Ten-year outcomes after percutaneous coronary intervention of in-stent restenosis in saphenous vein grafts.

BACKGROUND: Only few data is available for long-term outcomes of patients being treated for in-stent restenosis (ISR) in saphenous vein grafts (SVG). AIMS: Thus, the aim of this observational, retrospective study was to close this lack of evidence. METHODS: Between January 2007 and February 2021 a total of 163 patients with 186 ISR lesions located in SVG were treated at two large-volume centers in Munich, Germany. Endpoints of interest were all-cause mortality, target lesion revascularization (TLR) and target vessel myocardial infarction (TVMI). Furthermore, recurrent ISR were assessed. Outcomes are presented as Kaplan-Meier event rates. RESULTS: Mean age was 72.6 ± 8.6 years, 90.8% were male, 36.8% were diabetics and 42.3% presented an acute coronary syndrome. ISR were treated with DES in 64.0% and with balloon angioplasty (BA) in 36.0%. After 10 years, the rates for all-cause mortality, TVMI and TLR were 58.2%, 15.4%, and 22.6%, respectively. No statistically relevant differences were found between the types of treatment (DES or BA) regarding all-cause mortality (55.7% vs. 63.2%, p = 0.181), TVMI (13.8% vs. 18.6%, p = 0.215) and TLR (21.8% vs. 25.0%, p = 0.764). Median time between first and recurrent ISR was 270.8 days. Recurrent ISR were treated with DES in a comparable proportion as during first ISR (p = 0.075). Independent predictor of TLR is patient age (p = 0.034). The median follow-up duration was 5.1 years (75% CI 2.8; 8.5). CONCLUSIONS: Clinical event rates after intervention of ISR located in SVG are high without statistically relevant differences regarding the type of treatment. However, further studies are needed.

Value of PET ECG gating in a cross-validation study of cardiac function assessment by PET/MR imaging.

BACKGROUND: This work investigated the impact of different cardiac gating methods on the assessment of cardiac function by FDG-PET in a cross-validation PET/MR study. METHODS AND RESULTS: MR- and PET-based left ventricular end-diastolic, end-systolic volumes, and ejection fraction (EDV, ESV, and EF) were delineated in 30 patients with a PET/MR examination. Cardiac PET imaging was performed using three ECG gating methods: fixed number of gates per beat (STD), STD with a beat acceptance window (STD-BR), and fixed gate duration (FW). High MR-PET correlations were found in all the values. ESVs correlated better than EDVs and EFs: Pearson's r coefficient [0.92, 0.92, 0.92] in ESV vs [0.75, 0.81, 0.80] in EDV and [0.79, 0.91, 0.87] in EF, for each method [STD, STD-BR, FW]. Biases with respect to MRI for all the evaluated PET methods were less than 13% in EDV, 5% in ESV, and 14% in EF, but with wide limits of agreements, in the range (59-68)% in EDV, (65-70)% in ESV, and (49-71)% in EF. STD showed the strongest disagreement, while there were no marked differences between STD-BR and FW. CONCLUSION: Based on these findings, PET- and MR-based cardiac function parameters were highly correlated but in substantial disagreement with variabilities introduced by the selected PET ECG gating method. The most significant differences were associated with the ECG gating method susceptible to highly irregular beats, while similar performance was observed in the methods using uniform adjustment of gates width per beat with the beat acceptance window, and fixed gate width along all the beats. Thus, strict quality controls of R peak detection are needed to minimize its impact on the function assessment.

Outcomes of endovascular treatment for popliteal artery disease.

Background: Finding the appropriate endovascular revascularization strategy for patients with peripheral artery disease and a popliteal artery lesion remains particulary challenging. Data regarding predictors for a beneficial outcome are scarce. Patients and methods: All endovascular procedures of popliteal artery lesions (n=227) performed in 197 patients between February 2009 and May 2018 at our institution were retrospectively analyzed. Hemodynamically relevant restenosis represented the primary endpoint. Results: The overall technical success rate was 98% and yielded 99% for stenoses (n=145) and 97% for occlusions (n=82). In a median follow-up of 10 months, the overall rate of restenosis was 23%. After 1 and 2 years, the primary patency rates were 76% and 55% and the secondary patency rate was 100%, respectively. The estimated probability of restenosis was significantly higher in stented lesions (stent vs. no stent; 36.0% vs. 19.1%; p=0.030). Multivariate analysis identified stent implantation (hazard ratio: 2.4; overall P=0.010) and diabetes (hazard ratio 2.0; P=0.023) as significant predictors for the development of restenosis. Conclusions: Endovascular therapy for popliteal artery disease was associated with high technical success rates and accompanied with a promising mid-term outcome, particularly in lesions treated with balloon angioplasty alone.

