New-generation Drug-eluting Stents Research Articles

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.

Effects of delayed hospitalization on the 3-year clinical outcomes of patients with or without diabetes who had non-ST-segment-elevation myocardial infarction and underwent new-generation drug-eluting stent implantation.

Clinical outcomes after non-ST-segment-elevation myocardial infarction (NSTEMI) in patients with (symptom-to-door time [SDT] ≥ 24 h) or without (SDT < 24 h) delayed hospitalization among patients with or without diabetes were compared. From the Korea Acute Myocardial Infarction Registry-National Institute of Health, a total of 4517 patients with NSTEMI who underwent new-generation drug-eluting stents implantation were recruited and they were classified into the diabetes mellitus (DM) and non-DM groups. These two groups were subdivided into groups with and without delayed hospitalization. The primary clinical outcome was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was the occurrence of individual components of MACCE and stent thrombosis. Although after multivariable and propensity score-adjusted analyses in the DM group, the primary and secondary clinical outcomes between the SDT < 24 h and SDT ≥ 24 h groups were similar; in the non-DM group, all-cause (p = 0.003 and p = 0.007, respectively) and cardiac (p = 0.001 and p = 0.008, respectively) death rates were significantly higher in the SDT ≥ 24 h group than in the SDT < 24 h group. Our results suggested that there was no significant difference in prognosis between diabetic patients with and without delayed SDT, but delayed SDT was associated with poor prognosis in nondiabetic patients.

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Regarding stent expansion indices, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. We sought to evaluate the impact of various stent expansion and apposition indices by post-stent OCT on clinical outcomes and find OCT-defined optimal stent implantation criteria. A total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents with OCT guidance and final post-stent OCT analysis were included. Several stent expansion indices (MSA, MSA/average reference lumen area, MSA/distal reference lumen area, mean stent expansion, and stent expansion by linear model [stent volume/adaptive reference lumen volume]) were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization. MSA was negatively correlated with the risk of DoCE (hazard ratio [HR] 0.80 [0.68‒0.94]). However, stent expansion by linear model representing the overall volumetric stent expansion was associated with greater risk of DoCE (HR 1.02 [1.00‒1.04]). As categorical criteria, MSA < 5.0 mm2 (HR 3.90 [1.99‒7.65]), MSA/distal reference lumen area < 90% (HR 2.16 [1.12‒4.19]), and stent expansion by linear model ≥ 65.0% (HR 1.95 [1.03‒3.89]) were independently associated with DoCE. This OCT study highlights the importance of sufficient stent expansion to achieve adequate, absolute, and relative MSA criteria for improving clinical outcome. It also emphasises that overall volumetric excessive stent expansion may have detrimental effects.

Short-term outcomes of drug-coated balloon versus drug-eluting stent for de novo saphenous vein graft lesions in coronary heart disease.

As a device for percutaneous coronary intervention, drug-coated balloon (DCB) is widely used to treat in-stent restenosis. However, data regarding the use of DCB in treating de novo saphenous vein graft (SVG) lesions are limited. This study aimed to explore the outcomes of using the DCB in the treatment of de novo SVG lesions of coronary heart disease (CHD). This retrospective and observational study analyzed CHD patients with de novo SVG lesions treated with DCB or the new-generation drug-eluting stent (DES) between January 2018 and December 2020. Restenosis was the primary endpoint, whereas target lesion revascularization (TLR), major adverse cardiac events, restenosis, cardiac death, target vessel revascularization, and myocardial infarction were the secondary outcomes. We enrolled 31 and 23 patients treated with DCB and DES, respectively. The baseline clinical data, lesion characteristics, and procedural characteristics were similar between the two groups. Twenty-eight (90.3%) patients in the DCB group and 21 (91.3%) in the DES group completed follow-up angiography after 1 year. The quantitative coronary angiography measurements at angiographic follow-up showing late lumen loss were -0.07 ± 0.95 mm for the DCB group and 0.86 ± 0.71 mm for the DES group (P = 0.039), and the rates of restenosis were 13.3% and 21.7% for the DCB and DES groups, respectively (P = 0.470). No significant differences were observed in the rates of MACE (16.7% vs. 26.1%, P = 0.402) and TLR (13.3% vs. 4.3%, P = 0.374) during clinical follow-up. Our findings suggest that when pre-dilatation was successful, DCB might be safe and effective in treating de novo SVG lesions.

