2nd Generation Drug-eluting Stent Research Articles

The prognosis of acute myocardial infarction due to stent thrombosis after 2nd generation drug eluting stents era (comparative study with acute myocardial infarction due to plaque rupture or erosion)

Abstract Backgrounds Stent thrombosis (ST) is a rare complication after percutaneous coronary intervention (PCI), and more than 70% of ST cases result in acute myocardial infarction (AMI). Although a new generation of drug-eluting stents (DES) and newer antiplatelet therapies have been shown to reduce the incidence of ST, ST-related AMI continues to be observed in contemporary practice. The prevalence and prognosis of ST results in AMI have not been well evaluated after the 2nd generation DES (G2-DES) era. Purpose The purpose of this study was to evaluate the prevalence and prognosis of AMI due to ST after the G2-DES era compared with AMI due to plaque rupture or erosion. Methods Among 6601 AMI patients enrolled in the Mie ACS registry from January 2013 to November 2022, 6273 AMI patients with AMI due to ST(ST) and AMI due to plaque rupture and erosion (AMI:P) were included for this analysis after excluding other types of AMI. ST was confirmed by angiography. The primary endpoint was defined as all-cause mortality, and revascularization after PCI for AMI was also evaluated. Results Seventy-eight patients, or 1.2% of all AMI in this study, had AMI due to ST, including early ST n=13 (16.7%), late ST n=4 (5.1%), and very late ST n=61 (78.2%). Stent types were G2-DES n=35 (44%), G1-DES n=18 (23.1%), bare metal stent (BMS) n=12 (15.4%), and unknown n=13 (16.7%). According to the KM survival curve, the 30-day mortality rate of ST was 2.6%, while the AMI:P rate was 6.7%, which was not statistically significant, but the ST was half the mortality rate. Furthermore, in the landmark analysis, the 2-year mortality rates were 6.2% for ST and 7.0% for AMI:P (P=0.66, Figure 1). ST was not an independent predictor of poor prognosis by multivariate Cox regression analysis. Even after the propensity score matching analysis as a sensitivity analysis, ST was not an independent predictor of poor prognosis in AMI patients. Among ST patients, 82.2% were treated with balloon angioplasty (without additional stenting) at the time of AMI, whereas 9.7% of AMI:P patients were treated with balloon angioplasty (P<0.001). Compared to patients with AMI:P, patients with ST had a higher incidence of revascularization after PCI for AMI within 2 years (21.8% vs. 11.2%; P=0.02, Figure 2A). Multivariate Cox regression analysis also showed that ST was an independent predictor of revascularization after PCI for AMI with a hazard ratio of 2.00 (P<0.01, Figure 2B). Conclusion The prognosis of ST patients tended to be better than that of AMI:P patients. The proportion of ST in AMI has decreased in the G2-DES era, and the higher proportion of VLST in ST suggests that its prognosis may be better than that of AMI:P . However, the rate of revascularization is higher in ST patients because stenting was not performed in the acute phase of PCI for AMI, and the appropriate use of stents depending on the type of ST may lead to a reduction in revascularization.Figure1Figure2

Comparison of clinical outcomes in diabetic and non-diabetic patients undergoing coronary bifurcation stenting

Abstract Background Diabetes mellitus (DM) is a well-known risk factor for cardiovascular diseases, including coronary artery diseases (CAD). Due to poor post-intervention outcomes, bypass surgery is often recommended in preference to percutaneous coronary intervention (PCI) in DM patients with complex scenarios, such as bifurcation lesions. Methods In this retrospective, multicentre, observational, real-world registry of 2,648 patients with coronary bifurcation lesions undergoing PCI with 2nd-generation drug-eluting stents (DES), the effect of DM on cardiovascular outcomes was analysed. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, and stroke, at 5 years. The adjusted outcomes were compared using 1:1 propensity score (PS) matching. Results Overall, DM patients were more likely to be older, female, and have hypertension or chronic kidney disease. In the PS-matched cohort, the cumulative incidence of the primary outcome was numerically higher in the DM group, but without statistical significance (7.9% vs. 5.5%, log-rank p=0.276). Secondary outcomes including all-cause mortality (5.5% vs. 3.9%, log-rank p=0.090) and cardiac mortality (3.2% vs. 1.8%, log-rank p=0.060) were also comparable between the two groups. Conclusion For patients with coronary bifurcation lesions undergoing contemporary PCI, the outcomes were comparable for DM and non-DM patients. Bifurcation PCI can thus be successfully performed in diabetic patients with 2nd-generation DES.

