Target Vessel Revascularization Research Articles

Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry

Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated. We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n=551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n=35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the 2 populations. Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial, or venous grafts, and chronic total occlusions (P < .005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UMregarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, P=.14), cardiac death (HR 0.71, 95% CI 0.29-1.72, P=.45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, P=.44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, P=.63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, P=.002. A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.

Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial.

We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM). Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup (n = 252) was analyzed with respect to ITDM or NITDM. In NITDM patients (n = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29-1.58, p = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03, p = 0.057) were similar between DCB and DES. In ITDM patients (n = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74, p = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27, p = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95, p = 0.038). DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.

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

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

Intravascular Imaging–Guided or Angiography-Guided Complex PCI

BackgroundData regarding clinical outcomes after intravascular imaging–guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited.MethodsIn this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging–guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators’ discretion. The primary end point was a composite of death from cardiac causes, target-vessel–related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed.ResultsA total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging–guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P=0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel–related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events.ConclusionsAmong patients with complex coronary-artery lesions, intravascular imaging–guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel–related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).

Long-term outcomes of less drug-eluting stents by the use of drug-coated balloons in de novo coronary chronic total occlusion intervention: A multicenter observational study.

Data on drug-coated balloons (DCB) for de novo coronary chronic total occlusion (CTO) are limited. We aimed to investigate the long-term outcomes of substitution of drug-eluting stents (DES) by DCB. We compared the outcomes of less DES strategy (DCB alone or combined with DES) and DES-only strategy in treating de novo coronary CTO in this prospective, observational, multicenter study. The primary endpoints were major adverse cardiovascular events (MACE), target vessel revascularization, myocardial infarction, and death during 3-year follow-up. The secondary endpoints were late lumen loss (LLL) and restenosis until 1-year after operation. Of the 591 eligible patients consecutively enrolled between January 2015 and December 2019, 281 (290 lesions) were treated with DCB (DCB-only or combined with DES) and 310 (319 lesions) with DES only. In the DCB group, 147 (50.7%) lesions were treated using DCB-only, and the bailout stenting rate was relatively low (3.1%). The average stent length per lesion in the DCB group was significantly shorter compared with the DES-only group (21.5 ± 25.5 mm vs. 54.5 ± 26.0 mm, p < 0.001). A total of 112 patients in the DCB group and 71 patients in the DES-only group (38.6% vs. 22.3%, p < 0.001) completed angiographic follow-up until 1-year, and LLL was much less in the DCB group (-0.08 ± 0.65 mm vs. 0.35 ± 0.62 mm, p < 0.001). There were no significant differences in restenosis occurrence between the two groups (20.5% vs. 19.7%, p > 0.999). The Kaplan-Meier estimates of MACE at 3-year (11.8% vs. 12.0%, log-rank p = 0.688) was similar between the groups. Percutaneous coronary intervention with DCB is a potential "stent-less" therapy for de novo CTO lesions with satisfactory long-term clinical results compared to the DES-only approach.

A glimpse into the future of the percutaneous treatment of coronary chronic total occlusions.

Percutaneous coronary intervention (PCI) of coronary chronic total occlusion (CTO PCI) is one of the most challenging but rewarding procedures in the portfolio of interventional cardiologists. Several challenges, however, still must be overcome and many questions need to be answered. After coronary artery bypass graft (CABG), disease of the conduits and concomitant progression of atherosclerotic disease to CTO of the subtended native coronary vessels are common and associated with onset of new anginal symptoms and worsening of the prognosis. Which is the best strategy for these post-CABG CTOs? Furthermore, what is the role of physiology in the setting of CTO PCI? In the last decades, many researchers tried to demystify the complex maze but technical limitations and the demanding procedure itself, for both the patient and the operator, do not allow extensive investigation of its impact on clinical practice. Can we enhance periprocedural planning of CTO PCI with a more tailored and multidimensional evaluation? Analysis of coronary computed tomography angiography (CCTA) scans is getting more and more incorporated into the clinical routine and training of interventional cardiologists but mainly focuses on structural valvular disease. Nevertheless, with the appropriate expertise, a lot of information can be derived for coronary intervention to improve procedural planning and potentially outcomes. Finally, in the era of drug-eluting stent, is there a place for strategies that minimize metal implantation in the coronaries to further reduce late-onset adverse events in CTO PCI? This approach could be attractive in CTOs due to the higher risk of target vessel failure and revascularization shown in literature but, at the same time, more challenging due to the histological and anatomical complexity of the disease. In this review, we aim to tackle these questions and concomitantly provide a vision of potential future application of new techniques and technology in CTO PCI that could allow further advancement in this field.

