New-generation Drug-eluting Stents Research Articles

Comparison of Clinical Outcomes Among Various Percutaneous Coronary Intervention Strategies for Small Coronary Artery Disease

It remains unclear which percutaneous coronary intervention (PCI) strategy is the most preferable in patients with small-vessel coronary artery disease (CAD). We sought to evaluate the clinical efficacy of various PCI strategies for patients with small-vessel CAD through a network meta-analysis of randomized controlled trials (RCTs). We searched multiple databases for RCTs investigating the efficacy of the following PCI strategies for small-vessel CAD (<3mm in diameter): drug-coated balloons (DCB), early-generation paclitaxel-eluting stents and sirolimus-eluting stents (SES), newer-generation drug-eluting stents (DES), bare-metal stents (BMS), cutting balloon angioplasty, and balloon angioplasty (BA). The primary outcome was the trial-defined major adverse cardiovascular events (MACE), mostly defined as a composite of death, myocardial infarction, and revascularization. The secondary outcomes included each component of MACE and angiographic binary restenosis. We performed a sensitivity analysis for RCTs without BMS or first-generation DES. Our search identified 29 eligible RCTs, including 8,074 patients among the 8 PCI strategies. SES significantly reduced MACE compared with BA (hazard ratio 0.23, 95% confidence interval 0.10 to 0.54) with significant heterogeneity (I2=55.9%), and the rankogram analysis showed that SES was the best. There were no significant differences between DCB and newer-generation DES in any clinical outcomes, which was consistent in the sensitivity analysis. BMS and BA were ranked as the worst 2 for most clinical outcomes. In conclusion, SES was ranked as the best for reducing MACE. There were no significant differences in clinical outcomes between DCB and newer-generation DES. BMS and BA were regarded as the worst strategies for small-vessel CAD.

Mechanisms of very late stent thrombosis assessed by optical coherence tomographyin japanese patients

Abstract Background Although very late stent thrombosis (VLST) remains an important concern, the underlying etiology and clinical characteristics are not fully elucidated in Japanese patients who daily undergo intravascular imaging-guided percutaneous coronary intervention (PCI). Objectives The aim of this study was to explore the mechanisms of VLST in bare metal stents (BMSs) and drug eluting stents (DESs) in Japanese patients. Methods We identified 50 VLST lesions (BMS [n=16], 1ST generation DES [n=14], newer generation DES [n=20]) in patients managed in our institutes. The underlying mechanism of VLST was assessed by optical coherence tomography (OCT) and the major etiology of each lesion was determined. Results The median duration following stent implantation was 10 (range 1–20) years. The most frequent etiology of VLST was neoatherosclerotic rupture (44%) followed by neointimal erosion (24%). Edge disease (10%) and evagination (10%) were similarly observed. Malapposition (8%) was mostly acquired late by going back to the index procedure. Uncovered strut (2%) and in-stent calcified nodule (2%) were the least frequent etiologies. Regardless of etiology, signs of neoatherosclerosis were present in most (82%) lesions. Most patients received single (68%) or dual (8%) antiplatelet therapy or oral anticoagulation alone (4%), whereas considerable proportion of patients stopped any medication (20%). Regarding the treatment strategy, drug-coated balloon was the most frequent strategy (56%), followed by newer DES implantation (34%). Conclusion The mechanisms underlying VLST in Japanese patients were unique, with neoathersclerotic rupture and neointimal erosion accounting for two-thirds of cases of VLST. In these patients, biological responses seemed to be more relevant rather than index procedure-related factors.

STANLEy score: a new predictive model of 3-year major adverse cardiac events following "Full Metal Jacket" using new-generation drug-eluting stents