Long-term clinical outcomes after drug eluting stent implantation with and without stent overlap.

OBJECTIVE: The aim of this study was to investigate the impact of drug eluting stent (DES) overlap on clinical outcomes after percutaneous coronary intervention (PCI). BACKGROUND: While the use of overlapping bare metal stent has been associated with an increased risk of adverse clinical events, the long-term impact of DES overlap on clinical outcomes is not certain at present. Similarly, the effect of different DES generations and polymer types on DES overlap associated clinical outcomes has not previously been comprehensively elucidated. METHODS: We analyzed the angiographic and clinical outcomes of 5605 patients treated with DES in the setting of the ISAR-TEST 4 and ISAR-TEST 5 randomized control trials according to the presence or absence of stent overlap. The clinical endpoints assessed in this study were all-cause death, myocardial infarction (MI), target lesion revascularization (TLR), and definite or probable stent thrombosis at 10-years. We also compared rates of binary angiographic restenosis (BAR) at 6-8 months. RESULTS: At 10 years, all-cause mortality (Hazard ratios [HR] = 1.05 [0.95-1.16]; p = 0.348) did not differ between the stent overlap and no stent overlap groups. MI (8.4% vs. 5.2%; HR = 1.67 [1.35-2.07], p < 0.001) and TLR (23.7% vs. 16.3%; HR = 1.54 [1.36-1.74], p < 0.001) occurred more frequently in the stent overlap group. For MI, landmark analysis demonstrated that this increase in risk was primarily in the first 30 days post PCI. BAR at 6-8 months was also more frequent in the stent overlap group (16.0% vs. 10.3%; HR = 1.65 [1.41-1.92], p < 0.001). CONCLUSION: DES overlap is associated with an increased risk of adverse clinical events post PCI.

Imaging of cardiac fibroblast activation in a patient after acute myocardial infarction using 68Ga-FAPI-04.

Our previous study has demonstrated the feasibility of noninvasive imaging of fibroblast activation protein (FAP)-expression after myocardial infarction (MI) in MI-territory in a rat model with 68Ga-FAPI-04-PET. In the current extended clinical case, we sought to delineate cardiac uptake of 68Ga-FAPI-04 in a patient after MI with clinical indication for the evidence of fibroblast activation. Carcinoma patients without cardiac disease underwent 68Ga-FAPI-04-PET/CT as control. The patient with one-vessel disease underwent dynamic 68Ga-FAPI-04-cardiac-PET/CMR for 60 minutes. Correlation of cardiac 68Ga-FAPI-04 uptake with clinical findings, ECG, echocardiography, coronary-arteriography and enhanced cardiac-MRI with T1 MOLLI and ECV mapping were performed. No uptake was found in normal myocardium and in mature scar. A focal intense 68Ga-FAPI-04 uptake with continuous wash-out in the infarct territory of coronary occlusion correlating with T1 and ECV mapping was observed. The uptake of 68Ga-FAPI-04 extends beyond the actual infarcted area and overestimates the infarct size as confirmed by follow-up CMR.

Efficacy and safety of ECG-synchronized pulsatile extracorporeal membrane oxygenation in the clinical setting: The SynCor Trial.

INTRODUCTION: Mechanical circulatory support (MCS) devices are increasingly used as a treatment option in resuscitation or in patients with cardiogenic shock (CS). Prophylactic implantation in high-risk percutaneous coronary interventions (HRPCI) is another upcoming indication. The i-cor ECG-synchronized cardiac assist device combines the hemodynamic support of a veno-arterial extracorporeal membrane oxygenation (VA-ECMO) with the ability to generate a pulsatile flow and thus decreasing adverse effects of VA-ECMO on myocardial function. Aim of this study was to obtain data concerning feasibility, safety and outcomes in both indications. METHODS: A total of 47 patients (34 HRPCI, 13 CS) were included in nine German centers and participated in this study. Demographic and clinical parameters, procedural as well as follow-up data were prospectively recorded and analyzed. RESULTS: Device implantation and initiation of ECG-synchronized cardiac assist was technical successful in all cases and no failures of the consoles or disposable parts were observed. Furthermore, intended percutaneous coronary interventions and successful weaning from cardiac assist was achieved in 97.1% of HRPCI patients. We observed a 30d-survival of 94.1% in the HRPCI group and 69.2% in the CS group. Main complications in both groups were bleeding events (14.7% HRPCI, 23.1% CS) and critical limb ischemia (2.9% HRPCI, 38.5% CS). CONCLUSION: The i-cor ECG-synchronized cardiac assist device appears safe and feasible showing clinical outcomes comparable to existing data in the setting of high-risk percutaneous coronary interventions and acute cardiogenic shock. Further prospective trials are warranted to identify optimal patient and interventional characteristics that will benefit most of this novel kind of mechanical circulatory support.