Sex Differences in Delayed Hospitalization in Patients with Non-ST-Segment Elevation Myocardial Infarction Undergoing New-Generation Drug-Eluting Stent Implantation

We compared the effects of sex differences in delayed hospitalization (symptom-to-door time [SDT], ≥24 h) on major clinical outcomes in patients with non-ST-segment elevation myocardial infarction after new-generation drug-eluting stent implantation. A total of 4593 patients were classified into groups with (n = 1276) and without delayed hospitalization (SDT < 24 h, n = 3317). Thereafter, these two groups were subdivided into male and female groups. The primary clinical outcomes were major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, recurrent myocardial infarction, repeat coronary revascularization, and stroke. The secondary clinical outcome was stent thrombosis. After multivariable- and propensity score-adjusted analyses, in-hospital mortalities were similar between the male and female groups in both the SDT < 24 h and SDT ≥ 24 h groups. However, during a 3-year follow-up period, in the SDT < 24 h group, all-cause death (p = 0.013 and p = 0.005, respectively) and cardiac death (CD, p = 0.015 and p = 0.008, respectively) rates were significantly higher in the female group than those in the male group. This may be related to the lower all-cause death and CD rates (p = 0.022 and p = 0.012, respectively) in the SDT < 24 h group than in the SDT ≥ 24 h group among male patients. Other outcomes were similar between the male and female groups and between the SDT < 24 h and SDT ≥ 24 h groups. In this prospective cohort study, female patients showed higher 3-year mortality, especially in the SDT < 24 h, compared to male patients.

Ten-year clinical outcomes of drug-eluting stents with different polymer coating strategies by degree of coronary calcification: a pooled analysis of the ISAR-TEST 4 and 5 randomised trials.

Long-term data concerning the efficacy of different polymer-coating strategies of new-generation drug-eluting stents (DES) in patients with coronary artery calcification (CAC) are scant. We aimed to investigate 10-year outcomes by degree of CAC after new-generation DES implantation with different polymer-coating strategies. We analysed individual patient and lesion characteristics of patients randomised to treatment with polymer-free sirolimus-eluting, biodegradable-polymer sirolimus-eluting and permanent-polymer zotarolimus- or everolimus-eluting stents. Endpoints of interest at 10 years were all-cause mortality, myocardial infarction (MI), target lesion revascularisation (TLR) and definite or probable stent thrombosis (ST) according to the degree of CAC (no, mild, moderate or severe) and coating strategy (polymer-free vs biodegradable-polymer vs permanent-polymer). A total of 4,953 patients with 6,924 lesions were included. No, mild, moderate or severe CAC was present in 24.5%, 41.8%, 25.8% and 8.0% of patients, respectively. At 10-year follow-up, overall event rates were high, with an incremental increase according to the degree of CAC (all-cause mortality: no 25.3%, mild 32.1%, moderate 41.7%, severe CAC 46.5%; adjusted [adj.] p=0.004; TLR: no 17.4%, mild 16.5%, moderate 19.8%, severe CAC 28.7%; adj. p=0.001; MI: no 4.9%, mild 5.9%, moderate 6.0%, severe CAC 10.5%; adj. p=0.02; and ST: no 1.3%, mild 1.4%, moderate 1.8%, severe CAC 3.6%; adj. p=0.57). In patients with moderate-severe CAC, event rates were comparable, regardless of the DES polymer-coating strategy. At 10 years after PCI with new-generation DES, there was an incremental increase in adverse events by degree of coronary calcification. These detrimental effects do not seem to be impacted by different polymer-coating strategies.

