Comparison of the Efficacy and Safety of Sacubitril/Valsartan versus Ramipril in Patients With ST-Segment Elevation Myocardial Infarction.

The role of sacubitril and/or valsartan in patient with heart failure (HF) is established. Whether sacubitril and/or valsartan plays a role in improving outcomes in patients after ST-segment elevation myocardial infarction (STEMI) is unknown. The current study aims to comparing the efficacy and safety of sacubitril and/or valsartan versus ramipril in post-STEMI patients. Patients presenting with STEMI were randomized to receive either sacubitril and/or valsartan or ramipril after primary percutaneous coronary intervention. The main efficacy endpoint was major adverse cardiac events (MACE) at 30 days and 6 months, defined as a composite of cardiac death, myocardial infarction, and HF hospitalizations. Multiple secondary clinical safety and efficacy endpoints were examined. A total of 200 patients were randomized from January 2018 to March 2019, mean age 54.5±10.4, 87% men, 75% presented with anterior wall STEMI. Baseline clinical and echocardiographic characteristics were comparable between groups. The primary endpoint of MACE was similar with sacubitril/valsartan versus ramipril at 30 days (p = 0.18); however, at 6 months, sacubitril/valsartan was associated with significant reduction of MACE (p = 0.005), mainly driven by reduction in HF hospitalizations (18% vs 36%, OR 0.40, 95% 0.22 to 0.75; p = 0.004). At 6 months, LV ejection fraction was higher with sacubitril/valsartan (46.8±12.5% vs 42.09±13.8%; p = 0.012), with improved LV remodelling (LV end diastolic dimension 50.6±3.9 mm vs 53.2±2.7 mm, p = 0.047; and LV end systolic dimension 36.1±3.4 mm versus 39.9±6.3 mm, p = 0.001) compared with ramipril. No difference in other efficacy or safety clinical endpoints was observed. In conclusion, early initiation of sacubitril/valsartan may offer clinical benefit and improvement in myocardial remodelling in post-STEMI patients.

SAcubitril/valsartan versus ramipril in patients with ST-segment Elevation Myocardial Infarction and cardiogenic SHOCK (SAVE-SHOCK): a pilot randomized controlled trial.

OBJECTIVES: To evaluate the safety and efficacy of sacubitril/valsartan versus ramipril in patients with STEMI and cardiogenic shock. METHODS: Patients who received primary percutaneous coronary intervention (PPCI) for STEMI complicated with cardiogenic shock were randomized 1:1 to sacubitril/valsartan versus ramipril after clinical stabilization. The primary outcome was major adverse cardiac events (MACE) at 30 days and 6 months. Secondary in-hospital clinical outcomes included recurrent shock, new or re-initiation of vasoactive medications, and acute kidney injury (AKI). All-cause death, cardiac death, hospitalization due to heart failure (HF), myocardial infarction (MI), and stroke were examined at 30 days and 6 months. Study ID 016-01-2018. RESULTS: 100 patients with STEMI and cardiogenic shock were included (mean age 54.7±10.3 years, 87% men). Initiation of sacubitril/valsartan and ramipril occurred at 38.18±18.44 versus 39.0±21.03 hours after stabilization, respectively. The primary outcome was similar between both groups at 30 days and 6 months. No difference in in-hospital or 30-day clinical outcomes was observed. However, at 6 months, patients in the sacubitril/valsartan arm suffered less hospitalization with HF (18% vs 38%, P=0.044) compared with patients in the ramipril arm. Other clinical outcomes at 6 months were similar between both groups. CONCLUSIONS: Sacubitril/valsartan in patients with STEMI and cardiogenic shock may be associated with improved clinical outcome at 6 months compared with ramipril. Larger randomized controlled trials with longer follow-up are recommended.

Losartan for Preventing Aortic Root Dilatation in Patients with Marfan Syndrome: A Meta-Analysis of Randomized Trials.

INTRODUCTION: The role of losartan in preventing aortic root dilatation in Marfan syndrome has been evaluated in many clinical trials; however, the results are conflicting. METHODS: We performed a computerized search of MEDLINE, EMBASE and COCHRANE databases through February 2019 for randomized clinical trials evaluating the effect of losartan in patients with Marfan syndrome. The main outcome was the change in the aortic root diameter in the losartan versus control groups. RESULTS: Our final analysis included seven randomized trials with a total of 1352 patients and average weighted follow-up of 37.8 months. Change in aortic root diameter was significantly smaller with losartan compared with control [weighted means: 0.44 vs. 0.58 mm, mean difference (MD) = -0.13; 95% CI -0.24 to -0.02; p = 0.02]. Subgroup analysis according to the control group showed no significant subgroup interaction when comparing losartan with beta-blockers versus with standard therapy (pinteraction= 0.27). The composite outcome of aortic surgery, dissection or mortality did not differ between the losartan and control groups (risk ratio = 1.03; 95% CI 0.72-1.49, p = 0.86). CONCLUSION: In this meta-analysis including seven randomized trials, the use of losartan was associated with a significantly smaller change in aortic root diameter in patients with Marfan syndrome.

