Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.

Outcomes of predefined optimisation criteria for intravascular ultrasound guidance of left main stenting.

AIMS: This study sought to investigate the prognostic effect of a protocol with optimisation targets for intravascular ultrasound (IVUS)-guided left main (LM) revascularisation. METHODS AND RESULTS: A protocol was prospectively applied for IVUS-guided LM revascularisation (IVUS-PRO group) including predefined optimisation targets. Using propensity score matching, we selected as control groups patients with angiography-guided PCI (ANGIO group) and IVUS-guided PCI (IVUS group) from a large multicentre registry. The primary endpoint was a composite of cardiac death, LM-related infarction and LM revascularisation at 12 months. In each group, 124 patients with comparable characteristics were included. The incidence of the primary outcome was significantly higher in the ANGIO group compared to the IVUS-PRO group (12.9% vs 4.8%, HR 0.35, 95% CI: 0.15 to 0.82, p=0.02), but not with respect to the IVUS group (12.9% vs 8%, HR 0.51, 95% CI: 0.20 to 1.22, p=0.1), driven by a lower rate of LM revascularisation (8% in the ANGIO group, 6.4% in the IVUS group and 3.2% in the IVUS-PRO group). IVUS-PRO resulted in being an independent risk predictor (HR 0.45, 95% CI: 0.15 to 0.98; p=0.041). CONCLUSIONS: IVUS guidance of LM stenting provides prognostic benefit with respect to the use of angiography alone, particularly when following a protocol with these predefined optimisation criteria.

IVUS Findings in Late and Very Late Stent Thrombosis. A Comparison Between Bare-metal and Drug-eluting Stents.

INTRODUCTION AND OBJECTIVES: Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year). METHODS: Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis. RESULTS: The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60). CONCLUSIONS: Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS.

Systematic isolated post-dilatation of the side branch as part of the provisional stent technique in the percutaneous treatment of coronary bifurcations. CR12 Registry.

AIMS: To analyse systematic isolated post-dilatation of the side branch as a part of provisional stent technique. METHODS: 1960 angioplasties performed in two centres were prospectively registered, of which 382 were coronary bifurcations with a side branch>2mm. In centre A, isolated post-dilatation of the side branch was performed regardless its impairment after main vessel stenting. In centre B, side branch post-dilatation was performed only if it was severely affected after stent implantation. RESULTS: There was no difference between the two centres in the rate of side branch affection after stent implantation (A: 44.6 vs B: 49.3%, p=0.48) nor in the procedural success rate (A: 98.6% vs B: 96.7%, p=0.45). After one-year follow-up, a reduction of cardiovascular events was observed in centre A (A: 4.4% vs B: 10.4%, p=0.043) with a trend towards lower cardiac mortality (A: 2.2% vs B: 6.5%, p=0.093) and stent thrombosis (A: 0% vs B: 2.6%, p=0.077). There were no differences in the rate of myocardial infarction related to the treated artery (A: 1.4% vs B: 3.9%, p=0.29), or target lesion revascularization (A: 1.4% vs. B: 3.2%, p=0.45). CONCLUSIONS: Systematic isolated post-dilatation of the side branch in the provisional stent technique was associated with a high angiographic success rate, and a low rate of cardiovascular events during follow-up. Although the study design does not allow definitive conclusions, this strategy could be considered a valid option in some cases or even as part of the provisional stent technique.

Transcatheter closure of a complex atrial septal defect after occluder device embolization.

Percutaneous closure is nowadays considered the treatment of choice of ostium secundum atrial septal defects (ASD). However, transcatheter closure can be highly challenging when we face an ASD with complex morphological features. The combination of different imaging modalities can be very helpful. This case shows the great value of using both intracardiac and real time 3D transesophageal echocardiography for the percutaneous closure of a complex iatrogenic ASD after device embolization.

Primary Angioplasty in Patients Older Than 75 Years. Profile of Patients and Procedures, Outcomes, and Predictors of Prognosis in the ESTROFA IM+75 Registry.

INTRODUCTION AND OBJECTIVES: The proportion of elderly patients undergoing primary angioplasty is growing. The present study describes the clinical profile, procedural characteristics, outcomes, and predictors of outcome. METHODS: A 31-center registry of consecutive patients older than 75 years treated with primary angioplasty. Clinical and procedural data were collected, and the patients underwent clinical follow-up. RESULTS: The study included 3576 patients (39.3% women, 48.5% with renal failure, 11.5% in Killip III or IV, and 29.8% with>6hours of chest pain). Multivessel disease was present in 55.4% and nonculprit lesions were additionally treated in 24.8%. Radial access was used in 56.4%, bivalirudin in 11.8%, thromboaspiration in 55.9%, and drug-eluting stents in 26.6%. The 1-month and 2-year incidences of cardiovascular death were 10.1% and 14.7%, respectively. The 2-year rates of definite or probable thrombosis, repeat revascularization, and BARC bleeding>2 were 3.1%, 2.3%, and 4.2%, respectively. Predictive factors were diabetes mellitus, renal failure, atrial fibrillation, delay to reperfusion>6hours, ejection fraction<45%, Killip class III-IV, radial access, bivalirudin, drug-eluting stents, final TIMI flow of III, and incomplete revascularization at discharge. CONCLUSIONS: Notable registry findings include frequently delayed presentation and a high prevalence of adverse factors such as renal failure and multivessel disease. Positive procedure-related predictors include shorter delay, use of radial access, bivalirudin, drug-eluting stents, and complete revascularization before discharge.

