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.

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.

Ticagrelor or Prasugrel in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

BACKGROUND: Data on the comparative efficacy and safety of ticagrelor versus prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention are limited. We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head comparison in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS: In this prespecified subgroup analysis, we included 1653 patients with ST-segment-elevation myocardial infarction randomized to receive ticagrelor or prasugrel in the setting of the ISAR REACT-5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5). The primary end point was the incidence of death, myocardial infarction, or stroke at 1 year after randomization. The secondary end point was the incidence of bleeding defined as BARC (Bleeding Academic Research Consortium) type 3 to 5 bleeding at 1 year after randomization. RESULTS: The primary end point occurred in 83 patients (10.1%) in the ticagrelor group and in 64 patients (7.9%) in the prasugrel group (hazard ratio, 1.31 [95% CI, 0.95-1.82]; P=0.10). One-year incidence of all-cause death (4.9% versus 4.7%; P=0.83), stroke (1.3% versus 1.0%; P=0.46), and definite stent thrombosis (1.8% versus 1.0%; P=0.15) did not differ significantly in patients assigned to ticagrelor or prasugrel. One-year incidence of myocardial infarction (5.3% versus 2.8%; hazard ratio, 1.95 [95% CI, 1.18-3.23]; P=0.010) was higher with ticagrelor than with prasugrel. BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (hazard ratio, 1.22 [95% CI, 0.80-1.87]; P=0.36). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, there was no significant difference in the primary end point between prasugrel and ticagrelor. Ticagrelor was associated with a significant increase in the risk for recurrent myocardial infarction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.

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.

Ticagrelor-based antiplatelet regimens in patients with atherosclerotic artery disease-A meta-analysis of randomized clinical trials.

BACKGROUND: Randomized trials did not consistently support superiority of ticagrelor, as monotherapy or in combination with aspirin, in terms of efficacy or safety, in patients with atherosclerotic artery disease. METHODS: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, and scientific session abstracts were searched for trials of patients with coronary or peripheral artery disease (with >1,000 participants and a follow-up ≥3 months) randomly assigned to ticagrelor-based or conventional antiplatelet therapies. Trial-level hazard ratios (HRs) were pooled using a fixed- or random-effect model (in case of significant heterogeneity) with the inverse variance weighting. The primary outcome was all-cause mortality. Other outcomes were myocardial infarction (MI), stroke, and major bleeding. RESULTS: Overall 77,489 patients received either ticagrelor-based (n = 38,721) or conventional antiplatelet regimens (n = 38,768) in 6 trials. The primary outcome occurred in 4.5% of patients treated with experimental therapy and 4.9% of patients treated with control therapy (HR = 0.91, 95% CI 0.81-1.01; P = .07). Overall, patients treated with ticagrelor-based versus conventional antiplatelet regimens showed no significant difference in terms of all-cause death, MI, stroke, or major bleeding after 20 months. However, in trials of patients with coronary artery disease as primary diagnosis, the risk for all-cause death (HR = 0.84 [0.77-0.91], P < .001) and MI (HR = 0.87 [0.80-0.94], P = .007) was significantly reduced by experimental therapy. CONCLUSIONS: In patients with atherosclerotic artery disease, the benefit of ticagrelor-based therapies was confined to patients treated for coronary artery disease. The drug significantly reduced the risk for all-cause death and MI without excess risk of bleeding in these patients. In consideration of limitations of subgroup analyses, these results need further validation.

Hypocholesterolaemia and mortality in patients with coronary artery disease.

