Second-generation Drug-eluting Stents Research Articles

Clinical Impact of Single and Dual Antiplatelet Therapy Beyond 12 Months on Ischemic Risk in Patients With Acute Myocardial Infarction.

Background: There is ongoing debate regarding the optimal antiplatelet strategy beyond 12 months in patients with acute myocardial infarction (AMI) who undergo successful percutaneous coronary intervention (PCI). This study therefore aimed to investigate the clinical outcomes of single (SAPT) vs. dual antiplatelet therapy (DAPT) beyond 12 months in patients with stable AMI and second-generation drug-eluting stent (DES) implantation.Methods: Of 13,104 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health database, we selected 4,604 patients who underwent PCI with second-generation DES and exhibited no adverse clinical events within 12 months; they were classified into SAPT (aspirin or clopidogrel) or DAPT (aspirin and clopidogrel) groups. The primary endpoints were major adverse cardiac and cerebrovascular events (MACCE), including the composite of all-cause death, myocardial infarction (MI), and stroke between 12 and 36 months.Results: The SAPT group (n = 1,862) was associated with a significantly lower risk of MACCE between 12 and 36 months [4.2 vs. 8.5%, hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.37–0.61; p < 0.001] than the DAPT group (n = 2,742). The results were consistent after adjusting for confounders through multivariable and propensity score matching analysis. Moreover, in patients with complex features (defined as an unprotected left main PCI, implanted stent length of ≥38 mm, multivessel PCI, or ≥3 stents per patients), the SAPT group (n = 678) also demonstrated a significantly lower risk of MACCE between 12 and 36 months (4.9 vs. 9.9%, HR: 0.46, CI: 0.31–0.68, p < 0.001) than the DAPT group (n = 1,167).Conclusions: In patients with AMI who underwent successful PCI with second-generation DES and exhibited no adverse clinical events within 12 months, the use of SAPT was associated with a significantly lower MACCE between 12 and 36 months compared with the use of DAPT.

Long-term outcomes of delayed percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction: A propensity score-matched retrospective study.

The best time window of percutaneous coronary intervention (PCI) is within 12 hours for ST-segment elevation myocardial infarction (STEMI). However, there is limited evidence about the proper time of PCI for delayed STEMI patients.From June 2014 to June 2015, a total of 268 patients receiving PCI with second-generation drug-eluting stent in a Chinese hospital after 3 days of STEMI onset were enrolled in this retrospective study, who were divided into the early group (3–14 days) and the late group (>14 days). A propensity score match was conducted to reduce the baseline difference. The primary endpoint of all-cause death and secondary endpoints of major adverse cardiac and cerebrovascular event (myocardial infarction [MI], stroke, emergent revascularization, and rehospitalization due to heart failure) were compared using survival analysis.At last, 182 cases were matched after propensity score match, with no statistical difference in baseline characteristics and PCI data. Kaplan-Meier survival curve demonstrated no difference in all-cause death of the 2 groups (P = .512). However, the early group presented a higher incidence of MI than the late group (P = .036). The multivariate Cox regression analysis also demonstrated that the early PCI was an independent risk factor for MI compared with late PCI (hazard ratio = 3.83, 95%CI [1.91–8.82], P = .001). There was no statistical difference in other major adverse cardiac and cerebrovascular event, including stroke, emergent revascularization, and rehospitalization due to heart failure.Using the 2nd drug-eluting stent, early PCI (3–14 days) and late PCI (>14 days) have comparable efficacy and outcomes. However, patients receiving early PCI are subjected to a relatively higher risk of recurrent MI.

Abstract 12811: Dual Antiplatelet Therapy Duration and Long-Term Risks of Adverse Outcomes After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents

Introduction: Randomized trials show that short dual antiplatelet (DAPT) regimens have similar adverse events to longer regimens in patients treated by percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES2). However, these studies are underpowered for death. Hypothesis: After PCI with DES2, patients discontinuing DAPT before six months had higher risks of adverse ischemic outcomes than patients continuing DAPT for longer durations. Methods: We assessed adverse outcomes in patients having PCI between 2008-2016 in the Veterans Affairs Clinical Assessment Report and Tracking (CART) database. DAPT use was determined from the VA Pharmacy database. Outcomes after PCI were all-cause death (from the VA death index), and myocardial infarction, recurrent coronary revascularization, and major bleeding from ICD 9, ICD 10 and CPT codes in VA and Medicare/Medicaid records. Hazard ratios (HR) and 95% confidence intervals (95%CI) from Cox proportional hazards models weighted with a stabilized inverse probability of treatment weight were used to assess the risk of outcomes from stopping DAPT in 4 time intervals after PCI (1-5, 6-9, 10-12, and 13-18 months). Results: After exclusions, there were 40,871 PCIs with DES2 during the study period. Outcomes were followed for an average of 4.6 years. Compared to continuing DAPT, the risks for death were significantly higher for stopping DAPT 1-5 months after PCI (HR=2.04, 95%CI=1.82, 2.29) and stopping DAPT 6-9 months after PCI (HR=2.2, 95%CI=1.98, 2.44). There was no significant increase in death from stopping DAPT more than 10 months after PCI. Stopping DAPT 10 or more months after the index PCI associated with lower rates of myocardial infarction (HR=0.74, 95%CI=0.68, 0.81) and major bleeding (HR=0.81, 95%CI 0.73, 0.91), and lower repeat revascularization at all time periods. There was no interaction of effects with acute coronary syndrome at index PCI. Conclusion: Among Veterans having PCI with DES2, stopping DAPT less than 10 months after PCI was associated with a higher risk of death but no increased risk in myocardial infarction or major bleeding. Short DAPT regimens after PCI may increase the risk of death. Clinical trials of short DAPT duration should powered to assess this endpoint.

Differential Effects of Newer-Generation Ultrathin-Strut Versus Thicker-Strut Drug-Eluting Stents in Chronic and AcuteCoronary Syndromes.

The authors sought to compare the differential effects of ultrathin-strut and thicker-strut drug-eluting stents (DES) in patients with chronic (CCS) versus acute (ACS) coronary syndromes. Newest-generation ultrathin-strut DES reduce target lesion failure (TLF) compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing newer-generation ultrathin-strut (<70μm) versus thicker-strut (≥70μm) DES. Patients were divided based on baseline clinical presentation (CCS versus ACS). The primary endpoint was TLF, a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization (TLR). A total of 22,766 patients from 16 randomized controlled trials were included, of which 9 trials reported TLF rates in ACS patients. At a mean follow-up of 12.2months, the risk of TLF was lower among patients treated with ultrathin-strut compared with thicker-strut DES (risk ratio [RR]: 0.85; 95%CI: 0.75-0.95; P=0.006). The difference was driven by a lower risk of clinically-indicated TLR (RR: 0.75; 95%CI: 0.63-0.89; P< 0.001) among patients treated with ultrathin-strut DES. The treatment effect was consistent between patients presenting with CCS and ACS (relative RR: 0.97; 95%CI: 0.73-1.31; P for interaction=0.854). In patients with ST-segment elevation myocardial infarction, TLF risk was lower among those treated with ultrathin- compared with thicker-strut DES (RR: 0.74; 95%CI: 0.54-0.99; P=0.049). Ultrathin-strut DES reduce the risk of TLF compared with thicker-strut second-generation DES in patients undergoing percutaneous coronary intervention, a difference caused by a lower risk of ischemia-driven TLR. The treatment effect was consistent among patients with CCS and ACS.

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

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

Direct comparison of bioabsorbable and biodurable polymer everolimus-eluting stent in neointimal stent coverage and in-stent thrombus using high-resolution angioscope

Abstract Background/Introduction Although second-generation drug eluting stent (DES) employing biodurable polymer drastically shortened the duration of dual antiplatelet therapy (DAPT), previous reports raised concerns that switching from DAPT to single antiplatelet therapy increased rates of subsequent stent thrombosis with time. Third-generation DES employing bioabsorbable polymer has been introduced so as not to hinder the healing process of the vessel wall, however, at present, both DES with bioabsorbable polymer and those with biodurable polymer are used in parallel. It means there is no conclusive evidence regarding pros and cons of these two types of polymers. Purpose This study aims to clarify how bioabsorbable polymer and biodurable polymer act on the human coronary artery by observing neointimal stent coverage (NIC) and in-stent thrombus by comparing the third-generation DES with bioabsorbable-polymer cobalt-platinum everolimus-eluting stent (BP CoPt-EES), and the second-generation DES with biodurable-polymer cobalt-chromium everolimus-eluting stent (DP CoCr-EES). Methods This is a multicenter observational study including 11 hospitals. We investigated 70 stents (BP CoPt-EES: 40, DP CoCr-EES: 30) of 60 cases, who underwent stent implantation followed by simultaneous observation by coronary angiography, IVUS and angioscopy within 6 to 12 months. For angioscopy, we used a recently available, high-resolution angioscope with a pixel count of 9,000 which realized both stent coverage analysis and planar thrombus detection precisely. Neointimal stent coverage was graded from G0: non coverage to G3: full coverage, and heterogeneity value of neointima was measured as the difference between maximum and minimum NIC grade. Results A strong relationship was observed between NIC grade and in-stent thrombus in all stents (p=0.0011), and between the heterogeneity value and stent thrombus (p=0.012). There was no statistical difference in NIC grade between BP CoPt-EES vs. DP CoCr-EES; grade 0: 0 (0.0%) vs. 2 (6.7%), grade 1: 13 (32.5%) vs. 11 (36.7%), grade 2: 6 (15.0%) vs. 6 (20.0%), grade 3: 21 (52.5%) vs. 11 (36.7%), p=0.17) and neither in the heterogeneity value of neointima (p=0.49). The ratio of stent thrombus did not reach statistical difference; 16 (40.0%) in BP CoPt-EES vs. 17 (56.7%) in DP CoCr-EES (p=0.23). Conclusion The existence of stent thrombus was associated with the neointimal stent coverage. There was no significant difference both in neointimal stent coverage and stent thrombus between bioabsorbable polymer cobalt-platinum EES and biodurable polymer cobalt-chromium EES after 6 to 12 months following stent deployment. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boston Scientific JapanOvalis ltd

