Rates Of Target Vessel Revascularization Research Articles

Optical coherence tomography versus angiography and intravascular ultrasound to guide coronary stent implantation: A systematic review and meta-analysis.

Optical coherence tomography (OCT) is an adjunct to angiography-guided coronary stent placement. However, in the absence of dedicated, appropriately powered randomized controlled trials, the impact of OCT on clinical outcomes is unclear. To conduct a systematic review and meta-analysis of all available studies comparing OCT-guided versus angiography-guided and intravascular ultrasound (IVUS)-guided coronary stent implantation. MEDLINE and Cochrane Central were queried from their inception through July 2022 for all studies that sought to compare OCT-guided percutaneous coronary intervention (PCI) to angiography-guided and IVUS-guided PCI. The primary endpoint was minimal stent area (MSA) compared between modalities. Clinical endpoints of interest were all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). Risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs) were pooled using a random-effects model. Thirteen studies (8 randomized control trials and 5 observational studies) enrolling 6312 participants were included. OCT was associated with a strong trend toward increased MSA compared to angiography (MD = 0.36, p = 0.06). OCT-guided PCI was also associated with a reduction in the incidence of all-cause mortality [RR = 0.59, 95% CI (0.35, 0.97), p = 0.04] and cardiovascular mortality [RR = 0.41, 95% CI (0.21, 0.80), p = 0.009] compared with angiography-guided PCI. Point estimates favored OCT relative to angiography in MACE [RR = 0.75, 95% CI (0.47, 1.20), p = 0.22] and MI [RR = 0.75, 95% CI (0.53, 1.07), p = 0.12]. No differences were detected in ST [RR = 0.71, 95% CI (0.21, 2.44), p = 0.58], TLR [RR = 0.71, 95% CI (0.17, 3.05), p = 0.65], or TVR rates [RR = 0.89, 95% CI (0.46, 1.73), p = 0.73]. Compared with IVUS guidance, OCT guidance was associated with a nonsignificant reduction in the MSA (MD = -0.16, p = 0.27). The rates of all-cause and cardiovascular mortality, MACE, MI, TLR, TVR, or ST were similar between OCT-guided and IVUS-guided PCI. OCT-guided PCI was associated with reduced all-cause and cardiovascular mortality compared to angiography-guided PCI. These results should be considered hypothesis generating as the mechanisms for the improved outcomes were unclear as no differences were detected in the rates of TLR, TVR, or ST. OCT- and IVUS-guided PCI resulted in similar post-PCI outcomes.

Short- and long-term outcomes of percutaneous coronary interventions of high-risk vs. low-risk lesions performed at a hospital without an on-site cardiac surgery unit.

Aim Widespread utilization of technology has led to the construction of a growing number of facilities with coronary angiography units and percutaneous coronary intervention (PCI) capability. Some of these centers do not have cardiovascular surgery (CVS) on site. Studies regarding the efficacy and safety of PCIs performed at these hospitals have been conducted. However, to date, high-risk procedures in this context have not been evaluated. The present study compares the outcomes of PCI procedures performed on high- and low-risk lesions groups in a center without CVS back-up.Material and methods A total of 999 patients treated with PCI with diagnoses other than ST elevation myocardial infarction were included in this study. Patients with SYNTAX scores 22 or higher, bifurcation lesions, chronic total occlusions, left main coronary artery lesions and saphenous graft lesions were classified as a high-risk group. In contrast, patients with SYNTAX scores lower than 22 were included in the low-risk group. Coronary lesions were classified as Type-A, B, and C. The 30‑day major adverse cardiac events (MACE) and 1‑year target vessel revascularization (TVR) rates were compared.Results There was no significant difference between the groups in terms of the rates of MACE (2 (0.9 %) vs 5 (0.6 %); p=0.64) and TVR (9 (4.2 %) vs 25 (3.2 %); p=0.52). Analysis regarding the lesion type also revealed no significant difference between the MACE and TVR rates (p=0.56 and p=0.43, respectively).Conclusions The findings in this study demonstrated that, similar to low-risk procedures, complex and high-risk coronary interventions can safely and effectively be conducted in hospitals without a CVS unit.

