Rates Of Target Vessel Revascularization Research Articles

In-stent restenosis characteristics and repeat stenting underexpansion: insights from optical coherence tomography

The aim of this study was to use optical coherence tomography (OCT) to predict newly implanted stent expansion for treatment of in-stent restenosis (ISR). With OCT guidance, 143 ISR lesions were treated with a new stent. Stent underexpansion was defined as minimum stent area (MSA) <4.5 mm2 and MSA/average of reference lumen area <70%. New stent underexpansion was found in 33 lesions (23%). These had a smaller old stent MSA (4.13 [3.32-4.62] versus 5.18 [4.01-6.38] mm2, p=0.001), and had a higher prevalence of multiple old stent layers (51.5% versus 10.9%, p<0.001) and neointimal or peri-stent calcium (69.7% versus 37.3%, p=0.001) compared to those without new stent underexpansion. Old stent underexpansion, multiple layers of old stent, maximum calcium angle >180°, and maximum calcium thickness >0.5 mm were independently associated with new stent underexpansion. Patients with new stent underexpansion had a higher prevalence of major adverse cardiac events (35.5% vs 14.3%, p=0.009), mainly driven by a higher rate of myocardial infarction and target vessel revascularisation at two years. When re-stenting an ISR lesion, old stent underexpansion, the amount of neointimal or peri-stent calcium, and multiple old stent strut layers are important determinants of new stent underexpansion which is then associated with adverse long-term outcomes.

Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis.

Background Although drug-eluting stents (DES) have reduced the rates of in-stent restenosis (ISR) compared with bare-metal stents (BMS), DES related ISR (DES-ISR) still occurs and outcomes of DES-ISR remain unclear. The objective of this meta-analysis was to investigate the long-term clinical outcomes of patients with DES-ISR compared with patients with BMS related ISR (BMS-ISR) after the treatment of DES or drug-eluting balloon (DEB). Methods and results. We searched the literature in the main electronic databases including PUBMED, EMBASE, Cochrane Library, and Web of Science. The primary endpoints were target lesion revascularization (TLR) and target vessel revascularization (TVR). The secondary endpoints included all cause death (ACD), cardiac death (CD), myocardial infarction (MI), stent thrombosis or re-in-stent restenosis (ST/RE-ISR), and major adverse cardiovascular events (MACEs). A total of 19 studies with 6256 participants were finally included in this meta-analysis. Results showed that the rates of TLR (P < 0.00001), TVR (P < 0.00001), CD (P=0.02), ST/RE-ISR (P < 0.00001), and MACEs (P < 0.00001) were significantly higher in the DES-ISR group than in the BMS-ISR group. No significant differences were found between the two groups in the rates of MI (P=0.05) and ACD (P=0.21). Conclusions Our study demonstrated that patients with DES-ISR had worse clinical outcomes at the long-term follow-up than patients with BMS-ISR after the treatment of DES or DEB, suggesting that DES and DEB may be more effective for BMS-ISR than that for DES-ISR. Positive prevention of DES-ISR is indispensable and further studies concentrating on detecting the predictors of outcomes of DES-ISR are required.

Left ventricular systolic dysfunction in patients with unprotected left main coronary artery disease.

The optimal coronary revascularization strategy for patients with unprotected left main coronary artery (ULMCA) disease and left ventricular systolic dysfunction (LVSD) remains uncertain. The purpose of this study was to evaluate the clinical outcomes after percutaneous coronary intervention (PCI) with adrug-eluting stent (DES) versus coronary artery bypass grafting (CABG) in patients with ULMCA disease with or without LVSD. Atotal of 984 patients with ULMCA disease who received aDES (n = 511) or underwent CABG (n = 473) were included in this study. We retrospectively analyzed the clinical parameters and outcomes of ULMCA disease patients with different left ventricular ejection fraction levels. There were no significant differences in major adverse cardiac and cerebral events, all-cause death, cardiac death, myocardial infarction, or stroke between the CABG and DES groups with or without LVSD. The rate of target vessel revascularization was significantly higher with DES compared with CABG in patients without LVSD; however, the difference was not significant between the mild LVSD and severe LVSD groups. For patients with ULMCA disease and LVSD, there was no significant difference between DES and CABG in terms of efficacy and safety. Treatment with DES was an acceptable alternative to CABG.