Abstract Introduction Percutaneous Coronary Intervention (PCI) using a "Full Metal Jacket" (FMJ) procedure (≥60 mm of continuous stent length) is often required to treat very long lesions, but its clinical efficacy and safety using contemporary drug-eluting stents (DES) remains to be determined. Objectives To identify predictors of major adverse cardiac events (MACE) associated with FMJ using new-generation DES. We sought to develop a simple model capable of accurately predict 3-year MACE following FMJ PCI. Methods A retrospective single-centre analysis of consecutive FMJ PCI performed between January 2015 and December 2018. Exclusion criteria were use of non-third generation DES, unsuccessful procedure and loss to follow-up. The primary endpoint was a composite of all-cause death, myocardial infarction, and target vessel revascularization. Demographic, clinical, angiographic, and procedural variables were evaluated. Logistic regression analysis was performed to determine independent predictors of outcome. Based on the results, a weighted scoring system was developed. Results The derivation cohort included 162 patients, mean age 65.9 ± 11.1 years, 83% male. The mean stent length was 73.8 ± 12.3 mm (range 60 to 116 mm), and the average number of stents was 2.74 ± 0.74 (range 2 to 5). 30-day, 1-year and 3-year MACE were 5.5%, 12.9% and 29.0%, respectively. Multivariate analysis identified diabEtes mellitus (hazard ratio (HR) 5.92; 95% confidence interval (CI) 1.57-11.54; p=0.011), Smoking habits (HR 8.37; 95%CI 3.05-15.55; p=0.001), Acute coronary syndrome (HR 3.51; 95%CI 1.030-8.98; p=0.045), Non-right coronary artery (HR 4.38; 95%CI 1.09-7.68; p=0.038), osTial lesion (HR 10.01; 95%CI 2.91-19.14; p=0.006) and severe caLcification (HR 8.59; 95%CI 2.65-15.72; p=0.001) as independent predictors of 3-year MACE. A composite score based on these 6 variables (STANLEy score) was created, ranging from 0 to 10 (Fig.1). High acuity was verified by ROC curve analysis (AUC 0.941, p &amp;lt;0.001). A score ≤ 3 was associated with a reduced probability (&amp;lt;15%) and a score ≥ 7 with high probability (&amp;gt;90%) of 3-year MACE. Conclusion The STANLEy score is a good predictive model which relies on 6 simple clinical and angiographic characteristics. This score may assist physicians in selecting high-risk patients for closer monitoring or aggressive antithrombotic strategy.Figure 1

DRUG-COATED BALLOONS FOR THE TREATMENT OF STENT EDGE RESTENOSIS

This study aimed to compare the effectiveness of Drug-Coated Balloon (DCB) treatment with New-Generation Drug-Eluting Stent (DES) implantation for Stent Edge Restenosis (SER). The study was conducted at LRH Peshawar from 11-02-2022 to 11-02-2023 and included 130 patients with stent edge restenosis. Ethical approval was obtained from the hospital's ethical committee, and informed consent was taken from all patients. Patients were divided into two groups, Group A (DES) and Group B (DCB), and their clinical outcomes were analyzed using propensity score matching (PSM). The study showed that DCB therapy reduced the risk of target lesion revascularization (TLR) compared to DES during a median follow-up period of 1080 days. After conducting PSM, there was no significant difference in the risk of TLR between the two groups. Moreover, there were no significant differences in the risk of all-cause death, major adverse cardiovascular events (MACE), or TLR between Group A and Group B. In conclusion, DCB treatment for SER was found to be equally as effective as new-generation DES following PSM. Therefore, DCB can be considered a viable alternative to the new-generation DES for treating SER.

TCT-356 Patients With Moderate to Severe Lesion Tortuosity Undergoing Coronary Intervention With Newer-Generation Drug Eluting Stents: An Analysis From the Randomized BIOFLOW Trials

TCT-356 Patients With Moderate to Severe Lesion Tortuosity Undergoing Coronary Intervention With Newer-Generation Drug Eluting Stents: An Analysis From the Randomized BIOFLOW Trials

Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. ClinicalTrials.gov; identifier: NCT01839890.

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.

Dual antiplatelet therapy after percutaneous coronary intervention in patients at high bleeding risk: A systematic review and meta-analysis.