Long-term clinical impact of routine follow-up coronary angiography of asymptomatic patients after complex percutaneous coronary intervention in the drug-eluting stent era

Abstract Background Drug-eluting stent (DES) implantation has become the standard for treating coronary artery disease (CAD). While routine follow-up coronary angiography (FUCAG) post-percutaneous coronary intervention (PCI) is not recommended in the 2nd generation DES era, its efficacy and necessity in complex PCI remains unclear. This study aims to investigate the utility of FUCAG after complex PCI. Methods From 2014 to 2020, a study was conducted on patients at our university medical center who underwent complex PCI. Out of a total of 4,098 individuals, after excluding 848 individuals with a follow-up period of less than 4 years and 288 individuals who experienced an event within a year, a total of 2,962 was enrolled. Follow-up coronary angiography (FUCAG) was defined as angiography performed between 6- and 18-months post-index PCI for lesion evaluation. To adjust for any differences in baseline characteristics between the groups, propensity score matching (PSM) was implemented. The primary outcome was defined as Major Adverse Cardiac Events (MACE), comprising all-cause death, myocardial infarction, and target-lesion revascularization. Results PSM was conducted to correct the difference in baseline characteristics between the two groups. In the Kaplan-Meier analysis, there was no difference between FUCAG and clinical follow-up for MACE (Log-rank: P=0.410). Cox proportional regression analysis revealed a hazard ratio (HR) of 0.55 with a 95% confidence interval (CI) of 0.64-1.27, indicating no statistically significant difference. Conclusions In our study, FUCAG did not demonstrate a clinical benefit in patients who underwent complex PCI compared to clinical follow-up. Therefore, clinical follow-up may be considered post-PCI surveillance after complex PCI.

Long-term outcomes following ultrathin vs thin-strut drug-eluting stents for percutaneous coronary intervention: an updated systematic review and meta-analysis of randomized control trials.

Current thin-strut 2nd generation drug eluting stents (DES) are considered as optimal standard of care for revascularization of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). Ultrathin (≤ 70 μm strut thickness) strut DES have recently been shown to reduce target lesion failure (TLF) compared to thin-strut DES. Therefore, in order to assess the validity of improved outcomes associated with ultrathin-strut DES, we conducted an updated meta-analysis that includes recently published follow-ups of previously conducted randomized controlled trials (RCTs). MEDLINE and Scopus were queried from their inception to May 2024 to identify studies comparing outcomes between ultrathin and current thin-strut 2nd generation DES groups. A random-effects meta-analysis was conducted to derive risk ratios (RR) from dichotomous data. The primary endpoint was long-term TLF defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR). The secondary outcome was target-vessel failure (TVF) defined as a composite of cardiac death, TV-MI and clinically driven target-vessel revascularization (CD-TVR). A total of 17 RCTs (n=22141) with a mean follow-up of 34 months were included. The risk of TLF was significantly lowered in the ultrathin DES group in comparison to thin-strut DES. A significant decrease was also noted in rates of TVF, CD-TLR and CD-TVR in the ultrathin DES vs thin-strut DES group. The results of our analysis demonstrate a significantly reduced risk of TLF in the ultrathin DES group in comparison with thin-strut DES. Ultrathin DES was also associated with a significantly decreased risk of TVF, CD-TLR and CD-TVR.