BACKGROUND: The association between hypocholesterolaemia and outcome of patients with coronary artery disease (CAD) remains controversial. We undertook this study to investigate whether there is an association between spontaneous or under statin therapy occurring hypocholesterolaemia and mortality in patients with CAD. MATERIALS AND METHODS: This study included 14 952 patients with CAD undergoing percutaneous coronary intervention (PCI). Hypocholesterolaemia was defined as a total cholesterol (TC) <157 mg/dL (the upper limit of 1st quintile of TC). The study outcome was all-cause mortality at 30 days and 3 years after PCI. RESULTS: Patients are categorized in four groups according to TC and statin therapy on admission: statin-naïve patients with hypocholesterolaemia (n = 1102), statin-naïve patients without hypocholesterolaemia (n = 7490), statin-treated patients with hypocholesterolaemia (n = 1824) and statin-treated patients without hypocholesterolaemia (n = 4536). In these groups, 30-day all-cause deaths occurred in 3.7%, 1.4%, 1.2% and 0.6% of the patients, respectively; 3-year deaths occurred in 18.0%, 8.4%, 10.9% and 7.2%, of the patients, respectively. After adjustment, hypocholesterolaemia remained independently associated with 30-day (adjusted hazard ratio [HR] = 1.50, 95% confidence interval [CI] 1.07 to 2.09; P < 0001) and 3-year (HR = 1.29 [1.12-1.47]; P < .001) mortality. Statin therapy on admission was independently associated with 30-day (HR = 0.61 [0.43-0.86]; P = .012) and 3-year (HR = 0.82 [0.72-0.94]; P = .017) mortality with no statin-by-cholesterol interaction with respect to 30-day (adjusted Pint = 0.669) or 3-year (adjusted Pint = 0.767) all-cause mortality suggesting that statins reduce the risk of mortality irrespective of cholesterol level. CONCLUSIONS: In patients with CAD, hypocholesterolaemia on admission was independently associated with increased risk of all-cause mortality at 30 days and 3 years after PCI.

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.

Aspartate aminotransferase and mortality in patients with ischemic heart disease.

BACKGROUND AND AIMS: Evidence on the association between aspartate aminotransferase (AST) activity and mortality of patients with ischemic heart disease (IHD) is limited. We investigated whether there is an association between AST activity and mortality in IHD patients. METHODS AND RESULTS: The study included 6857 patients with coronary angiography-proven IHD and AST activity within the reference range. AST activity measurements were available in all patients. The primary outcome was 3-year cardiac mortality. Patients were categorized in groups according to the AST activity tertiles: a group with AST within the 1st tertile (AST < 17.0 U/L), a group with AST within the 2nd tertile (AST > 17-24.5 U/L) and a group with AST within the 3rd tertile (AST > 24.5 U/L). Cardiac death (n = 297) occurred in 109, 69 and 119 patients in the 1st to 3rd AST tertiles (Kaplan-Meier estimates of mortality: 5.3%, 3.6% and 5.9%; univariable hazard ratio [HR] = 1.75, 95% confidence interval [CI] 1.30-2.36, P < 0.001 for tertile 3 vs. 2; HR = 1.13 [0.87-1.46], P = 0.370 for tertile 3 vs. 1; and HR = 0.65 [0.48-0.87], P = 0.004 for tertile 2 vs. 1). The association between AST and cardiac mortality was U-shaped. AST values <15 U/L (HR = 1.118 [1.009-1.238]) and >23 U/L (HR = 1.029 [1.003-1.056]) were associated with higher cardiac mortality compared with the reference value (21 U/L). After adjustment, the association between AST and cardiac mortality was attenuated (P = 0.133) but remained non-linear (P = 0.047). CONCLUSIONS: In patients with IHD, AST activity was associated with the risk of cardiac mortality with a U-shaped relationship. After adjustment, the association between AST and mortality was attenuated.

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.

Relationship of left ventricular end-diastolic pressure with extent of myocardial ischemia, myocardial salvage and long-term outcome in patients with ST-segment elevation myocardial infarction.

OBJECTIVES: We aimed to assess the association of left ventricular end-diastolic pressure (LVEDP) with myocardial salvage and long-term mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: The association of LVEDP with myocardial salvage or long-term mortality in patients with STEMI has not been investigated. METHODS: This study included 1,312 patients with STEMI undergoing primary PCI between 2002 and 2007. LVEDP was measured at the time of intervention. Patients were divided into three groups: a group with LVEDP in the 1st tertile (LVEDP, 4-19 mmHg; n = 496), a group with LVEDP in the 2nd tertile (LVEDP >19-24 mmHg; n = 410) and a group with LVEDP in the 3rd tertile (LVEDP >24-45 mmHg; n = 406). The primary outcome was 8-year cardiac mortality. RESULTS: The primary outcome (cardiac deaths) occurred in 114 patients. Deaths occurred in 26 (7.9%), 36 (11.5%), and 52 (16.4%) patients with LVEDP in the 1st to 3rd tertiles, respectively (adjusted hazard ratio = 1.18, 95% confidence interval 1.02-1.36, P = 0.022, for 5 mmHg increment in the LVEDP values). LVEDP correlated with the extent of myocardial ischemia (R = 0.351; P < 0.001). In patients with LVEDP in the 1st to 3rd tertiles, the salvage index (proportion of initial area at risk salvaged) was 0.53 [0.27-0.84], 0.53 [0.28-0.80], and 0.43 [0.18-0.75], respectively (P = 0.012). After adjustment, LVEDP correlated inversely with myocardial salvage (P < 0.001). CONCLUSIONS: In patients with STEMI, elevated LVEDP correlated with the extent of myocardial ischemia, reduced myocardial salvage and increased risk of 8-year cardiac mortality.

Outcome after new generation single-layer polytetrafluoroethylene-covered stent implantation for the treatment of coronary artery perforation.

AIMS: Coronary artery perforation (CAP) is a rare but severe complication during percutaneous coronary intervention (PCI). Implantation of covered stents (CS) represents a potentially life-saving treatment. Concerns exist regarding limited efficacy and high stent thrombosis (ST) rates related to early generation CS. The aim of this study was to evaluate angiographic and clinical outcomes of patients with CAP treated with a new generation single-layer polytetrafluoroethylene (PTFE)-CS. METHODS: Between May 2013 and November 2017, we identified a total of 61 patients who underwent implantation of 71 single layer PTFE-CS after CAP. We analyzed angiographic results at follow up (including binary angiographic restenosis [BAR] and late-lumen-loss [LLL]) and clinical outcomes in hospital and at follow up, including target lesion revascularization (TLR), cardiovascular-, and all-cause mortality, myocardial infarction (MI) and stent thrombosis (ST). RESULTS: Procedural success was achieved in all but two patients (96.7%). Procedure related MI, occurred in 19 cases (31.1%), in hospital death occurred in five cases (8.2%). At follow-up, TLR occurred in 11 cases (18.0%), two patients (3.3%) died from non-cardiovascular cause, there was no case of MI or ST. CONCLUSIONS: In this retrospective analysis, implantation of a new generation PTFE-CS, for the treatment of CAP showed high technical success rates. Although, periprocedural MI-and in-hospital-death rates remain not inconsiderable, new generation PTFE-CS showed favorable angiographic and clinical efficacy and high safety profile, especially with regard to thrombotic events.

U-shaped association of central pulse pressure with long-term prognosis after ST-segment elevation myocardial infarction.

The relationship between central pulse pressure (CPP) measured at the time of primary percutaneous coronary intervention (PPCI) and long-term prognosis after ST-segment elevation myocardial infarction (STEMI) has not been investigated. CPP measurements were performed in 1348 patients with STEMI (327 women; mean age 62.5 ± 12.1 years) undergoing PPCI. Aortic systolic and diastolic blood pressure was measured before intervention. The primary outcome was 8-year all-cause mortality. The median [25-75th percentile] CPP value was 55.0 [43.0-70.0] mmHg. CPP correlated negatively with heart rate (P < 0.001), body mass index (P = 0.007), Killip class (P < 0.001) and initial area at risk (P < 0.001) and positively with age (P < 0.001), female sex (P < 0.001), diabetes (P = 0.012), arterial hypertension (P < 0.001) and glomerular filtration rate (P = 0.004). There were 181 deaths over the follow-up. In patients with CPP within the 1st, 2nd and 3rd tertiles, the Kaplan-Meier estimates of mortality were 17.3%, 10.8% and 24.2%, respectively; univariable hazard ratio [HR] =1.52, 95% confidence interval [CI] 0.99 to 2.32; P = 0.055 for tertile 1 vs. tertile 2 and HR =2.09 [1.36-3.21]; P < 0.001 for tertile 3 vs. tertile 2. For CPP values lower than 35 mmHg and higher than 71 mmHg, the association between CPP and all-cause mortality was significant (HR =1.276 [1.004-1.621] for the 35 mmHg value and HR =1.289 [1.003-1.657] for the 71 mmHg value) compared with the CPP reference value (54 mmHg). After adjustment, the association between CPP and all-cause mortality was attenuated (P = 0.304). In patients with STEMI undergoing PPCI there is a U-shaped association between CPP and mortality up to 8 years after PPCI.

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.

Comparative prognostic value of postprocedural creatine kinase myocardial band and high-sensitivity troponin T in patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.

OBJECTIVES: We aimed to assess the prognostic value of postprocedural creatine kinase myocardial band (CK-MB) and cardiac troponin (cTn) in patients with non-ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: Whether postprocedural CK-MB or cTn is a better biomarker to stratify the risk after percutaneous coronary intervention (PCI) remains unknown. METHODS: This study included 2,077 patients with NSTEMI undergoing early PCI. Peak postprocedural values of CK-MB and high-sensitivity cTn T (hs-cTnT) were analyzed. The primary outcome was 3-year mortality. RESULTS: The median values of peak postprocedural CK-MB and hs-cTnT were 18.3 U L-1 and 0.140 µg L-1 , respectively. Overall, 211 patients died during follow-up. There were 129 deaths in patients with CK-MB >the median value and 82 deaths in those with CK-MB ≤the median value (Kaplan-Meier estimates of 3-year mortality, 18.9% and 14.0%, respectively; hazard ratio [HR] = 1.52, 95% confidence interval [CI] 1.16-2.01; P < 0.001). There were 134 deaths in patients with hs-cTnT >the median value and 77 deaths in patients with hs-cTnT ≤the median value (Kaplan-Meier estimates of 3-year mortality, 19.9% and 13.2%, respectively; HR = 1.90 [1.44-2.52]; P < 0.001). After adjustment, peak postprocedural CK-MB (adjusted HR = 1.05 [1.02-1.07], P < 0.001 for each 24 U L-1 increment) and hs-cTnT (adjusted HR = 1.12 [1.01-1.25], P = 0.037 for each unit higher log hs-cTnT) remained independently associated with the risk of 3-year mortality. The C-statistic(s) of the model with CK-MB and hs-cTnT were 0.789 [0.757-0.817] and 0.793 [0.762-0.821], respectively (P = 0.585). CONCLUSION: In patients with NSTEMI undergoing early PCI, peak postprocedural CK-MB and hs-cTnT are independently associated with the risk of 3-year mortality. © 2017 Wiley Periodicals, Inc.

Ultrasound-guided thrombin injection for treatment of femoral artery pseudoaneurysm with concomitant AV-fistula - a retrospective single centre experience.

BACKGROUND: Increasing volume of complex percutaneous endovascular procedures in highly anticoagulated patients generate a not negligible percentage of femoral pseudoaneurysms (PSA) with concomitant arteriovenous fistulas (AVF). While ultrasound-guided thrombin injection (UGTI) is the therapy of choice for PSA, concomitant AVF is regarded as a contraindication for UGTI, as venous thromboembolism is feared. In this retrospective, register-based cohort study, we report on and evaluate the use of UGTI for the treatment of PSA with AFV. PATIENTS AND METHODS: All patients (n = 523), who underwent UGTI for femoral PSA at the German Heart Centre Munich from January 2011 until January 2018, were retrospectively reviewed for the presence of a concomitant AVF and outcomes were recorded. RESULTS: Forty femoral PSA/AVFs treated by UGTI were identified. The mean enddiastolic arterial-flow-velocity above the AVF, an estimate of the AVF size, was 14.61 ± 1.7 cm/sec. The Majority of patients exhibited flow-velocities < 25 cm/sec (n = 31; 77.5 %) and were on either uninterrupted oral anticoagulation (n = 32; 80 %) or dual antiplatelet therapy (n = 8). Twenty-eight (70 %) PSA/AVFs could be successfully closed by UGTI. In eight multicompartmental PSAs, partial obliteration necessitated combined treatment with manual compression, while one partial occlusion was treated by observation. There were three failures, of which two underwent covered-stent-graft-implantation and one surgical repair. One DVT (2.5 %) occurred two days after UGTI in the by far largest AVF (60 cm/sec) included in the study. Besides two late PSA recurrences treated by surgery, no other complications were observed. AVF persisted in 65 %, all of them asymptomatic. The mean follow-up was 6 ± 15.5 months. CONCLUSIONS: UGTI appears to be a treatment option in femoral PSA/AVF, at least under oral anticoagulation in small fistulas with enddiastolic arterial-flow-velocities ≤ 25 cm/sec. However, caution is necessary in larger AVFs, which should remain a contraindication for UGTI.

Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.

BACKGROUND: Bioresorbable coronary stents might improve outcomes of patients treated with percutaneous coronary interventions. The everolimus-eluting bioresorbable vascular scaffold is the most studied of these stent platforms; however, its performance versus everolimus-eluting metallic stents remains poorly defined. We aimed to assess the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation. METHODS: We searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites for randomised trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was target lesion revascularisation and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischaemia-driven target lesion revascularisation), myocardial infarction, death, and in-device late lumen loss. We derived odds ratios (ORs) and weighted mean differences with 95% CIs, and calculated the risk estimates for the main outcomes according to a random-effects model. This study is registered with PROSPERO, number CRD42015026374. FINDINGS: We included six trials, comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or an everolimus-eluting metallic stent (n=1401). Median follow-up was 12 months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularisation (OR 0.97 [95% CI 0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21), myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95 [0.45-2.00]; p=0.89) as those treated with metallic stents. Patients treated with a bioresorbable vascular scaffold had a higher risk of definite or probable stent thrombosis than those treated with a metallic stent (OR 1.99 [95% CI 1.00-3.98]; p=0.05), with the highest risk between 1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions treated with a bioresorbable vascular scaffold had greater in-device late lumen loss than those treated with a metallic stent (weighted mean difference 0.08 [95% CI 0.05-0.12]; p<0.0001). INTERPRETATION: Compared with everolimus-eluting metallic stents, everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularisation at 1 year of follow-up, despite inferior mid-term angiographic performance. However, patients treated with a bioresorbable vascular scaffold had an increased risk of subacute stent thrombosis. Studies with extended follow-up in a larger number of patients are needed to fully assess the long-term advantages of everolimus-eluting bioresorbable vascular scaffolds. FUNDING: None.

Alkaline phosphatase and prognosis in patients with coronary artery disease.

BACKGROUND: The evidence on the association between alkaline phosphatase (ALP) and prognosis of patients with coronary artery disease (CAD) is limited. The aim of this study was to assess the association of ALP with the risk of mortality or coronary events in patients with CAD. MATERIALS AND METHODS: The study included 5540 patients with angiography-proven CAD treated with catheter-based coronary revascularization. Baseline ALP measurements were available for analysis in all patients. Patients were divided into three groups: a group with an ALP activity in the 1st tertile (ALP ≤ 65·5 U/L; n = 1855), a group with an ALP activity in the 2nd tertile (ALP > 65·5 to 85·7 U/L; n = 1839) and a group with an ALP in the 3rd tertile (ALP > 85·7 U/L; n = 1846). The primary outcome was all-cause mortality at 3-year follow-up. RESULTS: All-cause deaths (number [Kaplan-Meier estimates]) occurred in 443 patients: 117 (7·2%), 130 (8·1%) and 196 deaths (11·8%) among patients of the 1st, 2nd and 3rd ALP tertiles (unadjusted hazard ratio [HR] = 1·33, 95% confidence interval [CI]: 1·19 to 1·50; P < 0·001, calculated per tertile increment in the ALP activity). After adjustment in multivariable Cox proportional hazards model, ALP was independently associated with the risk of all-cause mortality (adjusted HR = 1·33 [1·18-1·51], P < 0·001, calculated per unit increment in log ALP). The multivariable model for all-cause mortality with baseline variables without ALP had a C statistic of 0·820 [0·797-0·843] which increased to 0·825 [0·804-0·849] after ALP inclusion; delta C statistic 0·005 [0·001-0·011]; P < 0·001. CONCLUSIONS: In patients with CAD, elevated ALP activity was independently associated with the risk of 3-year all-cause mortality.

