Drug-eluting Stent Implantation In Patients Research Articles

Early vascular healing after neXt-generation drug-eluting stent implantation in Patients with non-ST elevation acute Coronary syndrome: a randomized optical coherence Tomography imaging study (EXPECT).

Early vascular healing after drug-eluting stent (DES) implantation is associated with better outcomes and lower incidence of in-stent thrombosis. To examine vascular healing response in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) guided by optical coherence tomography (OCT) versus angiography alone. Sixty patients were randomized 1:1:1 to OCT-guided PCI with 3-month OCT follow-up (O3 group, n = 20), angiography-guided PCI with 3-month OCT follow-up (A3 group, n = 20), or angiography-guided PCI with 6-month OCT follow-up (A6 group, n = 20). The primary endpoint was the proportion of covered struts at 3- or 6-month follow-up. The proportion of covered struts in the O3 group was significantly higher than in the A3 group (95.2% vs. 92.3%, p < 0.001), but lower than in the A6 group (95.2% vs. 97.4%, p < 0.001). The O3 group had a lower proportion of incomplete strut apposition (ISA) than the A3 group (0.46% vs. 0.76%, p = 0.006), and higher than the A6 group (0.46% vs. 0.27%, p = 0.018) at follow-up. The optimal cut-off value of ISA after implantation of DES for predicting stent coverage at 3 and 6-month follow-up was 200μm and 308μm, respectively. Only one patient experienced target lesion revascularization in the A3 group during a 3-year clinical follow-up. In patients with NSTE-ACS undergoing PCI with DES, OCT guidance achieved higher strut coverage compared with angiography guidance at 3-month follow-up. However, the difference in the strut coverage between the OCT-guided group and the angiography-guided group at 6 months indicates that the degree of endothelialization may be more time-dependent instead of invasive device guidance.

Predicting Individual Treatment Effects to Determine Duration of Dual Antiplatelet Therapy After Stent Implantation.

After coronary stent implantation, prolonged dual antiplatelet therapy (DAPT) increases bleeding risk, requiring personalization of DAPT duration. The aim of this study was to develop and validate a machine learning model to predict optimal DAPT duration after contemporary drug-eluting stent implantation in patients with coronary artery disease. The One-Month DAPT, RESET (Real Safety and Efficacy of 3-Month Dual Antiplatelet Therapy Following Endeavor Zotarolimus-Eluting Stent Implantation), and IVUS-XPL (Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesion) trials provided a derivation cohort (n=6568). Using the X-learner approach, an individualized DAPT score was developed to determine the therapeutic benefit of abbreviated (1-6 months) versus standard (12-month) DAPT using various predictors. The primary outcome was major bleeding; the secondary outcomes included 1-year major adverse cardiac and cerebrovascular events and 1-year net adverse clinical events. The risk reduction with abbreviated DAPT (3 months) in the individualized DAPT-determined higher predicted benefit group was validated in the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-Eluting Stent for Acute Coronary Syndrome) trial (n=3056), which enrolled patients with acute coronary syndrome treated with ticagrelor. The validation cohort comprised 1527 abbreviated and 1529 standard DAPT cases. Major bleeding occurred in 25 (1.7%) and 45 (3.0%) patients in the abbreviated and standard DAPT groups, respectively. The individualized DAPT score identified 2582 (84.5%) participants who would benefit from abbreviated DAPT, which was significantly associated with a lower major bleeding risk (absolute risk difference [ARD], 1.26 [95% CI, 0.15-2.36]) and net adverse clinical events (ARD, 1.59 [95% CI, 0.07-3.10]) but not major adverse cardiac and cerebrovascular events (ARD, 0.63 [95% CI, -0.34 to 1.61]), compared with standard DAPT in the higher predicted benefit group. Abbreviated DAPT had no significant difference in clinical outcomes of major bleeding (ARD, 1.49 [95% CI, -1.74 to 4.72]), net adverse clinical events (ARD, 2.57 [95% CI, -1.85 to 6.99]), or major adverse cardiac and cerebrovascular events (ARD, 1.54 [95% CI, -1.26 to 4.34]), compared with standard DAPT in the individualized DAPT-determined lower predicted benefit group. Machine learning using the X-learner approach identifies patients with acute coronary syndrome who may benefit from abbreviated DAPT after drug-eluting stent implantation, laying the groundwork for personalized antiplatelet therapy.