To date, it has not been ascertained whether shortening the duration of dual antiplatelet therapy (DAPT) can benefit high bleeding risk (HBR) patients. This systematic review and meta-analysis was performed to investigate the safety and efficacy of short (≤ 3 months) DAPT in HBR patients after percutaneous coronary intervention (PCI). The PubMed, Embase, and Clinical Trials databases were searched from inception until November 2021 to identify studies that evaluated the safety and efficacy of short DAPT in HBR patients implanted with new-generation drug-eluting stents (DES). Primary endpoints included major bleeding, definite or probable stent thrombosis (ST), and myocardial infarction (MI), while secondary endpoints included all-cause death and ischemic stroke. Based on the fixed and random effect model, the risk ratio (RR) and 95% confidence interval of each endpoint were measured. Five observational studies and one randomized controlled trial were included, involving 15,432 HBR patients. Short DAPT for HBR patients undergoing PCI had a lower incidence of major bleeding in comparison with standard (> 3 months) DAPT (2.3% vs. 3.2%, RR 0.64 [0.44, 0.95], p = 0.03), while short DAPT was comparable to standard DAPT with regard to definite or probable ST (0.4% vs. 0.3%, RR 1.31 [0.77, 2.23], p = 0.32) and MI (2.4% vs. 2.0%, RR 1.17 [0.95, 1.45], p = 0.14). Among HBR patients implanted with new-generation DES, short DAPT was associated with reduced risk of major bleeding without significantly increasing the risk of definite or probable ST and MI in comparison with standard DAPT.

Angiotensin converting enzyme inhibitors versus angiotensin II type 1 receptor blockers in patients with acute myocardial infarction and prediabetes after successful implantation of newer-generation drug-eluting stents.

Because limited data are available, the present study investigated 2-year major clinical outcomes after angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II type 1 receptor blockers (ARBs) therapy in patients with acute myocardial infarction (AMI) and prediabetes after successful implantation of newer-generation drug-eluting stents (DESs). Overall, 2932 patients with AMI and prediabetes were classified into two groups - the ACEIs group (n = 2059) and the ARBs group (n = 873). The primary endpoint was the occurrence of patient- -oriented composite outcome (POCO), defined as all-cause death, recurrent myocardial infarction (Re-MI), or any repeat revascularization. The secondary endpoint was definite or probable stent thrombosis (ST). The cumulative incidences of POCO (adjusted hazard ratio [aHR]: 1.020; 95% confidence interval [CI]: 0.740-1.404; p = 0.906), all-cause death (aHR: 1.394; 95% CI: 0.803-2.419; p = 0.238), Re-MI (aHR: 1.210; 95% CI: 0.626-2.340; p = 0.570), any repeat revascularization (aHR: 1.150; 95% CI: 0.713-1.855; p = 0.568), and ST (aHR: 1.736; 95% CI: 0.445-6.766; p = 0.427) were similar between the groups. These results were confirmed after propensity score-adjusted analysis. In this study, patients with AMI and prediabetes who received ACEIs or ARBs showed comparable clinical outcomes during the 2-year follow-up period.

First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents.

Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, percutaneously treated with new-generation drug-eluting stents between patients with premature and non-premature CAD. We pooled and analysed the characteristics and clinical outcome of all patients with a first MI (and no previous coronary revascularization) at time of enrolment, in four large-scale drug-eluting stent trials. Coronary artery disease was classified premature in men aged <50 and women <55 years. Myocardial infarction patients with premature and non-premature CAD were compared. The main endpoint was major adverse cardiac events (MACE): all-cause mortality, any MI, emergent coronary artery bypass surgery, or clinically indicated target lesion revascularization. Of 3323 patients with a first MI, 582 (17.5%) had premature CAD. These patients had lower risk profiles and underwent less complex interventional procedures than patients with non-premature CAD. At 30-day follow-up, the rates of MACE [hazard ratio (HR): 0.22, 95% confidence interval (CI): 0.07-0.71; P = 0.005), MI (HR: 0.22, 95% CI: 0.05-0.89; P = 0.020), and target vessel failure (HR: 0.30, 95% CI: 0.11-0.82; P = 0.012) were lower in patients with premature CAD. At 1 year, premature CAD was independently associated with lower rates of MACE (adjusted HR: 0.50, 95% CI: 0.26-0.96; P = 0.037) and all-cause mortality (adjusted HR: 0.24, 95% CI: 0.06-0.98; P = 0.046). At 2 years, premature CAD was independently associated with lower mortality (adjusted HR: 0.16, 95% CI: 0.05-0.50; P = 0.002). First MI patients with premature CAD, treated with contemporary stents, showed lower rates of MACE and all-cause mortality than patients with non-premature CAD, which is most likely related to differences in cardiovascular risk profile. TWENTE trials: TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714).

Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study.

New-generation drug-eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first-generation DES in clinical trials with 3-5 years follow-up. However, detailed clinical outcome data in very long-term follow-up is still scarce. To evaluate 10-year clinical outcomes after first- and new-generation DES implantation. In this extende follow-up study of the RESET, which is a largest randomized trial comparing everolimus-eluting stent (EES) with Sirolimus-eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10-year follow-up was achieved in 87.9% of patients. Cumulative 10-year incidences of TLR and non-TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log-rank p = 0.20, and 33.4% vs. 31.3%, Log-rank p = 0.30). The cumulative 10-year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log-rank p = 0.18). Cumulative 10-year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log-rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log-rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log-rank p = 0.006). During 10-yearof follow-up, the risks for primary efficacy and safety endpoints were not significantly different between new-generation EES and first-generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF.

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

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

Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) vs. thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs. We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES vs. Resolute-type thin-strut DP-ZES in trial participants with concomitant PADs. BIO-RESORT (December 2012 to August 2015) and BIONYX (October 2015 to December 2016) included all-comer patients who were aged 18 years or older, capable of providing informed consent, and required a PCI. The trials had web-based randomization, with block sizes of 4 and 8, performed in a 1:1:1 or 1:1 fashion. Assessors, research staff, and patients were blinded to the type of stent used. We assessed the composite main clinical endpoint target vessel failure [TVF: cardiac death, target vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization (TVR)], its components, and stent thrombosis. Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% vs. 11.0%; HR: 0.36, 95% CI: 0.15-0.86; P=0.016), but this did not translate into between-group differences in cardiac death or MI. In small vessels (<2.75 mm), the TVR rate was also lower in BP-SES (5.6% vs. 13.9%; HR: 0.32, 95% CI: 0.11-0.91; P=0.024). Definite-or-probable stent thrombosis rates were 1.2% and 2.3% (P=0.43). In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES vs. the thin-strut DP-ZES group. Furthermore, TVR risk was significantly lower in ultrathin-strut BP-SES, mainly driven by a lower TVR rate in small vessels. BIO-RESORT trial: clinicaltrials.gov (NCT01674803); BIONYX trial: clinicaltrials.gov (NCT02508714).

Rationale and design of the optimal antithrombotic treatment for acute coronary syndrome patients with concomitant atrial fibrillation and implanted with new-generation drug-eluting stent: OPtimal management of anTIthroMbotic Agents (OPTIMA)-4 trial.

About 5%-15% of acute coronary syndrome (ACS) patients undergoing stent implantation have concomitant atrial fibrillation and need both antiplatelet and anticoagulant therapies. The optimal antithrombotic regimen remains uncertain in this scenario. A multicenter randomized controlled trial (OPtimal management of anTIthroMbotic Agents [OPTIMA]-4) is designed to test the hypothesis that, for ACS patients with concomitant nonvalvular atrial fibrillation (NVAF) and having low-to-moderate risk of bleeding, clopidogrel is comparable in efficacy but superior in safety compared to ticagrelor while being used in combination with dabigatran after new-generation drug-eluting stent (DES) implantation. ACS patients who have low-to-moderate risk of bleeding (e.g., HAS-BLED score ≤ 2) and require anticoagulation therapy (CHA2 DS2 -VASc score ≥ 2) will be recruited after implantation of new-generation DES. A total of 1472 eligible patients will be randomly assigned to receive a 12-month dual antithrombotic treatment of either clopidogrel 75 mg daily or ticagrelor 90 mg twice daily in combination with dabigatran 110 mg twice daily. Participants will be followed upfor 12 months after randomization. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systemic thromboembolism. The primary safety endpoint is set as major bleeding or clinically relevant nonmajor bleeding defined by the International Society of Thrombosis and Hemostasis. The enrollment and follow-up have been launched. The first enrollment occurred on March 12, 2018. The recruitment is anticipated to be completed before December 31, 2024. The OPTIMA-4 trial offers an opportunity to assess the optimal dual antithrombotic regimen in ACS patients with concomitant NVAF after the implantation of new-generation DES.

Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study.

Early P2Y12 inhibitor monotherapy has emerged as a promising alternative to 12 months of dual antiplatelet therapy following percutaneous coronary intervention (PCI). In this single-arm pilot study, we evaluated the feasibility and safety of ticagrelor or prasugrel monotherapy directly following PCI in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Patients received a loading dose of ticagrelor or prasugrel before undergoing platelet function testing and subsequent PCI using new-generation drug-eluting stents. The stent result was adjudicated with optical coherence tomography in the first 35 patients. Ticagrelor or prasugrel monotherapy was continued for 12 months. The primary ischaemic endpoint was the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis or stroke within 6 months. The primary bleeding endpoint was Bleeding Academic Research Consortium type 2, 3 or 5 bleeding within 6 months. From March 2021 to March 2022, 125 patients were enrolled, of whom 75 ultimately met all in- and exclusion criteria (mean age 64.5 years, 29.3% women). Overall, 70 out of 75 (93.3%) patients were treated with ticagrelor or prasugrel monotherapy directly following PCI. The primary ischaemic endpoint occurred in 3 (4.0%) patients within 6 months. No cases of stent thrombosis or spontaneous myocardial infarction occurred. The primary bleeding endpoint occurred in 7 (9.3%) patients within 6 months. This study provides first-in-human evidence that P2Y12 inhibitor monotherapy directly following PCI for NSTE-ACS is feasible, without any overt safety concerns, and highlights the need for randomised controlled trials comparing direct P2Y12 inhibitor monotherapy with the current standard of care.

Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.

Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES). Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years. H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006). In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value. Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 .

Ischemic and Bleeding Outcomes in Patients Who Underwent Percutaneous Coronary Intervention With Chronic Kidney Disease or Dialysis (from a Japanese Nationwide Registry)

The relation between chronic kidney disease (CKD) and outcomes in patients receiving percutaneous coronary intervention (PCI) is thought to be bidirectional; these patients are at a higher risk of ischemic and bleeding events. From a Japanese nationwide PCI registry, ischemic (cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke) and bleeding events (fatal or nonfatal major bleeding) 1 year after discharge among patients who had second- or newer-generation drug-eluting stent implantation were analyzed. Patients on oral anticoagulants were excluded. Patients were stratified according to their preprocedural renal function: CKD stages 1 to 2 (estimated glomerular filtration rate [eGFR] ≥60ml/min/1.73m2), 3 (eGFR 30 to 59), or 4 to 5 (eGFR <30), or those receiving dialysis. Overall, 23,349 patients, including 2,798 patients with CKD 3 to 5 (12.0%) and 1,464 patients on dialysis (6.3%), were investigated. One-year ischemic events were observed in 1.5%, 5.2%, 9.7%, and 5.3% in the CKD stages 1-to-2, 3, 4-to-5, and dialysis groups, respectively; patients with CKD stages 3 or 4 to 5 and those receiving dialysis were associated with higher risks of ischemic events after adjustment of covariates than were patients without CKD. Compared with ischemic events, 1-year bleeding events were low, with incidence rates of 1.5%, 2.0%, 3.4%, and 2.3%, respectively. Furthermore, the presence of CKD or dialysis was not associated with a higher risk of bleeding events after adjustment of covariates. In conclusion, in the contemporary nationwide PCI registry, the presence of CKD and dialysis was independently associated with a higher risk of ischemic events but not with bleeding events, and this suggests a need to alter the models of care delivery in these patients.

Management of In-stent Restenosis

Despite recent improvements in percutaneous coronary intervention (PCI), in-stent restenosis (ISR) — which accounts for 5–10% of all PCI procedures in contemporary clinical practice remains a substantial problem and the most frequent reason for stent failure. While the absolute number of ISR-PCI operations performed in contemporary practice has increased as a result of rising procedural volume and complexity, the relative rate of ISR has decreased with newer-generation drug eluting stents (DESs) in comparison to the bare metal stent (BMS) period. While BMS ISR is usually early and characterized by neointimal hyperplasia, DES ISR tends to be late with neoatherosclerosis as a characteristic feature. According to recent research, drug-coated balloons or DESs are the most effective therapy options for the majority of ISR cases. Future ISR interventional paradigms may be influenced by intravascular imaging (IVI) ISR tissue patterns. IVI can provide useful information to guide treatment options in ISR-PCI.