Circulating intermediate monocytes CD14++CD16+ are increased after elective percutaneous coronary intervention

Aim Inflammation plays a central role in the pathogenesis of atherosclerosis and in the sequelae of percutaneous coronary intervention (PCI). Previous work demonstrated that intermediate monocytes (CD14++CD16+) are associated with adverse cardiovascular events, yet monocyte subset response following elective PCI has not been described. This article explores the changes in monocyte subset and humoral response after elective PCI. Methods This prospective study included 30 patients without inflammatory diseases being referred for elective PCI. We included patients treated with drug coated balloons or 2nd generation drug eluting stents. Patients underwent blood tests at baseline (prior to PCI), four hours, two weeks and two months later. Analyses were performed in terms of monocyte subsets (classical CD14++CD16-, intermediate CD14++CD16+ and non-classical CD14+CD16++), gene expression of CD14+ leucocytes and humoral biomarkers. Results Intermediate monocytes decreased significantly four hours after PCI, were recovered at two weeks, and increased significantly at two months post elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group. Gene expression analysis of CD14+ leucocytes showed IL18 had decreased expression at two weeks, CXCR4 and IL1β decreased at two months, while pentraxin 3 increased at two weeks and two months. In terms of humoral biomarkers, hsTnI remains elevated up to two weeks post PCI while IL6 and TNFα remain elevated till two months post PCI. Conclusion Intermediate monocytes increase significantly two months following elective, uncomplicated PCI. They remain significantly elevated in the DES group but not in the DCB group suggesting that the PCI strategy could be one of the ways to modulate the inflammatory response post PCI.

A novel scoring system devised by an international large-scale coronary bifurcation registry to guide the optimal choice between the 1- and 2-stent strategy: the BIFURCAT Two-Stent (BTS) score

Abstract Background and Aims Previous studies used predefined criteria to evaluate the outcomes of two stents over one stent. We sought to devise a scoring system based on data-driven criteria for the guiding the optimal choice between two approaches. Methods We analyzed an international coronary bifurcation cohort with 2nd-generation drug-eluting stents, the combined insights from the unified RAIN and COBIS bifurcation registries (BIFURCAT) registry. The primary endpoint was major adverse cardiac events (MACE), a composite of death, myocardial infarction, and target lesion failure. Results We analyzed 5333 patients (mean age: 66.2 years; male: 76%; 1-stent: 82%). We found one clinical and five angiographic factors associated with lower MACE risk when two stents were implanted compared with one. We assigned one point per each component the patient was positive for and defined this as the BIFURCAT Two-Stent (BTS) score. The 2-stent strategy was associated with significantly higher MACE rate in the total patient cohort (HR: 1.49; 95% CI: 1.19-1.87; P<0.001) and BTS score<4 (HR: 2.04; 95% CI: 1.64-2.56; P<0.001). However, the two stents had a lower chance of MACE in BTS score≥4 (HR: 0.56; 95% CI: 0.35-0.89; P=0.014) with or without adjustment for baseline and procedural characteristics and antiplatelet therapy. Conclusions Approximately 80% of the patients had low (<4) BTS score that showed favorable outcomes with the 1-stent strategy. However, those with high BTS scores (≥4) proved favorable outcomes with the 2-stent strategy. The BTS score may be able to guide interventionists to select an optimal stenting strategy in bifurcation lesions.

The Impact of Gender on In-Hospital Outcome after Elective Percutaneous Coronary Intervention: A Comparative Single Center Audit

Background: In the literatures, there is still argument regarding whether female gender is correlated with worse outcome following percutaneous coronary intervention (PCI). In recent years, using of PCI has steadily increased in Yemen. However, the impact of gender on the clinical outcome following PCI with 2nd generation drug-eluting stents is still unknown in Yemeni patients.