Novel insights on dual antiplatelet therapy duration following stenting for angiography-detected moderate-to-severe calcified coronary lesions

Dual antiplatelet therapy (DAPT), comprising both aspirin and the P2Y12 receptor inhibitor, is crucial in managing patients with coronary artery disease following percutaneous coronary intervention (PCI). The optimal duration for DAPT in patients with angiography-detected moderate-to-severe calcified coronary (MSCC) lesions who underwent PCI with drug-eluting stents (DES) implantation remains uncertain. We recruited patients with angiography-detected MSCC lesions who received DES implantation from the prospective Fuwai Percutaneous Coronary Intervention Registry. Patients were classified into two groups according to the duration of DAPT: those with a DAPT duration of one year or less, and those with a DAPT duration of more than one year. The primary endpoint was the major adverse cardiovascular and cerebrovascular event, which was defined as composed of all-cause death, nonfatal myocardial infarction, or nonfatal stroke. The key-safety endpoint was bleeding type 2, 3, or 5 according to the Bleeding Academic Research Consortium criteria. There were 1730 patients included in the study, and 470 (27.17 %) continued DAPT for more than one year after undergoing MSCC-PCI with DES implantation. The median follow-up time was 2.5 years. DAPT>1-year versus ≤1-year DAPT was significantly associated with a reduced risk of the primary outcome (1.59 % versus 3.19 %; adjusted hazard ratio=0.44; 95 % CI: 0.22–0.88). Similar trends were observed for all-cause death (0.16 % versus 1.91 %; P<0.001) and cardiovascular death (0.08 % versus 1.06 %; P=0.001). There was no significant difference in the key-safety endpoint between 2 regimens (1.75 % versus 0.85 %; adjusted hazard ratio=1.95; 95 % CI: 0.65–5.84). In conclusion, long-term DAPT after DES implantation in patients with MSCC lesions resulted in improved clinical outcomes at 2.5 years. This was achieved by reducing the risk of ischemia without increasing clinically significant bleeding.

Long-term outcomes of intravascular ultrasound-guided drug-eluting stents implantation in patients with acute coronary syndrome: ULTIMATE ACS subgroup

Objective: To explore the long-term effects of intravascular ultrasound (IVUS) guidance on patients with acute coronary syndrome (ACS) undergoing drug-eluting stents (DES) implantation. Methods: Data used in this study derived from ULTIMATE trial, which was a prospective, multicenter, randomized study. A total of 1 448 all-comer patients were enrolled between 2014 August and 2017 May. Primary endpoint of this study was target vessel failure (TVF) at 3 years, including cardiac death, target-vessel-related myocardial infarction, and clinically-driven target vessel revascularization. Results: ACS was present in 1 136 (78.5%) patients, and 3-year clinical follow-up was available in 1 423 patients (98.3%). TVF in the ACS group was 9.6% (109/1 136), which was significantly higher than 4.5% (14/312) in the non-ACS group (log-rank P=0.005). There were 109 TVFs in the ACS patients, with 7.6% (43/569) TVFs in the IVUS group and 11.6% (66/567) TVFs in the angiography group (log-rank P=0.019). Moreover, patients with optimal IVUS guidance were associated with a lower risk of 3-year TVF compared to those with suboptimal IVUS results (5.4% (16/296) vs. 9.9% (27/273),log-rank P=0.041). Conclusions: This ULTIMATE-ACS subgroup analysis showed that ACS patients undergoing DES implantation were associated with a higher risk of 3-year TVF. More importantly, the risk of TVF could be significantly decreased through IVUS guidance in patients with ACS, especially in those who had an IVUS-defined optimal procedure.