Impact of triglyceride-rich lipoproteins on early in-stent neoatherosclerosis formation in patients undergoing statin treatment

Neoatherosclerosis (NA), which refers to neointimal atherosclerosis within a stent, is considered one of the underlying causes of late-phase stent failure following a newer generation drug-eluting stent (DES) placement procedure. Even contemporary guideline-directed medical therapy may be insufficient to prevent NA. This study aimed to investigate how intricately lipid markers are associated with NA formation in the early phase of treatment with well-maintained low-density lipoprotein cholesterol (LDL-C) levels. We enrolled 114 consecutive patients undergoing statin treatment and percutaneous coronary intervention (PCI) with current-generation DES for coronary artery disease. At a median 12 months after PCI, optical coherence tomography (OCT) was performed. Various lipid markers, including LDL-C, triglyceride (TG), triglyceride-rich lipoprotein cholesterol (TRL-C), non-high-density lipoprotein cholesterol (non-HDL-C), malondialdehyde-modified LDL (MDA-LDL), and several apolipoproteins, were also evaluated. NA was observed in 17 (14.9%) patients. The LDL-C level was equivalent in patients with or without NA (77.2 vs. 69.8 mg/dL; p=0.15). However, the levels of TG, apolipoprotein C3 (apoC3), TRL-C, non-HDL-C, and apolipoprotein B (apoB), and MDA-LDL were significantly higher in the patients with NA. Furthermore, multivariate logistic regression adjusting for HbA1c and stent duration revealed apoC3, TRL-C, non-HDL-C, apoB, and MDA-LDL levels as risk factors for NA. However, when apoB was included as a covariate, other factors became nonsignificant. Abnormal triglyceride-rich lipoprotein metabolism and high atherogenic apoB-containing lipoprotein particle numbers are associated with the formation of NA in patients undergoing statin treatment at a median 12 months post-PCI.

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

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

Long-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry

Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.

First- Versus New-Generation Drug-Eluting Stents in Patients With Heart Transplant With Cardiac Allograft Vasculopathy

Although several studies have previously reported on the efficacy of percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) in heart transplant patients with cardiac allograft vasculopathy, few data regarding new-generation DES are currently available. We sought to compare the efficacy of new-generation versus first-generation DES in 90 consecutive patients with heart transplant (113 de novo coronary lesions) who underwent urgent or elective PCI with first-generation (28 patients) or new-generation (62 patients) DES. For each patient, the severity of cardiac allograft vasculopathy and postprocedural extent of revascularization were quantified calculating baseline and residual SYNTAX score, respectively. The primary end point was a composite of major adverse cardiac events-myocardial infarction, cardiovascular death, or target vessel revascularization-at 3years. Overall, the median baseline SYNTAX score was 8 (5 to 15), and a total number of stents per patient of 1.6 ± 0.9 was implanted. Post-PCI residual SYNTAX score was 1.5 (0 to 4), with 13 patients having a score >8. At 3 years, the Kaplan-Meier estimate of freedom from major adverse cardiac events was 64%, with no differences between first-generation and new-generation DES groups (log-rank test p=0.269). Nevertheless, patients treated with new-generation DES experienced a lower rate of target vessel revascularization (15% vs 31%, log-rank test p=0.058). In the multivariate Cox regression analysis, a post-PCI residual SYNTAX score >8 (hazard ratio 2.37, confidence interval 0.98 to 5.73, p=0.054) was identified as an independent predictor of the primary end point.

Abstract 11766: Impact of Increasing Stent Length on Long-Term Clinical Outcomes Undergoing Intracoronary Imaging-Guided Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents

Background: While longer stent length of first-generation drug-eluting stents (DES) has been associated with stent-related adverse events, the association between stent length of new-generation DES and clinical outcomes remains controversial. Methods and Results: Consecutive 1403 patients including 2277 lesions who underwent intracoronary imaging-guided percutaneous coronary intervention with 2nd- and 3rd-generation DES were enrolled. Patients were divided into two groups according to total stent length (TSL), and followed up for major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction and target lesion revascularization (TLR) for patients. Lesions were divided into two groups according to TSL as well, and followed up for TLR and stent thrombosis. In the per patient analysis, long TSL group (TSL ≥ 32 mm, n = 703) had higher prevalence of diabetes (54.5% vs. 45.2%, P &amp;lt 0.001), anemia (48.4% vs. 43.0%, P = 0.042), peripheral artery disease (&amp;lt% vs. 10.6%, P = 0.003), multi-vessel disease (64.7% vs. 36.2%, P &amp;lt 0.001) and chronic total occlusion (9.5% vs 3.4%, P 0.001) than short TSL group (TSL &amp;lt 32 mm, n = 691). In the follow up period (mean of 1528 days), MACE and TLR were significantly higher in long TSL group than in short TSL group (P = 0.009 and P = 0.037, respectively). In the multivariate analysis after adjusting for confounding factors, the long TSL was an independent predictor of MACE and TLR (hazard ratio [HR] 1.59, P = 0.002 and HR 1.74, P = 0.047). In the per lesion analysis, Kaplan-Meier curve revealed that TLR was significantly higher in long TSL group (TSL ≥ 26 mm, n = 1160) than short TSL group (TSL &lt; 26mm, n = 1117) (P = 0.017), while stent thrombosis was comparable between the two groups. In the multivariate analysis, TLR was an independent predictor of TLR (HR 1.62, P = 0.029). Conclusion: Longer stent length of new-generation DES was associated with MACE and TLR, but not with stent thrombosis.