Surgical strategies and long-term outcomes of total arterial coronary artery bypass grafting: a series of 208 patients

Objective: To examine the short and long-term clinical outcomes of total arterial coronary artery bypass grafting. Methods: Clinic data of 208 patients with left main and multiple vessel coronary artery disease and undertaken total arterial coronary artery bypass grafting from February 2009 to December 2019 in Department of Cardiac Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine were analyzed retrospectively. There were 188 males and 20 females with an age of (54.7±10.7) years (range: 32 to 79 years). The harvest of arterial conduits and grafting strategies were depended upon the individual patient characteristics and surgeon's experience. Left internal thoracic artery (LITA) was applied in 207 cases, right internal thoracic artery (RITA) in 38 cases (bilateral internal thoracic artery (BITA) in 37 cases), and radial artery (RA) in 187 cases (188 grafts). The graft number per case was 2.6±0.7 (range: 2 to 4). Surgical procedures was completed with off-pump technique in 98.1% patients (204/208). Subgroup analysis was carried out between subgroup BITA (n=37) and subgroup SITA (single ITA+RA) (n=171). The t test, χ(2) test or Fisher exact test were used to compare the clinic characteristics between the two subgroups. The Kaplan-Meier curve was used to estimate the rate of late mortality, major adverse cardiac cerebrovascular event (MACCE), and target vessel revascularization (TVR). A Cox proportional hazards model was used to identify the independent prognosis factors of late mortality. Results: The overall mortality within 30 days postoperatively was 1.4%(3/208). The incidences of perioperative MACCE, re-operation for bleeding and deep sternal wound infection (DSWI) were 1.9%(4/208), 0.5%(1/208) and 1.4%(3/208), respectively. Perioperative myocardial infarction and TVR were not observed. There was no significant difference of 30-day mortality, MACCE, bleeding and DSWI between subgroup BITA and SITA+RA (all P>0.05). In a follow-up period of (5.4±2.8)years (range: 0.2 to 10.9 years), the incidence of all-cause mortality at 1-, 5- and 10-year was 2.3%, 3.4% and 6.9%, respectively. The incidence of MACCE was 3.9%,11.2% and 28.5%, respectively. The rate of TVR was 0.4%, 3.7% and 11.9%, respectively. Age>65 was an independent prognosis factor of late mortality (HR=1.125, 95% CI:1.050 to 1.205, P<0.01). Conclusions: Total arterial coronary bypass grafting is safe and achievable with proper patient selection and surgical strategies. It significantly decreases the risks of late mortality and repeated revascularization.

Drug-eluting balloons versus drug-eluting stents for small vessel coronary artery disease: a meta-analysis.

We aimed to conduct a network meta-analysis of treatments for small vessels coronary artery disease between drug-eluting balloon (DEB) and drug-eluting stent (DES). A meta-analysis comparing DEB and DES outcomes was performed using the Medline, Embase, and Cochrane databases. The primary outcome was target lesion revascularization (TLR) or target vessel revascularization (TVR), and myocardial infarction (MI), death and major adverse cardiovascular events (MACE) were secondary outcomes. A total of six studies on 1813 patients were included. There was no significant difference in rates of TLR or TVR in the patients treated with the DEB strategy compares with the DES strategy [odds ratio (OR) = 0.96, 95% confidence interval (CI) 0.57-1.61, P = 0.89] within a follow-up period of 9-24 months. There was a significant reduction in rates of MI and death in the patients treated with a DCB strategy compared with those treated with a DES strategy (3.7%, 17 of 460 vs 6.1%, 36 of 595; 2.4%, 11 of 460 vs 6.1%, 36 of 595, respectively), and this difference was statistically significant (OR = 0.53, 95% CI 0.29-0.96, P = 0.04; OR = 0.44, 95% CI 0.22-0.88, P = 0.02, respectively). There was no difference between DEB and DES strategies in rates of MACE (OR = 0.94, 95% CI 0.66-1.33, P = 0.73). In summary, this study demonstrates that treatment of small vessel (diameter ≤ 3 mm) coronary artery disease (CAD) with DEB may lead to improving outcomes compared with the use of DES within a follow-up period of 9-24 months. Further large clinical trials are needed to verify this conclusion.

Ischemic Versus Bleeding Outcomes After Percutaneous Coronary Interventions in Patients With High Bleeding Risk

Patients undergoing percutaneous coronary intervention (PCI) often have high-bleeding-risk (HBR) factors. Dual antiplatelet therapy (DAPT) further increases this risk of bleeding. We sought to compare clinical outcomes according to presence or absence of HBR factors in patients with elevated ischemic risk (DAPT score ≥ 2) undergoing PCI. We evaluated all patients undergoing PCI at MedStar Washington Hospital Center (January 2009 to July 2018) with DAPT score ≥2, which is associated with elevated risk of ischemic events. Patients were categorized as HBR group (HBR score ≥1) or low-bleeding-risk (LBR) group (HBR score = 0). Outcomes included major adverse cardiac events such as target vessel revascularization, stent thrombosis, death, and bleeding events at 30 days, 6 months, 1 year, and 2 years. The final cohort consisted of 7,499 patients: 3,949 patients had LBR features, and 3,550 patients had HBR features. The 2 groups were different at baseline, with HBR patients being older and having a higher prevalence of congestive heart failure and renal dysfunction than the LBR group. The mean DAPT score was 2.96±1.1 for the LBR group and 3.7±1.4 for the HBR group (p <0.001). During follow-up at 30 days, 6 months, and 1 and 2 years, the rates of target vessel revascularization and stent thrombosis were not significantly different between the 2 groups. Bleeding events and all-cause mortality were significantly more frequent in the HBR group than in the LBR group. In conclusion, patients undergoing PCI often have pre-existing risk factors that predispose them to ischemic and bleeding complications. Prolonged duration of DAPT to mitigate ischemic events could lead to a disproportionate increase in bleeding events, especially in HBR patients.

Long-Term Outcomes of Unprotected Left Main Coronary Artery Disease: Comparison of Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention.

We compared the long-term outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) disease in a real-world population. CABG is the standard of care for ULMCA disease. Contemporary randomized trials have reported conflicting results with the two revascularization strategies for the treatment of ULMCA disease at intermediate-term follow-up. We evaluated 422 consecutive patients with ULMCA disease who underwent CABG (n = 273) or PCI (n = 149) from 1998-2008. The primary outcome measure was major adverse cardiac and cerebrovascular event (MACCE) rate, defined as the composite of all-cause death, myocardial infarction (MI), stroke, or target-vessel revascularization (TVR) at 10 years. Propensity-score matched (PSM) analysis was used to assess long-term MACCE. The cumulative 10-year incidence of risk for MACCE was not significantly different between the PCI and CABG groups (24.8% vs 20.5%, respectively; log rank P=.22; log rank PSM P=.45). The risk for all-cause death was not significantly different between the two groups (log rank P=.09; PSM log rank P=.51). The risk for stroke was significantly lower with PCI (log rank P=.02), but was not significant after matching (PSM log rank P=.27). The risk for TVR was significantly higher with PCI vs CABG prior to and after matching (log rank P<.001; log rank PSM P=.01). There were no significant differences in MACCE between the two groups when stratified by SYNTAX scores ≤22% (log rank P=.61) and >23% (log rank P=.06). In patients with ULMCA disease, PCI was comparable with CABG for long-term MACCE and death rates. The TVR rate was higher in the PCI group.

Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study.