Abstract 19047: Comparison of Drug-Eluting Stent With Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis

Introduction: Trials comparing drug eluting stent (DES) versus bare metal stents (BMS) in patients undergoing endovascular therapy for femoropopliteal artery disease (FPAD) have shown variable results. Data indicating clear patency benefit of DES has not been definitively demonstrated. Methods: Medline, Embase, &amp; Cochrane Central databases were searched to identify previous studies comparing efficacy of drug eluting stent versus bare metal stents in treatment of FPAD. The primary outcome of interest was risk of restenosis. Secondary outcomes included all-cause mortality, stent fracture, target vessel revascularization and primary patency. Odds ratios (OR) were pooled using a random-effect model while heterogeneity among studies was assessed using the Higgins I 2 value. Results: A total of 7 studies (5 RCTs and 2 retrospective cohorts) with 1786 patients were included in our analyses. The risk of target vessel revascularization was significantly reduced with the use of DES (OR: 0.69, 95% CI: 0.49-0.98, I 2 = 0) as compared with BMS. However, there was no significant difference observed in risk of restenosis (OR: 0.83, 95% CI 0.59-1.16), primary patency (OR: 1.09, 95% CI 0.91-1.29), stent fracture (OR: 0.84, 95% CI 0.27-2.67) and all-cause mortality (OR: 1.65, 95% CI 0.71-3.85). Conclusion: The risk of target vessel revascularization was significantly reduced with the use of DES implantation in patients with FPAD. However, DES does not seem to provide much benefit in terms of clinical outcomes. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.

Effect of delayed hospitalization on patients with non-ST-segment elevation myocardial infarction and complex lesions undergoing successful new-generation drug-eluting stents implantation

In the absence of available data, we evaluated the effects of delayed hospitalization (symptom-to-door time [SDT] ≥ 24 h) on major clinical outcomes after new-generation drug-eluting stent implantation in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and complex lesions. In total, 4373 patients with NSTEMI were divided into complex (n = 2106) and non-complex (n = 2267) groups. The primary outcome was the 3-year rate of major adverse cardiac events (MACE), defined as all-cause death, recurrent MI, and any repeat revascularization. Secondary outcomes included the individual MACE components. In the complex group, all-cause death (adjusted hazard ratio [aHR], 1.752; p = 0.004) and cardiac death (aHR, 1.966; p = 0.010) rates were significantly higher for patients with SDT ≥ 24 h than for those with SDT < 24 h. In the non-complex group, all patients showed similar clinical outcomes. Patients with SDT < 24 h (aHR, 1.323; p = 0.031) and those with SDT ≥ 24 h (aHR, 1.606; p = 0.027) showed significantly higher rates of any repeat revascularization and all-cause death, respectively, in the complex group than in the non-complex group. Thus, in the complex group, delayed hospitalization was associated with higher 3-year mortalities.

Identifying the Incidence, Predictors, Outcomes, and Prevention of Stent Thrombosis (ST) in Post-percutaneous Coronary Revascularization Patients With Drug-Eluting Stents (DES): A Systematic Review.

Stent thrombosis (ST) is a rare but catastrophic event to happen to a stented coronary artery. The incidence of ST has greatly been reduced after the advent of modern drug-eluting stent (DES) implants, which have become the most preferred treatment option in the stenting category for coronary artery disease (CAD). Although the risk reduction by newer category implant provides substantial benefits, the possibility of thrombosis still exists mostly during the early stage of DES implantation. The development of ST after percutaneous coronary intervention (PCI) can be predicted by multiple factors, but advancements in early diagnostic techniques and modified stent types have greatly reduced the occurrence of this complication. Mortality, which is one of the complications of ST, is primarily influenced by patient-related factors such as incomplete treatment duration of dual antiplatelet therapy (DAPT). The duration of DAPT after DES implantation in patients with acute coronary syndrome (ACS) is determined based on individual characteristics, mainly considered in view of bleeding or ischemia risk. Risk evaluation systems like DAPT/precise-DAPT scores help tailor and personalize the duration of DAPT for each individual patient. This systematic review contains pertinent articles extracted from the PubMed database. We retrieved articles from various study categories, encompassing publications from the period spanning 2014 to 2022. Our analysis highlighted results from studies investigating different aspects contributing to ST development. The most favorable prevention option was the use of customized DAPT intervention based on patient-specific predictable factors. Several complications associated with ST were identified, including recurrent ST, major adverse cardiovascular events (MACE) encompassing all-cause mortality (including cardiac and non-cardiac mortality), cerebrovascular accidents (CVA) or transient ischemic attacks (TIA), hospitalization due to heart failure, and myocardial infarction requiring revascularization. Mortality was also observed as a significant outcome. The umbrella term of ST includes multiple causative factors. Although DES has improved patient survival rates vastly with its usage, careful risk factor assessment and required follow-up, in each individual being stented, further guarantee a more promising reduction in late adverse outcomes.