Priority of non-HDL-C assessment to predict occurrence of new lesions after percutaneous coronary intervention in stable angina patients with diabetes mellitus prescribed strong statins

Abstract Background Diabetes mellitus (DM) patients are known to suffer from a higher risk of adverse outcomes following percutaneous coronary intervention (PCI) despite of low-density lipoprotein cholesterol (LDL-C)-lowering therapy with statins. Thus, identification of factors that may occurrence of new lesions following PCI in DM patients treated with strong statin is clinically important. Although LDL-C is generally calculated using the Friedewald equation method [LDL-C (F)], the effects of LDL-C measured by the Martin method [LDL-C (M)] or non-high-density lipoprotein cholesterol (non-HDL-C) on the occurrence of new lesions on coronary angiography after PCI among stable angina patients with DM receiving treatment with strong statins are unknown. Purpose The aim of the present study was to investigate the clinical factor on the occurrence of new lesions in stable angina patients with DM at 9-month follow-up coronary angiography and within 2 years after PCI. Methods The subject was 313 consecutive stable angina patients with DM who were admitted to undergo PCI. All patients had undergone successfully elective PCI using second-generation drug-eluting stents and intravascular ultrasound, and had been prescribed strong statins regardless dyslipidemia more than 2 week before PCI. We investigated the clinical factor on the occurrence of new lesions with myocardial ischemia. We estimated LDL-C (F), LDL-C (M), and non-HDL-C in this study. Acute coronary syndrome and hemodialysis patients were excluded from this study. Results Median of age and level of glycosylated hemoglobin (HbA1c) were 69 years (62–76) and 6.8% (6.3–7.3). New lesions appeared 9-month follow-up coronary angiography [New lesion(+) 9-month] and within 2 years [New lesion(+) 2-year] after PCI in 19 (6%) and 62 (20%) patients, respectively. The rate of history of smoking, using of β-blocker, and non-HDL-C ≥100 mg/dL and level of HbA1c were significantly higher in the New lesion(+) 9-month group than those in the New lesion(−) 9-month group after PCI. Age, level of high-sensitivity C-reactive protein and triglyceride, frequencies of LDL-C (F) ≥70 mg/dL, LDL-C (M) ≥70 mg/dL and non-HDL-C ≥100 mg/dL were significantly higher in the New lesion(+) 2-year group than those in the New lesion(−) 2-year group after PCI. Multivariate logistic regression analysis demonstrated only non-HDL-C ≥100 mg/dL was associated with the occurrence of new lesions both 9-month and within 2 years [9-month: hazard ratio (HR) 4.25, 95% confidence interval (CI) 1.30–19.23, p=0.014 and 2-year: HR 2.30, 95% CI 1.24–4.45, p=0.010]. Conclusion Only non-HDL-C ≥100 mg/dL was an independently associated with the occurrence of new lesions both 9-month and within 2 years after PCI in stable angina patients with DM treated with strong statins. Residual risk after PCI in DM patients should be considered by assessing non-HDL-C beyond the scope of LDL-C-lowering therapy with strong statins. Funding Acknowledgement Type of funding sources: None.