Diabetes mellitus and femoropopliteal in-stent restenosis.

Background: The influence of diabetes mellitus (DM) on recurrent in-stent restenosis (ISR) of femoropopliteal arteries remains understudied. We investigated whether DM has an impact on recurrent restenosis after femoropopliteal stenting in patients included in the dRug-coatEd balloon angioPlasty for femoropopliteAl In-stent Restenosis (REPAIR) cooperation. Patients and methods: The REPAIR cooperation pooled the patient-level data from 3 randomized trials in which patients with ISR of femoropopliteal arteries received either drug-coated balloon (DCB) or plain balloon angioplasty. For this analysis, patients were divided in two groups based on whether they had or had not a DM diagnosis at the time of enrollment. The primary outcome was target lesion revascularization (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were death, Rutherford class improvement and ankle-brachial index at follow-up. Results: 256 patients (DM, n=99 vs. non-DM, n=157) with 12-month follow-up were included in the analysis. Compared to non-DM patients, DM patients displayed no difference in terms of TLR [adjusted hazard ratio (95% Confidence intervals): 0.96 (0.55, 1.69), p=0.89] and recurrent ISR [1.04 (0.61, 1.77), p=0.88], whilst mortality was higher [9.38 (1.06, 83.11), p=0.044]. There were no differences between groups with respect to other secondary outcomes. The percutaneous treatment with DCB as compared to plain balloon angioplasty significantly reduced the risk of TLR and recurrent ISR without an excess risk of death irrespective of DM (p for interaction ≥0.70). Conclusions: In patients with femoropopliteal ISR, diabetes has a neutral effect on the risk of recurrence, but increases mortality at 12-month follow-up. DCB as compared to plain balloon angioplasty is associated with superior efficacy without trade-off in safety, regardless of diabetes.

Outcomes of endovascular treatment for infrapopliteal peripheral artery disease based on the updated TASC II classification.

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.

Influence of diagnosis of venous thromboembolism on immature platelets, absolute platelet count and platelet aggregation over time.

The extent of the involvement of platelets in venous thromboembolisms (VTE) is still not fully understood. Immature platelets are large, RNA-rich, prothrombotic platelets. They are involved in arterial thromboembolisms and are associated with adverse cardiovascular events. Their role in VTE has not been investigated before. The aim of this study was to assess different platelet parameters including immature platelet fraction (IPF), immature platelet count (IPC), absolute platelet count and platelet aggregation (PA) over time in patients with VTE at time of diagnosis, as well as at 3-10 days and at 90-110 days after diagnosis. 50 healthy volunteers similar in age and sex to patients served as controls at diagnosis. IPF was measured by the Sysmex XE-5000 analyzer, PA was assessed using the Multiplate analyzer. Diagnosis of VTE had no relevant effect on IPF and IPC whereas absolute platelet count and PA were significantly decreased compared to controls. In the course of VTE, IPF decreased significantly, whereas IPC, absolute platelet count and PA increased. In conclusion, VTE was associated with relevant changes of the absolute platelet count and PA at diagnosis, as well as changes in IPF and IPC over time reflecting a relevant and measurable platelet consumption in VTEs.

Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease.

BACKGROUND: New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up. METHODS: Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients. RESULTS: The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES. CONCLUSIONS: In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.

Hybrid PET/MR imaging for the prediction of left ventricular recovery after percutaneous revascularisation of coronary chronic total occlusions.