Short Versus Long Duration of Dual Antiplatelet Therapy After Second-Generation Drug-Eluting Stents Implantation in Patients with Diabetes.

Duration of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) remains uncertain, with increasing data suggestive of acceptable short-term duration. Metabolically accelerated atherosclerosis associated with diabetes makes it essential to study short-term DAPT in this subgroup. With limited studies determining optimal DAPT strategies after second-generation stents in this subset, we aimed to establish the optimal duration of DAPT in the diabetic population using second-generation stents. To determine optimal DAPT duration in diabetic population undergoing PCI in 2nd generation stents. We conducted an electronic database search of randomized controlled trials from PubMed/Medline, Embase, Cochrane, and Web of Science databases. A meta-analysis was conducted comparing outcomes of short-term (3-6 months) DAPT therapy versus long-term (12 months) DAPT therapy in the diabetic population undergoing PCI with second-generation stents. A total of 5 randomized controlled trials were included with a total of 3117 diabetic patients. Short-term DAPT did not show any statistical difference from long-term DAPT in achieving primary outcomes (relative ratio: 0.96, 95% confidence interval (CI) 0.68-1.35, P = 0.84). Overall mortality (OR 0.92; 95% CI, 0.52-1.63, P = 0.98), myocardial infarction [odds ratio (OR)OR 1.02; 95% CI, 0.53-1.94, P = 0.85], stent thrombosis (OR 1.20; 95% CI, 0.55-2.60, P = 0.55), target vessel revascularization (OR 1.10; 95% CI, 0.45-2.73, P = 0.74), and stroke (OR 0.50; 95% CI, 0.082-2.43, P = 0.81) did not show any statistical difference between the 2 groups. Similarly, a subgroup analysis of study population comparing 6 versus 12 months of DAPT in diabetic population did not show any difference in net primary outcomes (relative ratio: 0.86, 95% CI 0.45-1.45, P = 0.60). There was no significant heterogeneity noted between the 2 groups. This meta-analysis showed no statistically significant benefit of longer DAPT over shorter DAPT therapy in patients undergoing PCI with drug-eluting stent in patients with diabetes.

A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

BackgroundPercutaneous coronary intervention (PCI) has been developed using drug-eluting stents (DES); however, stent implantation is associated with concerns of stent thrombosis and target vessel revascularization (TVR). The stent diameter is a critical factor in TVR and clinical events. The nitrate administration in coronary angiography can dilate the reference vessel diameter, enabling accurate vessel size measurement and optimal stent implantation support. This study was designed to evaluate the effect of stent implantation in the maximally dilated coronary artery in patients with coronary artery disease (CAD).MethodsThis prospective double-blinded randomized (1:1) study is designed to compare the efficacy and safety between DES implantation into the nitrate-induced maximally dilated vessels and conventional DES implantation in patients with CAD. A total of 400 patients who underwent PCI with a sirolimus-eluting stent will be enrolled. The primary endpoint is the mean diameter of the deployed stents. Secondary endpoints include cardiac death, myocardial infarction, stent thrombosis, or ischemia-driven TVR 1 year after the procedure.DiscussionThis study will be the first randomized controlled trial to evaluate the effect of DES implantation on nitrate-induced maximally dilated vessels in patients with CAD.Trial registrationThe trial was registered on 18 June 2021 as Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels (ClinicalTrials.gov Identifier: NCT04931784).

Long-Term Outcomes of Drug-Eluting Stent Implantation for Patients With Atherosclerotic Erectile Dysfunction not Responding to PDE-5-Inhibitors.