Relationship between stent length and very long-term target lesion failure following percutaneous coronary intervention for ST-elevation myocardial infarction in the drug-eluting stents era: insights from the EXAMINATION-EXTEND study

Little data exist on the relationship between total stent length (TSL) and cardiovascular outcomes at very-long follow-up in patients with ST-elevation myocardial infarction (STEMI) in the 2nd generation drug-eluting stents (DES) era. To analyze the relationship between TSL and 10-year target-lesion failure (TLF) in STEMI patients treated with percutaneous coronary intervention enrolled in the EXAMINATION-EXTEND. The EXAMINATION-EXTEND was an extended-follow-up study of the EXAMINATION trial, which randomized 1:1 STEMI patients to receive DES or bare metal stent (BMS). The primary endpoint was TLF, defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TVMI), or definite/probable stent thrombosis (ST). Relationship between stent length and TLF was evaluated in the whole study group in a multiple-adjusted Cox regression model with TSL as a quantitative variable. Subgroup analysis was also performed according to stent type, diameter, and overlap. A total of 1,489 patients with a median TSL of 23 mm (Q1-Q318-35 mm) were included. TSL was associated with TLF at 10 years (adjusted HR per 5 mm increase of 1.07; 95% CI, 1.01-1.14; P=.02). This effect was mainly driven by TLR and was consistent regardless of stent type, diameter, or overlap. There was no significant relationship between TSL and TV-MI or ST. In STEMI patients, there is a direct relationship between TSL implanted in the culprit vessel and the risk of TLF at 10 years, mainly driven by TLR. The use of DES did not modify this association.

1127 APPLICABILITY OF THE EXCEL TRIAL CRITERIA IN AN ALL-COMERS REAL-WORLD POPULATION OF UNPROTECTED LEFT MAIN PCI

Abstract Background The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest randomized trial comparing percutaneous coronary intervention (PCI) with 2nd generation drug eluting stents (DES) and bypass surgery in unprotected left main disease (ULMD). Our aim was to assess which proportion of patients from a contemporary all-comers population of ULMD-PCI would be eligible for the EXCEL trial and whether these patients showed different short- and long-term outcomes than the rest of the population. Methods and results A total of 246 consecutive patients that underwent ULMD-PCI between January 2018 and December 2021, were retrospectively analyzed. After application of the EXCEL trial inclusion ed exclusion criteria, 98 patients (38.9%) were allocated in the "Excel-like" cohort and 148 in the "Non-Excel-like". Baseline characteristics of the two groups were substantially comparable. Mean baseline Syntax Score (SS) was significantly lower in the "Excel-like" patients (Excel 20.1 ± 7.1 VS Non-Excel 23.0 ± 11.2; p-value = 0.025) than the "Non-Excel-like" group with the latter showing also a higher degree of incomplete revascularization (rSS >8: Excel 11.2%.VS Non-Excel 25.7%; p-value 0.005). At 1 year the cumulative major adverse cardiovascular and cerebral events (MACCEs) rates were 7.2% and 17.2% for the "Excel-like" and "Non-Excel-like" patients respectively (Log-rank p-value = 0.03). At last follow-up available the significant difference in MACCEs rate persisted (Excel 19.3%, VS Non-Excel 37%, Log-rank p-value 0.02) and a significant difference in any unplanned revascularization was also shown (Excel 1.5% VS Non-Excel 12.6%; p-value 0.04). Conclusions in a contemporary real-world cohort of ULMD-PCI only a minority of the patients could be enrolled in the EXCEL trial. This cohort of patients showed a more extensive revascularization and less clinical events at long-term follow-up despite comparable burden of cardiovascular risk factors and atherosclerotic coronary disease. These findings "challenge" the external applicability of the results of the Excel trial in the routine clinical activity.

Random forest vs. logistic regression: Predicting angiographic in-stent restenosis after second-generation drug-eluting stent implantation.