Renal artery side branches patency protection during endovascular exclusion of giant renal artery aneurysm with covered stent: Well done is better than well said.

RATIONALE: Endovascular treatment of renal artery aneurysms has offered a viable alternative with a high success rate and low procedure-related morbidity and mortality. PATIENT CONCERNS: A 60-year-old man, having a right renal artery aneurysm involving the main vessel with two arteries (supplying the inferior and superior lobes of the kidney) originating from the aneurysm sac as well. INTERVENTIONS: A 6 × 28 mm covered stent was inflated in vitro and a side hole was made with a femoral needle in the polytetrafluoroethylene (PTFE) layer, through which a wire was placed in an outside/inside direction in to be inserted in the inferior pole branch. The other wire was inserted inside the main lumen of the stent (to be inserted in the main artery) and the latter, carefully re-crimped on the balloon. This way, the authors guaranteed continuous access to both arteries during aneurysm exclusion and if needed, a second stent could be advanced at the level of the bifurcation to preserve side branch patency. CONCLUSION: Perforating the PTFE of the stent before its introduction into the vessel and keeping a wire into the side branch could be a good strategy to protect any vessel arising from aneurysmal sac that needs to be excluded..

Outcomes with drug-coated balloons in small-vessel coronary artery disease.

BACKGROUND: Percutaneous coronary intervention (PCI) of small-vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug-coated balloons (DCBs) in SVD has received limited study. OBJECTIVES: To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. METHODS: We performed a meta-analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. RESULTS: Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow-up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug-eluting stents (DES). During a mean follow-up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04-0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08-0.37, P = <0.00001) compared with noncoated balloon angioplasty. CONCLUSION: The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

Meta-analysis of randomized trials on percutaneous patent foramen ovale closure for prevention of migraine.

BACKGROUND: The role of percutaneous patent foramen ovale (PFO) closure for prevention of migraine is controversial. METHODS: We performed a computerised search of MEDLINE, EMBASE and COCHRANE databases through December 2017 for randomised trials evaluating PFO closure versus control in patients with migraine headaches (with or without aura). The main study outcome was the reduction in monthly migraine attacks after PFO closure compared with the control group. RESULTS: The final analysis included three randomised trials with a total of 484 patients. Reduction in monthly migraine attacks was higher in PFO closure compared with the control group (standardised mean difference-SMD = 0.25; 95% CI: 0.06-0.43; p = .01). There was higher reduction of monthly migraine days in PFO closure group compared with control group (SMD = 0.30; 95% CI: 0.08-0.53; p = .01). There was no statistically significant difference in complete resolution of migraine attacks (OR: 3.67; 95% CI: 0.66-20.41; p = .14) and in responders' rate (OR: 1.92; 95% CI: 0.76-4.85; p = .17) between PFO closure and control groups. In patients whose majority of migraine attacks are with aura, there was an observed reduction in migraine attacks in PFO closure compared with control groups (SMD = 0.86; 95% CI: 0.07-1.65; p = .03). CONCLUSION: PFO closure might be beneficial in migraine patients by reducing migraine attacks and migraine days, especially in patients whose majority of migraine attacks are with aura. However, those benefits were not associated with an improvement in responders' rate or complete resolution of migraine; raising concerns on the magnitude of clinical benefit of PFO closure in migraine prevention.

Thrombus aspiration in late presenters with ST-elevation myocardial infarction: A single-center randomized trial.