Endovascular therapy of erection-related arteries was shown to be a promising treatment option for patients with severe erectile dysfunction. Purpose of this study was to assess the longer-term safety and clinical success rate of endovascular revascularization of erection-related arteries with the Angiolite BTK stent in patients with arteriogenic erectile dysfunction. A total of 147 consecutive men (63.5±9.3 years) with erectile dysfunction due to 345 atherosclerotic lesions underwent endovascular revascularization. Patients received an International Index of Erectile Function (IIEF)-15 questionnaire at 30.3±7.2 months (follow-up [FU] period no less than 18 months) after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference (MCID). Technical success was achieved in 99% of lesions. One major adverse event occurred after endovascular revascularization. Sixty-eight (46%) patients completed their latest FU at least 18 months following the last intervention. Minimal clinically important difference was achieved in 54% (37/68) of patients. In patients with arteriogenic erectile dysfunction not responding to phosphodiesterase-5-inhibitors (PDE-5-Is), endovascular therapy with a novel thin-strut sirolimus-eluting stent is a safe and effective treatment option during short- and longer-term FU. Patients with severe erectile dysfunction profit greatly from endovascular therapy of erection-related arteries. Stable clinical outcomes are seen beyond a 1-year timeframe. It is proven that, the drug-eluting stent therapy for atherosclerotic ED in patients who have not responded to PDE-5-I therapy is safe and effective during longer-term follow-up.

Comparison of 7-Year, Real-World Clinical Outcomes between Drug-Coated Balloon Angioplasty versus Drug-Eluting Stent Implantation in Patients with Drug-Eluting Stent In-Stent Restenosis.

There are no data available comparing the real-world, long-term clinical outcomes of drug-eluting balloon (DEB) angioplasty and drug-eluting stent (DES) implantation in DES in-stent restenosis (ISR) lesions. We aimed to compare the real-world, long-term data available between DEBs and DESs in DES-ISR lesions. We analyzed consecutive DES-ISR lesions (225 lesions from 205 patients; male: 66.3%; mean age: 62.4 years) treated with either DEB or DES. The primary endpoint was target lesion revascularization (TLR), and the primary safety endpoint was the lesion-oriented composite outcome (LOCO). The LOCO is composed of cardiac death, myocardial infarction, and target lesion thrombosis during follow-up. During the 7-year follow-up period, TLR did not differ significantly between the DEB (n = 108) and the DES groups (n = 117) (HR: 1.07; 95% CI: 0.59-1.93, p = 0.83). The LOCO was significantly lower in the DEB group compared to the DES group (HR: 0.40; 95% CI: 0.16-0.98, p = 0.04), which was mainly driven by the lower levels of myocardial infarction (HR: 0.24; 95% CI: 0.06-0.94, p = 0.04) and the absence of target lesion thrombosis in the DEB group (vs. DES group 6%, p = 0.02). Additionally, cardiac death was found to be similar between the DEB and DES groups (HR: 0.56; 95% CI: 0.18-1.75, p = 0.32). DEB angioplasty showed favorable safety with a similar efficacy to that of DES implantation in DES-ISR lesions during the long-term follow-up period.

Early vascular healing after neXt-generation drug-eluting stent implantation in Patients with non-ST Elevation acute Coronary syndrome based on optical coherence Tomography guidance and evaluation (EXPECT): study protocol for a randomized controlled trial.

There is limited evidence about vessel wall healing response following implantation of next-generation drug-eluting stents (DES) in patients admitted with a non-ST elevation acute coronary syndrome (NSTE-ACS). Cumulative data indicate that optical coherence tomography (OCT) imaging can optimize percutaneous coronary intervention results and expedite stent endothelialization in the general population but there is lack of data in NSTE-ACS patients. The EXPECT study is an investigator-initiated, prospective, randomized trial to assess early vascular healing response following next-generation DES implantation in patients admitted with NSTE-ACS based on OCT guidance and evaluation. Sixty patients are randomized at 1:1:1 ratio to OCT-guided percutaneous coronary intervention (PCI) with 3-month follow-up OCT imaging (O3 group, n = 20), to angiography-guided PCI with 3-month follow-up OCT imaging (A3 group, n = 20) and to angiography-guided PCI with 6-month follow-up OCT imaging (A6 group, n = 20). The primary endpoint of the study is stent strut coverage rate at 3- or 6- month follow-up in the studied groups. The secondary endpoints of the study include OCT imaging endpoints, clinical endpoints, and molecular biology endpoints at the different time points. The clinical endpoints comprised of major cardiovascular adverse events and individual components. The molecular biology endpoints comprised of lipid levels and the levels of inflammatory indicators. The findings of the EXPECT study are anticipated to provide novel insights into vessel wall healing in NSTE-ACS population following implantation of next-generation DES, underscore the value of OCT imaging in expediting strut coverage in this setting, and explore the potential of an early discontinuation of dual antiplatelet therapy (DAPT) in this population. ClinicalTrials.gov, NCT04375319.

Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial

BackgroundThe percutaneous treatment of severely calcified coronary lesions has been associated with lower performance of coronary stents and poor clinical long-term outcomes. Adequate lesion preparation before stent implantation is of paramount importance to minimize the risk of stent failure. Balloon-based techniques for lesion preparation have been the subject of numerous investigations, albeit comparative data from randomized trials are scarce. Study design and objectivesThe ISAR-CALC 2 (ClinicalTrials.gov: NCT05072730) is an investigator-initiated, prospective, randomized, multicentre, assessors-blind, open-label trial designed to compare a lesion preparation strategy with either super high-pressure balloon or intravascular lithotripsy (IVL) before drug-eluting stent (DES) implantation in patients with severely calcified, undilatable coronary lesions. In total, 80 patients are required for trial completion. The primary endpoint will be final angiographic minimal lumen diameter (MLD) after stent implantation. Key secondary endpoints include stent expansion assessed by optical coherence tomography (OCT), procedural and strategy success, need for complementary lesion preparation with rotational atherectomy, acute lumen gain, and major adverse cardiac events up to 30-day follow-up. ConclusionsThe ISAR-CALC 2 trial aims to demonstrate the superiority of a lesion preparation strategy with a super high-pressure balloon as compared with intravascular lithotripsy prior to DES implantation in patients with severely calcified undilatable coronary lesions.

Prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with diabetes mellitus: A nationwide retrospective cohort study.

BackgroundOptimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) who have undergone drug-eluting stent (DES) implantation is not clearly established. This study sought to impact of DAPT duration on real-world clinical outcome in patients with or without DM.MethodsUsing a nationwide cohort database, we investigate the association between DAPT duration and clinical outcome between 1 and 3 years after percutaneous coronary intervention (PCI). Primary outcome was all-cause death. Secondary outcomes were cardiovascular death, myocardial infarction, and composite bleeding events. After weighting, 90,100 DES-treated patients were included; 29,544 patients with DM and 60,556 without DM; 31,233 patients with standard DAPT (6–12 months) and 58,867 with prolonged DAPT (12–24 months).ResultsThe incidence of all-cause death was significantly lower in patients with prolonged DAPT [8.3% vs. 10.5% in those with standard DAPT, hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.72–0.84] in diabetic patients and non-diabetic patients (4.5% vs. 5.0% in those with standard DAPT, HR 0.89, 95% CI 0.83–0.96). The incidence of composite bleeding events was 5.7% vs. 5.4%, respectively, (HR 1.07, 95% CI 0.96–1.18) in diabetic patients and 5.6% vs. 5.0%, respectively, in non-diabetic patients (HR 1.13, 95% CI 1.05–1.21). There was a significant interaction between the presence of DM and DAPT duration for all-cause death (p for interaction, pint = 0.01) that further favored prolonged DAPT in diabetic patients. However, there was no significant interaction between the presence of DM and DAPT duration for composite bleeding events (pint = 0.38).ConclusionsThis study showed that prolonged rather than standard DAPT might be clinically beneficial in diabetic patients with DES implantation.Trial registrationClinicalTrial.gov (NCT04715594).

Benefit and risk of prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with chronic kidney disease: A nationwide cohort study

Background and aimsThe optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent in patients with chronic kidney disease (CKD) is not clearly established. This study purposed to compare clinical outcomes of patients with 6–12 (standard) versus 12–24 months (prolonged) DAPT according to CKD. MethodsUsing a nationwide, claim-based database, we retrospectively evaluated association between DAPT duration and clinical outcomes including death, composite ischemic event, and composite bleeding event between 1 and 3 years after PCI. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2. Of 73,941 eligible patients, 13,425 (18.2%) had CKD and 49,019 (66%) were prescribed prolonged DAPT. Prolonged DAPT had no significant impact on the risk of clinical outcomes in patients with normal renal function. ResultsIn patients with CKD, prolonged DAPT was associated with a lower risk of all-cause death (HR 0.85, 95% CI 0.76–0.95) and composite ischemic events (HR 0.87, 95% CI 0.78–0.96) and a higher risk of composite bleeding events (HR 1.18, 95% CI 1.02–1.37). Benefit of prolonged DAPT on reducing composite ischemic event increased significantly in patients with worsened renal dysfunction (pinteraction = 0.02) while there was no significant interaction between its bleeding risk and renal dysfunction (pinteraction = 0.22). ConclusionsWhile standard DAPT would be recommended in patients with normal renal function, tailored decision for DAPT duration would be considered in those with CKD to balance between ischemic and bleeding risks.