As the rate of percutaneous coronary intervention increases, in-stent restenosis (ISR) has become a burden. Random forest (RF) could be superior to logistic regression (LR) for predicting ISR due to its robustness. We developed an RF model and compared its performance with the LR one for predicting ISR. We retrospectively included 1501 patients (age: 64.0 ± 10.3; male: 76.7%; ISR events: 279) who underwent coronary angiography at 9 to 18 months after implantation of 2nd generation drug-eluting stents. The data were randomly split into a pair of train and test datasets for model development and validation with 50 repeats. The predictive performance was assessed by the area under the curve (AUC) of the receiver operating characteristic (ROC). The RF models predicted ISR with larger AUC-ROCs of 0.829 ± 0.025 compared to 0.784 ± 0.027 of the LR models. The difference was statistically significant in 29 of the 50 repeats. The RF and LR models had similar sensitivity using the same cutoff threshold, but the specificity was significantly higher in the RF models, reducing 25% of the false positives. By removing the high leverage outliers, the LR models had comparable AUC-ROC to the RF models. Compared to the LR, the RF was more robust and significantly improved the performance for predicting ISR. It could cost-effectively identify patients with high ISR risk and help the clinical decision of coronary stenting.

Angiographic complete revascularization versus incomplete revascularization in patients with diabetes mellitus

BackgroundConsidering the nature of diabetes mellitus (DM) in coronary artery disease, it is unclear whether complete revascularization is beneficial or not in patients with DM. We investigated the clinical impact of angiographic complete revascularization in patients with DM.MethodsA total of 5516 consecutive patients (2003 patients with DM) who underwent coronary stenting with 2nd generation drug-eluting stent were analyzed. Angiographic complete revascularization was defined as a residual SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) score of 0. The patient-oriented composite outcome (POCO, including all-cause death, any myocardial infarction, and any revascularization) and target lesion failure (TLF) at three years were analyzed.ResultsComplete revascularization was associated with a reduced risk of POCO in DM population [adjusted hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.52–0.93, p = 0.016], but not in non-DM population (adjusted HR 0.90, 95% CI 0.69–1.17, p = 0.423). The risk of TLF was comparable between the complete and incomplete revascularization groups in both DM (adjusted HR 0.75, 95% CI 0.49–1.16, p = 0.195) and non-DM populations (adjusted HR 1.11, 95% CI 0.75–1.63, p = 0.611). The independent predictors of POCO were incomplete revascularization, multivessel disease, left main disease and low ejection fraction in the DM population, and old age, peripheral vessel disease, and low ejection fraction in the non-DM population.ConclusionsThe clinical benefit of angiographic complete revascularization is more prominent in patients with DM than those without DM after three years of follow-up. Relieving residual disease might be more critical in the DM population than the non-DM population.Trial registration The Grand Drug-Eluting Stent registry NCT03507205.

Safety and Efficacy of Modern Stents in Patients with Metabolic Syndrome

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE.

Late Catch-up In-Stent Restenosis and Stent Thrombosis for 2nd Generation Biodegradable Polymer Drug Eluting Stents

Second generation drug-eluting stents (DES) have reduced the rate of in-stent restenosis (ISR) to < 10% [1, 2] in patients undergoing PCI. However, late catch-up in-stent restenosis remains an issue despite the advent in drug-eluting stent technology from 1st to 2nd generation drug eluting stents. The late catch-up phenomenon has been associated with serious consequences and adverse events and remains an important issue in modern practice, despite medical advances with more biocompatible and biodegradable polymers, as well as new therapeutic agents and thinner scaffolds in the development of 2nd generation DES polymer systems. The idea behind biodegradable polymers has been to provide a more controlled elution profile for DES drugs, allowing for long-term therapeutic, but sub-toxic, drug levels in the arterial tissue to prevent ISR and stent thrombosis. However, the late catch-up phenomenon remains an issue resulting in 2ndary revascularization beyond the first year of primary PCI, as it is defined as ISR >1 year. Late stent thrombosis (<1 year) and very late stent thrombosis (>1 year) also remain an issue for biodegradable polymer systems. A long-term presence of the polymer can cause inflammation and thrombogenesis, which is dependent upon polymer degradation kinetics in case of biodegradable polymer DES systems. However, the cause of late catch-up restenosis and stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective of drug release kinetics, e.g., drug elution profile, drug physiochemical properties, and polymer degradation kinetics. It appears that the focus should be on controlling burst release for both late catch-up restenosis and stent thrombosis phenomena.