OBJECTIVES: To examine whether routine thrombus aspiration (TA) is associated with improved myocardial salvage in patients with ST-elevation myocardial infarction (STEMI) presenting ≥12 h after onset of symptoms. BACKGROUND: TA is a recognized treatment option in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) especially in the setting of heavy thrombus burden. However, data on the role of TA in STEMI patients presenting late after onset of symptoms are limited. METHODS: In this single-center prospective randomized study, patients with subacute STEMI presenting ≥12 and ≤48 h after symptom onset were randomized to primary PCI with or without manual TA in a 1:1 ratio. The primary endpoint was the myocardial salvage index assessed with Single Photon Emission Computed Tomography (SPECT) on admission and 4 days later. RESULTS: A total of 60 patients underwent randomization. Baseline characteristics were comparable between groups. TA was associated with improved myocardial salvage index compared with control group (60.1 ± 11.1% vs 28.1 ± 21.3%; P = <0.001). Furthermore, TA was associated with improved post-procedural TIMI flow (2.9 ± 0.3 vs 2.5 ± 0.6; P = 0.003), myocardial blush grade (2.9 ± 0.3 vs 2.2 ± 0.8, P = <0.001), and reduction in left ventricular end-diastolic dimensions (50.4 ± 4.3 mm vs 54.4 ± 5.8 mm, P = 0.004) compared with the control group. Clinical outcomes at 30 days and 6 months were similar between both groups. CONCLUSIONS: TA might be associated with improved reperfusion and myocardial salvage especially in STEMI patients presenting after 12 h from symptom onset who are likely to have a heavy thrombus burden.

Extended follow-up following "full-metal jacket" percutaneous coronary interventions with drug-eluting stents.

OBJECTIVES: To report very long-term follow-up of "Full-Metal Jacket" (FMJ) percutaneous coronary interventions (PCI) in long-diffuse coronary lesions with drug-eluting stents (DES). BACKGROUND: PCI for long-diffuse lesions may result in FMJ, which is not preferred by some operators due to long-term risk of restenosis and stent thrombosis. The data on long-term follow-up of patients with FMJ are limited and would be useful in understanding the safety and feasibility of such a strategy. METHODS: Between April 2002 and March 2007, 274 patients (297 lesions in native coronary arteries) underwent PCI utilizing DES. FMJ was described as lesions requiring ≥ 60 mm of continuous stent. The measured endpoints were cardiac death, target-vessel myocardial infarction (MI), target lesion revascularization (TLR), target-vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as composite of cardiac death, target-vessel MI, and TVR. RESULTS: The mean age of patients was 62.1 ± 11 years. The mean length of total stents used was 75.1 ± 16.4 mm (60-150). During the median follow-up of 74.7 months (interquartile range: 58-96), the rates of cardiac death, MI, TLR, and TVR were: 5.8% (n = 16), 6.2% (n = 17), 27.3% (n = 81), and 30% (n = 89), respectively. The MACE rate was 34%. Definite and probable stent thrombosis occurred in 10 patients (3.6%). CONCLUSION: The long-term follow-up of patients with FMJ is acceptable especially in regards to hard endpoints (death and MI) given the complexity of lesions treated. The high MACE rate was driven mainly by TVR. The availability of newer-generation DES and bioabsorbable scaffolds may improve these results. © 2014 Wiley Periodicals, Inc.

Differences in the clinical and angiographic characteristics of chronic total occlusion lesions in the three major coronary arteries.

OBJECTIVES: The purpose of this study was to evaluate the differences in the clinical and angiographic characteristics of chronic total occlusion (CTO) lesions among the 3 major coronary arteries (LAD, LCx, and RCA). BACKGROUND: The success rate of percutaneous coronary intervention (PCI) of CTO lesions is not uniform among the 3 major coronary arteries and this may be influenced by the differences in angiographic and clinical characteristics that may exists between them. METHODS: We retrospectively evaluated clinical and angiographic characteristics of patients who underwent PCI of CTO lesions at our 2 centers between 2003 and 2010. RESULTS: We analyzed 708 CTO-PCI procedures between 2003 and 2010. The CTO lesions were located in LAD: 222 (31.4%), LCx: 167 (23.6%), and RCA: 319 (45.0%). Patients with CTO in LAD had lower incidence of previous history of PCI and CABG compared to those with CTO lesions in LCx or RCA. In regard to angiographic findings, LAD lesions tended to have more side branches and blunt occlusion stump. The LCx lesions presented more frequently as a part of multivessel disease. RCA lesions were significantly longer, more severely angulated, and calcified. Good collateral circulations were more often encountered in the RCA. In regard to success rates, RCA showed lower procedural success rates (71.8%) followed by LAD (74.8%) and LCx (79.0%). CONCLUSIONS: There were several differences in the clinical and angiographic characteristics of CTO lesions among the 3 major coronary arteries. These differences can explain the discrepancy in procedure success rates.

Impact of residual chronic total occlusion of right coronary artery on the long-term outcome in patients treated for unprotected left main disease: the Milan and New-Tokyo registry.

