Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome.

PURPOSE: This study evaluated whether patient support, administered via an electronic device-based app, increased adherence to treatment and lifestyle changes in patients with acute coronary syndrome (ACS) treated with ticagrelor in routine clinical practice. METHODS: Patients (aged ≥ 18 years) with diagnosed ACS treated with ticagrelor co-administered with low-dose acetylsalicylic acid were randomized into an active group (with support tool app for medication intake reminders and motivational messages) and a control group (without support tool app), and observed for 48 weeks (ClinicalTrials.gov Identifier: NCT02615704). Patients were asked to complete the 36-item Short-Form Health Survey (SF-36) and Lifestyle Changes Questionnaire (LSQ), and were assessed for blood pressure and body mass index (BMI) at baseline (visit 1) and at the end of the study (visit 2). Medication adherence was measured using the Brilique Adherence Questionnaire (BAQ). RESULTS: Patients (N = 676) were randomized to an active (n = 342) or a control (n = 334) group. BAQ data were available for 174 patients in the active group and 174 patients in the control group. Over the 48-week period, mean (standard deviation) adherence for the active and control groups was 96.4% (13.2%) and 91.5% (23.1%), respectively (effect of app intervention, p < 0.05). There were no significant differences in blood pressure and BMI between visits. General improvements in SF-36 and LSQ scores were observed for both groups. CONCLUSION: The patient support tool app was associated with significant improvements in patient-reported treatment adherence compared with a data collection app alone in patients prescribed ticagrelor for ACS.

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

BACKGROUND: A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: The DCB-only All-Comers Registry.

OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels.

OBJECTIVES: We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. METHODS: By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. RESULTS: Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. CONCLUSIONS: Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.

Propensity score matched all comers population treated with ultra-thin strut bare metal and sirolimus-probucol coated drug-eluting stents of identical stent architecture.

OBJECTIVE: The objective of this study was to compare the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture. BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES). METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months. RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388). CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis.

OBJECTIVES: The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either pre-dilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. METHODS: This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post-interventional lumen gain and late lumen loss (LLL) at 6 months. RESULTS: The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468). CONCLUSIONS: Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

9-month results of polymer-free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all-comer population.

OBJECTIVES: To evaluate the 9-month safety and efficacy of polymer-free sirolimus eluting drug eluting stents in septuagenarians and octogenarians. METHODS: An all-comer, worldwide single armed trial (ClinicalTrials.gov Identifier NCT02629575) was conducted to demonstrate the safety and efficacy of an ultra-thin strut, polymer-free sirolimus eluting stent (PF-SES). The primary endpoint was the 9-month target revascularization rate (TLR). Secondary endpoints included the rates of major adverse cardiac events (MACE), stent thrombosis (ST) and bleeding (BARC) in septuagenarians (≥70 years, <80 years), and in octogenarians (≥80 years) to be compared to the younger patient group (<70 years). RESULTS: A total of 1607 patients were treated with PF-SES in the sub-70-year-old age group, 694 in septuagenarians, and 371 in the octogenarian patient group. At 9 months, the MACE rates were 7.2% in octogenarians, 5.3% in septuagenarians, and 3.0% in the younger patient group (P = 0.001). These were mostly driven by all-cause mortality (4.4% vs 1.9% vs 0.6%, P < 0.001) while the TLR rates were only numerically lower in the younger age group (P = 0.080). BARC 1-5 bleeding events were more frequent in the older age group (1.9% vs 2.7% vs 4.6%, P = 0.012) whereas the rates for ST were not different (0.7% vs 0.6% vs 0.6%, P = 0.970). CONCLUSIONS: In octogenarians treated with PF-SES, the rates for MACE, overall mortality, and bleeding are higher as compared to the younger age groups. However, the rates for TLR and ST were not significantly different across the investigated age groups. PF-SES are safe and effective in octogenarians.

First clinical experience with the Multi-LOC multiple stent delivery system for focal stenting in long femoro-popliteal lesions.