Abstract 9972: Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings from the EXTEND-DAPT Study

Introduction: Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. Objectives: To evaluate whether the Dual Antiplatelet Therapy (DAPT) Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention (PCI), and to estimate the treatment effect of extended duration antiplatelet therapy after PCI in this more contemporary cohort. Methods: We compared characteristics of drug-eluting stent (DES)-treated patients randomized in the DAPT Study to a sample of more contemporary DES-treated patients in the NCDR CathPCI Registry from July 2016-June 2017. After linking trial and registry data, we employed inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary “real-world” treatment effect of 30 vs. 12 months of DAPT after coronary stent procedures. Results: The US DES-treated trial cohort included 8864 DAPT Study patients and the registry cohort included 568,540 patients. Compared to the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd generation DES. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40, 95% CI: -0.99%, 0.15%), MACCE ( reweighted treatment effect: -0.52, 95% CI: -2.62%, 1.03%), or MI (reweighted treatment effect: -0.97%, 95% CI: -2.75%, 0.18%), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect: 2.42%, 95% CI: 0.79%, 3.91%). Conclusions: Differences between patients and devices used in contemporary clinical practice compared with the DAPT Study may be associated with attenuation of benefits and relatively greater harms attributable to prolonged DAPT duration. These findings may limit applicability of average treatment effects from the DAPT Study in modern clinical practice.

Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings From the EXTEND-DAPT Study.

Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. The DAPT Study (Dual Antiplatelet Therapy) found that longer-duration DAPT decreased ischemic events at the expense of greater bleeding, but subsequent evolution in stent technology and clinical practice may attenuate the benefit of prolonged DAPT in a contemporary population. We evaluated whether the DAPT Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention and estimated the treatment effect of extended-duration antiplatelet therapy after percutaneous coronary intervention in this more contemporary cohort. We compared the characteristics of drug-eluting stent-treated patients randomly assigned in the DAPT Study to a sample of more contemporary drug-eluting stent-treated patients in the National Cardiovascular Data Registry CathPCI Registry from July 2016 to June 2017. After linking trial and registry data, we used inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary real-world treatment effect of 30 versus 12 months of DAPT after coronary stent procedures. The US drug-eluting stent-treated trial cohort included 8864 DAPT Study patients, and the registry cohort included 568 540 patients. Compared with the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd-generation drug-eluting stents. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40 [95% CI, -0.99% to 0.15%]), major adverse cardiac and cerebrovascular events (reweighted treatment effect, -0.52 [95% CI, -2.62% to 1.03%]), or myocardial infarction (reweighted treatment effect, -0.97% [95% CI, -2.75% to 0.18%]), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect, 2.42% [95% CI, 0.79% to 3.91%]). The differences between the patients and devices used in contemporary clinical practice compared with the DAPT Study were associated with the attenuation of benefits and greater harms attributable to prolonged DAPT duration. These findings limit the applicability of the average treatment effects from the DAPT Study in modern clinical practice.

Comparison of 2-Stenting Strategies Depending on Sequence or Technique for Bifurcation Lesions in the Second-Generation Drug-Eluting Stent Era - Analysis From the COBIS (Coronary Bifurcation Stenting) III Registry.