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

Abstract Background Recent clinical trials are testing strategies for short (1–3 months) dual antiplatelet therapy (DAPT) following newer-generation drug-eluting stent (DES) placement. However, the safety of short DAPT regimens is not supported by biological evidence in humans. Purpose We sought to evaluate early pathologic responses to newer-generation DES by comparing abluminal biodegradable polymer-coated DES (BP-DES) with circumferential durable polymer-coated DES (DP-DES) in human autopsy cases. Methods The study included a total of 37 coronary lesions with thin strut newer-generation DES (DP-DES=23 [XIENCE=18, Resolute Integrity=5] and BP-DES=14 [SYNERGY=9, Ultimaster=5]) with duration of implantation &amp;lt;90 days in 25 autopsy cases. The process of stent healing was precisely evaluated for every single strut in association with underlying tissue characteristics. The degree of strut coverage was defined as follows: grade 0 (bare struts), grade 1 (struts covered with thrombus, fibrin, or other tissues or cells without endothelium), grade 2 (struts covered with single-layered endothelium without underlying smooth muscle cell layers), and grade 3 (struts covered with endothelium and underlying smooth muscle cell layers) (Figure 1). Results Duration of implantation was similar in lesions with DP-DES and those with BP-DES (median=20 vs. 17 days). A total of 1986 struts (DP-DES=1261, BP-DES=725) were pathologically analyzed. Focal grade 2 coverage was observed as early as 5 days after the implantation in both stents. Multilevel mixed-effects ordered logistic regression model demonstrated that BP-DES exhibited greater strut coverage compared with DP-DES (odds ratio; 3.50, 95% CI; 1.31–9.41, P=0.013), which remained significant after adjustment for duration of implantation and underlying tissue characteristics (odds ratio; 2.64, 95% CI; 1.04–6.68, P=0.040). The time course of vessel healing assessed as predictive probability of strut coverage (grade 0–3) stratified by duration of implantation is shown in Figure 2. Predictive probability of grade 2 and 3 coverage was comparably limited at 30 days (DP-DES=17.7% vs. BP-DES=29.0%) and increased at 90 days (DP-DES=76.1% vs. BP-DES=85.9%). Both stents showed few inflammation and similar degree of fibrin deposition. Conclusions The current first pathologic study on early biological responses to newer-generation DES in humans demonstrated that single-layered endothelial coverage begins in days following the stent placement, and abluminal BP-DES potentially exhibit faster strut coverage with smooth muscle cell infiltration than circumferential DP-DES. Nevertheless, vessel healing remains suboptimal at 30 days in both DP- and BP-DES, which progresses with time to become substantial at 90 days. Our results suggest that very short duration of DAPT for 1 month should be applied with caution, taking into account the trade-off between bleeding and thrombotic risks. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Grant-in-Aid for Scientific Research (C) from the Japan Society for the Promotion of Science

