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Background: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.Objectives: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.Methods: A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.Results: The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).Conclusions: At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533). [ABSTRACT FROM AUTHOR]

Background: Whether there are sex differences in the outcome of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial. We undertook this study to assess whether there are sex-related differences in the long-term mortality in a large series of patients with CAD after PCI.Methods: The study included 18,334 patients (4735 women and 13,599 men) with CAD treated with PCI. Propensity matching was performed to obtain a group of patients (3000 women and 3000 men) matched for all characteristics available in database. The primary outcome was a composite of cardiac mortality, myocardial infarction or stroke at 3 years of follow-up.Results: The primary outcome occurred in 660 women and 1440 men (Kaplan-Meier [KM] estimates, 15.2% in women and 11.6% in men, unadjusted hazard ratio [HR] = 1.35, 95% confidence interval [CI] 1.24 to 1.49; P < 0.001). Women were at higher risk of all-cause mortality (15.4% vs. 12.3%; P < 0.001), cardiac mortality (10.2% vs. 7.6%; P < 0.001) and stroke (2.6% vs. 1.4%; P < 0.001) than men. In matched patients, the primary outcome occurred in 371 women and 322 men (KM estimates, 13.4% vs. 11.6%, HR = 1.18 [1.01-1.36], P = 0.033). Women were at higher risk of myocardial infarction (4.2% vs. 3.1%; P = 0.044) but not cardiac (8.7% vs. 8.2%; P = 0.306) or all-cause death (12.5% vs. 12.9%; P = 0.991) or stroke (1.9% vs. 1.6%; P = 0.550) than men.Conclusions: After propensity matching, women remained at a higher risk of a composite of cardiac mortality, myocardial infarction or stroke up to 3 years after PCI than men. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: In the ISAR-CABG (Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?) trial, clinical outcomes at 1 year in patients undergoing treatment of saphenous vein graft lesions were superior with drug-eluting stents (DES) versus bare-metal stents.Objectives: The authors compared outcomes between treatment groups at 5 years.Methods: Patients were randomized (1:1:1:3) to receive DES (either permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. The primary endpoint was the combined incidence of death, myocardial infarction (MI), or target lesion revascularization (TLR). Secondary endpoints were the composite of death or MI and TLR.Results: A total of 610 patients were allocated to treatment with DES (n = 303) or bare-metal stents (n = 307). At 5 years, the primary endpoint occurred in 159 (55.5%) versus 157 (53.6%) patients in the DES and bare-metal stent groups, respectively (hazard ratio [HR]: 0.98; 95% confidence interval [CI]: 0.79 to 1.23; p = 0.89). There was interaction between treatment effect and time (pinteraction = 0.005), with a lower event rate in the DES group at 1 year (HR: 0.64; 95% CI: 0.44 to 0.94; p = 0.02) but a numerically higher rate between 1 and 5 years (HR: 1.24; 95% CI: 0.94 to 1.63; p = 0.13). Death or MI occurred in 93 (32.8%) versus 108 (36.6%) patients, respectively (HR: 0.85; 95% CI: 0.64 to 1.12; p = 0.24), without significant interaction between treatment effect and time (pinteraction = 0.57). TLR occurred in 84 (33.1%) versus 69 (25.5%) patients in the DES and bare-metal stent groups, respectively (HR: 1.20; 95% CI: 0.87 to 1.64; p = 0.27). There was interaction between treatment effect and time (pinteraction <0.001): TLR was significantly lower in the DES group at 1 year (HR: 0.49; 95% CI: 0.28 to 0.86; p = 0.01) but significantly higher thereafter (HR: 2.02; 95% CI: 1.32 to 3.08; p = 0.001).Conclusions: In patients undergoing treatment of saphenous vein graft lesions, the advantage of DES over bare-metal stents demonstrated at 1 year was lost at 5 years due to higher attrition of efficacy in the DES group. (Efficacy Study of Drug-Eluting and Bare Metal Stents in Bypass Graft Lesions [ISAR-CABG]; NCT00611910). [ABSTRACT FROM AUTHOR]

Background The growing number of complex endovascular procedures is expected to increase the risk of iatrogenic injuries of peripheral arteries. A strategy of percutaneous transluminal angioplasty (PTA) with covered stent (CS) may represent a valuable alternative to open surgery. However, systematic evaluations of CS in this setting represent a scientific gap. In the present study, we investigate the procedural and clinical outcomes associated with PTA and CS implantation to repair iatrogenic injuries of peripheral arteries. Methods All patients undergoing PTA with CS for endovascular repair of iatrogenic injuries of peripheral arteries between August 2010 and July 2013 at our Institution were retrospectively analyzed. The primary endpoint was the technical success. Secondary endpoints were in-hospital mortality and cumulative death, target lesion revascularization (TLR), amputation and major stroke at 12-month follow-up. Results During the period of observation, a total of 30 patients underwent PTA with either self-expandable (43.3%) or balloon-expandable CS (56.7%) for iatrogenic injuries of peripheral arteries. Injuries consisted of perforation/rupture (76.7%), arteriovenous fistula (16.7%) and pseudoaneurysm (6.7%) of iliac–femoral arteries. Technical success was achieved in all cases. Median follow-up was 409 days [210–907]. The incidence of in-hospital mortality was 10.0%. At 12-month follow-up, the incidence of death, TLR, amputation and major stroke was 20.0%, 17.0%, 3.3% and 6.7%, respectively. Conclusion The use of covered stents for endovascular repair of iatrogenic injuries of peripheral arteries shows a high technical success and may be alternative to surgery. Further studies with larger populations are needed to confirm these preliminary findings. [ABSTRACT FROM AUTHOR]