It has not been determined which specific 2-stenting strategy is the best for bifurcation lesions. Our aim was to investigate the clinical outcomes of various 2-stenting strategies in the era of 2nd-generation drug-eluting stents (2G-DES). We analyzed 454 patients who finally underwent 2-stenting for a bifurcation lesion, from among 2,648 patients enrolled in the COBIS III registry. The primary outcome was target lesion failure (TLF). Patients were analyzed according to stenting sequence (provisional [main vessel stenting first] vs. systemic [side branch stenting first]) and stenting technique (crush vs. T vs. culotte vs. kissing/V stenting). Overall, 4.4 years' TLF after 2-stenting treatment for bifurcation lesion was excellent: TLF 11.2% and stent thrombosis 1.3%. There was no difference in TLF according to 2-stenting strategy (11.1% vs. 10.5%, P=0.990 for provisional and systemic sequence; 8.6% vs. 14.4% vs. 12.9% vs. 12.2%, P=0.326 for crush, T, culotte, kissing/V technique, respectively). Only left main (LM) disease and a shorter duration of dual antiplatelet therapy (DAPT) were associated with TLF. The distribution of DAPT duration differed between patients with and without TLF, and the time-point of intersection was 2.5 years. Also, the side branch was the most common site of restenosis. The stenting sequence or technique did not affect clinical outcomes, but LM disease and shorter DAPT were associated with TLF, in patients with bifurcation lesions undergoing 2-stenting with 2G-DES.

Factors Influencing 1st and 2nd Generation Drug-Eluting Stent Performance: Understanding the Basic Pharmaceutical Drug-in-Polymer Formulation Factors Contributing to Stent Thrombosis Do We Really Need to Eliminate the Polymer?

Drug-eluting stents (DES) have a major role in treating cardiovascular disease. The evolution of bare metal stents into 1st generation durable-polymer DES (DP-DES) reduced the rate of in-stent restenosis (ISR) and the need for repeat-revascularization. However, clinical outcomes showed similar rates of late stent thrombosis (ST<1 year) and higher rates of very late stent thrombosis (ST>1 year) necessitating the advent of 2nd generation more biocompatible polymer DES and biodegradable-polymer DES (BP-DES) that reduced ST rates with shorter dual anti-platelet therapy (DAPT). Despite the improvements in drugs and polymer biocompatibility for both durable and biodegradable polymers, stent thrombosis remains an issue. Doubts remain about the safety and efficacy of the more biocompatible 2nd generation durable polymers in respect to vessel inflammatory and thrombogenic response as compared to biodegradable polymers despite clinical trial and meta-analyses evidence indicating that 2nd generation DP-DES are non-inferior to BP-DES for stent thrombosis. A long-term presence of the polymer can cause inflammation and thrombogenesis. However, the cause of stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective; e.g., drug release kinetics, drug physiochemical and pharmacological properties, degradation kinetics; polymer biocompatibility and hemocompatibility and coating properties. It appears that the focus should be on controlling burst release and developing more biocompatible, durable polymers, especially considering the cost of PCI utilizing biodegradable, polymer-free and bioresorbable scaffolds. This may give an insight into certain DP-DES effectiveness as compared to BP-DES for the existing clinical data and improve future stent development.

Assessment of utility values and QALYs after primary PCI with DP-Xience and BP-Biomatrix stents.

BackgroundPrimary percutaneous coronary intervention (PPCI) is the recommended treatment in ST elevated myocardial infarction (STEMI). The determination of Quality of life (QoL) for various options of coronary revascularization is important for establishment of a comprehensive care plan. Studies of QoL in interventional cardiology are scarce. Our study has compared utility scores and quality adjusted life year (QALY) of 2nd and 3rd generation drug eluting stents (DES).MethodsAn observational cohort study was conducted to evaluate QoL and QALY using EQ-5D-5L questionnaire. Patients undergoing PPCI between July-Dec 2019 were evaluated after completion of one year of procedure.ResultsTotal 334 patients were evaluated, study population consisted of a greater number of males (87.13%) than females. Mean utility value was more in 3rd G Biomatrix stents; 0.829 ± 0.11 than 2nd G Xience stents; 0.794 ± 0.11 (p < 0.05). Visual analogue scale (VAS) value was also high in 3rd G DES (81.84 ± 8.29) as compared to 2nd G DES (77.81 ± 9.01); p< 0.05. A significant association was found between utility scores/VAS and age, DM, HTN, Current smoking, family history and CAD diagnosis. There was a gain of 0.035 QALY with the use of Biomatrix DES.ConclusionHealth related quality of life (HRQOL) is a leading support in the decision making of therapeutic interventions. Our study has found that Biodegradable polymer (BP) Biomatrix DES are superior to the Durable polymer (DP) Xience DES having better QoL and QALY.

Long-term follow-up after ultrathin vs. conventional 2nd-generation drug-eluting stents: a systematic review and meta-analysis of randomized controlled trials.

Contemporary 2nd-generation thin-strut drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. A previous meta-analysis of 10 randomized controlled trials (RCTs) with 11658 patients demonstrated a 16% reduction in the 1-year risk of target lesion failure (TLF) with ultrathin-strut DES compared with conventional 2nd-generation thin-strut DES. Whether this benefit is sustained longer term is not known, and newer trial data may inform these relative outcomes. We therefore sought to perform an updated systematic review and meta-analysis of RCTs comparing clinical outcomes with ultrathin-strut DES (≤70 µm strut thickness) with conventional 2nd-generation thin-strut DES. We performed a random-effects meta-analysis of all RCTs comparing ultrathin-strut DES to conventional 2nd-generation thin-strut DES. The pre-specified primary endpoint was long-term TLF, a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included the components of TLF, stent thrombosis (ST), and all-cause death. There were 16 eligible trials in which 20701 patients were randomized. The weighted mean follow-up duration was 2.5 years. Ultrathin-strut DES were associated with a 15% reduction in long-term TLF compared with conventional 2nd-generation thin-strut DES [relative risk (RR) 0.85, 95% confidence interval (CI) 0.76-0.96, P = 0.008] driven by a 25% reduction in CD-TLR (RR 0.75, 95% CI 0.62-0.92, P = 0.005). There were no significant differences between stent types in the risks of MI, ST, cardiac death, or all-cause mortality. At a mean follow-up of 2.5 years, ultrathin-strut DES reduced the risk of TLF, driven by less CD-TLR compared with conventional 2nd-generation thin-strut DES, with similar risks of MI, ST, cardiac death, and all-cause mortality.

Comparison of Endothelial Dysfunction in Coronary Arteries with Bare Metal and 2nd-Generation Drug-Eluting Stents.

Aims: Previous studies suggested that implantation with a 1st-generation DES was associated with coronary endothelial dysfunction, which was associated with Rho-kinase activation. Second-generation drug-eluting stents (DESs) may preserve coronary endothelial function in stented coronary arteries; however, because of methodological limitations, further study is needed to clarify the association between 2 nd -generation DESs and coronary endothelial dysfunction. Methods: We retrospectively analysed the CuVIC trial database, where we identified 112 patients who underwent coronary stenting in the left coronary arteries with either a bare metal stent (BMS, n =53) or 2 nd -generation DES ( n =59). We compared vasomotions of target vessels with stents and non-target vessels without stents. Furthermore, we measured the Rho-kinase activation detected in mononucleocytes from aortic and coronary sinus blood. Results: ACh-induced vasoconstrictive responses of target vessels were not enhanced with a 2 nd -generation DES (45±21% vs. 44±20%, P =0.56, paired t -test), but significantly enhanced in the coronary arteries with a BMS (50±18% vs. 42±20%, P =0.002). Rho-kinase activation did not differ between patients with a BMS and 2 nd -generation DES. In the target vessels with a BMS, large late lumen loss and acute coronary syndrome (ACS) at the index percutaneous coronary intervention (PCI) were associated with ACh-induced enhanced coronary vasoconstrictive responses. Conclusions: Evaluation of ACh-induced vasomotion of target vessels comparing with non-target vessels revealed that 2 nd -generation DESs were not associated with coronary endothelial dysfunction in target vessels, nor activation of Rho-kinase in the coronary sinus blood 6-8 months after stenting.