10.6) years. Among the 1370 of 1391 TWENTE trial participants (98.5% follow-up), TVF was similar between those in the ZES (16.1%) and EES (18.1%) groups (P = .36). Stent thrombosis rates were low: definite (7 of 697 [1.0%] vs 4 of 694 [0.6%]; P = .37) and occurred after more than 1 year in 3 (0.4%) with ZES vs 4 (0.6%) with EES (P = .69). The 318 nonenrolled eligible patients (308 patients [96.9%] of whom were followed up) were older and had more advanced disease than trial participants. Their TVF rate was higher than that of trial participants (71 of 318 [23.3%] vs 233 of 1391 [17.1%]; P = .02), which partly reflects a difference in cardiac mortality (23 of 318 [7.7%] vs 60 of 1391 [4.5%]; P = .03). Similar 5-year rates were found for myocardial infarction (91 of 1391 [6.7%] vs 22 of 318 [7.2%]; P = .80) and target vessel revascularization (129 of 1391 [9.7%] vs 34 of 318 [11.4%]; P = .36) between trial participants and nonenrolled eligible patients. In all eligible patients (ie, trial participants plus nonenrolled eligible patients), the TVF rate was only slightly higher than in trial participants only (18.3% vs 17.1%). Long-term outcome data from nonenrolled eligible patients support the validity of the TWENTE trial findings and present, with the trial, a strong case for the long-term safety and efficacy of the newer-generation DESs used. clinicaltrials.gov Identifier: NCT01066650.

Impact of Chronic Kidney Disease on Clinical Outcomes in Diabetic Patients Undergoing Percutaneous Coronary Intervention in the Era of Newer-Generation Drug-Eluting Stents

Background and ObjectivesChronic kidney disease (CKD) is known to be a major adverse predictor in diabetes mellitus (DM) patients undergoing percutaneous coronary intervention (PCI). It is expected that the use of newer-generation drug-eluting stents (DES) would improve clinical outcomes in these patients. We evaluated the impact of CKD on clinical outcomes in diabetic patients undergoing PCI using newer-generation DES in a real-world setting.Subjects and MethodsA total of 887 patients who underwent PCI with newer-generation DES and who had a history of DM or HbA1c >6.5% at the time of hospitalization were analyzed. These patients were divided into groups without CKD (n=549) and with CKD (n=338). Among survivors at discharge, a patient-oriented composite outcome (POCO) including all-cause mortality, myocardial infarction (MI), and revascularization was evaluated, together with a device-oriented composite outcome (DOCO) including cardiac death, target vessel-related MI, and target lesion revascularization at a follow-up period of one year.ResultsThe incidence of POCO (5.4% vs. 14.0%, log-rank p<0.001) and DOCO (1.1% vs. 4.1%, log-rank p<0.001) was higher in patients with CKD. According to multivariate analysis, which was adjusted for baseline differences in demographic, clinical, and angiographic factors, the presence of CKD was an independent predictor of POCO (hazard ratio [HR]: 1.82, 95% confidence interval [CI]: 1.07 to 3.12), but not of DOCO (HR 2.08, 95% CI: 0.69-6.28).ConclusionIn DM patients, CKD is an independent and powerful predictor of patient-related outcomes, but not of device-related outcomes in the era of newer-generation DES.

A new generation of drug-eluting stents: Indications and outcomes of bioresorbable vascular scaffolds

Drug-eluting stents (DES) are increasingly being used as a less invasive alternative to coronary artery bypass grafting. Early generation DES had durable polymers that provided acceptable efficacy outcomes but had high rates of stent thrombosis leading to myocardial infarction and death. Second-generation DES have improved outcomes by reducing stent thrombosis and recurrent stenosis. Newer DES with biodegradable polymers have similar efficacy as second-generation DES, but have higher rates of stent thrombosis. This review compares outcomes of bioresorbable scaffolds and looks at stent technology developments that may improve outcomes.

Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

ObjectivesThe aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

ST-segment Elevation Myocardial Infarction Resulting from Stent Thrombosis in Contemporary Real-World Practice.

Stent thrombosis (ST) is a rare but devastating complication after percutaneous coronary intervention. Newer generation drug-eluting stents (DES) and newer antiplatelet therapies have been shown to decrease the incidence of ST, but we continue to observe ST-segment elevation myocardial infarction (STEMI) due to ST in contemporary practice. A retrospective analysis of 527 patients who presented with STEMI was performed; 57 patients (11%) with angiographically confirmed ST were compared with the patients with STEMI due to de novo lesion. The type of previous stent, the timing of ST, and the use of antiplatelet therapy were reviewed in patients with ST. Patients with ST had higher prevalence of comorbid conditions, such as hypertension, diabetes mellitus, and coronary artery disease, and had lower left ventricular ejection fraction (37 ± 5 vs. 44 ± 16%, p = 0.0011). There was no difference in in-hospital mortality (2 vs. 4%, p = 0.7082). ST was seen most commonly as "very late" (56%), and with previous second-generation DES (40%). Eighty-two percent of patients among early ST, compared with 22% of patients with very late ST were on dual antiplatelet therapy (DAPT). In 12% of patients, ST happened after DAPT was stopped by physician for procedures. ST is seen in a variety of clinical settings with the most common presentation being very late ST and in second-generation DES, which most likely represent the growing population with previous second-generation stents.

DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial.

Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up. At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted.

Outcomes of Acute Myocardial Infarction Patients Implanted With Biodegradable Polymer Biolimus-Eluting Stents Versus New-Generation Durable Polymer Drug-Eluting Stents: A Retrospective Analysis.

We compared outcomes between biodegradable polymer biolimus-eluting stent (BP-BES) and new-generation durable polymer drug-eluting stent (DP-DES) implantations in patients with acute myocardial infarction (MI). Among 13472 patients with acute MI in a nationwide registry, 557 (64.8%) were in the BP-BES and 303 (35.2%) in the new-generation DP-DES group following coronary reperfusion. The occurrence of major adverse cardiac events (MACE; death, MI, revascularization) and stent thrombosis was compared. Major adverse cardiac events occurred in 53 (6.2%) patients and showed similar rates between the BP-BES and new-generation DP-DES groups (all: 6.6% vs 5.9%, P = .652; propensity score [PS] matched: n = 380, 6.3% vs 5.3%, P = .623). Stent thrombosis did not differ between groups (all: 0.3% vs 0.4%, P = .892; PS matched: 0.5% vs 0.5%, P = 1.000). Major adverse cardiac event-free survival was comparable between groups (all: 93.4% vs 94.1%, log-rank P = .357; PS matched: 93.7% vs 94.7%, log-rank P = .445). Biodegradable polymer biolimus-eluting stent was not associated with MACE (all: hazard ratio [HR], 1.67; 95% confidence interval [CI], 0.75-3.74; P = 0.212; PS matched: HR, 1.05; 95% CI, 0.40-2.75; P = .915). In conclusion, in patients with acute MI, BP-BES was equivalent to the new-generation DP-DES in terms of outcomes.

Impact of Patient and Lesion Complexity on Long-Term Outcomes Following Coronary Revascularization With New-Generation Drug-Eluting Stents

Long-term clinical outcomes of new-generation drug-eluting stents in complex anatomic and clinical settings are not well defined. This study assessed the impact of patient and lesion complexity on 2-year outcomes after coronary revascularization with ultrathin strut biodegradable-polymer (BP) sirolimus-eluting stents (SES) versus durable-polymer (DP) everolimus-eluting stents (EES). In a prespecified analysis of the BIOSCIENCE randomized trial (NCT01443104), complex patients (911 of 2,119; 43%) were defined by the presence of acute ST-elevation myocardial infarction (MI); left ventricular ejection fraction ≤30%; renal dysfunction; insulin-treated diabetes; treatment of ostial lesion, bypass graft, unprotected left main lesion; or 3-vessel intervention. The primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization. At 2years, complex compared with simple patients had a greater risk of TLF (14.5% vs 7.4%, risk ratio 2.05, 95% confidence interval 1.56 to 2.69; p <0.001). The difference was sustained beyond 1year on landmark analysis. Complex patients had higher rates of the patient-oriented composite end point of death, any MI, or any revascularization (23% vs 14.4%; p <0.001) as well as definite stent thrombosis (1.6% vs 0.4%, p= 0.006). There were no differences in TLF and patient-oriented composite end point between the BP-SES versus DP-EES, consistently among simple and complex patients. In conclusion, patient and lesion complexity had a durable adverse impact on clinical outcomes throughout 2years of follow-up in this all-comers randomized trial. Safety and efficacy of new-generation BP-SES and DP-EES were comparable, irrespective of complexity status.