Minimally Invasive Direct Coronary Artery Bypass Versus Percutaneous Coronary Intervention for Isolated Left Anterior Descending Artery Stenosis: An Updated Meta-Analysis.

The optimal revascularization strategy for isolated left anterior descending (LAD) coronary artery lesion between minimally invasive direct coronary artery bypass (MIDCAB) and percutaneous coronary intervention (PCI) remains controversial. This updated meta-analysis aims to compare the long- and short-term outcomes of MIDCAB versus PCI for patients with isolated LAD coronary artery lesions. The Pubmed, Web of Science, and Cochrane databases were searched for retrieving potential publications from 2002 to 2022. The primary outcome was long-term survival. Secondary outcomes were long-term target vessel revascularization (TVR), long-term major adverse cardiovascular events (MACEs), and short-term outcomes, including postoperative mortality, myocardial infarction (MI), TVR, and MACEs of any cause in-hospital or 30 days after the revascularization. Six randomized controlled trials (RCTs) and eight observational studies were included in this updated meta-analysis. In total, 1757 patients underwent MIDCAB and 15245 patients underwent PCI. No statistically significant difference was found between the two groups in the rates of long-term survival. MIDCAB had a lower long-term MACE rate compared with PCI. Besides, PCI resulted in an augmented risk of TVR. Postoperative mortality, MI, TVR, and MACEs were similar between the two groups. The updated meta-analysis presents the evidence that MIDCAB has a reduced risk of long-term TVR and MACEs, with no benefit in terms of long-term mortality and short-term results, in comparison with PCI. Large multicenter RCTs, including patients treated with newer techniques, are warranted in the future.

Five-year outcomes of biodegradable versus second-generation durable polymer drug-eluting stents used in complex percutaneous coronary intervention.

There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up. Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization. Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years. Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.

First‐Pass Effect With Aspiration Thrombectomy With the Penumbra System in Patients With Acute Ischemic Stroke: A Core Laboratory–Adjudicated Subset Analysis of the COMPLETE Registry

Background In patients with acute ischemic stroke, minimizing the time to revascularization can minimize neuronal death. First‐pass effect (FPE), defined as successful or complete revascularization of an occluded target vessel with 1 pass of a mechanical thrombectomy device(s), reduces the time to revascularization. The objective of this study was to determine the FPE rate, compare cases in which FPE was versus was not achieved, and determine predictors of good functional outcome at 90 days, in patients with large‐vessel occlusion acute ischemic stroke treated with the Penumbra System (Penumbra, Inc). Methods This study is a subset analysis of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D [3‐Dimensional] Revascularization Device) registry, a global, prospective, multicenter, observational registry. FPE rates were calculated. Subgroups who achieved versus did not achieve FPE were compared. Variables independently associated with good functional outcome at 90 days were determined. Results A total of 648 patients were included. FPE was achieved with a revascularization definition of modified thrombolysis in cerebral infarction score 2b to 3 in 56.8% of patients, with modified thrombolysis in cerebral infarction score 2c to 3 in 41.5%, and with modified thrombolysis in cerebral infarction score 3 in 31.8%. The percentage of patients who achieved good functional outcome at 90 days was higher for patients who achieved FPE than for patients who did not ( P &lt;0.01). Achieving FPE with modified thrombolysis in cerebral infarction score 2b to 3 was an independent predictor for good functional outcome at 90 days (adjusted odds ratio, 1.64; P =0.045). Conclusions For aspiration thrombectomy with the Penumbra System, achieving FPE was associated with a significantly higher rate of good functional outcome.

Clinical Implications of Fractional Flow Reserve Measured Immediately After Percutaneous Coronary Intervention.