Background: The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow limiting dissections, elastic recoil or recoil due to calcification required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this first analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superficial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The first clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.

Angiographic patterns of drug-eluting stent restenosis after treatment with drug-coated balloon versus balloon angioplasty: Late lumen loss subgroup analyses of the PEPCAD-DES study.

OBJECTIVES: This report provides the results of additional late lumen loss (LLL) analyses the predefined subgroup of diabetics and post hoc analyses of selected lesion morphologies to further elucidate the efficacy of paclitaxel coated balloon (PCB) angioplasty (clinical trials identifier NCT00998439). BACKGROUND: The PEPCAD-DES trial revealed that in lesion LLL and the target lesion revascularization rate (TLR) were significantly reduced with PCB angioplasty as compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent restenosis (DES-ISR). METHODS: A total of 110 patients with restenosis of Sirolimus- (SES), Everolimus- (EES), or Paclitaxel-eluting (PES) stents in native coronary arteries were randomized 2:1 to receive treatment with PCB (72 patients) or POBA (38 patients). RESULTS: In the PCB group, LLL did not differ for PES versus non-PES lesions (0.46 ± 0.55 mm vs. 0.41 ± 0.65 mm, P = 0.81). Moreover, there was no difference in LLL when PCB's were used in single and multiple layer DES-ISR (0.35 ± 0.60 mm vs. 0.51 ± 0.63 mm, P = 0.31). In contrast, patients treated with POBA for multilayer DES-ISR were more likely to have significantly higher LLL as compared with single layer DES-ISR (1.29 ± 0.76 mm vs. 0.65 ± 0.60 mm, P = 0.02). There was no LLL difference between diabetics and non-diabetics when treated with PCB angioplasty (0.46 ± 0.76 mm vs. 0.43 ± 0.54 mm, P = 0.83). CONCLUSION: Our hypothesis generating results indicated that there were no differences in terms of LLL when PCB angioplasty was applied in subgroups of single versus multiple layer DES-ISR and PES-ISR versus non-PES ISR. LLL was not higher in diabetic patients as compared with the their non-diabetic counterparts when treated with PCB's. © 2016 Wiley Periodicals, Inc.

Thin strut bare metal stents in patients with atrial fibrillation: Is there still a need for BMS?

OBJECTIVES: This observational study assessed the 9-month clinical outcomes in an « all comers ¼ population with a focus on patients with atrial fibrillation (AF) after thin strut bare metal stenting. BACKGROUND: Drug eluting stent (DES) implantation is the treatment of choice for coronary artery disease (CAD) leaving only marginal indications for the use of bare metal stents (BMS). However, selected treatment populations with DES contraindications such as patients who cannot sustain 6-12 months of dual antiplatelet therapy (DAPT) remain candidates for BMS implantations. METHODS: Thin strut bare metal stenting in a priori defined subgroups were investigated in a non-randomized, international, multicenter «all comers¼ observational study. Primary endpoint was the 9-month TLR rate whereas secondary endpoints included the 9-month MACE and procedural success rates. RESULTS: A total of 783 patients of whom 98 patients had AF underwent BMS implantation. Patient age was 70.4 ± 12.8 years. Cardiovascular risk factors in the overall population were male gender (78.2%, 612/783), diabetes (25.2%, 197/783), hypertension (64.1%, 502/783), cardiogenic shock (4.9%, 38/783) and end stage renal disease (4.9%, 38/783). In-hospital MACE was 4.1% (30/783) in the overall population. The 9-month TLR rate was 4.5% (29/645) in the non-AF group and 3.3% (3/90) in the AF group (P = 0.613). At 9 months, the MACE rate in the AF-group and non-AF group was not significantly different either (10.7%, 69/645 vs. 6.7%, 6/90; P = 0.237). Accumulated stroke rates were 0.3% (2/645) in the non-AF subgroup at baseline and 1.1% (1/90) in the AF subgroup (P = 0.264). CONCLUSION: Bare metal stenting in AF patients delivered acceptably low TLR and MACE rates while having the benefit of a significantly shorter DAPT duration in a DES dominated clinical practice. © 2015 Wiley Periodicals, Inc.

Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents?

OBJECTIVES: This observational study assessed the 9-month clinical outcomes in patients with coronary bifurcation lesions suitable for drug-coated balloon (DCB) angioplasty. It was the intention to use DCB's without additional stenting (DCB-only strategy) in selected patients for this chosen strategy. Bail-out main branch (MB) and/or side branch (SB) stenting, however, were permissible when flow limiting dissections or excessive recoil occurred. BACKGROUND: A multitude of interventional strategies have been studied to treat bifurcation lesions. With the availability of DCB angioplasty, investigators have been using this interventional tool with the optional implantation of bare metal stents (BMS). METHODS: This study is an international, prospective, multicenter registry enrolling patients with coronary bifurcation lesions including a side branch ≥2 mm in diameter. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit bifurcation lesion of any Medina classification type were recruited. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included 9-month major adverse cardiac events (death, myocardial infarction, or TLR), technical success, in-hospital outcomes and vessel thrombosis rates. RESULTS: A total 127 patients 66.1 ± 10.1 years of age were enrolled. Demographic characteristics were 80.3% (102/127) male gender, 31.5% (40/127) diabetes, 91.3% (116/127) hypertension, 7.1% (9/127) ST-elevation myocardial infarction (STEMI), and 9.4% (12/127) non ST-elevation myocardial infarction (NSTEMI). The 130 lesions were treated with 184 DCB's and 64 BMS. In 53.8% (70/130) of all lesions the DCB-only strategy could be used while 34.6% (45/130) of lesions had at least 1 stent (BMS) in the main branch, 8.5% (11/130) had at least 1 stent in the side branch and 3.1% (4/130) needed at least 1 stent in the main and side branch. 94.5% patients (121/127) were available for follow-up after 9.8 ± 2.0 months. The TLR rate was 4.6% in the absence of any thrombotic events in the treated vessels whereas the 9-month MACE rate was 6.2%. CONCLUSION: This observational study suggests that the DCB-only strategy is safe and effective to treat selected bifurcations while benefiting from a shortened dual antiplatelet therapy (DAPT).

First-in-man results of a novel vascular graft coated with resorbable polymer for aortic reconstructions--a multicenter, non-randomized safety study.

OBJECTIVES: The purpose of this "first-in-man" study was to investigate the safety of a novel vascular polyester prosthesis coated with a resorbable polymer and free of any animal-based coating agents such as gelatin or collagen. METHODS: In a nonrandomized first-in-man multicenter safety study, the frequency of perigraft seroma (PGS) as the primary endpoint was studied in consecutive patients undergoing aortic reconstructions. The follow-up control to study the primary endpoint was intended at 3 months under routine clinical conditions. Pre- and postoperative white blood cell counts (WBC), C-reactive protein (CRP), and liver enzyme levels to characterize the systemic inflammation response and possible metabolic consequences were determined at different postoperative time points (secondary endpoints). Additionally, the primary unassisted patency rate, perioperative complications and serious adverse events, as well as intraoperative handling properties of the graft based on a semiquantitative scale were assessed. Magnetic resonance angiography (MRA) follow-up investigations were scheduled postoperatively at 3 months to determine graft tissue integration and the presence of PGS. RESULTS: A total of 24 patients with comorbidities such as coronary artery disease (8.3 %, 2/24), chronic occlusive pulmonary disease (COPD, 8.3 %, 2/24), Fontaine III/IV (20.8 %, 5/24), and diabetes (20.8 %, 5/24) were enrolled from June 2011 to September 2012. Due to two early nongraft-related deaths, there were 22 patients that had a follow-up. In these 22 patients, the freedom from PGS was 90.9 % (20/22) suggesting that the graft/tissue integration was comparable to other vascular grafts described in the relevant literature. WBC counts were not significantly different (pre (8.67 ± 2.98 1/nl) vs. follow-up (7.97 ± 2.24 1/nlI, p = 0.203). Likewise, preoperative CRP serum levels (6.47 ± 11.59 mg/l) were not different from those at follow-up (7.87 ± 12.81 mg/l, p = 0.769). There were two patients with a documented coagulation disorder and two premature deaths (cardiac failure, cerebral bleeding). The primary unassisted patency at follow-up was 77.3 % (17/22) in all patients who reached the follow-up (85.0 % or 17/20 if two cases with documented coagulation disorders are excluded). The reasons for occlusions were technical/surgical difficulties (2/5) and documented coagulation disorders (2/5). In one occlusion, the cause was unknown. There were no graft infections. Intraoperative graft handling properties were evaluated less favorable as compared to the routinely used gelatin- or collagen-coated polyester grafts in each investigator's clinical practice. CONCLUSIONS: Our results suggest that Uni-Graft® Synthetic is a promising prosthetic vascular graft to reduce PGS. Our findings should be interpreted with caution noting the limitation of the lack of a control group.