631 First vs. second generation drug-eluting STNET in heart transplant patients with cardiac allograft vasculopathy: a single centre experience

Abstract Aims Cardiac allograft vasculopathy (CAV) remains the ‘Achilles’ heel’ of successful long-term outcome after heart transplantation (HTx). Percutaneous coronary intervention (PCI) with bare-metal stents (BMS) and first (I) generation drug-eluting stents (DES) has been previously considered as a palliative treatment option in this setting, for the higher rate of restenosis and the lack of a survival benefit over medical therapy. Few data on the performance of second (II) generation DES in CAV are currently available. Our study aims to compare the efficacy and safety of PCI with I and II generation DES in patients with CAV. Methods and results All consecutive heart transplant patients who underwent urgent or elective PCI with I or II generation DES between 2003 and 2020 at Foundation IRCCS Polyclinic San Matteo (Pavia) were enrolled. The extent of revascularization for each patient was assessed calculating the post-procedural residual SYNTAX score. The primary endpoint was a composite of MACE [any myocardial infarction, cardiovascular death and target vessel revascularization (TVR)] at 3-year. The secondary endpoint was target lesion failure (TLF) at 3-year—composite of cardiovascular death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). A total of 90 transplant patients (113 coronary lesions) were included: 28 patients (32 lesions) were treated with I generation DES and 62 patients (81 lesions) with II generation DES. No differences between the two study groups were identified in term of number of stents per patient implanted (overall 1.63 ± 0.87, P-value = 0.628), total stent length per patient [overall 26 (25th–75th : 18–44) mm, P-value = 0.486], pre-PCI [overall 8 (25th–75th: 5–15), P-value = 0.286], and post-PCI residual [overall 1.5 (25th–75th: 0–4), P-value = 0.187] SYNTAX score. In the whole study population, the primary and secondary endpoints occurred in 28 (33%) and 23 (27%) cases respectively, with a 3-year Kaplan–Meier estimate of freedom from MACE of 64%, and from TLF of 71%. No statistical differences between the two study arms were found (MACE log-rank test P-value = 0.269, TLF log-rank test P-value = 0.260). At multivariate Cox regression analysis, while treatment with II generation DES was confirmed to not predict the risk of MACE (HR: 0.70, CI: 0.32–1.5, P-value = 0.368), a borderline significant higher rate of events was found in patients with a post-PCI residual SYNTAX score >8 (HR: 2.37, CI: 0.98–5.73, P-value = 0.054). However, patients treated with II generation DES experienced a lower rate of TVR (3-year Kaplan-Meier estimate of freedom from TVR I generation DES 69% vs. II generation DES 85%, log-rank test P-value = 0.058, univariate Cox regression analysis HR: 0.4, CI: 0.13–1.07, P-value = 0.069). Conclusions In heart transplant patients with CAV, compared with I generation DES, PCI with II generation DES did not show to reduce the risk of MACE and TLF, guaranteeing however a lower rate of TVR. In this complex clinical scenario, incomplete revascularization (defined as a residual post-PCI SYNTAX score > 8) was associated with worse outcome at 3-year follow-up.

Hybrid coronary revascularization versus percutaneous coronary intervention: A systematic review and meta-analysis.