The purpose of the present study was to find the independent predictors of Fractional Flow Reserve (FFR) measured immediately after percutaneous coronary intervention with drug-eluting stent implantation (post-PCI FFR) and investigate if applying vessel-specific post-PCI FFR cut-off values to predict target vessel failure (TVF), a composite of cardiac death (CD), non-fatal myocardial infarction (MI) and target vessel revascularization (TVR), or a composite of CD and MI ameliorated its predictive power. Consecutive patients with post-PCI FFR measurement at our center between 2009 and 2021 were included in this analysis. A total of 434 patients with 500 vessels were included. Median pre-PCI FFR was 0.72 with no difference between LAD and non-LAD vessels. Median post-PCI FFR was 0.87. LAD location, male gender, smaller stent diameter, and lower pre-PCI FFR proved to be significant predictors of a lower post-PCI FFR. On a vessel-level, post-PCI FFR, stent length, and diabetes mellitus proved to be significant predictors of TVF and the composite of CD and MI. The best post-PCI FFR cut-off to predict TVF or a composite of CD and MI was 0.83 in the LAD and 0.91 in non-LAD vessels. LAD location is a predictor of a lower post-PCI FFR. Post-PCI FFR is an independent predictor of TVF as well as of the composite of CD and MI. No uniform target post-PCI FFR value exists; different cut-off values may have to be applied in LAD as opposed to non-LAD vessels.

Coronary CT angiography-derived plaque characteristics and physiologic patterns for peri-procedural myocardial infarction and subsequent events.

Peri-procedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) has been shown to be associated with worse clinical outcomes. We aimed to investigate the value of coronary plaque characteristics and physiologic disease patterns (focal vs. diffuse) assessed by coronary computed tomography angiography (CTA) in predicting PMI and adverse events. Three hundred fifty-nine patients with normal pre-PCI high-sensitivity cardiac troponin T (hs-cTnT) underwent CTA before PCI were analysed. The high-risk plaque characteristics (HRPC) were assessed on CTA. The physiologic disease pattern was characterized using CTA fractional flow reserve-derived pullback pressure gradients (FFRCT PPG). PMI was defined as an increase in hs-cTnT to >5 times the upper limit of normal after PCI. The major adverse cardiovascular events (MACE) were a composite of cardiac death, spontaneous myocardial infarction, and target vessel revascularization. The presence of ≥3 HRPC in the target lesions [odds ratio (OR) 2.21, 95% confidence interval (CI) 1.29-3.80, P = 0.004] and low FFRCT PPG (OR 1.23, 95% CI 1.02-1.52, P = 0.028) were independent predictors of PMI. In a four-group classification according to HRPC and FFRCT PPG, patients with ≥3 HRPC and low FFRCT PPG had the highest risk of MACE (19.3%; overall P = 0.001). Moreover, the presence of ≥3 HRPC and low FFRCT PPG was an independent predictor of MACE and showed incremental prognostic value compared with a model with clinical risk factors alone [C index = 0.78 vs. 0.60, P = 0.005, net reclassification index = 0.21 (95% CI: 0.04-0.48), P = 0.020]. Coronary CTA can evaluate plaque characteristics and physiologic disease patterns simultaneously, which plays an important role for risk stratification before PCI.

Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study.

Recently, questions around the efficacy and effectiveness of Fractional Flow Reserve (FFR) have arisen in various clinical settings. The Clinical Outcome of FFR-guided Revascularization Strategy of Coronary Lesions (HALE-BOPP) study is an investigator-initiated, multicentre, international prospective study enrolling patients who underwent FFR measurement on at least one vessel. In accordance with the decision-making workflow and treatment, the vessels were classified in three subgroups: (i) angio-revascularized, (ii) FFR-revascularized, (iii) FFR-deferred. The primary endpoint was the occurrence of target vessel failure (TVF, cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization). The analysis was carried out at vessel- and patient-level. 1305 patients with 2422 diseased vessels fulfilled the criteria for the present analysis. Wire-related pitfalls and transient adenosine-related side effects occurred in 0.8% (95% CI: 0.4%-1.4%) and 3.3% (95% CI: 2.5%-4.3%) of cases, respectively. In FFR-deferred vessels, the overall incidence rate of TVF was 0.024 (95% CI: 0.019-0.031) lesion/year. After a median follow-up of 3.6 years, the occurrence of TVF was 6%, 7% and 11.7% in FFR-deferred, FFR-revascularized and angio-revascularized vessels, respectively. Compared to angio-revascularized vessels, FFR-guided vessels (both FFR-revascularized and FFR-deferred vessels) showed a lower TVF incidence rate lesion/year (0.029, 95% CI: 0.024-0.034 vs. 0.049, 95% CI: 0.040-0.061 respectively, p = 0.0001). The result was consistent after correction for confounding factors and across subgroups of clinical interest. The patient-level analysis confirmed the lower occurrence of TVF in negative-FFR vs. positive-FFR subgroups. In a large prospective observational study, an FFR-based strategy for the deferral of coronary lesions is a reliable and safe tool, associated with good outcomes. NCT03079739.

