Use Of Drug-eluting Stents Research Articles

Coronary In-Stent Restenosis: Predictors and Treatment.

Despite the use of modern drug-eluting stents (DES), in-stent restenosis (ISR) may still occur in as many as 2-10% of percutaneous coronary interventions (PCI) in certain lesion/patient subsets. ISR causes increased morbidity after stent implantation; acute myocardial infarction is a frequent correlate to a clinical ISR, arising in 5-10% of cases. Compared to de novo stenosis, patients with ISR also present more frequently with symptoms of unstable angina pectoris (45% versus 61%). In this article, we discuss the risk factors for ISR and the corresponding diagnostic measures and effective treatment strategies. This review is based on pertinent publications retrieved by a selective search in PubMed, with special attention to current international guidelines and specialist society recommendations. The type of implanted stent, the presence of diabetes mellitus, previous bypass surgery, and small vessel caliber are predictors for ISR. In their guidelines, the European specialist societies (ESC/EACTS) recommend repeated PCI with DES implantation or drug-coated balloon (DCB) angioplasty as the methods of choice for the treatment of ISR. This approach is supported by evidence from meta-analyses. The RIBS-IV trial showed that revascularization treatment of the target lesion is needed less often after everolimus-eluting stent (EES) implantation than after DCB dilatation (11 [7.1%] versus 24 [15.6%]; p = 0.015; hazard ratio: 0.43; 95% confidence interval: [0.21; 0.87]). Because the pathogenesis of ISR is multifactorial, differentiated risk stratification is necessary. The identification of patient-, stent-, and lesion-related predictors is particularly important, as the most effective way to combat ISR is to prevent it.

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.

Trends in the Outcomes of High-risk Percutaneous Ventricular Assist Device-assisted Percutaneous Coronary Intervention, 2008-2018

Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time.

Efficacy of Drug-Eluting Stents in Diabetic Patients Admitted with ST-Elevation Myocardial Infarctions Treated with Primary Percutaneous Coronary Intervention.

Background: Diabetic patients show higher adverse ischemic event rates and mortality when undergoing percutaneous coronary intervention (PCI) in acute myocardial infarctions. Therefore, diabetic patients might benefit even more from modern-generation drug-eluting stents (DES). The aim of the present study was to compare adverse ischemic events and mortality rates between bare-metal stents (BMS) and DES in diabetic patients admitted with ST-elevation-myocardial infarction (STEMI) with non-diabetic patients as the control group. Methods: All STEMI patients undergoing emergency PCI and stent implantation documented between 2006 and 2019 in the Bremen STEMI registry entered the analysis. Efficacy was defined as a combination of in-stent thrombosis, myocardial re-infarction or additional target lesion revascularization at one year. Results: Of 8356 patients which entered analysis, 1554 (19%) were diabetics, while 6802 (81%) were not. 879 (57%) of the diabetics received a DES. In a multivariate model, DES implantation in diabetics compared to BMS was associated with lower rates of in-stent thrombosis (OR 0.16, 95% CI 0.05–0.6), myocardial re-infarctions (OR 0.35, 95%CI, 0.2–0.7, p < 0.01) and of the combined endpoint at 1 year ((ST + MI + TLR): OR 0.31, 95% CI 0.2–0.6, p < 0.01), with a trend towards lower 5-year mortality (OR 0.56, 95% CI 0.3–1.0, p = 0.058). When comparing diabetic to non-diabetic patients, an elevation in event rates for diabetics was only detectable in BMS (OR 1.78, 95% CI 0.5–0.7, p < 0.01); however, this did not persist when treated with a DES (OR 1.03 95% CI 0.7–1.6, p = 0.9). Conclusions: In STEMI patients with diabetes, the use of DES significantly reduced ischemic event rates and, unlike with BMS, adverse ischemic event rates became similar to non-diabetic patients.

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.