Background: Concern exists relating to potential attenuated efficacy of limus-eluting stents in patients with diabetes mellitus. In this respect diabetic patients with sirolimus-eluting stent (SES) failure requiring reintervention may be expected to derive particular benefit from a treatment-switch to paclitaxel-eluting stent (PES) implantation. Objective: The aim of the current report was to investigate outcomes of patients with SES restenosis randomized to treatment with SES (same stent strategy) or PES (switch stent strategy) in the pre-specified subgroups of patients with and without diabetes mellitus. Methods: In the setting of ISAR-DESIRE 2 trial, 450 patients with clinically significant SES restenosis were randomly assigned to receive either SES or PES. The primary end point was in-stent late loss at 6–8month follow-up angiography. Secondary endpoints were binary angiographic restenosis (diameter stenosis >50%) and target lesion revascularization (TLR), the composite of death or myocardial infarction (MI) and definite stent thrombosis at 12months. Results: Of 450 patients enrolled, 162 (36.0%) had a diagnosis of diabetes mellitus. In patients with diabetes 86 patients were randomly assigned to SES versus 76 to PES. In patients without diabetes 139 were assigned to SES versus 149 to PES. Late loss was comparable between SES and PES both in patients with diabetes (0.38±0.59mm vs. 0.37±0.59mm; p=0.97) and without (0.41±0.67mm vs. 0.38±0.6mm; p=0.98; pinteraction =0.89). Similarly binary restenosis was comparable between SES and PES in patients with diabetes (19.0% vs. 26.0%; p=0.32) or without (18.9% vs. 17.8%; p=0.98; pinteraction =0.36). TLR, death or MI and definite stent thrombosis were also similar in SES versus PES treatment groups regardless of diabetes status. Conclusions: In cases of SES-restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy, regardless of diabetic status. [ABSTRACT FROM AUTHOR]

Background: The association of aspirin loading with the risk of coronary no‐reflow (CNR) after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI) has not been investigated. We assessed the association of aspirin loading before PCI with CNR in patients with AMI. Materials and Methods: This study included 3100 patients with AMI undergoing PCI. Of them, 2812 patients received aspirin loading (a single oral [or chewed] or intravenous dose of 150–300 mg) and 288 patients did not receive aspirin loading before PCI. The primary endpoint was CNR, defined as Thrombolysis in Myocardial Infarction blood flow grade of <3 after the PCI. Results: CNR occurred in 130 patients: 127 patients in the group with aspirin loading and 3 patients in the group without aspirin loading before PCI (4.5% vs. 1.0%; odds ratio [OR] = 4.50, 95% confidence interval, [1.42–14.21], p = 0.005). After adjustment, the association between aspirin loading and CNR was significant (adjusted OR = 4.49 [1.56–12.92]; p < 0.001). There was no aspirin loading‐by‐P2Y12 inhibitor (ticagrelor or prasugrel) interaction (pint = 0.465) or aspirin loading‐by‐chronic aspirin therapy on admission (pint = 0.977) interaction with respect to the occurrence of CNR after PCI. Chronic low‐dose aspirin therapy on admission was not independently associated with higher risk of CNR after PCI (adjusted OR = 1.06 [0.65–1.72]; p = 0.824). Conclusion: In patients with AMI undergoing PCI, aspirin loading before the PCI procedure at the guideline‐recommended doses was associated with higher odds of developing CNR. However, due to the limited number of events, the findings should be considered as hypothesis generating. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Early-generation "sandwich-design" polytetrafluorethylene (PTFE) covered coronary stents (CS) are associated with a high frequency of adverse events. New-generation single layer PTFE-CS offers the potential to enhanced procedural efficacy and improves clinical safety. Data from a dedicated study, concerning outcomes after treatment with single-layer PTFE-CS in patients undergoing percutaneous coronary intervention are scant. This is a retrospective multicenter registry including 30 patients undergoing implantation of 39 single-layer PTFE-CS (BeGraft-coronary Stent Graft System, Bentley InnoMed GmbH, Hechingen, Germany) in native coronary arteries or saphenous bypass grafts, in 3 centers in Europe, between May 2013 and May 2019. Endpoints of interest were procedural success (placement of covered stent), binary-angiographic restenosis (BAR), percent diameter stenosis (% DS) and late-lumen loss at 6–8 months follow-up angiography, rates of target lesion revascularization (TLR), myocardial infarction (MI), stent thrombosis (ST) and mortality at 12 months. 28 patients underwent implantation of 37 CS due to coronary artery perforation 2 patients due to coronary artery aneurysm. Technical success was achieved in all patients (100 %). More than one stent was implanted in 7 patients (25 %) all in the perforation group. Follow-up angiography was available in 23 patients (77 %) showing favorable results: BAR = 21.8 %, %DS = 30.3 ± 27.5; LLL = 0.16 ± 0.81 mm. At 12 months all patients were alive, rates of TLR were low (3 patients, 10.0 %), there was one case of late stent thrombosis (3.3 %) and one MI (3.3 %). In this dedicated study, implantation of a new single layer PTFE-CS for the treatment of native coronary arteries or saphenous vein grafts after perforation or due to aneurysm showed high technical success rates and favorable angiographic and clinical efficacy. Clinical safety outcomes are encouraging, but larger prospective studies are needed to determine long-term safety of this device. • This is a multicenter registry including 30 patients undergoing PCI with implantation of 39 PTFE-CS in native coronary arteries or SVG due to perforation or aneurysm at 3 centers in Europe. • Procedural and postprocedural outcome at index PCI, angiographic FU at 6-8 months and clinical FU out to 12 months was obtained. • We observed high technical success rate (100%) at index PCI and favorable angiographic results in terms of binary angiographic restenosis, late lumen loss, % diameter stenosis and low clinical event rates at 12 months: TLR (10.0%), MI (3.3%) and ST (3.3%). [ABSTRACT FROM AUTHOR]