The effect of gender on clinical outcomes following routine revascularizations with polymer-free sirolimus-eluting stents.

BACKGROUND: Gender-specific outcomes after percutaneous coronary interventions were studied by a number of research groups with different endpoints and cohorts of different ethnic extractions. The purpose of this report is to use propensity score matching to determine gender-specific differences in clinical outcomes after percutaneous coronary interventions with polymer-free sirolimus-coated stents. MATERIALS AND METHODS: The basis for this post hoc analysis was two large all-comers studies with prospectively enrolled patients from Europe and Asia. Data were pooled and analyzed in terms of clinical outcomes to assess the impact of gender in patients with stable coronary artery disease and acute coronary syndrome. The primary endpoint was the accumulated target-lesion revascularization rate whereas secondary endpoints consisted of the event rates for major adverse cardiac events (MACE), myocardial infarction, bleeding events and death from all causes. The purpose of these post hoc analyses was to detect potential differences in clinical outcomes between females and males in unselected and propensity-score-matched cohorts. RESULTS: Overall, in the unmatched cohorts, accumulated target-lesion revascularization rates did not differ between both genders (2.7% vs. 2.0%; P = 0.101), however, accumulated MACE rates were higher in females than in males (5.2% vs. 3.9%; P = 0.020). After propensity-score-matching, primarily adjusting for age, hypertension and diabetes, our data revealed similar accumulated MACE in women and men (5.5% vs. 5.2%; P = 0.749). In the unmatched STEMI subgroup, all-cause mortality was significantly higher in females driven by older age ( P < 0.001). CONCLUSION: In the propensity-score-matched real-world cohorts, female gender was not a predictor for increased rates of accumulated MACE. In the unmatched STEMI subgroup, all-cause mortality was significantly higher in females due to older age. Age seems to be the determining factor for increased clinical event rates and not gender.

Successful Endovascular Microembolization for Post-Traumatic High-Flow Priapism: A Case Report.

BACKGROUND High-flow (non-ischemic) priapism is a rare urological condition usually related to blind trauma to the penis or perineum causing an arterial-lacunar fistula. It can be treated conservatively, but in some cases when conservative treatment fails, the interventional approach is indicated. In the past, only surgical treatment was available, which was associated with a significant risk of complications. Endovascular techniques use a novel approach and offer clinical benefits for the patient. CASE REPORT A 51-year-old man was admitted to the hospital after referral from the urology department with high-flow priapism related to blunt trauma. Angio-computed tomography showed extravasation of contrast medium to the corpus cavernosum, and angiography revealed a fistula between the distal segment of the left internal pudendal artery and corpora cavernosa. A successful endovascular microembolization of the arterial-lacunar fistula with the use of microcoils was performed. The postprocedural period was uneventful and the patient was discharged. Despite incomplete angiographic follow-up at 6 months, the initial symptoms were fully resolved with the absence of any erectile dysfunction and no recurrence of priapism occurred. CONCLUSIONS Post-traumatic high-flow priapism can be safely and effectively treated by endovascular means. Microembolization has proven to be successful and beneficial to preserve sexual functions.

Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study).

AIM: We evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent). METHODS: From April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI. The 12-month primary end-point was a composite of major adverse cardiac events (MACE) defined as all-cause death, nonfatal myocardial infarction, nonfatal stroke, and target lesion revascularization. Patients were classified into conventional or no-stent strategy groups according to the PCI strategy. In the no-stent strategy group, they were further classified into BO-stent or DCB-only groups. Their metal index was calculated by stent length divided by the total lesion length. RESULTS: The no-stent strategy was applied in 85% of the patients, and it was successful for 65% of them. MACE occurred in 7.1% of the study population, including 4.2% of all-cause death. Target lesion revascularization was required in 1.4%, 3.6%, and 1.5% of patients in the conventional DES, BO-stent, and DCB-only groups, respectively. MACE occurred more often in the elderly and in those treated with at least one stent (metal index greater than 0). CONCLUSIONS: The no-stent strategy, i.e., revascularization of coronary lesions by SCBA followed by DCB and with DES bailout stenting, was effective and safe at 1 year. This PCI approach was applicable on a daily practice in our cath lab. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov (NCT03893396, first posted on March 28, 2019). Feasibility, safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease. DES: drug eluting stent; SCBA: scoring balloon angioplasty; BO-stent: at least one stent; DCB: drug coated balloon; BMS: bare metal stent; Bailout (dash lines); MACE: major adverse cardiac event.

The 'all comer' Coroflex Please drug-eluting stent registry in Europe and Asia - an overall and transcontinental assessment of the 10-month major adverse cardiac events.

BACKGROUND: Randomized trials assess the potential of a medical device in well defined indications while "all comer studies" reveal the device performance in the real clinical environment. AIMS: This 'all comers' registry assessed the 10-month outcome of the Coroflex(®) Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events. METHODS: The Coroflex(®) Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses. RESULTS: Of the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate. CONCLUSIONS: TLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization.

Prognostic Role of High Sensitivity Troponin T (hsTnT) After Recanalization of Chronic Total Occlusions (CTO).

BACKGROUND: The prognostic role of periprocedural hsTnT after percutaneous coronary intervention (PCI) of CTOs is unknown. We evaluated the incidence and impact of hsTnT elevations on clinical and angiographic outcomes after CTO-PCI. METHODS: In a retrospective database analysis we identified 309 successfully treated CTO-PCI patients that had a re-angiography 6 months after the initial procedure. Both catheterizations were used for quantitative coronary angiography (QCA). HsTnT was measured before and 18-24 h after CTO-PCI. According to periinterventional hsTnT release patients were divided into 4 quartiles (QI: 0-99 ng/l; QII: 100-199 ng/l; QIII: 200-299 ng/l; QIV: ≥300 ng/l) and correlated with QCA and clinical data. RESULTS: Mean age of the patient population was 67 ± 10.6 years. The antegrade approach was used in 91% of the procedures. After treatment, in-CTO-segment minimal lumen diameter (MLD) was 2.97 ± 0.42 mm. On 6 months follow up In-CTO-segment MLD decreased to 2.74 ± 0.71 mm which corresponded to an In-CTO-segment late lumen loss (LLL) of 0.23 ± 0.45 mm. Target lesion revascularization rate (TLR) occurred in 21 of 309 patients (6.8%). Higher periinterventional hsTnT release (QIII-IV) was associated with more frequent TLR compared to lower hsTnT release (QI-II) (28.6% vs. 4%; p < 0.0001). In a multivariable model hsTnT release emerged as an independent predictor of TLR (OR 7.3; 95%CI 2.12-26.9). CONCLUSIONS: Our findings suggest that hsTnT release is associated with increased TLR. Therefore, peri-interventional hsTnT measurement might be useful in the risk stratification of CTO procedures.