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Abstract Background Regarding stent expansion indexes, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. Purpose We sought to evaluate the impact of various stent expansion indexes by post-stent OCT on long-term clinical outcomes, and hence to find OCT-defined optimal stent expansion criteria. Methods Of the patients registered in the Yonsei OCT registry, a total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents under the OCT guidance and analyzable final post-stent OCT were included. Stent expansion indexes and different suboptimal stent expansion criteria were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (TVMI) or stent thrombosis, and target lesion revascularization. Major safety events (MSE) included cardiac death, TVMI or stent thrombosis. Results The median follow-up period was 40.6 (interquartile range 22.0–50.0) months. As a continuous variable, MSA, adaptive volumetric stent expansion (stent volume/adaptive reference lumen volume) and overall volumetric stent expansion (stent volume/post-stent lumen volume) were significantly predictive of DoCE. As a categorical criteria, MSA &amp;lt;5.0 mm2 (hazard ratio [HR] 3.80; 95% confidence interval [CI] 1.53–9.45), MSA/distal reference lumen area &amp;lt;90% (HR 2.13; 95% CI 1.10–4.14), and overall volumetric stent expansion ≥96.6% (HR 2.38; 95% CI 1.09–5.22) were independently associated with DoCE after adjusting for confounders, and a total malapposition volume ≥7.0 mm3 (HR 3.38; 95% CI 1.05–10.93) was linked to MSE. Conclusions This OCT study highlights that sufficient stent expansion to achieve adequate absolute MSA and relative MSA by distal reference lumen area and alleviate significant malapposition is important to improve clinical outcome, but overall stent overexpansion may have deleterious effect. Funding Acknowledgement Type of funding sources: None.

The vascular response to ultrathin biodegradable polymer sirolimus-eluting stent at 2-weeks and 1-year follow up in patients with ST-elevation myocardial infarction

Abstract Background Recent clinical study suggests newer-generation drug-eluting stents (DES) that combine ultrathin strut and nano-coating with biodegradable polymers sirolimus-eluting stent (BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) over current generation DES. However, the details of vascular response in very early and chronic phase have not been systematically addressed. Objective and method We exploratory investigate early and chronic vascular response following BP-SES implantation in patients with STEMI to reveal mechanism of the favorable clinical outcomes in recent studies using frequency domain-optical coherence tomography (FD-OCT). Consecutive twenty-four patients with STEMI who underwent FD-OCT after primary PCI and were eligible for follow-up FD-OCT at 2 weeks and 1 year after implantation were enrolled between June 2018 and August 2020. OCT was performed immediately after PCI, at 2-weeks (2W) and 1-year (1Y) after the primary PCI. Struts were recorded as uncovered if any part was visibly exposed in the lumen or covered if a layer of tissue covered all reflecting surfaces. Struts of stents that are smaller than 3.0mm of diameter with more than 80μm between the center reflection and the adjacent vessel surface were recorded as malapposed. The reduction of atherothrombotic protrusion burden within the stent was also assessed. Results Twenty-four patients (age 64.9±11.4 years, male 83.3%) were enrolled. The percentage of uncovered struts significantly decreased from post-PCI to 2W follow-up and from 2W follow-up to 1Y follow-up (62±20% post-PCI versus 27±11% at 2W follow up, p&amp;lt;0.0001 and 2W follow-up versus 3.3±3.3% at 1Y follow up, p&amp;lt;0.0001). Malapposed struts also decreased from post-PCI to 2W follow-up (4.1±3.6% post-PCI versus 1.5±2.2% at 2W follow-up, p&amp;lt;0.0001), but no significant difference was shown between 2W follow-up and 1Y follow-up (2W follow-up versus 1.0±2.3 at 1Y follow up, p=0.12). The average protrusion area of athero-thrombotic burden decreased (0.57±0.32 at post-PCI versus 0.42±0.22 mm2 at 2W follow up, p&amp;lt;0.0001) and its volume showed similar tendency (16.6±10.7 at post-PCI versus 12.9±8.23 mm3 at 2W follow up, p=0.0011). Thrombus was shown in all patients at post-PCI, but two patients (8.0%) showed it at 1Y follow-up. Conclusion(s) This study elucidated very early and chronic vascular responses following ultrathin strut BP-SES implantation in STEMI patients by FD-OCT. It showed resolution of athero-thrombotic materials in very early phase and favorable progression of strut coverage in very early and chronic phase. Funding Acknowledgement Type of funding sources: None.

The Residual Lipid-Rich Coronary Atheroma Behind the Implanted Newer-Generation Drug-Eluting Stent and Future Stent-Related Event Risks.