Background Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR. Methods We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6–8 month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1 year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups. Results In total, 264 patients were treated with BTHC-PCB ( n = 127) or iopromide-PCB ( n = 137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P = 0.001). At 6–8 month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively ( P = 0.16, P adjusted = 0.32). At 1 year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62–1.70], P = 0.91, P adjusted = 0.96). Conclusions In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1 year compared with iopromide-PCB. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up. METHODS: Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed. RESULTS: Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HRadj], 0.94 [95% CI, 0.80–1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HRadj, 0.80 [95% CI, 0.74–0.87]), target vessel (HRadj, 0.81 [95% CI, 0.76–0.87]), and nontarget vessels (HRadj, 0.69 [95% CI, 0.62–0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HRadj, 1.65 [95% CI, 1.24–2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HRadj, 1.14 [95% CI, 0.89–1.47]). CONCLUSIONS: Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients. [ABSTRACT FROM AUTHOR]

Background: Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial. Methods: In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models. Results: A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52). Conclusions: In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. [ABSTRACT FROM AUTHOR]

• ALP predicts 3-year mortality in patients with diabetes mellitus and ischemic heart disease. • Low and high ALP activity levels were associated with increased risk of mortality. • Impaired renal function and elevated C-reactive protein correlated with higher ALP activity. The association between alkaline phosphatase (ALP) and mortality in patients with diabetes mellitus (DM) and ischemic heart disease (IHD) remains poorly investigated. The study included 1426 patients with DM and IHD who underwent percutaneous coronary intervention. Patients were divided in groups according to tertiles of ALP activity: a group with ALP activity in 1st tertile (ALP activity: 20.8–65.0 U/L; n = 478), a group with ALP activity in 2nd tertile (ALP activity: 65.1–87.0 U/L; n = 473) and a group with ALP activity in 3rd tertile (ALP activity: 87.1–1520 U/L; n = 475). The primary endpoint was 3-year all-cause mortality. At 3 years, all-cause deaths occurred in 182 patients: 50 deaths (12.4%) in patients of 1st tertile, 47 deaths (11.7%) in patients of 2nd tertile and 85 deaths (20.8%) in patients of 3rd tertile of ALP activity (adjusted hazard ratio [HR] = 1.20, 95% confidence interval [CI] 1.02 to 1.42, P = 0.031); cardiac deaths occurred in 110 patients: 28 deaths (7.0%) in patients of 1st tertile, 30 deaths (7.6%) in patients of 2nd tertile and 52 deaths (12.7%) in patients of 3rd tertile of ALP activity (adjusted HR = 1.27 [1.04–1.56], P = 0.021, with both risk estimates calculated for unit increment in the log scale of ALP activity). The C-statistic of the multivariable model with baseline data without and with ALP was 0.787 [0.750–0.818] and 0.804 [0.757–0.851], (P = 0.575) for all-cause mortality and 0.832 [0.798–0.864] and 0.876 [0.833–0.918], (P = 0.115) for cardiac mortality. In patients with DM and IHD, elevated ALP activity was associated with increased risk of 3-year mortality. [ABSTRACT FROM AUTHOR]