Hybrid coronary revascularization (HCR) is an emerging approach for multivessel coronary artery disease (MVD) which combines the excellent long-term outcomes of surgery with the early recovery and reduced short-term complications of percutaneous coronary intervention (PCI). Here, we evaluated the effectiveness of HCR compared to PCI in patients with MVD. A systematic database search in PubMed/MEDLINE, Embase, Scopus, and CENTRAL/CCTR was conducted by June 2021. Random-effects meta-analysis was performed, comparing major adverse cardiac and cerebrovascular events (MACCE) at 30days and at latest follow-up between patients undergoing HCR versus PCI. A total of 27,041 patients (HCR: 939 patients, PCI: 26,102 patients) were included from seven studies published between 2013 and 2021. At latest follow-up, HCR was associated with lower rates of myocardial infarction (OR 0.40, 95% CI 0.20-0.80, p=0.010) and target vessel revascularization (OR 0.49, 95% CI 0.37-0.64, p<0.001), while the difference for MACCE did not reach statistical significance (OR 0.46, 95% CI 0.20-1.05, p=0.061). No differences were observed in terms of 30-day outcomes, nor rates of mortality or stroke at latest follow-up. HCR might be a valid alternative to multivessel PCI, demonstrating a lower incidence of MI and TVR. Center experience, well-coordinated heart team discussions, and good patient selection likely remain essential to ensure optimal outcomes. Future comparative studies are required to define the optimal target population.

Abstract 11557: Rates of Early Target Vessel Revascularization and Target Lesion Revascularization Amongst Third Generation Drug-Eluting Stents

Background: While the benefits of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) are well established, the frequency and timing of repeat revascularization events, particularly early events, is not well described in contemporary clinical practice. Methods: Patients undergoing PCI at two large tertiary centers in a single health system from April 2014 to December 2019 were prospectively enrolled into the NCDR CathPCI Registry. Target vessel revascularization (TVR) and target lesion revascularization (TLR) were defined as a repeat intervention to the index vessel or lesion respectively and determined by linking to subsequent PCI events and CABG admissions in the EMR. Early TVR and TLR rates were identified at 30 days, 90 days, six months, and one year. Logistic regression was used to estimate the association between stent type and TVR/TLR at the pre-specified time points. Generalized estimating equations with nested modeling were used to account for patients with multiple vessels and lesions. Results: Overall, 8,221 PCI procedures were identified in 7,128 patients with 9,558 vessel interventions and 12,019 lesion interventions. There were similar rates of TVR for Zotarolimus eluting durable polymer stents (ZES-DP), Everolimus eluting bioabsorbable polymer stents (EES-BAP), and Everolimus eluting durable polymer stents (EES-DP) at 30 days (p=0.61), 90 days (p=0.79), six months (p=0.58), and one year (p= 0.35). There were similarly no differences in TLR between stent types at each time point (p= 0.57, 0.79, 0.16, 0.13 respectively). The total rates of TLR and TVR progressed linearly throughout the year following PCI with nearly half of all repeat revascularization events occurring within 6 months. Table 1. Conclusions: Within a single health system from 2014 to 2019, ZES-DP, EES-BAP, and EES-DP were associated with similar rates of TVR and TLR. These events appear to occur earlier than typically reported in clinical trials.

Prevalence and Impact of High Bleeding Risk in Patients Undergoing Left Main Artery Disease PCI.

The aim of this study was to determine the prevalence and prognostic impact of high bleeding risk (HBR), as determined by the Academic Research Consortium HBR criteria, in real-world patients undergoing left main (LM) percutaneous coronary intervention (PCI). LM PCI is often reserved for patients at increased risk for periprocedural adverse events. Patients at HBR represent a relevant percentage of this cohort, but their outcomes after LM PCI are still poorly investigated. All patients undergoing LM PCI between 2014 and 2017 at a tertiary care center were prospectively enrolled. Patients were defined as having HBR if they met at least 1 major or 2minor Academic Research Consortium HBR criteria. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 12months. Among 619 enrolled patients, 55.3% were at HBR. The rate of the primary endpoint was 4-fold higher in patients at HBR compared with those without HBR (20.5% vs 4.9%; HR: 4.43; 95% CI: 2.31-8.48), driven by an increased risk for all-cause death (HR: 3.88; 95%CI: 1.88-8.02) and MI (HR: 6.18; 95%CI: 1.83-20.9). Rates of target vessel or lesion revascularization and stent thrombosis were comparable in the 2 groups. Bleeding occurred more frequently in patients at HBR (HR: 3.77; 95%CI: 1.83-7.76). Consistent findings were observed after Cox multivariable regression adjustment. Among patients undergoing LM PCI, those with HBR are at increased risk for all-cause death, MI, and bleeding. Conversely, rates of repeat revascularization and stent thrombosis were comparable, suggesting frailty and comorbidities as primary causes of worse outcomes in patients at HBR.

Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials

BackgroundDiabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia.MethodsFor this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization.ResultsBaseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38–2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85–2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49–5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29–2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03–2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23–2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant.ConclusionsNot only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors.Trial registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015.

Safety and Efficacy of Intracoronary Brachytherapy Protocol for Resistant In-Stent Restenosis

The aim of our prospective study is to evaluate the safety and the long-term clinical efficacy of Intracoronary Brachytherapy (ICBT) for In-stent Restenosis utilizing a prespecified interventional and radiation protocol.Single center prospective analysis of patients undergoing ICBT with at least 2 prior layers of coronary stents compared to patients undergoing balloon angioplasty alone. Per our protocol, the first step is to perform an intravascular ultrasound (IVUS) study to evaluate the lesion for degree of calcification, etiology of ISR, length of the lesion and diameter of the vessel. Then, laser atherectomy is performed using 0.9, 1.4- or 1.7-mm catheters for 3 runs. Percutaneous transluminal coronary angioplasty (PTCA) of the culprit lesion with a 1:1 sized cutting balloon is performed. Then, ICBT is performed and IVUS is repeated to confirm appropriate MLA. Target Vessel Revascularization rates within one year of ICBT will be assessed. Periprocedural complications will be assessed for up to 72 hours. Side branch occlusion: > 50% stenosis of the side-branch of the target vessel during/immediately after completion of ICBT. Absence of TIMI III flow distally in the target vessel after ICBT will also be assessed.Results for our project are forthcoming however we have completed 32 brachytherapy treatments in our laboratory since 2016 and their results are presented herein. Significant side branch occlusion occurred in only 4 cases (13%). Distal slow flow or no flow occurred in 3 cases (9%). TIMI 3 flow was restored in all 3 cases. TVR occurred in only 3 cases (9%). Bleeding complications occurred in 3 cases, 2 patients had a hematoma and one had bleeding at the access site. Only one case required one unit of blood transfusion. Acute renal failure occurred in one case. There were no 30-day readmissions to our hospital for any of the patients who received ICBT. 30-day survival was observed in all 32 patients. The 8 patients who qualified for ICBT during the same time period of January 2016 to December 2020 but had PTCA alone or atherectomy and PTCA had TVR observed in 5/8 cases (63%); This was significantly higher than in those patients who underwent ICBT (P < .001). Side branch occlusion did not occur in any of the 8 cases. None of the cases had a distal slow flow or no flow phenomenon. None of the patients had acute renal failure. There were no 30-day readmissions and all of the patients survived to 30 days.In-stent restenosis of DES is an important clinical issue. Intracoronary brachytherapy is a safe and well tolerated treatment option that may serve as a form of therapy for high-risk patients with recurrent ISR of DES. At our high-volume institution we have created a systematic protocol for ICBT. We look forward to updating the clinical results from our prospective study.

Biodegradable polymer drug eluting stents versus durable polymer drug eluting stents for percutaneous coronary intervention

Abstract Background Invasive angiography with subsequent revascularization is a widely used treatment method in patients with coronary heart disease. Although biodegradable polymer drug eluting stents (BP-DES) have been used for almost a decade now, clinical trials regarding their long-term outcomes are both sparse and inconsistent. We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with BP-DES versus durable polymer drug eluting stents (DP-DES). Methods Among 11,517 PCIs with second generation drug eluting stents preformed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was the composite of all-cause mortality, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and coronary artery bypass grafting (CABG). Propensity score matching was used to create a well-balanced cohort. Results Mean follow up was 4.8 years. Of the 3,413 matched pairs, 21% were females, and the mean age was 66. At one year, the primary outcome occurred in 9.6% patients versus 8.3% (p=0.05), and TVR rate was 4.1% versus 3% (p=0.005) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in in 24.9% versus 24.8% (p=0.83), and the rate of TVR was 9.8% versus 9.1% (p=0.07) in patients with DP-DES and BP-DES respectively. Conclusions Similar rates of the composite outcome were observed throughout the entire follow-up. TVR rates were lower in the DP-DES group at 1-year but equalized within 5 years. Funding Acknowledgement Type of funding sources: None.

Duration of dual antiplatelet therapy and long-term outcomes following drug-eluting balloon or drug-eluting stents for treatment of in-stent restenosis (DAPT-Dragon Registry)

Abstract Objectives The aim of the DAPT-DRAGON registry was to asses long-term outcomes and the length of dual antiplatelet therapy (DAPT) in patients treated with percutaneous coronary intervention (PCI) due to drug-eluting stent in stent restenosis (DES-ISR) with drug-eluting balloons (DEB) or thin-DES. Background Data regarding the duration of DAPT in patients with DES-ISR treated with PCI is still undergoing research and observation, and the adequate duration of DAPT in this group of patients is not unambiguously sanctioned. Methods Overall, 1,367 consecutive patients with DES-ISR who underwent PCI with DEB or DES, were entered into the multi-center DAPT-DRAGON Registry (Fig. 1). The mean age was 66.7±9 years (70.5% males). The median follow-up was 3.3 years. There were 34.1% patients with chronic coronary syndrome, 35.2% with unstable angina, 2.9% with ST segment elevation myocardial infarction and 27.7% with non-ST segment elevation myocardial infarction (MI). We assessed selected study endpoints according to the duration of DAPT (≤3 vs. &amp;gt;3 months and ≤6 vs. &amp;gt;6 months), before and after propensity score matching (PSM): stroke, target lesion revascularization (TLR), target vessel revascularization (TVR), MI, death and device-oriented composite endpoints (DOCE). Results Among predictors of increased DOCE rate before PSM, we demonstrated: PCI with DEB vs. DES (p&amp;lt;0.001), recurrent ISR (p=0.002), treatment with glycoprotein IIb/IIIa inhibitor during PCI (p&amp;lt;0.001), lower left ventricle ejection fraction (p=0.004) and extent of stenosis (p&amp;lt;0.001). Pairwise contrast analysis considering type of PCI (thin-DES vs. DEB) and duration of DAPT (≤6 vs. &amp;gt;6 months) before PSM revealed superiority of thin-DES+DAPT &amp;gt;6 months vs. DEB+DAPT &amp;gt;6 months for DOCE (p&amp;lt;0.001), TVR (p=0.02) and TLR (p=0.01). After PSM analysis, the length of DAPT (≤3 vs. &amp;gt;3 months) had no significant influence on assessed long-term outcomes, while the percentage of stroke free survival was significantly lower in the group of patients with DAPT ≤6 months vs. &amp;gt;6 months (p=0.01; Fig. 2). Conclusions Long-term treatment with DAPT (&amp;gt;6 months) in patients with DES-ISR with DES implantation is related to better long-term outcomes in terms of lower rate of DOCE, TVR and TLR compared to PCI with DEB. DAPT &amp;gt;6 months is related to a greater rate of strokes, independently of the type of treatment (thin-DES and DEB) compared to DAPT ≤6 months. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Clinical impact of intravascular ultrasound guidance in patients of ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention with drug eluting stent

Abstract Background There is little data about clinical role of intravascular ultrasound (IVUS)-guided Percutaneous (PCI) in the setting of ST-segment elevation myocardial infarction (STEMI). Methods From 2005 to 2018, a total of 8,129 patients who underwent PCI with STEMI were investigated from the Korea Acute Myocardial Infarction Registry-National Institute of Health database. Patients with Non-ST segment elevation myocardial infarction, cardiogenic shock, bare metal stent implantation, thrombolytic treatment, and coronary artery bypass graft surgery were excluded. We categorized patients into two groups based on the treatment strategy: IVUS-guided PCI group (n=1,544), and coronary angiography guidance (CAG)-guided PCI group (n=6,585). The primary endpoint was composite of major adverse cardiovascular (MACE), including, cardiac death, myocardial infarction (MI), repeat target vessel revascularization (TVR) and stent thrombosis (ST). Results IVUS-guided PCI was performed in 19% patients (1544/8129). After propensity score matching, there were no statistically difference in the rate of cardiac death (0% in IVUS vs. 0.26% in CAG, p=0.947), MI (2.01% vs. 2.01%, p=0.408), TVR (1.23% vs. 0.91%, p=0.131), ST (0.32% vs. 0.45%, p=0.828) and composite of MACE at 1 year between two groups (2.01% vs. 2.40%, p=0.843). Independent risk factors for MACE were diabetes mellitus and multi-vessel disease, but not IVUS-guided PCI (HR 1.167, 95% CI, 0.896–1.520, p=0.251). Conclusion This study suggests that routine usage of IVUS in the setting of STEMI may not be necessary. Large-scaled random study will be needed for further evaluation. Funding Acknowledgement Type of funding sources: None.

Long-Term Clinical Impact of Intravascular Ultrasound Guidance in Stenting for Left Main Coronary Artery Disease

[Figure: see text].

Anterior, Posterior, or All-Vessel Infrapopliteal Revascularization in Patients With Moderate-Severe Claudication: Insights From the LIBERTY 360 Study

Background Little data guides revascularization of infrapopliteal peripheral arterial disease (PAD) in patients with claudication. We assessed outcomes after infrapopliteal-only intervention for claudication in the LIBERTY 360 observational study. Methods In this post hoc analysis, LIBERTY 360 patients (N = 128) with claudication and isolated infrapopliteal disease undergoing endovascular revascularization were divided by territory into anterior-vessel, posterior-vessel, or all-vessel groups. Patients were followed for periprocedural, in-hospital, and long-term outcomes. Logistic regression for odds ratios, Cox proportional hazard models, ANOVA, and Kaplan-Meier estimates were utilized to compare outcomes. Results Patients underwent anterior (N = 37), posterior (N = 76), or all-vessel (N = 15) infrapopliteal revascularization. Initial procedural success was 86%, 86%, and 69% for anterior, posterior, and all-vessel groups, respectively. Each group had improvements in Rutherford classification (RC) from baseline to 2 years (mean RC change: -1.3, -1.5, and -1.5, respectively). Compared with all-vessel intervention, both anterior and posterior groups had lower rate of major adverse events (MAE) and target vessel revascularization (TVR) at 3 years (MAE: 12% and 15% in anterior and posterior groups, respectively compared with 51% in the all-vessel group; hazard ratios and 95% CIs 0.22 [0.06-0.74], p = .015; 0.24 [0.09-0.64], p = .004). Other outcomes were similar among the three groups. The anterior group showed more improvement in pain subdomain and total VascuQoL scores compared with posterior and all-vessel groups at 2 years (p = .016, p = .020 and p = .068, p = .009, respectively). Conclusions Both anterior or posterior revascularization have favorable outcomes and may be beneficial for improvement of symptoms in claudicants with isolated infrapopliteal PAD.

MID TERM OUTCOMES IN WELLENS SYNDROME

Background. Wellens syndrome (WS) has been described as a clinical and electrocardiographic (ECG) complex that identifies a subset of patients with unstable angina (UA) at an impending risk of myocardial infarction (MI) and death in studies published almost 4 decades ago, before the wide use of cardiac biomarkers such as troponins. The mid and long term outcomes of patients with Wellens syndrome have never been compared with a contemporary cohort of patients with non-ST elevation acute coronary syndromes (NSTEACS). Objectives. The primary endpoints of our study were the rate of cardiovascular rehospitalizations, the rate of ischaemic reccurences, the rate of subsequent or reccurent revascularization and the rate of mortality at six months from the index event. Materials and methods. We performed a prospective analysis of 64 consecutive patients with WS who underwent coronary angiography and we compared them with an age and sex matched cohort of patients with NSTEACS who underwent coronary angiography. The study took place at Bagsadar-Arseni Emergency Clinical Hospital and included a total of 127 patients recruited within 2 years (from January 2018 until December 2019), who were followed for a period of 6 months. Results. Within 6 months of follow-up, patients in the control group had a significantly higher rate of cardiovascular rehospitalizations (41.9% vs. 21.9%, p = 0.016), although the rate of ischaemic recurrences was similar between the 2 groups. Other interventional end-points, such as subsequent interventional revascularization, repeat interventional revascularization and repeat target vessel revascularization (TVR) were comparable between the 2 groups at 6 months follow-up. There was no significantly difference with respect to global mortality (6.3% in WS group vs. 7.9% in the control group, p = 0.74). Discussions. To our knowledge, this is the first prospective study with mid term follow up that compared a consecutive cohort of patients with WS who underwent coronary angiography with an age and sex matched cohort of patients with NSTEACS. Patients with WS had similar event rates with respect to ischaemic recurrences, subsequent or repeat interventional revascularization and repeat target vessel revascularization (TVR) and mortality rate at 6 months, although significantly more patients in WS group were considered at low risk. Conclusions. Wellens sign is frequently overlooked in the emergency department and risk assessment based on risk scores is frequently misleading. Prompt recognition of subtle ECG ischaemic changes, such as WS, in patients with chest pain is crucial, as it reflects a large area of myocardium at risk and identifies a subgroup of patients who can benefit from early invasive management.

Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study.

Little data guides revascularization of infrapopliteal peripheral arterial disease (PAD) in patients with claudication. We assessed outcomes after infrapopliteal-only intervention for claudication in the LIBERTY 360 observational study. In this post hoc analysis, LIBERTY 360 patients (N=128) with claudication and isolated infrapopliteal disease undergoing endovascular revascularization were divided by territory into anterior-vessel, posterior-vessel, or all-vessel groups. Patients were followed for periprocedural, in-hospital, and long-term outcomes. Logistic regression for odds ratios, Cox proportional hazard models, ANOVA, and Kaplan-Meier estimates were utilized to compare outcomes. Patients underwent anterior (N=37), posterior (N=76), or all-vessel (N=15) infrapopliteal revascularization. Initial procedural success was 86%, 86%, and 69% for anterior, posterior, and all-vessel groups, respectively. Each group had improvements in Rutherford classification (RC) from baseline to 2 years (mean RC change: -1.3, -1.5, and -1.5, respectively). Compared with all-vessel intervention, both anterior and posterior groups had lower rate of major adverse events (MAE) and target vessel revascularization (TVR) at 3 years (MAE: 12% and 15% in anterior and posterior groups, respectively compared with 51% in the all-vessel group; hazard ratios and 95% CIs 0.22 [0.06-0.74], p=.015; 0.24 [0.09-0.64], p=.004). Other outcomes were similar among the three groups. The anterior group showed more improvement in pain subdomain and total VascuQoL scores compared with posterior and all-vessel groups at 2 years (p=.016, p=.020 and p=.068, p=.009, respectively). Both anterior or posterior revascularization have favorable outcomes and may be beneficial for improvement of symptoms in claudicants with isolated infrapopliteal PAD.

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.

Bioresorbable polymer and durable polymer metallic stents in coronary artery disease: a meta-analysis

ABSTRACT Background Literature on bioresorbable-polymer-stents (BPS) and second-generation durable-polymer-stents (DPS) in percutaneous coronary intervention (PCI) for all comer CAD is conflicting. Methods Randomized controlled studies comparing PCI among BPS and second-generation DPS were identified up until May-2020 from online databases. Primary outcomes included are all-cause myocardial infarction (MI), cardiac-death, target-vessel-revascularization (TVR), target-vessel MI (TVMI), and stent-thrombosis (ST). Random effect method of risk ratio and confidence interval of 95% was used. Results 25 prospective randomized controlled trials with 31,822 patients (BPS n = 17,065 and DPS n = 14,757) were included in the study. Follow–up ranged between a minimum of 6 months to more than 5 years. Cardiac death (RR 1.02, 95% CI 0.89–1.45, p = 0.16) was comparable in BPS and second-generation DPS. Risk of all-cause MI was similar between BPS and DPS (RR 0.97, 95% CI 0.84–1.11, p = 0.73). TVMI (RR 0.88, 95% CI 0.69–1.11, p = 0.33) and ST rates were also comparable in BPS and DPS groups (RR 1.06, 95% CI 0.80–1.40, p = 1.00). Overall TVR had comparable outcomes between BPS and DPS (RR 0.95, 95% CI 0.79–1.14, p < 0.001); however, higher TVR was seen among BPS group at follow-up of ≥5 years (RR 1.39, 95% CI 1.12-1.14, p = 0.02). Bias was low and heterogeneity was moderate. Conclusion Patients undergoing PCI treated with BPS had comparable outcomes in terms of cardiac death, TVR, ST, TVMI, and all-cause MI to patients treated with second-generation DPS; however, BPS had higher rates of TVR for follow-up of ≥5-years.

A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

ObjectiveWe performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients.MethodsA systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality.ResultsEES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001).ConclusionAmong those three types of stents, EES should be the first recommended stent for DM patients.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Invasive versus conservative management in spontaneous coronary artery dissection: A meta-analysis and meta-regression study

BackgroundData regarding the best treatment for spontaneous coronary artery dissection (SCAD) are limited. The aim of the present study was to compare the clinical outcomes of conservative versus invasive treatment in SCAD patients. MethodsWe systematically searched the literature for studies evaluating the comparative efficacy and safety of invasive revascularization versus medical therapy for the treatment of SCAD from 1990 to 2020. The study endpoints were all-cause death, cardiovascular death, myocardial infarction, heart failure, SCAD recurrence and target vessel revascularization (TVR) rates. Random effect meta-analysis was performed by comparing the clinical outcomes between the two groups. A univariate meta-regression analysis was also performed. ResultsTwenty-four observational studies with 1720 patients were included. After 28 ± 14 months, a conservative approach was associated with lower TVR rate compared with invasive treatment (OR = 0.50; 95%CI 0.28–0.90; P = 0.02). No statistical difference was found regarding all-cause death (OR = 0.81; 95%CI 0.31–2.08; P = 0.66), cardiovascular death (OR = 0.89; 95%CI 0.15–5.40; P = 0.89), myocardial infarction (OR = 0.95; 95%CI 0.50–1.81; P = 0.87), heart failure (OR 0.96; 95%CI 0.41–2.22; P = 0.92) and SCAD recurrence (OR = 0.94; 95%CI 0.52–1.72; P = 0.85). The meta-regression analysis suggested that male gender, diabetes mellitus, smoking habit, prior coronary artery disease, left main coronary artery involvement, lower ejection fraction and low TIMI flow at admission were related with high overall mortality, whereas SCAD recurrence was higher among patients with fibromuscular dysplasia. ConclusionsA conservative approach was associated with similar clinical outcomes and lower TVR rates compared with an invasive strategy in SCAD patients; future prospective studies are needed to confirm these results.