Drug-coated balloons for the treatment of stent edge restenosis.

Drug-coated balloon (DCB) is a device for treating patients with in-stent restenosis; however, there are scant data on its efficacy for stent edge restenosis (SER). This study aimed to investigate the clinical outcomes of DCB use for treating SER compared with new-generation drug-eluting stent (DES) implantation. From December 2013 to January 2019, patients who underwent DES implantation or DCB for SER were enrolled. Clinical outcomes were analyzed, and propensity score with matching was conducted. The primary outcome was target-vessel revascularization (TVR). The secondary outcomes were the incidence of all-cause mortality, major adverse cardiovascular events (MACE), and target lesion revascularization (TLR). A total of 291 patients with SER were included: 160 were treated with DCB, and 131 with new-generation DES. DCB treatment for SER treatment was associated with a lower risk of TVR than DES [hazard ratio, 0.549; 95% confidence interval (CI), 0.339-0.891] at a median follow-up of 1080 days (interquartile range; 729-1080 days). Propensity score matching (PSM) was performed to adjust for baseline clinical and lesion characteristics. After PSM, no significant difference in the risk of TVR was observed (hazard ratio, 0.965; 95% CI, 0.523-1.781). Similarly, the risk for all-cause death (hazard ratio, 0.507; 95% CI, 0.093-2.770), MACE (hazard ratio: 0.812; 95% CI, 0.451-1.462), and TLR (hazard ratio: 0.962; 95% CI, 0.505-1.833) were comparable between the two groups. DCB treatment efficacy for SER was similar to that of new-generation DES after PSM. DCB is a significant alternative to obtain comparable results with new-generation DES for the treatment of SER.

Early vascular responses to abluminal biodegradable polymer-coated versus circumferential durable polymer-coated newer-generation drug-eluting stents in humans: a pathological study.

Recent clinical studies are testing strategies for short (1-3 months) dual antiplatelet therapy following newer-generation drug-eluting stent (DES) placement. However, detailed biological responses to newer-generation DES remain unknown in humans. We sought to evaluate early pathologic responses to abluminal biodegradable polymer-coated(BP-) DES compared with circumferential durable polymer-coated (DP-) DES in human autopsy cases. The study included 38 coronary lesions with newer-generation DES implanted for<90 days(DP-DES=24, BP-DES=14) in 26 autopsy cases. The degree of strut coverage was defined as follows: grade 0 (bare), grade 1 (with fibrin or tissues/cells without endothelium), grade 2 (with single-layered endothelium), and grade 3 (with endothelium and underlying smooth muscle cell layers). The duration following implantation was similar in DP- and BP-DES (median=20 vs 17 days). A total of 2,022 struts (DP-DES=1,297, BP-DES=725) were pathologically analysed. Focal grade 2 coverage was observed as early as 5 days after the implantation in both stents. The multilevel mixed-effects ordered logistic regression model demonstrated that BP-DES exhibited greater strut coverage compared with DP-DES (odds ratio [OR]: 3.64, 95% confidence interval [CI]: 1.37-9.67; p=0.009), which remained significant after adjustment for the duration following implantation and underlying tissue characteristics (OR: 2.74, 95% CI: 1.10-6.80; p=0.030). The predictive probability of grade 2 and 3 coverage was comparably limited at 30 days (DP-DES=17.1%, BP-DES=28.7%) and increased at 90 days (DP-DES=76.5%, BP-DES=86.6%). Both stents showed low inflammation and a similar degree of fibrin deposition. Single-layered endothelial coverage begins in the days after newer-generation DES placement, and BP-DES potentially exhibit faster strut coverage with smooth muscle cell infiltration than DP-DES in humans. Nevertheless, vessel healing remains suboptimal in both stents at 30 days.