Background: Whether the access site influences the comparative efficacy and safety of ticagrelor and prasugrel in patients with acute coronary syndrome (ACS) undergoing invasive treatment strategy remains unstudied.Methods: This post-hoc analysis included ACS patients undergoing invasive treatment via radial or femoral access and randomized to either ticagrelor or prasugrel in the ISAR-REACT 5 trial. The primary efficacy endpoint was the composite of death, myocardial infarction (MI) or stroke, safety endpoint was BARC 3 to 5 bleeding. Outcomes were assessed out to 12 months after randomization.Results: Out of 4018 patients, 3984 underwent invasive treatment via radial or femoral access. 1479 had coronary angiography via radial access (ticagrelor, N = 748; prasugrel, N = 731) and 2505 via femoral access (ticagrelor, N = 1245; prasugrel, N = 1260). There was no interaction between access route and assignment to either ticagrelor or prasugrel regarding the primary efficacy or safety endpoints (P for interaction≥0.616). In the radial group, the primary efficacy endpoint (7.6% versus 5.8%, HR: 1.32 [0.88-1.97], P = 0.151) and the safety endpoint (4.3% versus 3.0%, HR: 1.36, [0.73-1.31], P = 0.300) were not statistically different in patients receiving either ticagrelor or prasugrel. In the femoral group, the primary efficacy endpoint occurred more frequently in patients assigned to ticagrelor as compared to prasugrel (10.3% versus 7.3%, HR: 1.44 [1.10-1.88], P = 0.006) without significant difference in terms of safety endpoint (6.4% versus 5.8%, HR: 1.14, [0.81-1.60], P = 0.470).Conclusions: In patients with ACS undergoing an invasive treatment strategy, the access route does not influence the comparative efficacy and safety of ticagrelor and prasugrel.Clinical Trial Registration: NCT01944800. [ABSTRACT FROM AUTHOR]

• Cockcroft-Gault creatinine clearance and EKFC equations predict mortality better than MDRD-4 and CKD-EPI equations. • Cockcroft-Gault creatinine clearance and EKFC equations predict bleeding better than MDRD-4 and CKD-EPI equations. • All four eGFR equations failed to improve risk prediction for myocardial infarction. It remains unknown which equation used to assess the glomerular function is better for risk stratification in patients with acute coronary syndrome (ACS). This study included 3985 patients with ACS. Glomerular function was assessed using 4 equations: the Cockcroft-Gault creatinine clearance (C-G CrCl), Modification of Diet in Renal Disease-4 (MDRD-4), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and European Kidney Function Consortium (EKFC) equations. The primary outcome was one-year all-cause mortality. For each 30 ml/min decrement, the adjusted hazard ratio [HR] with 95% confidence interval [CI] for one-year mortality was 1.67 [1.27–2.25] for C-G CrCl , 1.45 [1.16–1.81] for MDRD-4, 1.76 [1.35–2.30] for CKD-EPI and 1.94 [1.44–2.63] for EKFC equation. Area under the receiver operating characteristic curve (AUC) for one-year mortality was 0.748 [0.709–0.788] for C-G CrCl , 0.670 [0.621–0.718] for estimated glomerular filtration rate (eGFR) calculated by MDRD-4 equation, 0.725 [0.684–0.765] for eGFR calculated by CKD-EPI equation and 0.741 [0.703–0.779] for eGFR calculated by EKFC equation (P = 0.342 for C-G CrCl , vs. EKFC equation and P ≤ 0.009 for all other AUC comparisons). In patients with ACS, C-G CrCl and EKFC equations showed a similar discriminatory power regarding prediction of one-year mortality. Both equations were better than MDRD-4 and CKD-EPI equations for risk discrimination for mortality. Clinical Trial Registration: NCT01944800. [ABSTRACT FROM AUTHOR]

Background: The prognostic value of in‐hospital haemoglobin drop in patients with acute coronary syndrome (ACS) undergoing invasive therapy remains insufficiently investigated. Materials and Methods: This observational study included 3838 patients with ACS with admission and in‐hospital nadir haemoglobin values available. Haemoglobin drop was defined as a positive difference between admission and nadir haemoglobin values. The primary endpoint was one‐year all‐cause mortality. Results: In‐hospital haemoglobin drop occurred in 3142 patients (82%). Patients were categorized into 4 groups: no haemoglobin drop (n = 696 patients), <3 g/dl haemoglobin drop (n = 2703 patients), 3 to <5 g/dl haemoglobin drop (n = 344 patients) and ≥5 g/dl haemoglobin drop (n = 95 patients). The primary endpoint occurred in 156 patients: 17 patients (2.5%) in the group with no haemoglobin drop, 81 patients (3.0%) in the group with <3g/dl haemoglobin drop, 37 patients (10.9%) in the group with 3 to <5 g/dl haemoglobin drop and 21 patients (22.2%) in the group with ≥5 g/dl haemoglobin (adjusted hazard ratio [HR] = 1.30, 95% confidence interval 1.17 to 1.45; p <.001 for one g/dl haemoglobin drop). The association of haemoglobin drop with one‐year mortality remained significant after exclusion of patients with in‐hospital overt bleeding (adjusted HR = 1.27 [1.11–1.46]; p <.001 for one g/dl haemoglobin drop). The lowest haemoglobin drop associated with mortality was 1.23 g/dl in all patients (HR = 1.03 [1.02–1.04]) and 1.13 g/dl in patients without overt bleeding (HR = 1.03 [1.01–1.04]). Conclusions: In patients with ACS, in‐hospital haemoglobin drop was associated with higher risk of one‐year mortality even in the absence of overt bleeding. [ABSTRACT FROM AUTHOR]

The efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with acute coronary syndromes (ACS) are not known. We assessed the efficacy and safety of ticagrelor versus prasugrel according to smoking status in patients with ACS undergoing invasive management. This pre-specified analysis of the ISAR-REACT 5 trial included 1349 smokers and 2652 nonsmokers randomized to receive ticagrelor or prasugrel. The primary endpoint was the incidence of death, myocardial infarction, or stroke; the secondary endpoint was the incidence of Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding (both endpoints assessed at 12 months). There was no significant treatment arm-by-smoking status interaction regarding the efficacy outcome. The primary endpoint occurred in 47 patients (7.0%) in the ticagrelor group and 41 patients (6.2%) in the prasugrel group in smokers (hazard ratio [HR] = 1.15; 95% confidence interval [CI] 0.76–1.75; P = 0.510) and in 133 patients (10.2%) in the ticagrelor group and 94 patients (7.2%) in the prasugrel group in nonsmokers (HR = 1.44 [1.10–1.87]; P = 0.007; P for interaction = 0.378). The secondary endpoint occurred in 27 patients (4.6%) in the ticagrelor group and 33 patients (5.6%) in the prasugrel group in smokers (HR = 0.81 [0.49–1.35]; P = 0.412) and in 66 patients (6.0%) in the ticagrelor group and 46 patients (4.4%) in the prasugrel group in nonsmokers (HR = 1.38 [0.94–2.01]; P = 0.097). In patients with ACS undergoing an invasive management strategy, the smoking status did not significantly interact with the relative treatment effect of ticagrelor vs. prasugrel. NCT01944800 • In ACS patients, ticagrelor and prasugrel showed similar efficacy regardless of smoking status. • Bleeding risk was comparable between ticagrelor and prasugrel in smokers and nonsmokers. • Smoking status does not interfere with the relative treatment effect of ticagrelor vs. prasugrel. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI).Objectives: This study sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management.Methods: This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5.Results: The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio [HR]: 1.41; 95% confidence interval [CI]: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month.Conclusions: In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800). [ABSTRACT FROM AUTHOR]

Purpose: Everolimus-eluting bioresorbable scaffolds (BRS) demonstrated an increased risk of very late scaffold thrombosis (VLScT) in comparison with conventional drug-eluting stents. However, characterization of VLScT cases remains scant and the role of interim angiographic surveillance in identifying patients at risk of VLScT is unclear. We therefore set out to identify angiographic predictors of VLScT in our present case series.Methods: We analyzed a series of consecutive patients with VLScT presenting to two centers in Munich, Germany. Of interest, all patients had undergone interim planned surveillance angiography. Angiographic films were collected and reviewed and quantitative coronary angiography analysis was done at a core laboratory. Optical coherence tomography (OCT) images at presentation with VLScT were analyzed in patients with available data.Results: Nine patients presented with 10 VLScT events. Mean age was 62.6 years. Surveillance angiography (between 159 and 476 days) were unremarkable in all cases. Time from index intervention to VLScT ranged from 393 to 1494 days. Nine of 10 events occurred after discontinuation of dual antiplatelet therapy. Four patients underwent OCT. The dominant finding at the time of VLScT was scaffold discontinuity.Conclusions: In a series of patients with VLScT after treatment with BRS, routine interim surveillance angiography was available in all patients and failed to identify features predictive of subsequent adverse events. [ABSTRACT FROM AUTHOR]

Background: Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death worldwide, with acute coronary syndromes accounting for most of the cases. While the benefit of early revascularization has been clearly demonstrated in patients with ST-segment-elevation myocardial infarction (STEMI), diagnostic pathways remain unclear in the absence of STEMI. We aimed to characterize OHCA patients presenting to 2 tertiary cardiology centers and identify predicting factors associated with survival. Methods: We retrospectively analyzed 519 patients after OHCA from February 2003 to December 2017 at 2 centers in Munich, Germany. Patients undergoing immediate coronary angiography (CAG) were compared to those without. Multivariate regression analysis and inverse probability treatment weighting (IPTW) were performed to identify predictors for improved outcome in a matched population. Results: Immediate CAG was performed in 385 (74.1%) patients after OHCA with presumed cardiac cause of arrest. As a result of multivariate analysis after propensity score matching, we found that immediate CAG, return of spontaneous circulation (ROSC) at admission, witnessed arrest and former smoking were associated with improved 30-days-survival [(OR, 0.46; 95% CI, 0.26–0.84), (OR, 0.21; 95% CI, 0.10–0.45), (OR, 0.50; 95% CI, 0.26–0.97), (OR, 0.43; 95% CI, 0.23–0.81)], and 1-year-survival [(OR, 0.39; 95% CI, 0.19–0.82), (OR, 0.29; 95% CI, 0.12–0.7), (OR, 0.43; 95% CI, 0.2–1.00), (OR, 0.3; 95% CI, 0.14–0.63)]. Conclusions: In our study, immediate CAG, ROSC at admission, witnessed arrest and former smoking were independent predictors of survival in cardiac arrest survivors. Improvement in prehospital management including bystander CPR and best practice post-resuscitation care with optimized triage of patients to an early invasive strategy may help ameliorate overall outcome of this critically-ill patient population. [ABSTRACT FROM AUTHOR]