BACKGROUND: The presence of chronic total occlusion of the right coronary artery (CTO-RCA) in patients undergoing percutaneous interventions for unprotected left main (ULM) disease may affect the prognosis. In this study, we evaluated the immediate results and follow-up of patients with ULM-percutaneous interventions and with or without associated CTO-RCA. METHODS AND RESULTS: Between March 2002 and December 2008, a total of 568 consecutive patients with ULM stenosis treated with drug-eluting stent were included in this analysis. The mean EuroScore and SYNTAX scores were 4.05±2.62 and 28.12±10.82, respectively. Of these, 522 had ULM lesions without residual CTO-RCA (493 ULM without CTO-RCA+29 ULM with treated CTO-RCA), and 46 patients had residual CTO-RCA. At 1466 days (interquartile range, 1150-1917) follow-up, the cardiac-death occurred in 41 patients (7.2%). Cardiac-death was more frequently observed in patients with ULM and residual CTO-RCA as compared with those without residual CTO-RCA (adjusted hazard ratios, 2.163 [95% confidence interval, 1.018-4.597]; P=0.045). However, target lesion revascularization occurred less frequently in patients with residual CTO-RCA (adjusted hazard ratios, 0.321 [95% confidence interval, 0.13-0.794]; P=0.014), resulting in the similar major adverse cardiovascular events rates between the 2 groups. When we analyzed patients with concomitant ULM and CTO-RCA, cardiac-death was significantly higher in patients with residual as compared with treated CTO-RCA (log-rank P=0.01) despite no difference in baseline characteristics. CONCLUSIONS: Cardiac-death occurred more frequently in patients with residual CTO-RCA as compared with those without residual CTO-RCA. These findings suggest that recanalization of CTO-RCA has significant impact on the long-term cardiac-mortality in patients undergoing ULM-percutaneous interventions probably by offering reserve coronary circulation, if in-stent restenosis were to occur in the treated left main.

Assessment of efficacy and safety of combining "paclitaxel" eluting balloon and "limus" eluting stent in the same lesion.

OBJECTIVES: To assess the safety and efficacy of combining drug-eluting balloon (DEB) and drug-eluting stents (DES) in the same coronary lesion. BACKGROUND: Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk-profile for restenosis. We have opted for DES over BMS in such situations and present our follow-up data. METHODS: Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second-generation DES. All patients had at-least one or more risk-factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in-stent restenosis [ISR], and/or long diffuse lesions ≥ 30 mm). RESULTS: Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI-3 flow post PCI with no in-lab complications. At median follow-up of 12.3 months (interquartile range [IQR]: 7.5-18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac-death, MI, and TVR occurred in 11% of patients. CONCLUSION: The results from this novel strategy of combining "Paclitaxel" eluting balloon and "Limus" eluting stent in a same lesion are encouraging. Dual drug-elution acting on two different pathways may provide potential synergy that may explain the favorable outcome.

Pioneer re-entry device for iliac chronic total occlusion: truly a paradigm shift.

The number of percutaneous revascularization procedures performed for symptomatic peripheral arterial disease has significantly increased over the past several years. Traditionally, the use of percutaneous techniques were limited to certain anatomic subsets, such as stenosis or focal occlusions, with surgical treatment preferred for more extensive disease. More recently, endovascular specialists are facing the challenge of peripheral chronic total occlusions. Furthermore, unlike the coronary circulation, these occlusions are often very long and associated with other features of complexity such as severe calcifications. One of the primary issues concerning these lesions is the ability to safely achieve initial angiographic success. This article focus indeed on the Pioneer catheter, a new lumen re-entry device exploiting intravascular ultrasound imaging that was used in a case of totally occluded left common iliac artery with favorable results. The details of this technique, and how this catheter helped in re-entering the true lumen at the aortic bifurcation after subintimal dissection, are thoroughly discussed.

Long-term outcome of percutaneous exclusion of huge saphenous vein graft aneurysms using peripheral covered-stents as alternative to surgical repair.

Giant vein graft aneurysms occur infrequently after coronary artery bypass graft surgery and are most often detected incidentally during coronary angiography for suspected angina or as a mediastinal mass on chest radiographs. Hereby, we describe the percutaneous treatment of a huge right coronary artery saphenous vein bypass graft aneurysm by using peripheral stent-graft. Twelve months after the procedure, the aneurysm was completely sealed at computed tomographic angiography with a good distal run-off in the bypass graft. Different strategies adopted and the feasibility as well as the long-term outcomes of this technique are described thoroughly.

Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.

OBJECTIVES: The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS: All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS: Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS: Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.