PURPOSE: To evaluate myocardial viability assessment with hybrid 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/magnetic resonance imaging ([18F]FDG-PET/MR) in predicting left ventricular (LV) wall motion recovery after percutaneous revascularisation of coronary chronic total occlusion (CTO). METHODS AND RESULTS: Forty-nine patients with CTO and corresponding wall motion abnormality (WMA) underwent [18F]FDG-PET/MR imaging for viability assessment prior to percutaneous revascularisation. After 3-6 months, 23 patients underwent follow-up MR to evaluate wall motion recovery. In total, 124 segments were assigned to the CTO territories, while 80 segments displayed impaired wall motion. Of these, 68% (54) were concordantly viable in PET and MR; conversely, only 2 segments (2%) were assessed non-viable by both modalities. However, 30% showed a discordant viability pattern, either PET non-viable/MR viable (3 segments, 4%) or PET viable/MR non-viable (21 segments, 26%), and the latter revealed a significant wall motion improvement at follow-up (p = 0.033). Combined imaging by [18F]FDG-PET/MR showed a fair accuracy in predicting myocardial recovery after CTO revascularisation (PET/MR area under ROC curve (AUC) = 0.72, p = 0.002), which was superior to LGE-MR (AUC = 0.66) and [18F]FDG-PET (AUC = 0.58) alone. CONCLUSION: Hybrid PET/MR imaging prior to CTO revascularisation predicts more accurately the recovery of dysfunctional myocardium than PET or MR alone. Its complementary information may identify regions of viable myocardium with increased potential for functional recovery.

Significant prevalence of peripheral artery disease in patients with disturbed wound healing following elective foot and ankle surgery: Results from the ABI-PRIORY (ABI as a PRedictor of Impaired wound healing after ORthopedic surgerY) trial.

Disturbed wound healing (DWH) following elective foot and ankle surgery is associated with a number of known risk factors. The purpose of this study was to determine if peripheral artery disease (PAD) is a potential risk factor that contributes to an increase in postoperative DWH. In a case-control study, we analyzed all patients undergoing elective foot and ankle surgery between January 1, 2014 and December 31, 2017 at two institutions and identified 51 patients with postoperative DWH. After matching with 51 control patients without DWH, all 102 patients were evaluated for PAD. The prevalence of PAD was significantly higher in the DWH group compared to the control group (41.2% vs 19.6%, p < 0.01). This difference was even more distinctive for patients with any abnormal ankle-brachial index (ABI) (51.0% vs 19.6%, p < 0.001). After adjustment for diabetes, hypertension, hypercholesterolemia, and smoking, any abnormal ABI or a history of PAD remained an independent risk factor for DWH (odds ratio 3.28; 95% CI 1.24-8.71). In this dual-center study, postoperative DWH was associated with significantly higher rates of PAD. These findings suggest that preoperative evaluation for PAD could be a helpful tool to identify patients at high risk for postoperative wound complications undergoing foot and ankle surgery. This trial is registered with drks.de, number DRKS00012580.

Endovascular therapy of subclavian artery occlusive disease involving the vertebral artery origin.

Background: While the majority of subclavian artery (SA) lesions are localized in the proximal segment, the evidence in patients with medial SA disease involving the vertebral artery (VA) origin are scarce. PATIENTS AND METHODS: We retrospectively analyzed all patients who underwent percutaneous revascularization of the SA at our institution. RESULTS: A total of 196 patients were retrospectively analyzed. The majority of SA lesions (n = 163, 83 %) were located in the proximal segment, whereas 28 lesions (14 %) were located in the medial segment, and only 5 lesions (3 %) involved the distal segment. Procedural success was high for both stenosis (96 %) and occlusion (89 %) and did not differ depending on lesion location. Revascularization techniques in the medial segment included stenting of the SA only (13 patients), additional VA balloon-dilatation (6 patients), and bifurcation stenting of the SA and VA using T-stenting technique (9 patients). Outcome after a median of 12 months showed no significant differences in freedom from restenosis between proximal and medial lesions (90 % vs. 95 %; p = 0.67). CONCLUSIONS: Endovascular revascularization of SA disease with medial segments involving the VA origin required more complex techniques and showed long-term patency rates comparable to those in lesions located within the proximal SA.

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

BACKGROUND: Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. METHODS: One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. RESULTS: Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P=0.009) or DA (55±29%, P=0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. CONCLUSIONS: Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752.

Myocardial perfusion quantification using simultaneously acquired 13 NH3 -ammonia PET and dynamic contrast-enhanced MRI in patients at rest and stress.