Lipid-rich plaque is an important substrate that causes future coronary events. However, the clinical implications of underlying plaque characteristics in coronary lesions after newer-generation drug-eluting stent (DES) implantation remain unknown. The current study analyzed 445 target lesions after newer-generation DES implantation in 416 patients with coronary artery disease (CAD) (chronic coronary syndrome/acute coronary syndrome = 264/181) from the REASSURE-NIRS multicentre registry. Near-infrared spectroscopy (NIRS) imaging was used to evaluate maximum lipid core burden index after stent implantation in target lesions (residual maxLCBI4mm). The primary and secondary outcomes were 3-year lesion-oriented clinical outcomes (LOCO): cardiac death, nonfatal target-lesion-related myocardial infarction (MI), or ischemia-driven target-lesion revascularization (ID-TLR) and patient-oriented clinical outcomes (POCO): all-cause death, nonfatal MI, or ID unplanned revascularization. Outcomes were compared by residual maxLCBI4mm tertile. Median residual maxLCBI4mm was 183; 16% of lesions had residual maxLCBI4mm > 400. Higher residual maxLCBI4mm was not associated with a greater likelihood of LOCO or POCO during the observational period (LOCO, log-rank P= 0.76; POCO, log-rank P= 0.84). Mixed-effects logistic regression demonstrated that residual maxLCBI4mm does not predict LOCO (odds ratio [OR], 1.000; 95% confidence interval [CI], 0.997-1.003; P= 0.95). There was no significant relationship between residual maxLCBI4mm and POCO (OR, 1.001; 95% CI, 0.999-1.002; P= 0.30). Residual maxLCBI4mm is not associated with LOCO or POCO in patients with CAD after newer-generation DES implantation. Our findings suggest that NIRS-derived underlying lipid-rich plaque is not associated with the risk of stent-related events and patient-based outcomes in patients with CAD who have received newer-generation DESs.

Percutaneous coronary intervention using new-generation drug-eluting stents versus coronary arterial bypass grafting in stable patients with multi-vessel coronary artery disease: From the CREDO-Kyoto PCI/CABG registry Cohort-3.

AimsThere is a scarcity of studies comparing percutaneous coronary intervention (PCI) using new-generation drug-eluting stents (DES) with coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery disease.Methods and resultsThe CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who underwent first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. The current study population consisted of 2464 patients who underwent multi-vessel coronary revascularization including revascularization of left anterior descending coronary artery (LAD) either with PCI using new-generation DES (N = 1565), or with CABG (N = 899). Patients in the PCI group were older and more often had severe frailty, but had less complex coronary anatomy, and less complete revascularization than those in the CABG group. Cumulative 5-year incidence of a composite of all-cause death, myocardial infarction or stroke was not significantly different between the 2 groups (25.0% versus 21.5%, P = 0.15). However, after adjusting confounders, the excess risk of PCI relative to CABG turned to be significant for the composite endpoint (HR 1.27, 95%CI 1.04–1.55, P = 0.02). PCI as compared with CABG was associated with comparable adjusted risk for all-cause death (HR 1.22, 95%CI 0.96–1.55, P = 0.11), and stroke (HR 1.17, 95%CI 0.79–1.73, P = 0.44), but with excess adjusted risk for myocardial infarction (HR 1.58, 95%CI 1.05–2.39, P = 0.03), and any coronary revascularization (HR 2.66, 95%CI 2.06–3.43, P<0.0001).ConclusionsIn this observational study, PCI with new-generation DES as compared with CABG was associated with excess long-term risk for major cardiovascular events in patients who underwent multi-vessel coronary revascularization including LAD.

Individual Patient Data Meta-analysis of Drug-eluting Versus Bare-metal Stents for Percutaneous Coronary Intervention in Chronic Versus Acute Coronary Syndromes

New-generation drug-eluting stents (DES) strongly reduce restenosis and repeat revascularization compared with bare-metal stents (BMS) for percutaneous coronary intervention. There is residual uncertainty as to whether other prognostically relevant outcomes are affected by DES versus BMS concerning initial presentation (chronic coronary syndrome [CCS] vs acute coronary syndrome [ACS]). We performed an individual patient data meta-analysis of randomized trials comparing new-generation DES versus BMS (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction (MI). Outcomes were examined at maximum follow-up and with a 1-year landmark. Risk estimates are expressed as hazard ratio (HR) with 95% confidence interval (CI). A total of 22,319 patients were included across 14 trials; 7,691 patients (34.5%) with CCS and 14,628 patients (65.5%) with ACS. We found evidence that new-generation DES versus BMS consistently reduced the risk of cardiac death or MI in both patients with CCS (HR 0.83, 95% CI 0.70 to 0.98, p &lt;0.001) and ACS (HR 0.83, 95% CI 0.75 to 0.92, p &lt;0.001) (p-interaction=0.931). This benefit was mainly driven by a similar reduction in the risk of MI (p-interaction=0.898) for both subsets (HR_CCS 0.80, 95% CI 0.65 to 0.97; HR_ACS 0.79, 95% CI 0.70 to 0.89). In CCS and ACS, we found a time-dependent treatment effect, with the benefit from DES accumulating during 1-year follow-up, without offsetting effects after that. In conclusion, patients with CCS were slightly underrepresented in comparative clinical trials. Still, they benefited similarly to patients with ACS from new-generation DES instead of BMS with a sustained reduction of cardiac death or MI because of lower event rates within 1 year.

Provisional or 2-Stent Technique for Bifurcation Lesions in the Second-Generation Drug-Eluting Stent Era.

For bifurcating coronary lesions, a provisional stent technique is recommended compared with a routine 2-stent strategy. However, much of these data are from trials involving first-generation drug-eluting stents (DES) or bare-metal stents where the risk of restenosis with the 2-stent technique is higher. We investigated the efficacy of various 2-stent techniques versus a provisional stent technique for bifurcation lesions with newer-generation DES. PubMed and Embase were searched through May 2022 for randomized control trials investigating bifurcation percutaneous coronary intervention techniques using newer-generation DES, and a meta-analysis was conducted. The primary end point was major adverse cardiovascular events (MACE) at the longest reported follow-up time. Our study identified 13 randomized control trials including 4041 patients. Compared with the provisional technique, 2-stent techniques significantly decreased MACE (hazard ratio [HR], 0.76; 95% CI, 0.59-0.97; P = .03), target vessel myocardial infarction (HR, 0.38; 95% CI, 0.20-0.71; P = .002), and target vessel revascularization (HR, 0.66; 95% CI, 0.47-0.93; P = .02). There were no significant differences in all-cause mortality (HR, 0.94; 95% CI, 0.62-1.45; P = .79), cardiovascular mortality (HR, 0.82; 95% CI, 0.49-1.38; P = .45), myocardial infarction (HR, 1.00; 95% CI, 0.73-1.37; P = .99), and stent thrombosis (HR, 0.86; 95% CI, 0.52-1.44; P = .58). Of the 2-stent techniques, the double kissing crush technique significantly decreased MACE and target lesion revascularization than other 2-stent techniques. In this era of newer-generation DES, a 2-stent approach, especially the double kissing crush technique, is superior to a provisional stenting technique for a bifurcation lesion, with a significant reduction in MACE, target vessel myocardial infarction, and revascularization.

Comparison of Clinical Outcomes after Non-ST-Segment and ST-Segment Elevation Myocardial Infarction in Diabetic and Nondiabetic Populations.

Using a new-generation drug-eluting stent, we compared the 2-year clinical outcomes of patients with diabetes mellitus (DM) and non-DM concomitant with a non-ST-segment elevation myocardial infarction (NSTEMI) and an ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention. A total of 11,798 patients with acute myocardial infarction were classified into two groups: DM (NSTEMI, n = 2399; STEMI, n = 2693) and non-DM (NSTEMI, n = 2694; STEMI, n = 4012). The primary clinical outcome was the occurrence of major adverse cardiac events (MACE), defined as all-cause death, recurrent myocardial infarction, or any coronary repeat revascularization. The secondary outcome was the occurrence of definite or probable stent thrombosis. In all the patients, both multivariable and propensity score-adjusted analyses revealed that the incidence rates of MACE (adjusted hazard ratio (aHR), 1.214; p = 0.006 and aHR, 1.298; p = 0.002, respectively), all-cause death, cardiac death (CD), and non-CD rate were significantly higher in the NSTEMI group than in the STEMI group. Additionally, among patients with NSTEMI, there was a higher non-CD rate (aHR, 2.200; p = 0.007 and aHR, 2.484; p = 0.004, respectively) in the DM group and a higher CD rate (aHR, 2.688; p < 0.001 and 2.882; p < 0.001, respectively) in the non-DM group. In this retrospective study, patients with NSTEMI had a significantly higher 2-year mortality rate than those with STEMI did. Furthermore, strategies to reduce the non-CD rate in patients with DM and the CD rate in patients without DM could be beneficial for those with NSTEMI.