Background: The association of postprocedural high-sensitivity troponin T (hs-TnT) with prognosis of non-ST-segment elevation myocardial infarction (NSTEMI) patients is incompletely investigated.Aim: To assess the prognostic value of hs-TnT in NSTEMI patients undergoing early percutaneous coronary intervention (PCI).Methods: This study included 3783 patients with NSTEMI undergoing early PCI. Preprocedural and peak postprocedural hs-TnT was measured. Patients were divided into 3 groups: a group with postprocedural hs-TnT in the 1st tertile (hs-TnT <105ng/L; n=1264), a group with postprocedural hs-TnT in the 2nd tertile (hs-TnT ≥105ng/L to 470ng/L; n=1258) and a group with postprocedural hs-TnT in the 3rd tertile (hs-TnT >470ng/L; n=1261). The primary outcome was 1-year all-cause mortality.Results: Overall, there were 299 deaths: 59 (5.5%), 98 (8.2%) and 142 deaths (12.6%) among patients of the 1st, 2nd and 3rd postprocedural hs-TnT tertiles (unadjusted hazard ratio [HR]=1.65, 95% confidence interval [CI] 1.20 to 2.67; P=0.002 for tertile 2 vs tertile 1 and unadjusted HR=2.41 [1.79-3.25]; P<0.001 for tertile 3 vs tertile 1). After adjustment postprocedural hs-TnT was independently associated with the risk of all-cause mortality (adjusted [HR]=1.22 [1.13-1.33], P<0.001 for 1 unit higher log hs-TnT). Postprocedural hs-TnT improved the risk prediction of the model of all-cause mortality (the C statistic of the model without [with baseline variables only] and with incorporation of postprocedural hs-TnT was 0.759 [0.732-0.782] and 0.772 [0.746-0.794], respectively; P<0.001).Conclusions: In patients with NSTEMI undergoing early PCI, postprocedural hs-TnT is independently associated with increased risk of mortality up to 1year after PCI. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The frequency and pattern of progression or regression of coronary atherosclerosis in contemporary patients with diabetes remain unknown. This study included 605 patients with coronary artery disease (CAD). Two coronary angiographic examinations at baseline and after 2 years were performed. The analysis focused on non-stented segments with diameter stenosis ≥25 %. Atherosclerosis progression (or regression) was defined as a decrease (or increase) in the mean minimal lumen diameter (MLD) in the 2-year angiogram compared to mean MLD in the baseline angiogram of >0.2 mm. Statins were prescribed in 576 patients (95.2 %). The primary outcome was atherosclerosis progression or regression in the 2-year angiogram. One hundred sixty-nine patients (28 %) had diabetes. Diabetic patients had greater reduction of mean MLD in the 24 angiogram compared to baseline angiogram than nondiabetic patients (0.11 ± 0.18 vs. −0.08 ± 0.15 mm, P < 0.001). Atherosclerosis progression was observed in 37 patients with diabetes and 16 nondiabetic patients (21.9 vs. 3.7 %; P < 0.001). Atherosclerosis regression was observed in two diabetic patients and 78 nondiabetic patients (1.2 vs. 17.9 %; P < 0.001). A progression pattern across all coronary segments was observed in 70 patients (41.4 %) with diabetes and 60 patients (13.8 %) without diabetes ( P < 0.001). Diabetic patients with a low-density lipoprotein cholesterol ≥70 mg/dl showed more atherosclerosis progression than diabetic patients with LDL cholesterol <70 mg/dl (delta-MLD: 0.12 ± 0.19 vs. 0.08 ± 0.16 mm; P = 0.04). In conclusion, in contemporary patients with CAD treated with moderate-intensity statin therapy, diabetes is associated with the increased risk of progression and decreased probability of regression of coronary atherosclerosis. [ABSTRACT FROM AUTHOR]