PURPOSE: Systematic differences with respect to myocardial perfusion quantification exist between DCE-MRI and PET. Using the potential of integrated PET/MRI, this study was conceived to compare perfusion quantification on the basis of simultaneously acquired 13 NH3 -ammonia PET and DCE-MRI data in patients at rest and stress. METHODS: Twenty-nine patients were examined on a 3T PET/MRI scanner. DCE-MRI was implemented in dual-sequence design and additional T1 mapping for signal normalization. Four different deconvolution methods including a modified version of the Fermi technique were compared against 13 NH3 -ammonia results. RESULTS: Cohort-average flow comparison yielded higher resting flows for DCE-MRI than for PET and, therefore, significantly lower DCE-MRI perfusion ratios under the common assumption of equal arterial and tissue hematocrit. Absolute flow values were strongly correlated in both slice-average (R2 = 0.82) and regional (R2 = 0.7) evaluations. Different DCE-MRI deconvolution methods yielded similar flow result with exception of an unconstrained Fermi method exhibiting outliers at high flows when compared with PET. CONCLUSION: Thresholds for Ischemia classification may not be directly tradable between PET and MRI flow values. Differences in perfusion ratios between PET and DCE-MRI may be lifted by using stress/rest-specific hematocrit conversion. Proper physiological constraints are advised in model-constrained deconvolution.

Real clinical experiences of dual versus triple antithrombotic therapy after percutaneous coronary intervention.

OBJECTIVES: We aimed to assess the impact of omitting aspirin on clinical outcomes in a real-world collective of patients receiving oral anticoagulation (OAC) therapy who were treated with a current-generation drug-eluting stent (DES) or an everolimus-eluting bioresorbable vascular scaffold (BVS). BACKGROUND: Limited data are available regarding the clinical benefit of triple antithrombotic therapy (TAT) with aspirin compared with dual antithrombotic therapy (DAT) without aspirin in patients undergoing percutaneous coronary intervention (PCI) and requiring OAC. METHODS: In total, 237 patients were analyzed. The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE) within 1 year after PCI. Secondary outcomes were the individual components of the primary endpoint, cardiovascular death, and any bleeding according to Bleeding Academic Research Consortium (BARC) or Thrombolysis in Myocardial Infarction (TIMI) criteria. RESULTS: Eighty-nine patients (37.6%) received DAT, and 148 (62.4%) received TAT. The rate of MACCE was significantly higher in DAT patients than in TAT patients (16 (18%) vs. 11 (7.4%); hazard ratio [HR] 2.73, 95% confidence interval [CI] 1.24-6.03; P = 0.01). The results of the multivariable Cox proportional hazards model including corrections for imbalances in baseline characteristics confirmed a significant independent association between DAT and MACCE (HRadj 3.14, 95% CI 1.31-7.54; P = 0.01). Major bleeding did not differ significantly between treatment groups. CONCLUSION: DAT was associated with a significantly higher rate of MACCE than TAT after DES or BVS implantation. Further studies are required to evaluate the safety and efficacy of dual versus TAT after PCI in clinical practice.

Quantitative cardiovascular magnetic resonance: extracellular volume, native T1 and 18F-FDG PET/CMR imaging in patients after revascularized myocardial infarction and association with markers of myocardial damage and systemic inflammation.

BACKGROUND: Characterization of tissue integrity and inflammatory processes after acute myocardial infarction (AMI) using non-invasive imaging is predictive of patient outcome. Quantitative cardiovascular magnetic resonance (CMR) techniques such as native T1 and extracellular volume (ECV) mapping as well as 18F-FDG positron emission tomography (PET) imaging targeting inflammatory cell populations are gaining acceptance, but are often applied without assessing their quantitative potential. Using simultaneously acquired PET/CMR data from patients early after AMI, this study quantitatively compares these three imaging markers and investigates links to blood markers of myocardial injury and systemic inflammatory activity. METHODS: A total of 25 patients without microvascular obstruction were retrospectively recruited. All imaging was simultaneously performed 5 ± 1 days after revascularization following AMI on an integrated 3T PET/MRI scanner. Native and post-contrast T1 data were acquired using a modified Look-Locker inversion recovery (MOLLI) sequence, ECV maps were calculated using individually sampled hematocrit. 18F-FDG PET was executed after 1 day of dietary preparation, 12 h of fasting, and administration of heparin. ECV, 18F-FDG and native T1 data were compared mutually as well as to peak counts of peripheral blood markers (creatine kinase, creatine kinase-MB, troponin, leukocytes, monocytes) and infarct size. RESULTS: High intra-patient correlations of relative ECV, 18F-FDG PET and native T1 signal increases were observed in combination with no inter-patient correlation of maximum absolute values at the infarct center, suggesting well-colocalized but physiologically diverse processes begetting the respective image signals. Comparison of maximum image signals to markers of myocardial damage and systemic inflammation yielded highly significant correlations of ECV to peak creatine kinase-MB and overall infarct size as well as between native T1 and peak monocyte counts. CONCLUSIONS: Absolute native T1 values at the infarct core early after AMI can be linked to the systemic inflammatory response independent of infarct size. Absolute ECV at the infarct core is related to both infarct size and blood markers of myocardial damage.