There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P=0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P=0.030) and target lesion revascularization (7.3% versus 15.2%; P=0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P=0.034), while long overlap was not (6.8% versus 5.4%; P=0.567). In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

Effect of inter-arm blood pressure differences on outcomes after percutaneous coronary intervention

BackgroundWe investigated the effect of inter-arm blood pressure differences (IABPD) on the percutaneous coronary intervention (PCI) outcomes of patients with coronary artery diseases. MethodsWe retrospectively reviewed the data of blood pressures measured simultaneously in the bilateral arms of 855 patients (560 males) who underwent PCI with drug-eluting stents for coronary artery diseases. IABPD was defined as the difference of blood pressure in both arms. The primary outcome was the presence of major adverse cardiac events (MACE) consisting of cardiovascular death, myocardial infarction, stroke, and ischemia-driven target vessel revascularization. ResultsThe mean age of the included patients was 66.2 ± 11.6 years, with a mean follow-up period of 44.5 ± 26.4 months. MACE occurred in 15.2% of patients, showing a higher rate in the higher IABPD group (≥10 mmHg) than in the lower IABPD group (<10 mmHg) (22.5% vs 14.5%, p = 0.081). The difference was induced by a higher rate of ischemia-driven target vessel revascularization (17.5% vs 8.3%, p = 0.011). The Kaplan-Meier survival analysis revealed a greater incidence of MACE in patients with a higher IABPD (log rank p = 0.054). The Cox proportional hazard analysis showed that IABPD was an independent predictor of long-term MACE (hazard ratio, 1.028; 95% confidence interval, 1.002–1.055; p = 0.037), along with age, diabetes mellitus, and number of implanted stents. ConclusionAmong patients treated with PCI, the incidence of MACE was significantly higher in those with a higher IABPD (≥10 mmHg) than in those with a lower IABPD (<10 mmHg), which was mainly driven by ischemia-driven target vessel revascularization.

Relationship of quantitative flow ratio after second-generation drug-eluting stent implantation to clinical outcomes

The correlation of fractional flow reserve, which is presently the gold standard for evaluating myocardial ischemia, with three-dimensional quantitative coronary analysis-based quantitative flow ratio (QFR) is well-known. This study aims to evaluate the relationship of QFR after second-generation drug-eluting stent (2nd gen-DES) implantation to clinical outcomes. A total of 61 consecutive lesions, on which 2nd gen-DES implantation was performed from October 2014 to December 2015, were analyzed. Contrast-flow QFR (c-QFR) was obtained using reliable software (QAngio XA 3D) by modeled hyperemic flow velocity derived from coronary angiography without pharmacologically induced hyperemia. Clinical and angiographic data at the follow-up (18-30months) were obtained from all cases. c-QFR measurement was possible in 52 (85%) lesions. Of these, clinically-driven target vessel revascularization (TVR) was performed in 8 (15%) lesions. Vessel c-QFR was significantly lower in the TVR group (0.703 ± 0.163 vs. 0.883 ± 0.103, p = 0.016). In the results of the receiver operating characteristics analysis for TVR, area under the curve for vessel c-QFR was 0.857. The cutoff point for the prediction of TVR was defined as vessel c-QFR of ≤ 0.82, the sensitivity of 88%, and specificity of 80%. Conclusion: Vessel c-QFR can predict TVR after 2nd gen-DES implantation. Further investigation is warranted to evaluate whether c-QFR guided coronary intervention ameliorates TVR rate.

The Current Literature on Bioabsorbable Stents: a Review.

The purpose of this review is to explore the evolution of the coronary stent, from the advent of bare-metal stents, to the newest adopted technology of bioresorbable vascular scaffolds (BVS) used in bioresorbable stents. To date, there have been conflicting data regarding the safety and efficacy of BVS stents, especially when compared to current-generation drug-eluting stents (DES). This review will cover the data that exist regarding current BVS stents, as well as the active clinical trials for future iterations of BVS. The ABSORB BVS, the most widely circulated stent of its class, was promised to decrease rates of stent thrombosis and target vessel revascularization. Several randomized control trials, however, found the opposite to be true, with the ABSORB BVS demonstrating higher rates of thrombosis, target vessel revascularization, and even target lesion myocardial infarctions when compared to current-generation DES. These data caused the product to be pulled from all markets, leaving the field with uncertainty as to the role of BVS in coronary interventions. Coronary stents have evolved significantly from 1977, when they were first introduced. The original bare-metal stent was later fitted with a drug-eluting polymer, to prevent restenosis and thrombosis over time. Subsequent iterations of the stent attempted to further mitigate that risk by replacing the durable polymer to one that is bioresorbable. The final step in this progression was to create a stent that was fully bioresorbable, which Abbott did with the creation of their ABSORB BVS stent. The product, however, was found to perform poorly when compared to current-generation drug-eluting stents, with several trials showing high rates of stent thrombosis (ST), late stent thrombosis (LST), target-lesion myocardial infarction, and target vessel revascularization. Observational studies of BVS stents have proposed several mechanisms for their thrombogenicity, including higher stent-strut profiles leading to turbulent flow, low radial strength leading to strut disruption, and a higher propensity for neoatherosclerosis. Given the failure of the first-generation BVS stent, but the lingering desire for fully bioresorbable scaffolds, various manufacturers have proposed their solutions with new stents. Until data from their clinical trials emerge, it remains unclear whether fully bioresorbable stents will play any role in coronary interventions.

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

P2799Long-term outcomes after percutaneous coronary intervention with biodegradable polymer drug-eluting stent versus second-generation durable polymer drug-eluting stent: evidence from a meta-analysis

Abstract Background The true benefit of biodegradable polymer drug-eluting stent (BP-DES) over second-generation durable polymer drug-eluting stent (DP-DES) expected to be represented during late period of follow-up after percutaneous coronary intervention (PCI), but prior meta-analysis only evaluated short-term outcomes. Purpose We aimed to compare the long-term clinical outcomes after PCI with BP-DES versus second-generation DP-DES by a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing BP-DES with second-generation DP-DES implantations were searched through PubMed, MEDLINE, EMBASE, and Cochrane databases. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), and definite/probable stent thrombosis (ST) were compared between the groups. In addition, a landmark analysis with the landmark set at 1-year and a subgroup analysis based on stent characteristics were performed. Results Fifteen trials that included a total of 21311 randomized patients with at least 2 years follow-up were analyzed. At a median follow-up of 4.2 years, no significant differences in the risks of all-cause death (odds ratio [OR] 1.03, 95% confidence interval [CI] 0.94–1.14), cardiac death (OR 1.03, 95% CI 0.88–1.20), MI (OR 0.90, 95% CI 0.79–1.01), TVR (OR 0.96, 95% CI 0.82–1.12), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.84, 95% CI 0.67–1.05) were found between the groups. In the 1-year landmark analysis, the rates of all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.94, 95% CI 0.67–1.31) were similar between the groups. There were comparable rates of any study endpoints between the groups regardless of stent platform (stainless steel vs. alloy), the polymer degradation period (&lt;6 months vs. &gt;6 months) or the drug release duration (&lt;6 months vs. &gt;6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the use of BP-DES with sirolimus eluting (OR 0.82, 95% CI 0.70–0.97), circumferential drug distribution (OR 0.79, 95% CI 0.65–0.96), thin strut (defined as &lt;100μm; OR 0.83, 95% CI 0.70–0.97), or ultrathin strut (defined as &lt;70μm; OR 0.78, 95% CI 0.64–0.94) were associated with lower rates of MI than did second-generation DP-DES. Moreover, BP-DES with circumferential drug distribution (OR 0.82, 95% CI 0.69–0.98) was predictive for reduced rates of TVR. Clinical outcomes Conclusions In this meta-analysis, long-term clinical outcomes were equivalent between BP-DES and second-generation DP-DES implantations. However, among BP-DESs, the improved risks of MI in those with sirolimus eluting, circumferential drug distribution, thin strut, or ultrathin strut and decreased rates of TVR in those with circumferential drug distribution were noted.

Long-term clinical outcomes of direct absorb bioresorbable vascular scaffold implantation in acute coronary syndrome.

Preferred technique for bioresorbable vascular scaffold (BVS) implantation included high pressure predilation. Data about direct BVS implantation in acute coronary syndrome (ACS) patients are scarce. Analysis of 90 consecutive patients with acute myocardial infarction (MI) treated with primary PCI with Absorb deployment between 2013-2016 in a single center. In 45 patients, scaffolds were implanted in the direct technique, other 45 patients underwent Absorb deployment after balloon predilation. Follow-up was available in 100% of patients with mean duration of 32±11 months. No cardiac death or scaffold thrombosis were observed in both groups. In the direct group, no target lesion revascularization (TLR) was reported. In the predilation arm, TLR occurred in 4 (9%) patients (P=0.12). Target vessel revascularization (TVR) was observed in 1 (2%) case in the direct group and in 6 (13%) patients from the predilation group (P=0.11). Target vessel MI was reported in one patient from each group. In an intention to treat analysis, we observed significantly higher rates of TVR (15% vs. 2%; P<0.043) and TLR (10% vs. 0%; P=0.038) in the predilation arm. Kaplan-Meier survival analysis did not show significant differences in TLR, TVR and device oriented composite endpoint (a combination of cardiac death, target vessel MI and ischemia driven TLR) between patients treated with both methods. Direct Absorb implantation in patients with ACS may be feasible and safe.

Incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: Data from the CTO-IVUS randomized trial.

To evaluate the incidence, predictors, and outcomes of distal vessel expansion on intravascular ultrasound (IVUS) after recanalization of chronic total occlusion (CTO) particularly using new-generation drug-eluting stent (DES). The luminal changes of narrowed vessels distal to CTO segments after recanalization using new-generation DES have rarely been studied. This substudy of the CTO-IVUS (Chronic Total Occlusion InterVention with drUg-eluting Stents) trial included a total of 69 new-generation DES-treated CTOs with serial matched IVUS analyses at index percutaneous coronary intervention (PCI) and at 1-year follow-up. The predictors of distal vessel expansion, any increase of lumen area at the distal reference (LAdistal ) on 1-year follow-up IVUS, were evaluated by multivariable binary logistic analyses. Distal vessel expansion was identified in 46 (67%). Independent determinants of distal vessel expansion were proximal CTO, a smaller LAdistal at the index PCI, a greater minimal stent area-to-LAdistal (MSA-to-LAdistal ) ratio, and a greater lumen area at the distal stent edge-to-LAdistal (LAedge -to-LAdistal ) ratio. The cut-off values of a MSA-to-LAdistal ratio and a LAedge -to-LAdistal ratio predicting the distal vessel expansion by receiver operating characteristic curve analysis were 1.0 and 1.1, respectively. During the median 5.1 years, rates of target vessel revascularization, cardiac death, and stent thrombosis were similar in the distal vessel-expanded and nonexpanded groups. After opening CTO with new-generation DES, two-thirds of patients exhibited distal vessel expansion on 1-year follow-up IVUS. Expansion determinants were a proximal CTO, lower LAdistal , and larger stent areas relative to the LAdistal (modifiable procedural predictors).

Left main percutaneous coronary intervention-Radial versus femoral access: A systematic analysis.

Debate still occurs of the benefits of transradial access (TRA) versus transfemoral access (TFA), especially for complex percutaneous coronary interventions. Recent data has shown equivalent efficacy and improved safety outcomes with TRA. To systematically review and perform a meta-analysis comparing procedural characteristics and clinical outcomes of TRA versus TFA in patients who underwent percutaneous coronary intervention (PCI) for left main (LM) disease. We conducted an electronic database search of all published data for studies that compared TRA with TFA in patients undergoing PCI of LM disease. Event rates were compared using the odds ratio (OR) as a measure of effect size. Random-effects models were used to account for interstudy heterogeneity. A total of 12 observational studies including 17,258 patients (TRA n = 7,971; TFA n = 9,287) were included. Compared to TFA, TRA was associated with a significant reduction in access site bleeding (OR = 0.11; 95% confidence interval [CI] = 0.04-0.26; I2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I2 = 11%; p = .004) were also lower in the TRA group. There were no significant differences in procedural outcomes between TRA and TFA except for a significant reduction in the rate of long-term target vessel revascularization (TVR) in the TRA group (OR = 0.62; 95% CI = 0.41-0.94: I2 = 0%: p = .02). We further performed a subgroup analysis for unprotected left main PCI only, which showed a significant reduction in rates of any bleeding episode, lower access site or vascular complications, and in-hospital mortality with TRA as compared to TFA. Patients undergoing PCI for LM disease via TRA have with less bleeding, reduced access site or vascular complications, reduced in-hospital mortality, comparable procedural success, and possibly better long-term clinical efficacy when compared to those undergoing the procedure via TFA.

Three-year major clinical outcomes of phosphorylcholine polymer- vs biolinx polymer-zotarolimus-eluting stents

There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.

A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial.

The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

Minimally invasive surgical approaches to left main and left anterior descending coronary artery revascularization are superior compared to first- and second-generation drug-eluting stents: a network meta-analysis.

There are a number of minimally invasive approaches to revascularization of coronary artery disease that involve the left main or proximal left anterior descending artery; however, studies to date provide mixed results. A Bayesian network meta-analysis was performed to compare early and late postoperative outcomes between percutaneous coronary intervention with first- and second-generation drug-eluting stents (DESs), off-pump coronary artery bypass and minimally invasive direct coronary artery bypass (MIDCAB) in patients with involvement of left main or left anterior descending disease. A total of 37 studies with 31728 patients were included in the analysis. There were no significant differences in early mortality rates, strokes or myocardial infarctions (MIs). The long-term all-cause mortality rate was equivalent between the groups. Patients who had off-pump coronary artery bypass had fewer late MI compared with those who had first-generation DES (DES1) [odds ratio (OR) 0.38, 95% confidence interval (CI) 0.20-0.72] and MIDCAB (OR 0.41, 95% CI 0.17-0.97) and reduced late target vessel revascularization compared with DES1 (OR 0.17, 95% CI 0.09-0.32) and second-generation DES (DES2) (OR 0.32, 95% CI 0.14-0.72). The rate of late major adverse cardiac events was lower with off-pump coronary artery bypass compared with that with DES1 (OR 0.33, 95% CI 0.26-0.43) and DES2 (OR 0.62, 95% CI 0.45-0.90). The rate of late major adverse cardiac events with MIDCAB was lower than that with DES1 (OR 0.43, 95% CI 0.31-0.62) as was that with DES2 compared with DES1 (OR 0.53, 95% CI 0.39-0.70). Surgical approaches to left main or proximal left anterior descending disease remain superior to first- or second-generation DES in terms of long-term freedom from MI and target vessel revascularization as well as improved overall long-term survival. Conflicting rates of late MI and target vessel revascularization in patients who underwent MIDCAB suggest disease in alternate vessels that may best be approached via hybrid techniques.

Long-term outcomes of multiple arterial off-pump coronary artery bypass grafting

Objective: To evaluate the long-term clinical outcomes of multiple arterial off-pump coronary artery bypass grafting (OPCAB) on left main coronary artery or multivessel disease. Methods: A total of 329 patients [303 males and 26 females, with a mean age of (55.1±9.1) years old] with left main coronary artery or multivessel disease who underwent isolated multiple arterial OPCAB in Ruijin Hospital between January 2006 and June 2018 were included. The baseline characteristics, perioperative and long-term outcomes were analyzed. Kaplan-Meier analysis was applied for estimation of freedom from major adverse cardiac and cerebrovascular events (MACCE) and overall survival. Independent predictors of MACCE were assessed by Cox regression analysis. Results: The perioperative mortality was only 0.9% (3/329). The median follow-up time was 65(22, 126) months, and 302 (91.8%) patients were followed up. The long-term MACCE rate, mortality, cardiac mortality, myocardial infarction (MI) rate, stroke rate and target vessel revascularization (TVR) rate were 13.9%, 4.6%, 1.3%, 3.6%, 6.0% and 6.0%, respectively. Among the alive patients, 51.3% were in New York Heart Association (NYHA) Ⅰ class and 80.9% had no recurrence of angina pectoris. The estimated 5-year and 10-year overall survival rates were 97.3% and 93.1%, respectively. The estimated 5-year and 10-year freedom from MACCE survival rates were 91.5% and 78.0%, respectively. Senility (OR=1.058, 95%CI: 1.020-1.097, P=0.002) and history of MI (OR=2.200, 95%CI: 1.131-4.412, P=0.021) were the independent risk factors for late MACCE. Conclusion: Multiple arterial OPCAB appears to be safe and with excellent clinical outcomes in treating left main coronary artery or multivessel disease.