Background: The prognostic value of high-sensitivity troponin T (hs-TnT) elevation after elective percutaneous coronary intervention (PCI) in patients with or without raised baseline hs-TnT levels is unclear.Objectives: The goal of this study was to assess whether the prognostic value of post-procedural hs-TnT level after elective PCI depends on the baseline hs-TnT level.Methods: This study included 5,626 patients undergoing elective PCI who had baseline and peak post-procedural hs-TnT measurements available. The primary outcome was 3-year mortality (with risk estimates calculated per SD increase of the log hs-TnT scale).Results: Patients were divided into 4 groups: nonelevated baseline and post-procedural hs-TnT levels (hs-TnT ≤0.014 μg/l; n = 742); nonelevated baseline but elevated post-procedural hs-TnT levels (peak post-procedural hs-TnT >0.014 μg/l; n = 2,721); elevated baseline hs-TnT levels (hs-TnT >0.014 μg/l) with no further rise post-procedure (n = 516); and elevated baseline hs-TnT levels with a further rise post-procedure (n = 1,647). A total of 265 deaths occurred: 6 (1.6%) in patients with nonelevated baseline and post-procedural hs-TnT levels; 54 (3.8%) in patients with nonelevated baseline but elevated post-procedural hs-TnT levels; 50 (16.0%) in patients with elevated baseline hs-TnT levels with no further rise post-procedure; and 155 (18.2%) in patients with elevated baseline hs-TnT levels with a further rise post-procedure (p < 0.001). After adjustment, baseline hs-TnT levels (hazard ratio [HR]: 1.22; 95% confidence interval [CI]: 1.09 to 1.38; p < 0.001) but not peak post-procedural hs-TnT levels (HR: 1.04; 95% CI: 0.85 to 1.28; p = 0.679) were associated with an increased risk of mortality. Peak post-procedural hs-TnT findings were not associated with mortality in patients with nonelevated (HR: 0.93; 95% CI: 0.69 to 1.25; p = 0.653) or elevated (HR: 1.24; 95% CI: 0.91 to 1.69; p = 0.165) baseline hs-TnT levels.Conclusions: In patients with coronary artery disease undergoing elective PCI, an increase in post-procedural hs-TnT level did not offer prognostic information beyond that provided by the baseline level of the biomarker. [ABSTRACT FROM AUTHOR]

Objectives The aim of the study was to investigate the association between gamma-glutamyl transferase (GGT) activity and mortality in patients with diabetes mellitus and coronary artery disease (CAD). Design and methods The study included 1448 patients with diabetes and angiography-proven CAD who underwent percutaneous coronary intervention (PCI). Baseline GGT measurements were available in all patients. The primary outcome was 3-year mortality. Results Patients were divided into 3 groups: a group consisting of patients with a GGT activity in the 1st tertile (GGT ≤ 29.4 U/L; n = 487), a group consisting of patients with a GGT activity in the 2nd tertile (GGT > 29.4–52.5 U/L; n = 479) and a group consisting of patients with GGT in the 3rd tertile (GGT > 52.5 U/L; n = 482). Overall, there were 179 deaths: 46 (11.9%), 49 (12.1%) and 84 deaths (21.4%) among patients of the 1st, 2nd and 3rd GGT tertiles, respectively (adjusted hazard ratio [HR] = 1.25, 95% confidence interval [CI] 1.05–1.49, P = 0.011). Cardiac death occurred in 101 patients: 22 (5.8%), 30 (7.2%) and 49 deaths (12.9%) among patients of the 1st, 2nd and 3rd GGT tertiles, respectively (adjusted HR = 1.23 [0.96–1.58], P = 0.104, with risk estimates calculated per standard deviation increase in the logarithmic scale of GGT). GGT improved the risk prediction of models of all-cause (P = 0.020) but not cardiac (P = 0.135) mortality (P values show the difference in C-statistics between the models without and with GGT). Conclusion In patients with diabetes and CAD treated with PCI, elevated GGT was independently associated with the risk of 3-year all-cause mortality. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Prognostic impact of procedure-related bleeding in patients with stable coronary artery disease ( CAD) undergoing elective percutaneous coronary intervention ( PCI) remains incompletely investigated. The aim of this study was to investigate the association between peri- PCI bleeding and 1-year outcome of patients with stable CAD. Materials and methods The study included 9035 patients with stable CAD who underwent elective PCI. Bleeding within 30 days of PCI was defined using the Bleeding Academic Research Consortium ( BARC) criteria. The primary outcome was 1-year mortality. Results Bleeding occurred in 844 patients (9·3%). Actionable bleeding ( BARC class ≥ 2) occurred in 442 patients (4·9%). There were 210 deaths (2·3%) at 1 year following PCI: 41 deaths among patients with bleeding and 169 deaths among patients without bleeding [Kaplan-Meier estimates of mortality, 4·9% and 2·1%; odds ratio = 2·41, 95% confidence interval ( CI) 1·73-3·36, P < 0·001]. The association between bleeding and mortality remained significant after adjustment for baseline risk variables (adjusted hazard ratio = 1·87, 95% CI 1·27-2·76, P = 0·002). Bleeding increased the discriminatory power of the model regarding prediction of 1-year mortality (absolute and relative integrated discrimination improvement, 0·006% and 16·3%, respectively, P = 0·001). Conclusions In patients with stable CAD undergoing elective PCI, the occurrence of bleeding within 30 days of the procedure was associated with increased risk of death at 1 year after PCI. These findings suggest that procedure-related bleeding may contribute to less than optimal results of PCI in terms of mortality reduction in patients with stable CAD. [ABSTRACT FROM AUTHOR]