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.

Increased bleeding risk during percutaneous coronary interventions by arterial hypertension.

OBJECTIVES: We aimed to assess the association between arterial hypertension and bleeding in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: The impact of arterial hypertension on bleeding risk of patients with coronary artery disease undergoing PCI is unknown. METHODS: This study included 14,180 patients who underwent PCI. Bleeding was defined using the Bleeding Academic Research Consortium (BARC) criteria. Arterial hypertension was defined as treatment with antihypertensive drugs or a systolic blood pressure >140 mm Hg and/or diastolic blood pressure value >90 mm Hg documented on at least 2 occasions. The primary outcome was bleeding rate within 30 days of PCI. RESULTS: Overall, 11,066 patients (78.0%) had arterial hypertension. Bleeding events occurred in 1,232 patients with arterial hypertension and 278 patients without arterial hypertension (11.1% vs 8.9%; odds ratio [OR] = 1.28, 95% confidence interval [CI] 1.11-1.46, P < 0.001). Access-site bleeding occurred in 730 patients with arterial hypertension and 175 patients without arterial hypertension (6.6% vs 5.6%: OR = 1.19 [1.01-1.41], P = 0.049). Non-access-site bleeding occurred in 502 patients with and 103 patients without arterial hypertension (4.5% vs 3.3%; OR = 1.39 [1.12-1.72], P = 0.003). After adjustment, arterial hypertension was significantly associated with any bleeding (adjusted OR = 1.41 [1.19-1.67], P < 0.001), access-site bleeding (adjusted OR = 1.36 [1.10-1.68], P = 0.005) and non-access-site bleeding (adjusted OR = 1.42 [1.09-1.83], P = 0.008). A history of arterial hypertension increased the risk of non-access-site bleeding (P = 0.002), whereas systolic blood pressure at the time of PCI increased the risk of access site bleeding (P = 0.018). CONCLUSIONS: Arterial hypertension is associated with increased risk of bleeding during PCI procedures. © 2015 Wiley Periodicals, Inc.

Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting.

AIM: Routine control angiography is a valuable tool with high-sensitivity in detecting restenosis after coronary stenting. However, the prognostic role of restenosis is still controversial. We investigated the impact of restenosis on 4-year mortality in patients undergoing routine control angiography after coronary stenting. METHODS AND RESULTS: All the patients undergoing successful implantation of coronary stents for de novo lesions from 1998 to 2009 and routine control angiography after 6-8 months at two centres in Munich, Germany were studied. Restenosis was defined as diameter stenosis ≥50% in the in-segment area at follow-up angiography. The primary outcome was 4-year mortality. The study included 10 004 patients with 15 004 treated lesions. Restenosis was detected in 2643 (26.4%) patients. Overall, there were 702 deaths during the follow-up. Of these, 218 deaths occurred among patients with restenosis and 484 deaths occurred among patients without restenosis [unadjusted hazard ratio: HR: 1.19; (95% confidence interval CI: 1.02-1.40); P = 0.03]. The Cox proportional hazards model adjusting for other variables identified restenosis as an independent correlate of 4-year mortality [HR: 1.23; (95% CI: 1.03-1.46); P = 0.02]. Other independent correlates of 4-year mortality were age [for each 10-year increase, HR: 2.34; (95% CI: 2.12-2.60); P < 0.001], diabetes mellitus [HR: 1.68; (95% CI: 1.41-1.99); P < 0.001], current smoking habit [HR: 1.39; (95% CI: 1.09-1.76); P = 0.01], and left ventricular ejection fraction [for each 5% decrease, HR: 1.39; (95% CI: 1.31-1.48); P < 0.001]. CONCLUSIONS: In this large cohort of patients, the presence of restenosis at follow-up angiography after coronary stenting was predictive of 4-year mortality. Whether routine control angiography after coronary stenting is beneficial and influences outcomes should be evaluated by properly designed randomized trials.