Second-generation drug-eluting stents in the elderly patients with acute coronary syndrome: the in-hospital and 12-month follow-up of the all-comer registry

BackgroundKatowice–Zabrze registry provides data that can be used to evaluate clinical outcomes of percutaneous coronary interventions in elderly patients (≥70 y/o) treated with either first- (DES-I) or second-generation (DES-II) drug-eluting stents (DES).MethodsThe registry consisted of data from 1916 patients treated with coronary interventions using either DES-I or DES-II stents. For our study, we defined patients ≥70 years of age as elderly. We evaluated any major adverse cardiac and cerebral events (MACCE) at 12-month follow-up.ResultsCoronary angiography revealed a higher incidence of multivessel coronary artery disease in this elderly patient population. There were no differences in acute and subacute stent thrombosis (0.4 vs. 0.6%, p = 0.760; 0.4 vs. 0.4%; p = 0.712). Elderly patients experienced more in-hospital bleeding complications requiring blood transfusion (2.0 vs. 0.9%; p = 0.003). Resuscitated cardiac arrests (2.0 vs. 0.9%; p = 0.084) were observed more often in this elderly patients during hospitalization. The composite in-hospital MACCE rates did not differ statistically between both groups (1.4 vs. 1.1%; p = 0.567). Data from a twelve-month follow-up disclosed that mortality was higher (7.1 vs. 1.8%; p < 0.001) in the elderly, with no difference in TVR (7.2 vs. 9.9%, p = 0.075), MI (6.0 vs. 4.8%, p = 0.300), stroke (0.8 vs. 0.6%, p = 0.600) and composite MACCE (15.0 vs. 13.4%, p = 0.324). The age of 70 years or over was an independent predictor of death [HR = 2.55 (95% CI 1.49–4.37); p < 0.001]. The use of DES-II reduced the risk of MI [HR = 0.40 (95% CI 0.19–0.82); p = 0.012] in the elderly.ConclusionThis elderly patient population had an increased risk of in-hospital bleeding complications requiring blood transfusion and a higher risk of death at 12-month follow-up. The use of new-generation DES reduced the risk of MI in the elderly population.

In-Stent Atherosclerosis at a Crossroads: Neoatherosclerosis … or Paleoatherosclerosis?

Accumulating histopathologic and intravascular imaging studies indicate that atherosclerosis development inside a coronary stent is a complication that may be identified as the substrate in a considerable proportion of late/very late stent thrombosis and restenosis cases.1 The frequency of in-stent atherosclerosis-related very late stent thrombosis is similar between early and new-generation drug-eluting stents but with considerably shorter implantation-to-thrombosis interval in the latter.2 Although in-stent atherosclerosis has recently been the subject of continued concern and investigation, the mechanisms of its development remain unknown. The prevailing hypothesis is that it occurs due to the formation of de novo atherosclerosis within the neointima, which has led to the widespread adoption of the term “neoatherosclerosis.” However, the underlying native atherosclerotic plaque might as well contribute to the pathogenesis of this disease entity, a hypothesis largely overlooked in recent reports. Our current understanding of in-stent atherosclerosis derives solely from pathological and retrospective observational clinical studies, which only provide a single snapshot of atherosclerotic lesion evolution. The term “neoatherosclerosis” has been adopted on the assumption that the atherosclerotic tissue within the stent does not communicate with the underlying native atherosclerotic plaque (ie, de novo atherosclerosis). However, whereas in autopsy studies it may be feasible to identify lesions without evidence of direct communication between the …

Association Between Duration of Dual Antiplatelet Therapy and Angiographic Multivessel Disease on Outcomes in Patients Treated With Newer-Generation Drug-Eluting Stents.

There is general agreement that the optimal duration of dual antiplatelet therapy (DAPT) in patients treated with drug-eluting stents should be individualized. We hypothesized that the extent of coronary artery disease may affect the clinical outcomes of DAPT. We pooled patient-level data from 5 large, randomized trials comparing short-term DAPT with prolonged therapy. From the data, we identified 5476 patients who received newer-generation drug-eluting stents. Net adverse clinical event (NACE) was defined as a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding. At 1 year, NACE had occurred in 171 patients (3.1%). Independent predictors of NACE were older age (>65 years), sex, presence of diabetes mellitus, left ventricular dysfunction (ejection fraction <40%), and angiographic multivessel disease. Multivessel disease and DAPT duration were significantly associated with NACE (P for interaction=0.002); the association was driven by the greater occurrence of myocardial infarction in patients with multivessel disease. In patients with multivessel disease, 6-month DAPT (versus 12-month DAPT) was associated with a higher incidence of myocardial infarction (adjusted hazard ratio=2.748; 95% confidence interval=1.375-5.491; P=0.004), compared with patients with single-vessel disease (P for interaction=0.001). In patients treated with newer-generation drug-eluting stents, a significant interaction between DAPT strategy and multivessel disease was found regarding the occurrence of NACE at 1 year. Among adverse events, myocardial infarction was more frequent in 6-month DAPT than in 12-month DAPT in patients with multivessel disease.