Importance: The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial.Objective: To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications. A secondary objective was the comparison of the 2 types of VCD.Design, Setting, and Participants: Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014.Interventions: After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio.Main Outcomes and Measures: Primary end point: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons.Results: Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, -1.0% [1-sided 97.5% CI, 0.7%]; P for noninferiority<.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001).Conclusions and Relevance: In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis.Trial Registration: clinicaltrials.gov Identifier: NCT01389375. [ABSTRACT FROM AUTHOR]

IMPORTANCE The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial. OBJECTIVE To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access--a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access--site complications. A secondary objective was the comparison of the 2 types of VCD. DESIGN, SETTING, AND PARTICIPANTS Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014. INTERVENTIONS After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio. MAIN OUTCOMES AND MEASURES Primary end point: the composite of access site--related vascular complications at 30 days after randomization with a 2%noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons. RESULTS Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, --1.0% [1-sided 97.5%CI, 0.7%]; P for noninferiority <.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001). CONCLUSIONS AND RELEVANCE In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis. [ABSTRACT FROM AUTHOR]

Abstract: Background: There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES). Methods: We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis. Results: Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio=0.95, 95% CI=0.74–1.21, P =0.67). Target lesion revascularization was also comparable between the groups (hazard ratio=0.89, 95% CI=0.65–1.22, P =0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio=0.52, 95% CI=0.28–0.96, P =0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4years (hazard ratio=0.15, 95% CI=0.03–0.70, P =0.02). Conclusions: In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4years. Rates of stent thrombosis were significantly lower with BP-DES. [Copyright &y& Elsevier]

Objectives: For patients with sirolimus-eluting stent (SES) restenosis requiring reintervention, we compared a strategy of repeat SES (Cypher, Cordis, Miami Lakes, Florida) implantation with paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) implantation. Background: Despite their high anti-restenotic efficacy, the widespread utilization of SES therapy has led to a significant absolute number of patients presenting with SES treatment failure. The optimal treatment strategy for such patients remains unclear. Methods: The ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study was a randomized, open-label, active-controlled trial conducted among 450 patients with clinically significant in-SES restenosis at 2 centers in Munich, Germany. After pre-treatment with 600 mg clopidogrel, all patients were randomly assigned to either SES or PES implantation. The primary end point was late lumen loss, based on in-stent analysis, at 6- to 8-month follow-up angiography. Secondary end points were binary angiographic restenosis (diameter stenosis >50%) at 6- to 8-month follow-up, target lesion revascularization, the composite of death or myocardial infarction, and definite stent thrombosis at 12 months. Results: Regarding anti-restenotic efficacy, there were no differences between SES and PES in late loss (0.40 ± 0.65 mm vs. 0.38 ± 0.59 mm; p = 0.85), binary restenosis (19.6% vs. 20.6%; p = 0.69), or target lesion revascularization (16.6% vs. 14.6%; p = 0.52). In terms of safety outcomes, the rates of death/myocardial infarction (6.1% vs. 5.8%; p = 0.86) and stent thrombosis (0.4% vs. 0.4%; p > 0.99) were also similar. Conclusions: In cases of SES restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy and safety. Drug resistance at an individual patient level may play a contributory role to the somewhat higher than expected late loss observed with the SES in the current study. (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for In-Stent Restenosis 2 [ISAR-DESIRE 2]; NCT00598715) [Copyright &y& Elsevier]

Introduction: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is still a question of debate. Hypothesis: We hypothesized that in patients with DES implantation a 6 month duration is not inferior to a 12 month duration of DAPT with aspirin and clopidogrel in terms of clinical outcomes. Methods: ISAR-SAFE is a randomized, double-blind, multicenter trial comparing 6 versus 12 months of clopidogrel therapy duration in patients with DES implantation. Patients were enrolled at 6 months after DES implantation and randomly assigned to either 6 further months of clopidogrel therapy or placebo. Based on sample size calculations the planned total number of patients was 6,000. A blinded overall analysis showed lower than expected event rates. This along with slow recruitment induced the DSMB to recommend stopping the trial after inclusion of 4,000 patients. A total of 4,005 patients have been enrolled. Primary endpoint is the composite of death, myocardial infarction, stent thrombosis, stroke and major bleeding at 9 months after randomization. Results: Results for clinical endpoints will be available in November 2014. Conclusions: ISAR-SAFE is the largest and the only double-blind, randomized clinical trial assessing the value of shortening DAPT duration from 12 to 6 months in patients with DES implantation. Although the trial was stopped prematurely after inclusion of two thirds of patients it has the potential to provide major insights into the optimal DAPT duration after DES implantation. The trial was supported by the BMBF (FKZ 01KG0901) and Abbott Vascular. [ABSTRACT FROM AUTHOR]