Measurement of extracellular volume and transit time heterogeneity using contrast-enhanced myocardial perfusion MRI in patients after acute myocardial infarction.

PURPOSE: To assess the ability of dynamic contrast-enhanced myocardial perfusion MRI to measure extracellular volume (ECV) and to investigate the possibility of estimating capillary transit time heterogeneity (CTH) in patients after myocardial infarction and successful revascularization. METHODS: Twenty-four perfusion data sets were acquired on a 3 Tesla positron emission tomography (PET)/MRI scanner. Three perfusion models of different complexity were implemented in a hierarchical fashion with an Akaike information criterion being used to determine the number of fit parameters supported by the data. Results were compared sector-wise to ECV from an equilibrium T1 mapping method (modified look-locker inversion recovery (MOLLI)). RESULTS: ECV derived from the perfusion analysis correlated well with equilibrium measurements (R² = 0.76). Estimation of CTH was supported in 16% of sectors (mostly remote). Inclusion of a nonzero CTH parameter usually led to lower estimates of first-pass extraction and slightly higher estimates of blood volume and flow. Estimation of the capillary permeability-surface area product was feasible in 81% of sectors. CONCLUSION: Transit time heterogeneity has a measurable effect on the kinetic analysis of myocardial perfusion MRI data, and Gd-DTPA extravasation in the myocardium is usually not flow-limited in infarct-related pathology. Measurement of myocardial ECV using perfusion imaging could provide a scan-time efficient alternative to methods based on T1 mapping. Magn Reson Med 77:2320-2330, 2017. © 2016 International Society for Magnetic Resonance in Medicine.

Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction.

BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing drug-eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable-polymer stent coatings. OBJECTIVES: We sought to investigate whether implantation of polymer-free DES would reduce this risk. METHODS: In the ISAR-TEST 5 (the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents) trial, patients were randomly allocated to receive a polymer-free sirolimus- and probucol-eluting stent or a new generation durable-polymer zotarolimus-eluting stent. We analyzed late clinical outcomes in the subgroup of patients presenting with STEMI. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction or target lesion revascularization at 5 years. RESULTS: 311 patients with STEMI were randomized to receive sirolimus- and probucol-eluting stents (n = 215) or zotarolimus-eluting stents (n = 96). At 5 years, there was no difference in the incidence of the primary endpoint in patients treated with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents (18.3% versus 20.1% respectively, hazard ratio = 0.87, 95% CI, 0.50-1.51; P = 0.62). Rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite/probable stent thrombosis was 1.4% versus 1.0% respectively (hazard ratio = 1.35, 95% CI, 0.14-12.94, P = 0.80). CONCLUSIONS: Long-term outcomes of patients with STEMI treated with polymer-free sirolimus- and probucol-eluting stents versus durable-polymer zotarolimus-eluting stents were similar. Stent thrombosis rates were low and comparable in both treatment groups, with no events beyond 12 months. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov (Identifier NCT 00598533) © 2016 Wiley Periodicals, Inc.

Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

OBJECTIVES: To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. BACKGROUND: Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. METHODS: The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. RESULTS: At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P < 0.01 for all comparisons). The discriminatory power of a multivariable model for prediction of 3-year mortality was significantly improved after the inclusion of EuroSCORE (adjusted area under the receiver operating characteristic (ROC) curve = 0.779, 95% confidence interval 0.747 to 0.810, P = 0.008), but not after the inclusion of SxScore, SS II, or GRC. CONCLUSIONS: In patients undergoing DES implantation for uLMCA disease, all evaluated risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc.