Drug-eluting Stent Percutaneous Coronary Intervention Research Articles

Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial

Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P=.35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

Long noncoding RNA metastasis-associated lung adenocarcinoma transcript 1 correlates with microRNA-125b/microRNA-146a/microRNA-203 and predicts 2-year restenosis risk in coronary heart disease patients.

Aim: To investigate correlations of long noncoding RNA metastasis-associated lung adenocarcinoma transcript 1 (lnc-MALAT1) and its target microRNAs with clinical features and restenosis risk in coronary heart disease (CHD) patients post drug-eluting stent-percutaneous coronary intervention(DES-PCI). Materials & methods: A total of274 CHD patients undergoing DES-PCI were enrolled, pre-operative plasma samples were obtained to detect lnc-MALAT1, miR-125b, miR-146a, miR-203 by RT-qPCR; 2-year restenosis was determined by quantitative coronary angiography. Results: Lnc-MALAT1 negatively correlated with miR-125b, miR-146a and miR-203. Furthermore, lnc-MALAT1, miR-125b, miR-146a and miR-203 correlated with diabetes mellitus, hyperuricemia, lesion properties, cholesterol, inflammation and cardiac function indexes. Additionally, lnc-MALAT1 was increased, while miR-125b and miR-146a were decreased in patients with 2-year restenosis than patients without 2-year restenosis; however, miR-203 did not differ. Conclusion: Lnc-MALAT1 and its target miRNAs might help manage restenosis risk in CHD patients post DES-PCI.

Percutaneous Coronary Intervention With Drug Eluting Stents Versus Coronary Artery Bypass Graft Surgery in Patients With Advanced Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Το perform a systematic review and meta-analysis of the available literature comparing safety and efficacy outcomes between percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and coronary artery bypass grafting (CABG) in patients with chronic kidney disease (CKD). Eligible studies included patients with eGFR < 60 mL/min/1.73 m2 that underwent revascularization. Subgroup analyses according to DES generation and dialysis status were performed. A total of 7157 and 8156 patients were included in the CABG and PCI arms respectively across 16 studies eligible studies. Weighted mean age was 68.6 and 63.8 years for the CABG and PCI arms, respectively. Mean follow-up time was 3.2 and 2.9 years respectively. Compared to CABG, PCI was associated with increased risk for all-cause mortality (hazard ratio [HR]: 1.28, 95% confidence interval [CI]: 1.13, 1.46; P < 0.01), cardiac mortality (HR: 1.59, 95% CI: 1.13, 2.23; P = 0.01), myocardial infarction (MI) (HR: 1.89, 95% CI: 1.43, 2.49; P < 0.01), and repeat revascularization (HR: 2.97, 95% CI: 2.20, 3.97; P < 0.01). Risk for stroke was lower (HR: 0.64, 95% CI: 0.50, 0,81; P < 0.01) in the PCI group. These results were unchanged when 1st or 2nd DES were used. A subgroup analysis showed no difference in all-cause mortality for DES PCI vs CABG in dialysis patients (HR: 1.11, 95% CI: 0.71, 1.73; P = 0.65). In patients with CKD, PCI is associated with higher risk of mortality, MI, and repeat revascularization compared with CABG and regardless of DES generation. Risk of stroke is higher with CABG. Type of revascularization had no impact on survival of dialysis patients.

Minimally invasive coronary bypass versus percutaneous coronary intervention for isolated complex stenosis of the left anterior descending coronary artery

ObjectiveDebate continues as to the optimal minimally invasive treatment modality for complex disease of the left anterior descending coronary artery, with advocates for both robotic-assisted minimally invasive direct coronary artery bypass and percutaneous coronary intervention with a drug-eluting stent. We analyzed the midterm outcomes of patients with isolated left anterior descending disease, revascularized by minimally invasive direct coronary artery bypass or drug-eluting stent percutaneous coronary intervention, focusing on those with complex lesion anatomy. MethodsA retrospective review was undertaken of all patients who underwent coronary revascularization between January 2008 and December 2016. From this population, 158 propensity-matched pairs of patients were generated from 158 individuals who underwent minimally invasive direct coronary artery bypass for isolated complex left anterior descending disease and from 373 patients who underwent percutaneous coronary intervention using a second-generation drug-eluting stent. Midterm survival and incidence of repeat left anterior descending intervention were analyzed for both patient groups. ResultsOverall 9-year survival was not significantly different between patient groups both before and after propensity matching. Midterm mortality in the matched minimally invasive direct coronary artery bypass group was low, irrespective of patient risk profile. By contrast, advanced age (hazard ratio, 1.10; P = .012) and obesity (hazard ratio, 1.09; P = .044) predicted increased late death after drug-eluting stent percutaneous coronary intervention among matched patients. Patients who underwent minimally invasive direct coronary artery bypass were significantly less likely to require repeat left anterior descending revascularization than those who had percutaneous coronary intervention, both before and after propensity matching. Smaller stent diameter in drug-eluting stent percutaneous coronary intervention was associated with increased left anterior descending reintervention (hazard ratio, 3.53; P = .005). ConclusionsIn patients with complex disease of the left anterior descending artery, both minimally invasive direct coronary artery bypass and percutaneous coronary intervention are associated with similar excellent intermediate-term survival, although reintervention requirements are lower after surgery.

Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main.

Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES) on unprotected left main (ULM) represent a complex subset. The role of routine coronary angiography at follow up in this subset remains debated. At the documented center, all patients undergoing successful PCI on ULM lesions performing angiographic follow-up is suggested, but adherence to such a recommendation is inhomogeneous. Consecutive patients undergoing DES PCI on ULM were enrolled and experienced no adverse events during the first 6 months. Patients were then allocated to two groups: those undergoing routine control angiography (CA) and those undergoing clinical follow-up (CF). Primary endpoint was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and urgent repeat target vessel revascularization. A total of 190 patients underwent successful DES implantation on ULM and the study population was without early events. CA was performed at 6 months after the index procedure in 91 (48%) patients. After 35 ± 21 months, MACE rates were significantly more common in the CF group as compared with the CA group (16.2% vs. 4.3%, p = 0.009). At multivariable analysis, CA was associated with reduced MACE risk (HR 0.13, 95% CI 0.1-0.7, p = 0.028). Of note, this was mainly driven by higher cardiac death rate in those undergoing CF than in those undergoing CA (p = 0.01). CA after complex PCI, such as ULM PCI, is associated with reduced MACE. Such an observation calls for appropriately designed randomized trials.

Impact of percutaneous coronary intervention extent, complexity and platelet reactivity on outcomes after drug-eluting stent implantation

BackgroundRisk stratification after percutaneous coronary intervention (PCI) is mainly based on demographics and clinical presentation (stable coronary artery disease [CAD] vs. acute coronary syndromes [ACS]). We investigated the impact of PCI extent and complexity on 2-year clinical outcomes after successful implantation of drug-eluting stents (DES) and whether this effect is influenced by clinical presentation and/or high platelet reactivity (HPR) on clopidogrel. Methods and resultsPatients from the prospective, multicenter Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents study were stratified according to PCI complexity, with complex PCI (C-PCI) defined as ≥3 stents implanted, bifurcation PCI with 2 stents, rotational atherectomy use for severely calcified lesions, or left main or saphenous vein graft (SVG) PCI. Major adverse cardiac events (MACE; cardiac death, myocardial infarction, and stent thrombosis) were compared at 2-year follow-up in patients with and without C-PCI. Successful DES PCI was performed in 8582 patients—2255 (26.3%) with C-PCI. C-PCI was independently associated with higher 2-year risk of MACE (adjusted HR [adjHR]: 1.56; 95%CI: 1.29–1.89; p<0.0001), MI (adjHR: 1.71; 95%CI: 1.37–2.14; p<0.0001), and ST (adjHR: 2.26; 95%CI: 1.42–3.59; p=0.0006). The association between C-PCI vs. non–C-PCI and the risk of MI and ST was greater in stable CAD than in ACS (Pinteraction=0.04 and 0.03, respectively). SVG PCI, 2-stent bifurcation treatment, and implantation of ≥3 stents were independently associated with MACE. ConclusionsPatients undergoing extensive and more complex PCI experienced worse outcomes after successful PCI. Considering the extent and complexity of PCI revascularization may improve risk stratification.

Abstract 21201: Stent Length Remains an Important Risk for Recurrent Events in Women With or Without Diabetes Mellitus After New Generation DES PCI: From the WIN DES Collaboration

Introduction: New Generation drug eluting stents (DES) have overcome the limitations of bare metal stents and first generation DES resulting in lower risk of ischemic events in women. Hypothesis: We sought to compare increasing total stent length per patient for 3-yr outcomes in DM and non-DM women after percutaneous coronary intervention (PCI) with new generation DES. Methods: The WIN-DES collaboration is a pooled database of women undergoing PCI with coronary stents in 26 randomized trials. We compared total stent length per patient treated with new generation DES in quartiles (Among DM - Q1: 8-18mm, Q2: 18-24mm, Q3: 24-38mm and Q4: 38+mm; among non-DM Q1: 8-18mm, Q2: 18-24mm, Q3: 24-36mm and Q4: 36+mm). 3-yr outcomes were analyzed in a time to event manner and adjusted using multivariable methods. Major adverse cardiovascular events (MACE) were defined as a composite of death, myocardial infarction (MI) or target lesion revascularization (TLR). Results: The study sample comprised 5403 patients, of which 31.8% (n = 1719) had DM. In both DM and non-DM groups, patients in Q4 had greater prevalence of B2/C type and calcified lesions with smaller stent diameter compared to others. 3-yr MACE increased from Q1-Q4 in DM and non-DM patients, albeit DM patients experienced higher event rates ( Figure ). After multivariable adjustment, findings were unchanged, and increasing stent length remained associated with greater risk of 3-yr MACE in DM (p-trend=0.003) and non-DM (p-trend &lt;0.0001) patients. No interaction was observed between DM status and stent length for any outcomes. Conclusions: Despite the use of new generation DES, increasing total stent length per patient was associated with greater risk of MACE in both DM and non-DM women undergoing PCI. Women with DM experienced worse outcomes, and a greater risk of TLR regardless of total stent length. Meticulous attention to stent optimization and post PCI pharmacotherapy is needed to mitigate long-term adverse outcomes in women.

Meta-Analysis of Randomized Controlled Trials of Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Left Main Coronary Artery Disease

Few randomized controlled trials (RCTs) and observational studies had shown acceptable short-term efficacy and safety of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) in selected patients with left main coronary artery disease (LMCAD). We aimed to evaluate long-term outcomes of PCI using DES compared with CABG in patients with LMCAD. On November 1, 2016, we searched available databases for published RCTs directly comparing DES PCI with CABG in patients with LMCAD. Odds ratios (ORs) were used as the metric of choice for treatment effects using a random-effects model. I-squared index was used to assess heterogeneity across trials. Prespecified end points were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stroke, and repeat revascularization at maximal available follow-up. We identified 5 RCTs including a total of 4,595 patients, with a median follow-up of 60months. The risk of all-cause mortality (OR 1.01; 95% confidence interval [CI] 0.76 to 1.34) and cardiovascular mortality (OR 1.02; 95% CI 0.73 to 1.42) were comparable between PCI with DES and CABG. Similarly, there were no statistically significant differences between PCI with DES and CABG for MI (OR 1.45; 95% CI 0.87 to 2.40) and stroke (OR 0.87; 95% CI 0.38 to 1.98). Conversely, repeat revascularization was significantly higher with PCI compared with CABG (OR 1.82; 95% CI 1.51 to 2.21). In conclusion, in patients with LMCAD, PCI with DES appears to be a viable alternative to CABG at long-term follow-up, with similar risks of ischemic adverse events (mortality, MI, and stroke) but a higher risk of repeat revascularization.

Abstract 211: Racial Gaps in Percutaneous Coronary Intervention in Patients with End-stage Renal Disease

Background: End-stage renal disease (ESRD) increases risk of coronary artery disease (CAD) and also worsens prognosis in CAD patients. Percutaneous coronary intervention (PCI) with stenting is an effective treatment procedure for certain categories of CAD patients. It remains unclear whether post-procedure mortality in ESRD patients is associated with patients’ race and a type of stent [[Unable to Display Character: &amp;#8211;]] a drug-eluting stent (DES) or a bare-metal stent (BMS). Hypothesis: We hypothesized that disparities in utilization of DES and BMS stents and post-procedure mortality would exist in CAD patients with ESRD (CAD-ESRD). Methods: We conducted a retrospective cohort study of in-hospital mortality in 12,289 CAD-ESRD patients [mean + SD age: 65.4 + 11.9 years; 60.3% (7,414 of 12,289) males] after PCI with DES and BMS during 2007-2011. Patients’ race was defined as white, black, or other (Asian, Pacific Islander, Native American). Due to short length of stay, in-hospital death was defined as a binary variable (discharged alive or deceased). Multivariable logistic regression was used to obtain adjusted odds ratios (OR) for in-hospital death after DES and BMS PCI in relation to patients’ race, adjusting for clinical and demographic characteristics, including age, gender, number of stents inserted, number of vessels treated, socio-economic status, emergency department (ED) admission, rural/urban area status. Results: Crude (unadjusted) post-PCI mortality was 4.4%, with crude post-DES mortality being 3.4% and post-BMS mortality being 6.7% ( P &lt;0.001). In the adjusted multivariable analysis, DES stents were also associated with lower mortality as compared to BMS (adjusted OR, 0.49; 95% confidence interval (CI), 0.42-0.57; P &lt;0.001). DES stents were received by the majority of patients in all racial groups: 68.3% black, 68.9% white, and 76.9% other patients received DES. In the adjusted multivariable analysis, black patients had a borderline lower risk of post-procedure death than white patients (adjusted OR, 0.70; 95% CI, 0.49-0.99; P =0.046), while in white and other patients the risk of post-procedure death was similar (adjusted OR, 0.70; 95% CI, 0.48-1.03; P =0.072). Conclusions: Our results are indicative of the persistence of racial differences in post-PCI mortality in CAD-ESRD patients still exist, regardless of the improvements in the technique. Further studies investigating the mechanisms responsible for these disparities are warranted.

Bioresorbable vascular scaffold implantation in acute coronary syndromes: clinical evidence, tips and tricks.

Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) is routine treatment for patients with acute coronary syndromes (ACS). However, permanent metallic caging of the vessel has several shortcomings, such as side branch jailing and impossibility of late lumen enlargement. Moreover, DES PCI is affected by vasomotion impairment. In ACS a high thrombus burden and vasospasm lead to a higher risk of acute and late acquired stent malapposition than in stable patients. This increases the risk of acute, late and very late stent thrombosis. In this challenging clinical setting, the implantation of bioresorbable vascular scaffolds (BVS) could represent an appealing therapeutic option. Temporary vessel scaffolding has proved to have several advantages over metallic stent delivery, such as framework reabsorption, late lumen enlargement, side branch patency, and recovery of physiological reactivity to vasoactive stimuli. In the thrombotic environment of ACS, BVS implantation has the benefit of capping the thrombus and the vulnerable plaque. Bioresorbable vascular scaffolds also seems to reduce the incidence of angina during follow-up. Acute coronary syndromes patients may therefore benefit more from temporary polymeric caging than from permanent stent platform implantation. The aim of this review is to update the available knowledge concerning the use of BVS in ACS patients, by analyzing the potential pitfalls in this challenging clinical setting and presenting tricks to overcome these limitations.

ISAR-SAFE: No Difference in 6-Month vs 12-Month DAPT after DES

Current treatment guidelines recommend that patients undergoing drug-eluting stent percutaneous coronary intervention take dual antiplatelet therapy (DAPT) consisting of aspirin plus an adenosine diphosphate receptor inhibitor for at least 12 months after the procedure. The Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting [ISAR-SAFE] trial was designed to determine whether 6 months of DAPT treatment was non-inferior to 12 months, as discussed in this article.

Abstract P161: Drug-Eluting Stent Utilization and Post-Coronary Revascularization Procedure Mortality: Do Racial Disparities Matter?

Background: Besides being a major risk factor for coronary artery disease (CAD), diabetes mellitus (DM) also worsens CAD patients’ prognosis. Percutaneous coronary intervention (PCI) with stenting is an effective treatment procedure for certain categories of CAD patients with DM (CAD-DM). Newer drug-eluting stents (DES) were developed to minimize the occurrence of restenosis known to hinder PCI with older non-drug-eluting stents (non-DES). We hypothesized that disparities in DES utilization and post-procedure mortality would exist in CAD-DM patients. Methods: We conducted a retrospective cohort study of in-hospital mortality in 132,934 CAD-DM patients [mean+SD age: 65.3+11.4 years; 62.7% (83,409 of 132,934) males] after PCI with DES and non-DES in the years 2007,2009. Patient race was classified as white, black, or other Asian, Pacific Islander, Native American). Due to short length of stay, in-hospital death was defined as a binary variable (discharged alive vs. deceased). Multivariable logistic regression was used to obtain adjusted odds ratios (ORs) for in-hospital death after DES and non-DES PCI in relation to patients’ race, adjusting for confounders: age, gender, comorbidities, number of stents inserted, number of vessels treated, socio-economic status, emergency department (ED) admission, rural/urban area status. Results: Blacks were less likely to receive newer DES stent than any other racial group: 75.7% blacks, 76.9% whites, 79.0% other (p&lt;0.04). Blacks were more likely to undergo an emergency rather than planned procedure: 45.7% blacks, 39.8% whites, and 42.7% other were ED-admitted (p&lt;0.01). In adjusted multivariable analysis, controlling for the type of stent and confounding factors, post-PCI mortality in blacks was similar to whites (adjusted OR 0.824, 95% CI: 0.672-1.010, p=0.06), but in other was higher than in whites (adjusted OR 1.284, 95% CI: 1.151-1.434, p&lt;0.001). Conclusions: Racial disparities exist in DES utilization by CAD-DM patients and in post-PCI in-hospital mortality: blacks are least likely to receive DES, but patients of other racial groups are more likely to die after PCI. Further studies investigating the mechanisms responsible for these disparities are warranted.

A novel regimen of alternate day clopidogrel would provide a cost-effective strategy to prevent very late stent thrombosis

Background/objectivesACC/AHA/SCAI recommendations include dual anti-platelet therapy (aspirin and clopidogrel) for 12months after drug-eluting stent percutaneous coronary intervention (DES PCI). Numerous case reports have emerged of “very late stent thrombosis” (VLST) (>1year post-DES-PCI) even 1–5years after DES-PCI manifesting with myocardial infarction and death when clopidogrel therapy was interrupted or stopped. HypothesisWe hypothesize that a novel regimen of alternate day clopidogrel would provide a cost-effective strategy to prevent VLST taking into account the known facts about clopidogrel pharmacodynamics, stent endothelialization and stent thrombosis.We hypothesized that the degree of anti-platelet effect required to prevent VLST decreases with time as the stent endothelializes-that is the “therapeutic threshold” required to prevent VLST decreases with time. The anti-platelet effect of clopidogrel lasts for 5–7days. Typically, stent thrombosis on interruption of clopidogrel (with bare metal stents within first 30days) occurs after 3–4days signifying recovery of enough platelet function to produce stent thrombosis – recovery of platelet inhibition beyond the therapeutic threshold. Since the therapeutic threshold required to prevent VLST in DES after 1year is much lower, this degree of platelet inhibition can be conceivably achieved with just administering clopidogrel on alternate days. Empirical dataWe studied efficacy and safety of regimen of daily aspirin 81mg and alternate-day clopidogrel 75mg beyond 12months after PCI with DES for prevention of VLST by following 347 patients for occurrence of death, myocardial infarction (MI), VLST, target vessel revascularization (TVR) and bleeding. There were no occurrence of major bleeding, VLST events or death. ConclusionsLong term dual anti-platelet therapy with aspirin 81mg daily and clopidogrel 75mg every other day beyond 12months after PCI with DES may be a safe and efficacious cost-saving strategy to prevent VLST.

Hybrid strategy of a bare metal stent combined with a drug-eluting stent versus exclusive drug-eluting stent implantation for multivessel percutaneous coronary intervention

This study aimed to examine the strategy of hybrid percutaneous coronary intervention (PCI) -bare metal stent (BMS) and drug-eluting stent (DES)- versus exclusive DES implantation for patients undergoing multivessel PCI. A cohort of 2,065 patients who underwent PCI (698 hybrid, 1,367 exclusive DES) were followed clinically up to one year. The primary outcome was target vessel revascularisation-major adverse cardiac events (TVR-MACE). Patients presenting with cardiogenic shock, anaemia (haematocrit <25), and bypass graft PCI were excluded. Only patients with ≥ 2 stents in two different lesions were analysed for this study. Baseline and procedural characteristics were similar. Major in-hospital complications and subacute stent thrombosis rates were similar. At one year, there was no difference in TVR-MACE (hybrid 17.2% vs. DES 14.6%, p=0.128). On multivariable analysis, hybrid PCI was not a predictor of TVR-MACE. The strongest predictors of TVR-MACE at one year were hypertension and African American race. Cumulative stent thrombosis rates at one year were similar in both groups. Patients who undergo hybrid PCI have similar composite in-hospital and 1-year outcomes as those who undergo exclusive DES PCI. The hybrid stent approach should be considered for patients with multivessel PCI since it can lower the procedure cost without increasing adverse events.

Drug-Eluting Stent Safety

Drug-eluting stents (DESs) held the promise of mitigating, if not abolishing, in-stent restenosis. This led to early adoption and high penetration of DES use in percutaneous coronary intervention (PCI). Outcomes have not demonstrated an improvement in the hard end points of death and myocardial infarction with these devices, but repeat procedures for in-stent restenosis have decreased. The problem of stent thrombosis, a major obstacle that arose early in coronary stent development, has raised new contemporary concerns about the safety of DESs. The risk for stent thrombosis after bare metal stent placement appears to diminish with time, while very late stent thrombosis (>1 year after index PCI) occurs in small but measurable numbers after DES placement at a rate that continues to increase. Late-acquired incomplete stent apposition and abnormal endothelial function have also been reported. Restenosis, although significantly lessened, does occur after DES PCI. This report reviews DES safety issues that have been described.