Plasma PCSK9 levels increase following percutaneous coronary interventions

Abstract Background Beside its role in cholesterol homeostasis, Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) has been associated with the processes of vascular inflammation and atherosclerosis. The protein is expressed in endothelial cells, smooth muscle cells and macrophages and it is detected inside the human atherosclerotic plaque. Purpose We aimed to investigate the effect of acute inflammation associated with plaque rupture and vascular injury during elective percutaneous coronary intervention (PCI) on plasma levels of PCSK9 in patients with coronary artery disease (CAD). Methods We measured PCSK9, C-reactive protein (CRP), Interleukin-6 (IL-6) and high-sensitivity cardiac Troponin T (hs-cTnT) plasma levels immediately before and 18–24 hours after PCI via the radial approach, in 68 consecutive patients with stable CAD referred for elective PCI of a de novo lesion in a native coronary artery. Patients with unstable coronary syndrome &amp;lt;3 months old, baseline inflammatory condition, malignancy, auto-immune disease or intervention via the femoral access, were excluded. Results All patients were treated with balloon angioplasty and implantation of a second-generation drug eluting stent (DES). Baseline plasma levels of PCSK9 were higher in women and in patients treated with statins. At 18–24 hours after the procedure, plasma levels of PCSK9, CRP, IL-6 and hs-cTnT increased significantly compared to baseline (table). The change (elevation) in CRP plasma levels was statistically correlated with that of IL-6 (r=0.33; p=0.006) and with that of hs-cTnT (r=0.28; p=0.023). However, there was no correlation between the change (elevation) in plasma PCSK9 levels and those of IL-6 (r=−0.09; p=0.47), CRP (r=0.01; p=0.9), and hs-cTnT (r=0.1; p=0.41). Conclusions Plasma levels of PCSK9 increased by 26% following PCI with DES. That elevation was however, not correlated with the degree of myocardial injury (hs-cTnT) or of inflammation (IL-6 and CRP). The mechanism underlying PCK9 elevation post PCI requires further investigation. Funding Acknowledgement Type of funding sources: None.

Prognostic impact of malnutrition on cardiovascular events in coronary artery disease patients with myocardial damage

BackgroundStable coronary artery disease (CAD) patients with myocardial damage have a poor prognosis compared to those without myocardial damage. Recently, malnutrition has been reported to affect the prognosis of cardiovascular diseases. However, the effects of malnutrition on prognosis of CAD patients with myocardial damage remains uncertain. We investigated the effects of malnutrition on prognosis of CAD patients with myocardial damage who received percutaneous coronary intervention (PCI).MethodsSubjects comprised 241 stable CAD patients with myocardial damage due to myocardial ischemia or infraction. Patients underwent successful revascularization for the culprit lesion by PCI using second-generation drug-eluting stents and intravascular ultrasound. The geriatric nutritional risk index (GNRI), which is widely used as a simple method for screening nutritional status using body mass index and serum albumin, was used to assess nutritional status. Associations between major cardiovascular and cerebrovascular events (MACCE) and patient characteristics were assessed.ResultsMean GNRI was 100 ± 13, and there were 55 malnourished patients (23%; GNRI < 92) and 186 non-malnourished patients (77%). MACCE occurred within 3 years after PCI in 42 cases (17%), including 34 deaths (14%), and the malnourished group showed a higher rate of MACCE (38%) compared with the non-malnourished group (11%, p < 0.001). Univariate Cox proportional hazards analyses showed that MACCE was associated with age [hazard ratio (HR), 1.04; 95% confidence interval (CI), 1.04–1.07; p = 0.004], prior heart failure (HR 2.35; 95% CI 1.10–5.01; p = 0.027), high-sensitivity C-reactive protein (HR 1.08; 95% CI 1.03–1.11; p < 0.001), hemodialysis (HR 2.63; 95% CI 1.51–4.58; p < 0.001) and malnutrition (HR 3.69; 95% CI 2.11–6.42; p < 0.001). Multivariate Cox proportional hazards analysis revealed hemodialysis (HR 2.17; 95% CI 1.19–3.93; p = 0.011) and malnutrition (HR 2.30; 95% CI 1.13–4.67; p = 0.020) as significantly associated with MACCE. Furthermore, Cox proportional hazards models using malnutrition and hemodialysis revealed that patients with malnutrition and hemodialysis were at greater risk of MACCE after PCI than patients with neither malnutrition nor hemodialysis (HR 6.91; 95% CI 3.29–14.54; p < 0.001).ConclusionsIn CAD patients with myocardial damage, malnutrition (GNRI < 92) represents an independent risk factor for MACCE. Assessment of nutritional status may help stratify the risk of cardiovascular events and encourage improvements in nutritional status.