Outcomes of optical coherence tomography guided percutaneous coronary intervention against angiography guided in patients with coronary artery disease: A systematic reviews and meta-analyses

BackgroundPrevious studies compared optical coherence tomography (OCT) guided percutaneous coronary intervention (PCI) and angiography-guided was still limited. Therefore, we performed comprehensive meta-analyses to investigate the clinical outcomes of OCT-guided compared with angiography-guided PCI to provide a higher level of evidence. MethodsA systematic search from electronic databases such as Pubmed, EMBASE, SpringerLink, and Cochrane Library was conducted to obtain original articles comparing OCT and angiography. Major adverse cardiac events (MACE), cardiovascular death, myocardial infarction (MI), stent thrombosis, target vessel revascularization, stenosis area, PCI procedure time, contrast volume, and procedural side effects were the measured outcomes. The primary end-points were MACE and cardiovascular death. ResultsTotal 11 studies included 5814 patients were analyzed, with 3431 using OCT-guided and 2383 using angiography-guided. Pooled estimates of outcomes, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models. Regarding clinical outcomes, OCT-guided PCI showed significantly lower rate of MACE (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.38 to 0.72, p < 0.001), cardiovascular death (OR 0.47, 95% CI 0.33 to 0.67, p < 0.001), and higher contrast volume (OR 1.6, 95% CI 0.81 to 2.39, p < 0.001). OCT-guided has longer PCI procedure time (OR 2.42, 95% CI 1.33 to 4.42, p = 0.004). OCT-guided has no significant difference in lower risk of periprocedural MI (OR 0.59, 95% CI 0.35 to 1.00, p = 0.05), stent thrombosis (OR 0.69, 95% CI 0.2 to 2.43, p = 0.56), target vessel repeat revascularization (OR 0.74, 95% CI 0.47 to 1.14, p = 0.17), stenosis area (OR -0.63, 95% CI -1.5 to 0.25, p = 0.56), and adverse events related to procedures (OR 1.33, 95% CI 0.8 to 2.19, p = 0.27). ConclusionOur meta-analysis demonstrated that OCT-guided PCI is significantly associated with lower MACE, cardiovascular death, and higher contrast volume. It is also associated with a longer duration of PCI. However, it is not associated with MI, stent thrombosis, target vessel revascularization, stenosis area, and adverse events related to procedures.

Cre8 Drug Eluting Stent Performance in Daily Cardiology Practice.

In patients undergoing percutaneous coronary intervention (PCI), drug eluting stents (DES) are currently the standard of care. Stent design and alloy composition, biocompatibility of the drug-eluting polymer coating, the antiproliferative agent properties and release are the three main characteristics that affects DES performance. Cre8 (Alvimedica, Istanbul, Turkey) is a polymer-free amphilimus-eluting stents (PF-AES). In this study, we aimed to investigate the clinical efficacy and safety of Cre8 DES in daily cardiology practice. Patients presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) including unstable angina pectoris (USAP), myocardial infarction with and without ST-segment elevation and treated with PCI using Cre8 DES between December 2015 and 2016 were retrospectively analyzed in this study. Between December 2015 and 2016, 808 lesions of 664 patients treated with Cre8 DES in a single center were included in this retrospective analysis. The mean age of study group was 60 years (between 33 and 93 years) and were predominantly consisting of male patients (79.4%). The median follow-up duration was 487 days (min: 30 days, max: 919 days) and two-thirds of all patients presented with ACS. The culprit lesion was on left anterior descending artery (LAD) (40.5%) and right coronary artery (RCA) (25.9%) in most of the patients. The procedural success rate was 97.3%. Most of the lesions were type B1 (40.6%) according to American College of Cardiology/American Heart Association (ACC/AHA) coronary lesion classification. The device oriented primary end-point defined as target lesion failure (TLF) occurred in 52 (6.4%) of 808 lesions. The primary safety end-point was cardiac death in 20 patients (3.0%) and target vessel myocardial infarction in 2 patients (0.3%). Target vessel revascularization (TVR) occurred in 29 patients (4.4%) as primary safety endpoint. Multivariable logistic regression analysis revealed diabetes mellitus and ejection fraction as the predictors of mortality and device oriented primary end-point. This trial revealed clinical efficacy and safety of Cre8 stents in real world practice. Device oriented primary end points were similar with previous studies which are randomized, open label in nature and showed the efficacy and safety of Cre8 stent towards latest generation DES.

Sex differences between serum uric acid levels and cardiovascular outcomes in patients with coronary artery disease after stent implantation.

The relationship between elevated serum uric acid (SUA) levels and cardiovascular outcomes after stent implantation remains uncertain. This study sought to evaluate the impact of SUA on 12-month cardiovascular outcomes after stent implantation. We performed a retrospective study of patients who successfully underwent stent implantation and enrolled 3,222 patients with coronary artery disease (CAD) from a single center. SUA levels were measured before stent implantation. The patients were divided into six groups (<4, 4-4.9, 5-5.9, 6-6.9, 7-7.9 and ≥ 8 mg/dL) at SUA intervals of 1.0 mg/dL. The incidence of cardiovascular outcomes in the six groups was monitored for 1 year after stent implantation and the hazard ratios were estimated. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cardiovascular outcomes were estimated using a Cox proportional hazard regression analysis. The primary endpoint was all-cause death. The secondary endpoint was a composite of all-cause death, myocardial infarction, target vessel revascularization, stent thrombosis and stroke. The follow-up duration was 12 months. Over the 12-month follow-up period, there were 101 all-cause deaths and 218 MACCE. After adjustment for several parameters, the group with SUA levels of more than or equal to 8 mg/dL had significantly higher hazard ratios in the incidence of all-cause death or MACCE. The group with <4.0 mg/dL had significantly higher hazard ratios in all-cause death only in male patients. In contrast, there were no significant differences observed for cardiovascular outcomes in female patients. Our study identified a U-shaped association between SUA levels and cardiovascular outcomes during 12-month follow-up for males, but not for females. Further studies are warranted to clarify the sex differences between SUA levels and clinical outcomes.

Prognostic Impact of Periprocedural Myocardial Infarction in Patients with Heavily Calcified Coronary Artery Disease Receiving Rotational Atherectomy.

Periprocedural myocardial infarction (PMI) occurs more frequently in patients with heavily calcified lesion and undergoing rotational atherectomy (RA). However, there are limited studies addressing prognostic impact of PMI in patients requiring RA due to severe coronary artery calcification (CAC). Therefore, the objective of this study was to determine the prognostic impact of PMI in patients who underwent percutaneous coronary intervention (PCI) using RA. A total of 540 patients (583 lesions) who received PCI using RA were enrolled between January 2010 and October 2019. PMI was defined as elevations of creatine kinase-myocardial band (CK-MB) 10 times the upper limited normal. Patients were divided into a PMI group and a non-PMI group. Primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), a composite of cardiac death, target-vessel myocardial infarction, target-vessel revascularization, and cerebrovascular accident. Although in-hospital events occurred more frequently in the PMI group than in the non-PMI group (15 [3.0%] vs. 6 [13.3%], p = 0.005), the incidence of MACCEs at 1 month, 1-12 months, or 12 months failed to show a significant difference between the two groups (1 month, 10 [2.0%] vs. 1 [2.2%], p 0.999; 1-12 months, 39 [7.9%] vs. 7 [15.6%], p = 0.091; 12 months, 49 [9.9%] vs. 8 [17.8%], p = 0.123). This study shows that PMI after RA in patients with severe CAC was associated with more frequent in-hospital events and a nonsignificant trend for more events during 1 year follow-up.

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Safety and efficacy of the expressman extension system for complex coronary lesions during percutaneous coronary intervention.

Short-Term Risk Stratification of Non–Flow-Limiting Coronary Stenosis by Angiographically Derived Radial Wall Strain

BackgroundDeferred revascularization of mildly stenotic coronary vessels based exclusively on physiological evaluation is associated with up to 5% residual incidence of future adverse events at 1 year. ObjectivesWe aimed to evaluate the incremental value of angiography-derived radial wall strain (RWS) in risk stratification of non–flow-limiting mild coronary narrowings. MethodsThis is a post hoc analysis of 824 non–flow-limiting vessels in 751 patients from the FAVOR III China (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients With Coronary Artery Disease) trial. Each individual vessel had ≥1 mildly stenotic lesion. The primary outcome was vessel-oriented composite endpoint (VOCE), defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction (nonprocedural), and ischemia-driven target vessel revascularization at 1-year follow-up. ResultsDuring 1-year follow-up, VOCE occurred in 46 of 824 vessels, with a cumulative incidence of 5.6%. Maximum RWS (RWSmax) was predictive of 1-year VOCE with an area under the curve of 0.68 (95% CI: 0.58-0.77; P < 0.001). The incidence of VOCE was 14.3% in vessels with RWSmax >12% vs 2.9% in those with RWSmax ≤12%. In the multivariable Cox regression model, RWSmax >12% was a strong independent predictor of 1-year VOCE in deferred non–flow-limiting vessels (adjusted HR: 4.44; 95% CI: 2.43-8.14; P < 0.001). The risk of deferred revascularization based on combined normal RWSmax and Murray–law-based quantitative flow ratio (μQFR) was significantly reduced compared with μQFR alone (adjusted HR: 0.52; 95% CI: 0.30-0.90; P = 0.019). ConclusionsAmong vessels with preserved coronary flow, angiography-derived RWS analysis has the potential to further discriminate vessels at risk of 1-year VOCE. (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients With Coronary Artery Disease [FAVOR III China Study]; NCT03656848)

Impact of Complete or Incomplete Revascularization for Left Main CoronaryDisease: The Extended PRECOMBAT Study.

Whether complete revascularization (CR) or incomplete revascularization (IR) may affect long-term outcomes after PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease is unclear. The authors sought to assess the impact of CR or IR on 10-year outcomes after PCI or CABG for LMCAdisease. In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) 10-year extended study, the authors evaluated the effect of PCI and CABG on long-term outcomes according to completeness of revascularization. The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE) (composite of mortality from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization). Among 600 randomized patients (PCI, n=300 and CABG, n=300), 416 patients (69.3%) had CR and 184 (30.7%) had IR; 68.3% of PCI patients and 70.3% of CABG patients underwent CR, respectively. The 10-year MACCE rates were not significantly different between PCI and CABG among patients with CR (27.8% vs 25.1%, respectively; adjusted HR: 1.19; 95%CI: 0.81-1.73) and among those with IR (31.6% vs 21.3%, respectively; adjusted HR: 1.64; 95%CI: 0.92-2.92) (P for interaction=0.35). There was also no significant interaction between the status of CR and the relative effect of PCI and CABG on all-cause mortality, serious composite of death, myocardial infarction, or stroke, and repeat revascularization. In this 10-year follow-up of PRECOMBAT, the authors found no significant difference between PCI and CABG in the rates of MACCE and all-cause mortality according to CR or IR status. (Ten-Year Outcomes of PRE-COMBAT Trial [PRECOMBAT], NCT03871127; PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT], NCT00422968).

The Impact of Renal Insufficiency upon Admission on the Clinical Outcome of Patients with Acute ST-elevation Myocardial Infarction undergoing Primary Percutaneous Coronary Intervention

Background: Coronary artery disease is common in patients with renal insufficiency. In acute coronary syndrome, impaired renal function is present in approximately 30-40% of patients and is associated with worse prognosis. Local data regarding the risks and benefits for those patients suffering from acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) is scarce. We evaluated the clinical outcomes of patients suffering from STEMI with and without renal insufficiency upon admission who underwent PPCI. Methods: From 1st January 2009 to 30th September 2017, all patients with STEMI treated with PPCI were identified. The primary composite endpoint was defined as a composite outcome of all-cause mortality and MACE (cardiovascular mortality, non-fatal MI, stroke and target vessel revascularization). The secondary endpoints were the individual components of the primary composite endpoint. Estimated GFR was calculated by the CKD-EPI equation. Renal insufficiency was defined as eGFR <60mL/min/1.73m2. Results: The cohort consisted of 450 patients of whom 191 patients (42.4%) had renal insufficiency. Compared with patients with normal renal function, they were older, more often female and more likely to have other co-morbidities. After taking potential confounders into account in the multivariate analysis, patients with renal insufficiency had a higher risk of primary composite outcome during long-term follow up with an adjusted hazard ratio of 1.48 (95% CI 1.02-2.15, p=0.038). They also had significantly higher risk of all-cause mortality, MACE and cardiovascular death with adjusted hazard ratios of 1.66, 1.90 and 2.01 respectively (p Conclusion: In an unselected cohort of STEMI patients treated with PPCI, renal insufficiency was associated with adverse clinical outcome when compared to STEMI patients without renal insufficiency.