Comparison of Coronary Artery Bypass Grafting and Drug-Eluting Stent Implantation in Patients With Chronic Kidney Disease: A Propensity Score Matching Study.

ObjectivesTo compare the long-term outcomes of coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for coronary artery disease (CAD) patients with chronic kidney disease (CKD).MethodsCoronary artery disease patients with decreased kidney function (estimated glomerular filtration rate <60 ml/min/1.73 m2) who underwent CABG (n = 533) or PCI with DES (n = 952) from 2013 to 2020 were enrolled at a single center. The baseline characteristics and clinical outcomes were compared between the CABG and PCI groups for each matched pair of patients with CKD. The primary endpoint was the occurrence of all-cause death. The secondary endpoints were major adverse cardiovascular events (MACCEs) such as death, myocardial infarction (MI), stroke, and repeat revascularization.ResultsA total of 1,485 patients underwent revascularization, such as 533 CABG and 952 patients with PCI. The median follow-up duration was 55.6 months (interquartile range 34.3–74.7 months). Multivariable Cox regression models were used for risk adjustment, and after propensity score matching (PSM), 399 patients were well matched in each group. The in-hospital mortality rate in the CABG group was higher than that in the PCI group, but the difference was not statistically significant (5.0 vs. 2.5%, p = 0.063). At the 1-year follow-up, CABG was associated with a lower survival rate than PCI (94.2 vs. 98.0%, hazard ratio [HR] of 3.72, 95% CI = 1.63–8.49, p < 0.01). At the end of the 5-year follow-up, the freedom from MI and the freedom from repeated revascularization were both better in the CABG group compared to the PCI group (89.1 vs. 81.7%, HR of 0.59, 95% CI = 0.38–0.92, p = 0.019; 86.9 vs. 73.8%, HR of 0.54, 95% CI = 0.36–0.81, p = 0.003, respectively). Furthermore, the freedom from MACCEs was also better in the patients of CABG compared with the patients of PCI (58.5 vs. 51.3%, HR of 0.71, 95% CI = 0.55–0.91, p = 0.030). CABG had a higher cumulative survival rate (68.4 vs. 66.0%) but without a statistically significant difference (HR of 0.92, 95% CI = 0.67–1.27, p = 0.602) compared with that of PCI.ConclusionsCompared to the use of PCI with a drug-eluting stent among patients with CKD, the use of CABG was associated with a lower MI rate, repeat revascularization rate, and lower number of MACCEs during the long-term follow-up. At a follow-up of 1 year, the number of MACCEs and other adverse events were comparable between the two cohorts, but CABG showed a lower survival rate than PCI.

A comparison of drug-eluting stent and coronary artery bypass grafting in mildly to moderately ischemic heart failure.

AimsThe best revascularization strategy for patients with ischaemic heart failure (IHF) remains unclear. Current evidence and guidelines mainly focus on patients with severe ischaemic heart failure (ejection fraction [EF] < 35%). There are limited data comparing clinical outcomes of coronary artery bypass grafting (CABG) with implantation of drug‐eluting stents (DESs) in patients with mild to moderate ischaemic heart failure (EF 35–50%). It is therefore unknown whether percutaneous coronary intervention (PCI) with DES implantation can provide comparable outcomes to CABG in these patients.Methods and resultsFrom January 2016 to December 2017, we enrolled patients with mildly to moderately reduced EF (35–50%) who had undergone PCI with DESs or CABG. Patients with a history of CABG, presented with acute ST‐elevation myocardial infarction (MI) or acute heart failure, and patients who had undergone CABG concomitant valvular or aortic surgery were excluded. Propensity score‐matching analysis was performed between the two groups. Kaplan–Meier analysis and multivariate Cox proportional hazard regression were applied to assess all‐cause mortality and individual end points. A total of 2050 patients (1330 PCIs and 720 CABGs) were included, and median follow‐up was 45 months (interquartile range 40 to 54). There were significant differences in all‐cause death between the two groups: 77 patients in the PCI group and 27 in the CABG group (DES vs. CABG: 5.8% vs. 3.8%, P = 0.045). After propensity score matching for the entire population, 601 matched pairs were obtained. The long‐term cumulative rate of all‐cause death was significantly different between the two groups (DES vs. CABG: 5.8% vs. 2.7%, P = 0.006). No differences were found in the rates of cardiac death (DES vs. CABG: 4.8% vs. 3.0%, P = 0.096), recurrent MI (DES vs. CABG: 4.0% vs. 2.8%, P = 0.234), and stroke (DES vs. CABG: 6.8% vs. 5.2%, P = 0.163). The rate of repeat coronary revascularization was significantly higher in the PCI group than in the CABG group (12.1% vs. 6.0%, P = 0.000).ConclusionsConsidering the higher long‐term survival rate and lower repeat‐revascularization rate, CABG may be superior to DES implantation in patients with mildly to moderately reduced EF (35–50%) and significant CAD.