24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent

PurposeThe purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease.Materials and methodsPatients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures.ResultsThe Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan–Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time.ConclusionThe results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia.Clinical trial RegistrationClinicaltrials.gov identifier NCT02574481.https://clinicaltrials.gov/ct2/show/NCT02574481Level of EvidenceEBM Level III; cohort analysis of randomized trial.

Warning system improve the clinical outcomes in transfer patients with ST-segment elevation myocardial infarction.

A warning system included directly faxing electrocardiography information to the mobile phone immediately after an ST-segment elevation myocardial infarction (STEMI) diagnosis was made at a non-percutaneous coronary intervention (PCI) capable hospital. This study aimed to explore the outcomes after using a warning system in transfer STEMI patients.From October 2013 to December 2016, 667 patients experienced a STEMI event and received primary PCI at our institution. 274 patients who were divided into transfer group were transferred from non-PCI capable hospitals and connected to a first-line cardiovascular doctor by the warning system. Other 393 patients were divided into the non-transfer group.The transfer group still had a longer pain-to-reperfusion time and presented higher troponin-I level when compared with non-transfer group. There was no significant difference in the use of drug-eluting stent and procedural devices between non-transfer and transfer groups. The prevalence of different anti-platelet agents loading did not differ between non-transfer and transfer groups. Non-significant trend about higher prevalence of statin use was noted in transfer group (78.9% vs 86.1%, P = .058). The transfer group presented similar clinical short-term results regarding both cardiovascular and all-cause mortality when comparing with non-transfer group. The transfer group provided non-significant trend about lower one-year cardiovascular mortality (10.7% vs 6.2%, P = .052) and lower all-cause mortality (12.2% vs 6.9%, P = .026) when compared with non-transfer group. There was a significant difference in the Kaplan–Meier curve of 1-year cardiovascular mortality between the transfer group and the non-transfer group (P = .049).After using the warning system, the inter-facility transfer group had comparable outcomes even though a longer pain-to-reperfusion time and a higher peak troponin-I level when comparing with non-transfer group.

Profiles of Hospitalized Patients with Angiographic Coronary Heart Disease in Taiwan during 2014-2016: Report of a Tertiary Hospital.

The Taiwan Society of Cardiology (TSOC) has established multicenter registries for coronary artery disease (CAD) to investigate clinical characteristics, management and risks for mortality. However, the impacts of newly-emerged evidence-based therapies, including the use of drug-eluting stents (DESs), on patients with CAD in Taiwan remain unclear. The Tri-Service General Hospital-Coronary Heart Disease (TSGH-CHD) registry is a single-center, prospective, longitudinal registry in Taiwan containing data from 2014-2016. Individuals who were admitted for coronary angiography were enrolled. Patient profiles, management and in-hospital outcome data were collected. We included 3352 patients: 2349 with stable angina and 1003 with acute coronary syndrome (ACS). In the stable angina group, both patients receiving stenting and those receiving medical treatment had a 0.7% mortality rate; DESs were used in 70.4% of the patients receiving stenting. In the ACS group, the patients receiving stenting and those receiving medical treatment had a 4.9% and 10.7% mortality rate, respectively; DESs were used in 63.1% of the patients receiving stenting. In the 2008-2010 Taiwan ACS registry, DESs were used in only 28% of all stenting procedures, and the estimated hospital mortality rate was 1.8%. Multivariate analysis indicated that older age, prior stroke, and cardiogenic shock on admission were associated with an increased risk of in-hospital mortality in the ACS group. Compared with the Taiwan ACS cohort, the TSGH-CHD registry revealed increased DES use and increased disease complexity and severity after 2010. Although unlikely to significantly improve survival, interventionists seemed to perform high-risk procedures for complex CAD more often in the new DES era.

Use of drug-eluting stents in patients with critical limb ischemia and infrapopliteal arterial disease: a real-world single-center experience

BackgroundAlthough no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience. MethodsA total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates. ResultsOf the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively. ConclusionsThe clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective

PurposeImprovement in long-term outcomes through innovative, cost-effective medical technologies is a focus for endovascular procedures aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). The advent of drug-eluting stents (DES) has improved symptomatic PAD treatment via a reduction in high rates of target lesion revascularisation (TLR). The present study aimed to compare the 5-year financial impact of treatment with Eluvia, a new paclitaxel-eluting stent, versus treatment with Zilver PTX, a drug-coated stent, among patients in Australia by developing a budget impact model (BIM).MethodsA BIM was developed from an Australian public hospital payer perspective using Australian national cost weights (AUD), published literature, and public hospital audit data. Clinical outcomes, including clinically driven TLRs (CD-TLRs), adverse events, and length of stay, were based on the 2-year results of the IMPERIAL trial, which compared Eluvia DES to Zilver PTX.ResultsAssuming EVP eligibility rate of 80% and DES uses rate ranging from 10 to 28% (superficial femoral artery lesions only), the 5-year model forecasted a treatment population between 14,428 and 40,399 patients. The model estimated 1499–4198 fewer CD-TLRs and 16,515–46,243 fewer hospital days with Eluvia DES use. This translated to 5-year potential savings of $4.3–$12.1 million to the Australian public hospital payer attributable to reduced CD-TLRs for Eluvia DES and $33.1–$92.6 million to Australian public hospitals owing to reduced adverse events and hospital bed days.ConclusionEluvia DES use as treatment for symptomatic lower-limb PAD could lead to potential savings for the Australian public healthcare system based on improved patient outcomes.

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).

Surface engineering at the nanoscale: A way forward to improve coronary stent efficacy.

Coronary in-stent restenosis and late stent thrombosis are the two major inadequacies of vascular stents that limit its long-term efficacy. Although restenosis has been successfully inhibited through the use of the current clinical drug-eluting stent which releases antiproliferative drugs, problems of late-stent thrombosis remain a concern due to polymer hypersensitivity and delayed re-endothelialization. Thus, the field of coronary stenting demands devices having enhanced compatibility and effectiveness to endothelial cells. Nanotechnology allows for efficient modulation of surface roughness, chemistry, feature size, and drug/biologics loading, to attain the desired biological response. Hence, surface topographical modification at the nanoscale is a plausible strategy to improve stent performance by utilizing novel design schemes that incorporate nanofeatures via the use of nanostructures, particles, or fibers, with or without the use of drugs/biologics. The main intent of this review is to deliberate on the impact of nanotechnology approaches for stent design and development and the recent advancements in this field on vascular stent performance.

Very Long-term Safety and Effectiveness of Drug-Eluting or Bare-Metal Stents for Left Main Coronary Disease

BackgroundLimited data are available on the long-term outcomes of drug-eluting stents (DES) vs bare-metal stents (BMS) in patients with left main coronary artery (LMCA) disease. MethodsIn this observational cohort of the Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty vs Surgical Revascularization (MAIN-COMPARE) registry, we evaluated patients with unprotected LMCA stenosis who received DES or BMS between January 2000 and June 2006. The primary outcome was a composite of all-cause death or myocardial infarction (MI) at 10 years. Adjusted outcomes were compared using propensity scores and inverse probability of treatment weighting. ResultsA total of 1102 patients underwent DES (n = 784) or BMS (n = 318) during the study period. At 10 years, the adjusted rate of the primary outcome was significantly lower in DES group than in the BMS group (27.9% vs 37.0%; hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.53-0.94; P = 0.02). The adjusted 10-year mortality rate was significantly lower in DES group than in the BMS group (20.6% vs 29.6%; HR, 0.65; 95% CI, 0.46-0.91; P = 0.01), whereas the 10-year rate of MI was similar between the 2 groups (9.9% vs 11.0%; HR, 0.93; 95% CI, 0.54-1.59; P = 0.78). DES use was associated with a significant reduction in the rate of target-lesion revascularization (10.2% vs 21.8%; HR, 0.41; 95% CI, 0.27-0.61; P < 0.001). ConclusionsIn this 10-year follow-up study in patients with LMCA disease, DES use was associated with a significant reduction in the rate of the composite of death or MI, mortality, and target-lesion revascularization, when compared with BMS.

Trends in ST-elevation myocardial infarction.

Despite recent progress in coronary artery disease treatment, ST-segment elevation myocardial infarction (STEMI) remains a very high-risk medical condition. Whether recent patients' outcomes, following implementation of the 2012 European Society of Cardiology (ESC) STEMI guidelines have improved, is yet unclear. The study was based on a prospective detailed registry of 2004 consecutive patients with STEMI treated with primary percutaneous coronary intervention (pPCI). We compared trends during two different time periods (2006-2012 vs. 2012-2018). Endpoints included mortality and major adverse cardiac events (MACE: death, repeat myocardial infarction, target vessel revascularization and coronary artery bypass surgery) at 1 month, 1 and 2 years. Rates of transradial interventions have risen significantly (67.3 vs. 42.0%; P < 0.01), as have rates of prasugrel administration (69.8 vs. 4.5%; P < 0.01) and use of drug eluting stents (75.5 vs. 56.5%; P < 0.01). Both at 1 and at 2 years, MACE was significantly lower in the later period (11.6 vs. 20.9%; P < 0.01 and 18.9 vs. 25.4%; P < 0.01 respectively), whereas mortality was only significantly lower after 1 year (5.8 vs. 8.6%; P = 0.02). Cox regression identified the later period (2012-2018) to independently and favorably impact MACE (hazard ratio, -0.69; 95% CI, 0.56-0.85; P < 0.01) but not mortality (hazard ratio, -0.76; 95% CI, 0.54-1.05; P = 0.09). Among patients treated with pPCI for STEMI, adoption of the contemporary evidence-based treatments is associated with better MACE derived outcomes, following the inception of the 2012 ESC guidelines. Nonetheless, the long-term mortality was marginally (but not significantly) lower, which indicates an unmet need for further improvement.

Efficacy and safety of drug-eluting stents in elderly patients: A meta-analysis of randomized trials.

Current guidelines recommend newer generation drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ischemic heart disease. However, there is no age-specific recommendation in elderly patients. Meta-analysis was performed of 6 randomized studies enrolling 5,042 elderly patients who underwent percutaneous coronary intervention (PCI) with stent implantation (DES, n = 2,579; BMS, n = 2,463). Combined data indicated a significant reduction in major adverse cardiovascular events (MACEs) with use of DES (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.44-0.71, p < 0.001). Moreover, use of DES was associated with a significantly lower incidence of myocardial infarction (OR 0.54, 95% CI 0.36-0.81, p = 0.003) and repeat revascularization (OR 0.44, 95% CI 0.31-0.62, p < 0.001), was compared to that with the use of BMS. Stent thrombosis and bleeding complication rates were not significantly different between groups. In a subgroup meta-analysis, short duration (1 or 6 months) dual antiplatelet therapy (DAPT) was associated with a significantly lower MACE rate (OR 0.49, 95% CI 0.34-0.80; p = 0.003) in elderly patients who underwent PCI with everolimuseluting stent implantation, compared with that using long duration DAPT. This meta-analysis provides clinically relevant evidence that DES rather than BMS should be selected for elderly patients.

Evolution of Antithrombotic Management of Atrial Fibrillation After Percutaneous Coronary Intervention Over 10 Years and Guidelines Uptake

BackgroundThe management of atrial fibrillation and/or flutter (AF) patients requiring percutaneous coronary intervention (PCI) has evolved significantly. The Canadian Cardiovascular Society AF guidelines, last updated in 2020, seek to aid physicians in balancing both bleeding and thrombotic risks. MethodsA tertiary academic centre registry of patients with AF who had PCI was examined for the antithrombotic therapy at discharge in 4 time periods (cohort 2010–2011; cohort 2014–2015; cohort 2017; cohort 2019). Discharge prescription patterns were compared among the cohorts, using the χ2 test. In addition, antithrombotic management in cohorts 2017 and 2019 were compared to guideline-expected therapy, using the χ2 test. ResultsA total of 576 AF patients undergoing PCI were included. Clinical and procedural characteristics were similar among cohorts, except for an increase in drug-eluting stent use in the most recent cohort (94% vs 99%; P = 0.04). The rate of oral anticoagulation increased over time (75% vs 89%; P < 0.01), driven primarily by an increase in direct oral anticoagulants prescription (63% vs 84%; P < 0.01). In contrast to previous cohorts, there was no significant difference between the observed and the guideline-expected anticoagulation rate in cohort 2019 (89% vs 94%; P = 0.23). ConclusionsA combination of expert guidance and educational initiatives in the past decade contributed to dramatic changes in the management of patients with AF undergoing PCI.

Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery

Although the drug-eluting stent (DES) has become the standard for percutaneous coronary intervention (PCI)-based revascularization, concerns remain regarding the use of DES, mainly due to its permanent rigid constraint to vessels. A drug-eluting bioresorbable stent (BRS) was thus developed as an alternative to DES, which can be absorbed entirely after its therapeutic period. Magnesium (Mg)-based BRSs have attracted a great deal of attention due to their suitable mechanical properties, innovative chemical features, and well-proven biocompatibility. However, the primary disadvantage of Mg-based BRSs is the rapid degradation rate, resulting in the early loss of structural support long before the recovery of vascular function. Recently, a new type of patented Mg–Nd–Zn-Zr alloy (JDBM) was developed at Shanghai Jiao Tong University to reduce the degradation rate compared to commercial Mg alloys. In the present investigation, a poly(d,l-lactic acid)-coated and rapamycin eluting (PDLLA/RAPA) JDBM BRS was prepared, and its biosafety and efficacy for coronary artery stenosis were evaluated via in vitro and in vivo experiments. The degree of smooth muscle cell adhesion to the PDLLA/RAPA coated alloy and the rapamycin pharmacokinetics of JDBM BRS were first assessed in vitro. JDBM BRS and commercial DES FIREHAWK were then implanted in the coronary arteries of a porcine model. Neointimal hyperplasia was evaluated at 30, 90, and 180 days, and re-endothelialization was evaluated at 30 days. Furthermore, Micro-CT and optical coherence tomography (OCT) analyses were performed 180 days after stent implantation to evaluate the technical feasibility, biocompatibility, and degradation characteristics of JDBM BRS in vivo. The results show the ability of a PDLLA/RAPA coated JDBM to inhibit smooth muscle cell adhesion and moderate the drug release rate of JDBM BRS in vitro. In vivo, low local and systemic risks of JDBM BRS were demonstrated in the porcine model, with preserved mechanical integrity after 6 months of implantation. We also showed that this novel BRS was associated with a similar efficacy profile compared with standard DES and high anti-restenosis performance. These findings may confer long term advantages for using this BRS over a traditional DES.

Practice and long-term outcome of unprotected left main PCI: real-world data from a nationwide registry

Background Percutaneous coronary intervention (PCI) is increasingly performed in significant left main (LM) lesions. Left untreated, the prognosis is poor, but PCI and coronary bypass surgery (CABG) behold risks as well. Additional long-term outcome data might guide future treatment decisions. Methods Between 2012 and 2019, all 6783 patients who underwent LM PCI were prospectively enrolled in a national registry. Patients with prior CABG or prior LM PCI, and patients presenting in cardiogenic shock or after out-of-hospital cardiac arrest were excluded. From the remaining 5284 patients, baseline and procedural data as well as long-term survival were assessed. Results The annual rate of LM PCI increased from 422 (2.2% of PCIs) in 2012 to 868 in 2018 (3.0%). By 2018, 71% of the interventional cardiologists performed at least 1 LM PCI a year, though only 5 on average. Use of transradial access (TRA) in LM PCI increased from 20.4% in 2012 to 59.5% in 2019. All-cause mortality was 6.0% at 30 days and 18.5% at a mean follow-up of 33.5 months. Independent predictors of higher long-term mortality were older age, diabetes, multivessel disease, an urgent indication, a suboptimal angiographical result, and non-exclusive use of drug-eluting stents. TRAand higher operator and centre LM PCI experience were independent predictors of a lower long-term mortality. Conclusion LM PCI is associated with high short- and long-term mortality. Use of TRA and higher expertise in LM PCI were associated with better survival.

Comparison of Long-Term Outcomes After Percutaneous Coronary Intervention in Patients With Insulin-Treated Versus Non-Insulin Treated Diabetes Mellitus

There are conflicting data on whether patients with insulin-treated diabetes mellitus (ITDM) have poorer outcomes compared with non-insulin treated diabetic (non-ITDM) patients following percutaneous coronary intervention (PCI). We therefore compared clinical outcomes following PCI in ITDM versus non-ITDM patients. We prospectively collected data on 4,579 patients with diabetes underwent PCI between 2005 and 2014 in a large multicenter registry and dichotomized them as having ITDM (n = 1,111) or non-ITDM (n = 3,468). The non-ITDM group was further divided into diet control only (diet-DM; n = 786) and those taking oral hypoglycemic agents (OHG-DM; n = 2,639), and clinical outcomes were compared with ITDM patients. Median follow-up for long-term mortality was 4.2 years (IQR 2.0 to 6.6 years). ITDM patients were more likely to be female, obese, and have severe renal impairment (all p <0.001). Procedural characteristics were similar other than a greater use of drug-eluting stents in ITDM patients. On multivariable analysis, ITDM was an independent predictor of 12-month major adverse cardiovascular and cerebrovascular events (MACCE; OR 1.26, 95% CI 1.02 to1.55, p = 0.03). Dividing the non-ITDM group further by treatment, a progressively higher rate of 12-month MACCE across the 3 groups was observed (13.5% vs 17.9% vs 21.8%; p <0.001). Long-term mortality was similar in the diet-DM and OHG-DM groups, but significantly higher in the ITDM group on Kaplan-Meier analysis (log-rank p <0.001). In conclusion, there is a clear gradient of adverse outcomes with escalation of therapy from diet control to OHGs to insulin.

Coronary revascularization in patients with stable coronary disease and diabetes mellitus.

Purpose of Study:Diabetes mellitus accelerates the development of atherosclerosis. Patients with diabetes mellitus have higher incidence and mortality rates from cardiovascular disease and undergo a disproportionately higher number of coronary interventions compared to the general population. Proper selection of treatment modalities is thus paramount. Treatment strategies include medical management and interventional approaches including coronary artery bypass graft (CABG) surgery and percutaneous coronary interventions (PCI). The purpose of this review is to assimilate emerging evidence comparing CABG to PCI in patients with diabetes and present an outlook on the latest advances in percutaneous interventions, in addition to the optimal medical therapies in patients with diabetes.Key Methods:A systematic search of PubMed, Web of Science and EMBASE was performed to identify prospective, randomized trials comparing outcomes of CABG and PCI, and also PCI with different generations of stents used in patients with diabetes. Additional review of bibliography of selected studies was also performed.Main Conclusions:Most of the trials discussed above demonstrate a survival advantage of CABG over PCI in patients with diabetes. However, recent advances in PCI technology are starting to challenge this narrative. Superior stent designs, use of specific drug-eluting stents, image-guided stent deployment, and the use of contemporary antiplatelet and lipid-lowering therapies are continuing to improve the PCI outcomes. Prospective data for such emerging interventional technologies in diabetes is however lacking currently and is the need of the hour.