Long-Term Outcomes After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents or Coronary Artery Bypass Grafting for Multivessel Coronary Disease

More evidence is required with respect to the comparative effectiveness of percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) in contemporary clinical practice. This prospective observational registry-based study compared the outcomes of 6,647 patients with multivessel disease who underwent PCI with second-generation DES (n=3,858) or CABG (n=2,789) between January 2006 and June 2018 and for whom follow-up data were available for at least 2 to 13 years (median 4.8). The primary outcome was a composite of death, spontaneous myocardial infarction, or stroke. Baseline differences were adjusted using propensity scores and inverse probability weighting. In the overall cohort, there were no significant between-group differences in the adjusted risks for the primary composite outcome (hazard ratio [HR] for PCI vs CABG 1.03, 95% confidence interval [CI] 0.86 to 1.25, p=0.73) and all-cause mortality (HR 0.95, 95% CI 0.76 to 1.20, p=0.68). This relative treatment effect on the primary outcome was similar in patients with diabetes (HR 1.15, 95% CI 0.91 to 1.46, p=0.25) and without diabetes (HR 0.95, 95% CI 0.73 to 1.22, p=0.67) (p for interaction=0.24). The adjusted risk of the primary outcome was significantly greater after PCI than after CABG in patients with left main involvement (HR 1.39, 95% CI 1.01 to 1.90, p=0.044), but not in those without left main involvement (HR 0.94, 95% CI 0.76 to 1.16, p=0.56) (p=0.03 for interaction). In this prospective real-world long-term registry, we observed that the risk for the primary composite of death, spontaneous myocardial infarction, or stroke was similar between PCI with contemporary DES and CABG.

Risk factors for revascularization and in-stent restenosis in patients with triple-vessel disease after second-generation drug-eluting stent implantation: a retrospective analysis

ObjectivesCoronary artery disease (CAD) is a common cardiac disease with high morbidity and mortality, and triple-vessel disease (TVD) is a severe type of CAD. This study investigated risk factors for revascularization and in-stent restenosis (ISR) in TVD patients who underwent second-generation drug-eluting stent implantation.MethodsA retrospective clinical study was conducted, and 246 triple-vessel disease (TVD) patients with 373 vessels after second-generation drug-eluting stent (DES) implantation who received follow-up coronary angiography (CAG) were consequently enrolled. According to the follow-up angiography, patients were categorized into the revascularization group and nonrevascularization group as well as the in-stent restenosis (ISR) group and non-ISR group. Univariate and multivariate logistic regression analyses were used to identify risk factors for revascularization and ISR. Receiver operating characteristic (ROC) curve with area under the curve (AUC) analysis was performed to assess the predictive power of these risk factors.ResultsIn the median follow-up period of 28.0 (14.0, 56.0) months, 142 TVD patients (57.7%) with 168 vessels underwent revascularization, and ISR occurred in 43 TVD patients (17.5%) with 47 vessels after second-generation DES implantation. Compared to the nonrevascularization group, the revascularization group presented with an increased rate of current smoking and higher levels of TC, LDL-C, HDL-C, non-HDL-c, ApoB, neutrophils, and Hs-CRP as well as a longer follow-up of months but with a lower level of HDL-C. In addition, patients in the ISR group had an older age, longer follow-up (months) and elevated rates of current smoking and stage 4–5 chronic kidney disease (CKD4-5). In multivariate analysis, current smoking and higher non-HDL-c were independent risk factors for revascularization. In addition, older age, current smoking and CKD4-5 were considered independent risk factors for ISR. Importantly, the receiver operating characteristic curve showed that non-HDL-C and age displayed predictive power for revascularization and ISR, respectively.ConclusionCurrent smoking is an independent risk factor for both revascularization and in-stent restenosis. Higher non-HDL-c is independently related to revascularization; moreover, increased age and CKD4-5 are potential risk factors for ISR in TVD patients after second-generation drug-eluting stent implantation.

The Current State of Coronary Revascularization: Percutaneous Coronary Intervention versus Coronary Artery Bypass Graft Surgery.

The question of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery remains among the most important questions in the treatment of coronary artery disease. The leading North American and European societies largely agree on the current guidelines for the revascularization of unprotected left-main disease (ULMD) and multivessel disease (MVD) which are largely supported by the outcomes of several large randomized trials including SYNTAX, PRECOMBAT, NOBLE, and EXCEL. While these trials are of the highest quality, currently available, they suffer several limitations, including the use of bare metal and/or first-generation drug-eluting stents in early trials and lack of updated surgical outcomes data. The objective of this review is to briefly discuss these key early trials, as well as explore contemporary studies, to provide insight on the current state of coronary revascularization. Evidence suggests that in ULMD and MVD, there are similar mortality rates for CABG and PCI but PCI is associated with fewer "early" strokes, whereas CABG is associated with fewer "late" strokes, myocardial infarctions, and lower need for repeat revascularization. Additionally, studies suggest that CABG remains superior to PCI in patients with intermediate/high SYNTAX scores and in MVD with concomitant proximal left anterior descending (pLAD) artery stenosis. Despite the preceding research and its basis for our current guidelines, there remains significant variation in care that has yet to be quantified. Emerging studies evaluating second-generation drug-eluting stents, specific lesion anatomy, and minimally invasive and hybrid approaches to CABG may lend itself to more individualized patient care.

Intervenção percutânea no tronco da coronária esquerda em doença coronariana aguda e crônica. Experiência de um centro

Background Improvements in percutaneous coronary intervention have reduced complications in the treatment of left main coronary artery disease. The objective of this study was to characterize percutaneous coronary intervention procedures in left main coronary artery, and evaluate patients’ outcomes. Methods A retrospective study performed from January 2015 to December 2018, in patients submitted to percutaneous coronary intervention in left main coronary artery for stable coronary artery disease or myocardial infarction, with second-generation drug-eluting stents. Results A total of 82 patients were submitted to percutaneous coronary intervention in left main coronary artery. Among them, 26.8% had stable coronary artery disease, 50% had non-ST segment elevation myocardial infarction, and 23.2% had ST segment elevation myocardial infarction. Cardiogenic shock was present in 20.7% of them. Most patients were male, elderly, with cardiovascular risk factors, namely diabetes, hypertension and hyperlipemia. Among patients with stable coronary artery disease, patients had low to intermediate SYNTAX score. During hospitalization, patients did not develop any complications. During follow-up, cardiovascular death was of 4.5% (n=1). Regarding non-ST segment elevation myocardial infarction, during hospitalization, there were no registries of events. During follow-up, 9.1% of patients had cardiovascular-related hospitalizations. A patient died (3%) during the re-hospitalization from severe heart failure. Concerning ST segment elevation myocardial infarction patients, there was one case of acute stent thrombosis during hospitalization resulting in death. One patient was readmitted for percutaneous coronary intervention in left main coronary artery due to restenosis. Regarding the patients admitted in cardiogenic shock, in-hospital mortality was 58.8%. During follow-up, two patients experienced restenosis and were hospitalized (one underwent coronary artery bypass grafting, and the other, percutaneous coronary intervention). Conclusion This is a real-world study in which we described our experience with percutaneous coronary intervention in left main coronary artery. In general, percutaneous coronary intervention in left main coronary artery in stable left main coronary artery disease, or in unstable disease with no cardiogenic shock, was a safe procedure. Further studies with extended follow-up are needed.

Factors Associated with Coronary In-Stent Restenosis after Drug-Eluting Stent Implantation in Patients on Chronic Hemodialysis

Aims: Recently, drug-eluting stents (DESs) have been widely adopted for patients on chronic hemodialysis (HD). However, whether DES implantation is associated with a reduced rate of in-stent restenosis (ISR) is unclear. We investigated the incidence of ISR and its predictors in patients on HD after DES implantation. Methods and Results: We analyzed 194 consecutive patients (331 lesions) on HD who underwent follow-up angiography after DES implantation. ISR was observed in 74 lesions (22.4%). Angiographically, the relative incidence of AHA/ACC type C lesion was increased (47 vs. 32%; p = 0.043), the minimal lumen diameter (MLD) before DES implantation was smaller (0.82 ± 0.49 vs. 0.97 ± 0.45 mm; p < 0.01), and the lesion length (LL) was increased (30.2 ± 16.1 vs. 24.4 ± 12.1 mm; p = 0.023) in lesions with ISR compared to those without ISR. The rate of rotational atherectomy use was also increased in lesions with ISR compared to those without ISR (50% vs. 25%; p < 0.01). In a multivariate analysis, the MLD before DES implantation (odds ratio [OR] = 0.50, 95% confidence interval [CI] 0.27–0.91, p = 0.024), LL (OR = 1.02, 95% CI 1.00–1.04, p = 0.030) and the use of rotational atherectomy (OR = 2.71, 95% CI 1.55–4.72, p < 0.01) were independent predictors of ISR. The incidence of ISR was similar between lesions treated with the first-generation (25.8%) and the second-generation DESs (20.4%). Conclusions: ISR was observed in 74 lesions (22.4%). A small MLD, long LL, and the use of rotational atherectomy were independent predictors of ISR after DES implantation in patients on HD. There was no significant difference in the ISR rate between the first- and the second-generation DESs.

Long term outcomes of ultrathin versus standard thickness second-generation drug eluting stents: Meta-analysis of randomized trials.

Identify the effect of ultrathin drug eluting stents on long term outcomes in coronary artery disease. Although second-generation drug eluting stents (DES) are superior to first-generation DES, persistence of adverse outcomes has led to continued refinement in design. Ultrathin second-generation DES have been shown to improve outcomes at 1-year follow-up. Beyond 1-year their effect remains unknown. PubMed, Embase and Cochrane Database were searched for randomized controlled trials that compared ultrathin (defined as <70 um) to standard thickness second-generation DES. Studies were chosen according to the PROSPERO protocol (CRD42020185374). Data from randomized controlled trials were pooled using random-effects model (Mantel-Haenszel). The primary outcome was target lesion failure (TLF) at 2 years, a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Secondary outcomes included TLF at 3 and 5 years, the components of TLF and definite or probable stent thrombosis. Differences in outcomes between groups were presented in Forest plots as risk ratios (RR) with corresponding 95% confidence intervals (CIs) for each trial. We identified 18 publications from 10 trials with14,649 patients. At 2-years there was a significant 12% reduction in TLF (RR, 0.88; 95% CI 0.78-0.99; p < 0.05) associated with the use of ultrathin DES. At 3-years, there was a significant 19% reduction in TLF with ultrathin DES (RR, 0.79; 95% CI 0.64-0.98; p < 0.05). In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.

Long-term safety and efficacy of the Resolute stent: 5-year results from the RESOLUTE China Registry: RESOLUTE China Registry 5-year outcomes.

Long-term clinical outcome data for second-generation drug-eluting stents (DES) are critical for the assessment of safety and efficacy. Five-year results from the RESOLUTE China Registry are presented in this report. The RESOLUTE China Registry is a prospective, multicentre, observational study for all-comers requiring coronary stent implantation. The primary endpoint was target lesion failure (TLF) at one year, and the main secondary endpoint was definite or probable stent thrombosis at one year. Additional secondary endpoints assessed up to 5 years include rates of all deaths, target vessel myocardial infarction (TVMI) and target lesion revascularisation (TLR). A total of 1,800 patients were enrolled from December 2010 to March 2012 at 30 sites in China and implanted with Resolute DES. At 5 years, TLF was 9.8%, TVMI 3.2%, TLR 4.6% and very late stent thrombosis 0.5%. Results of pre-specified subgroup analyses show 5-year TLF rates of 14.3% for diabetics and 13.4% for patients with chronic total occlusions. The RESOLUTE China Registry is the largest study of Asian patients treated with second-generation Resolute DES. Clinical outcomes illustrate a robust safety and efficacy profile of Resolute DES in a real-word Asian population, including favourable performance in complex patient subsets.

Differential Long-Term Effects of First- and Second-Generation DES in Patients With Bifurcation Lesions Undergoing PCI

There is a paucity of data regarding the long-term clinical outcomes of first- versus second-generation drug-eluting stent (DES), especially when used to treat complex lesions such as bifurcation lesions. The current study compares the efficacy and safety of first- versus second-generation DES at the 5-year follow-up in patients who underwent bifurcation percutaneous coronary intervention (PCI). A total of 5,498 patients with a bifurcation lesion who underwent PCI were pooled at a single patient level from COBIS (Coronary Bifurcation Stenting) registries II and III. Five-year target lesion failure (TLF) (the composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and cardiac death or MI were compared between the use of first-generation DES (n=2,436) and second-generation DES (n=3,062) during PCI. Propensity score matching was performed to reduce selection bias. After a 1:1 propensity score matching procedure was conducted, the cohort consisted of 1,702 matched pairs. Patients treated with second-generation DES had a significantly lower risk of TLF at 5 years than those treated with first-generation DES in both overall and propensity-matched populations (matched hazard ratio [HRmatched]: 0.576; 95% confidence interval [CI]: 0.456 to 0.727; p<0.001). There were no significant differences in risk of a composite of cardiac death or MI between the 2 groups (HRmatched: 0.782; 95%CI: 0.539 to 1.133, P = 0.193). However, among patients who required a 2-stent technique, use of the second-generation DES reduced cardiac death or MI (HRmatched:0.422; 95%CI: 0.209 to 0.851, P = 0.016). On the other hand, among patients who required a one-stent technique, the risk of a composite of cardiac death or MI was similar between the 2 groups (HRmatched: 1.046; 95%CI: 0.664 to 1.650, P = 0.845). There was a significant interaction between stent generation and treatment strategy for cardiac death or MI (interaction P = 0.029). In patients treated with PCI for a bifurcation lesion, the use of second-generation DES was associated with a significantly reduced risk of 5-year TLF than the use of first-generation DES. (Korean Coronary Bifurcation Stenting Registry II [NCT01642992]; COBIS II) (Korean Coronary Bifurcation Stenting Registry III [NCT03068494] COBIS III).

Academic Research Consortium for High Bleeding Risk Definitions for Early, Late, and Very Late Bleeding Events.

The validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) definitions of early (<1 year), late (1-4 years), and very late (>4 years) bleeding events is unknown.Methods and Results:This study was performed on patients (n=3,453) implanted with second-generation drug-eluting stents (DES) between 2010 and 2013. Data on all criteria of the ARC-HBR definition were collected retrospectively. The primary endpoint was Bleeding Academic Research Consortium Type 3 or 5 bleeding events; the ischemic endpoint was a composite of cardiac death, myocardial infarction, and ischemic stroke. The mean follow-up period was 7.5 years. Compared with non-high bleeding risk (HBR) patients, HBR patients (n=1,840; 53.3%) had an increased risk of the primary endpoint (early events, 3.6% vs. 0.5% [P<0.0001]; late events, 5.3% vs. 2.5% [P<0.0001]; very late events, 5.5% vs. 2.1% [P<0.0001]) and of ischemic events during follow-up. The discrimination ability of the ARC-HBR definition for late and very late bleeding events was comparable to that of early bleeding events (C statistics 0.679, 0.621, and 0.620, respectively) with high negative predictive value (96.6%, 95.1%, and 93.1%, respectively). Multivariate analysis revealed the different effects of individual criteria on bleeding events in each follow-up period. The ARC-HBR definition consistently identified patients at risk of long-term bleeding and ischemic events after second-generation DES implantation.

Outcomes of Drug-Eluting Stent Thrombosis After Treatment for Acute Versus Chronic Coronary Syndrome

The primary objective of the current analysis was to assess the association between the clinical presentation at index procedure and mortality in patients with second-generation drug-eluting stent thrombosis (G2-ST). Patients with acute coronary syndrome (ACS) have a higher risk for stent thrombosis (ST) as compared with those with chronic coronary syndrome (CCS). However, clinical outcomes of patients with G2-ST after treatment for ACS and CCS remain poorly understood. From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 313 patients with G2-ST. According to baseline clinical presentation, patients were divided into the 2 groups: the ACS and CCS groups (n = 147 and n = 166, respectively). The primary endpoint was the cumulative 3-year incidence of all-cause death after the index ST events. Timing of ST, target lesion revascularization, and recurrent ST were also assessed. Early ST was more frequently observed in the ACS group (71.4% vs. 44.6%), while very late ST was less likely to occur in the ACS group than in the CCS group (11.6% vs. 30.7%). Cumulative 3-year incidence of all-cause death after the index ST events was comparable between the ACS and CCS groups (28.6% vs. 28.3%; hazard ratio: 1.14; 95% confidence interval: 0.75 to 1.73; p = 0.55). Compared with the CCS group, the ACS group showed higher incidences of target lesion revascularization and recurrent ST (23.8% vs. 17.2%; p = 0.06; and 9.9% vs. 1.4%; p = 0.001, respectively). Patients with G2-ST were associated with higher mortality irrespective of baseline clinical presentation.

Malapposed Struts with Cre8, Biomatrix, and Xience Stents Assessed with OCT Immediately after Implantation and at 6-Month Follow-Up: Can the Different Biomechanical Characteristics of the Three Stents Impact on Struts Malapposition?

Background. Although the clinical effects of stent malapposition remain controversial, several analyses of stent registries consistently have found that malapposed struts were frequently identified in patients who experienced stent thrombosis. In this study, which is a subanalysis of the previously published CREBX-OCT study, we compared optical coherence tomography (OCT) analysis at the index percutaneous coronary intervention (PCI) and at six-month follow-up in 37 patients randomly assigned to receive, by a single operator, three different second-generation drug-eluting stents (Cre8, Biomatrix, and Xience) aiming to clarify if the malapposition observed at six-month follow-up was persistent or late-acquired. Moreover, we investigated if there were some differences in the behavior of the three different kinds of stents in relation to the struts malapposition. Material and Methods. We analyzed 614 and 599 cross sections and 5514 and 5377 struts at the index PCI and at six-month follow-up, respectively. The qualitative analysis of the plaque composition among the three groups did not show significant differences. Results. The lumen area did not significantly change from the index procedure to the six-month follow-up in the three groups; on the contrary, the number of malapposed struts increased significantly in the Cre8 and Biomatrix groups but not in the Xience group: 0.58 ± 1.51 and 3.29 ± 5.33 ( p &lt; 0.023 ) in the Cre8 group, 0.55 ± 1.81 and 1.73 ± 2.28 ( p &lt; 0.024 ) in the Biomatrix group, and 0.55 ± 1.5 and 0.25 ± 0.87 ( p &lt; 0.166 ) in the Xience group, respectively. Conclusions. Therefore, the malapposition observed at six-month follow-up in our study population could be mainly considered as acquired and attributable to biomechanical reasons due to the structural differences among the three stents. This trial is registered with Clinical Trials.gov Identifier: NCT02850497.