A Simple Model to Predict Repeat Revascularization After Drug-Eluting Stent Implantation in Patients With Stable Coronary Artery Disease.

Repeat revascularization is still common in the era of drug-eluting stents (DES), especially for non-target lesions. However, few validated models exist to predict the need for revascularization. We aimed to develop and validate an easy-to-use predictive model for repeat revascularization after DES implantation in patients with stable coronary artery disease (CAD). A total of 1,653 stable CAD patients with angiographic follow-up after DES implantation were consecutively enrolled. Split-sample testing was adopted to develop and validate the model. In the training set, male, diabetes, number of target lesions, occlusion lesion, number of non-target lesions, recurrent angina, suboptimal low density lipoprotein-cholesterol level, and high lipoprotein (a) level were independent predictors of repeat revascularization using logistic regression analyses. The established model (Model 1) yielded a bias-corrected concordance index of 0.700 (95% confidence interval: 0.667 to 0.735), with good calibration. It also performed well in the validation set. Compared with the traditional empirical model only including recurrent angina (Model 2), Model 1 had better discriminative ability and clinical usefulness. In conclusion, we established and validated a simple model including 8 easily accessible variables to predict repeat revascularization after DES implantation in stable CAD patients, contributing to better risk stratification, decision making, and patient consultation.

Early- and Middle-Phase Angioscopic Assessment of Arterial Healing Following Current Drug-Eluting Stent Implantation in Patients With Acute Coronary Syndrome.

Background: Drug-eluting stents (DESs) have been widely used for the treatment of acute coronary syndrome (ACS). However, there are few reports on early- and middle-phase arterial repair after DES implantation in ACS patients.Methods and Results: Coronary angioscopy (CAS) findings covering the early and middle phases (mean [±SD] 4±1 and 10±2 months, respectively) of arterial healing after second- and later-generation DES placement between May 2009 and January 2020 were extracted from the Kansai Rosai Hospital Cardiovascular Center database. Neointimal coverage (NIC), yellow color intensity, and the incidence of thrombus adhesion were compared between ACS and chronic coronary syndrome (CCS) in the early (54 stents of 47 lesions, 38 ACS patients; 86 stents of 70 lesions, 52 CCS patients) and middle (179 stents of 154 lesions from 136 ACS patients; 459 stents of 374 lesions from 287 CCS patients) phases. In the early phase, NIC, the incidence of thrombus adhesion (ACS, 39.1%; CCS, 38.0%), and maximum yellow color grade were similar between the 2 groups. In the middle phase, although the maximum yellow color grade was significantly higher in the ACS group (P=0.013), NIC and the incidence of thrombus adhesion (ACS, 24.6%; CCS, 23.4%) were similar in the 2 groups.Conclusions: Arterial healing assessment with CAS showed that NIC and the incidence of thrombus adhesion after DES implantation were similar between ACS and CCS patients.

Risk-Benefit of 1-Year DAPT After DES Implantation in Patients Stratified by Bleeding and Ischemic Risk

BackgroundAlthough a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain. ObjectivesThe authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events. MethodsIschemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, “all-comers” registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES. ResultsIn the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis. ConclusionsIn the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.