Sequential Atrioventricular Pacing in Patients With Hypertrophic Cardiomyopathy: An 18-year Experience.

INTRODUCTION AND OBJECTIVES: Controversy persists regarding the role of sequential atrioventricular pacing in patients with obstructive hypertrophic cardiomyopathy and disabling symptoms. The aim of this study was to evaluate the effect of pacing on symptoms, dynamic gradient, and left ventricular function in patients with hypertrophic cardiomyopathy. METHODS: From 1991 to 2009, dual-chamber pacemakers were implanted in 82 patients with obstructive hypertrophic cardiomyopathy and disabling symptoms despite optimal medical therapy. Sequential pacing was performed with a short atrioventricular delay. Clinical and echocardiographic parameters were measured before and immediately after implantation and after a long follow-up (median, 8.5 years [range, 1-18 years]). RESULTS: The New York Heart Association functional class was immediately reduced after pacemaker implantation in 95% of patients (P < .0001), and this improvement was maintained until the final follow-up in 89% (P = .016). The gradient was significantly reduced after implantation (94.5 ± 36.5 vs 46.4 ± 26.7mmHg; P < .0001) and at final follow-up (94.5 ± 36.5 vs 35.9 ± 24.0mmHg; P < .0001). Mitral regurgitation permanently improved in 52% of the patients (P < .0001). There were no differences in ventricular thickness or diameters, ejection fraction, or diastolic function. CONCLUSIONS: Sequential pacing in selected patients with obstructive hypertrophic cardiomyopathy improves functional class and reduces dynamic gradient and mitral regurgitation immediately after pacemaker implantation and at final follow-up. Prolonged ventricular pacing has no negative effects on systolic or diastolic function in these patients.

Does reducing ischemia time justify to catheterize firstly the culprit artery in every primary PCI?

No consensus exists about which coronary artery should be firstly catheterized in primary PCIs. Initial catheterization of the "culprit artery" could reduce reperfusion time. However, complete knowledge of coronary anatomy could modify revascularization strategy. The objective of the study was to analyze this issue in ST-elevation myocardial infarction patients undergoing primary PCI. PCIs were performed in 384 consecutive patients. Choice of ipsilateral approach (IA): starting with a guiding catheter for the angiography and PCI of the "culprit artery", or contralateral approach (CA): starting with a diagnostic catheter for the "non-culprit artery" and completing the angiography and PCI of the culprit with a guiding catheter was left to the operator. Differences between two approaches regarding reperfusion time, acute events or revascularization strategies were analyzed. There were no differences between two approaches regarding reperfusion time or clinical events. When the left coronary artery was responsible, IA was more frequent (76.4 vs 22.6 %), but when it was the right coronary artery, CA was preferred (20 vs 80 %); p < 0.0001. With CA, bare metal stents (BMS) were more used than drug eluting (DES) (60.8 vs 39.2 %) inversely than with IA (BMS 41.3 vs DES 59.7 %; p < 0.0001). With CA there were more patients with left main or multivessel disease in which revascularization was completed with non-urgent surgery (4.13 vs 2.4 %, p < 0.0001). Initial CA does not involve higher reperfusion time. Furthermore, overall knowledge of coronary anatomy offers more options in revascularization strategy and may imply a change in management. Despite the need to individualize each case, contralateral approach may be the first option with the exception of unstable patients.

IVUS-guided treatment strategies for definite late and very late stent thrombosis.

AIMS: Our aim was to describe the intravascular ultrasound (IVUS) findings of patients with late stent thrombosis (ST) undergoing percutaneous intervention, and to compare the pre- and post-intervention IVUS findings of patients treated with balloon angioplasty (BA) vs. additional stent implantation (ASI). METHODS AND RESULTS: A total of 117 patients with late ST imaged with IVUS were included (51.2% had drug-eluting stent ST). Treatment was left to the operator's discretion: BA was performed in 53.8% and ASI in 46.2%. Pre-intervention, incomplete stent apposition (ISA) was observed in 69.8% vs. 63.0% (p=0.43), underexpansion in 33.3% vs. 18.5% (p=0.07) and restenosis in 15.9% vs. 27.8% (p=0.12), respectively. Post-intervention, persistent ISA was observed in 37.2% vs. 60.9% (p=0.03) and malapposition volume decreased by 43.6% vs. 2.6% (p=0.03). Persistent underexpansion was observed in 9.3% vs. 17.4% (p=0.26); however, the stent expansion index was largely increased with BA (from 0.75 to 0.88) compared to ASI (from 0.80 to 0.82); p=0.046. At two years, recurrent ST was observed in one (1.7%) vs. four (7.7%) patients, respectively; p=0.09. CONCLUSIONS: Non-optimal IVUS criteria of stent implantation are often observed in patients with late ST. Treatment of late ST with BA leads to a larger reduction of malapposition and underexpansion with respect to ASI and is associated with favourable outcomes.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 24th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2014).

INTRODUCTION AND OBJECTIVES: The Working Group on Cardiac Catheterization and Interventional Cardiology presents its annual report on the data from the registry of the activity in Spain in 2014. METHODS: Data were voluntarily provided by participating centers. The information was introduced online and was analyzed by the Steering Committee of the Working Group on Cardiac Catheterization and Interventional Cardiology. RESULTS: Data were reported by 106 hospitals. A total of 140 461 diagnostic procedures (125 484 coronary angiograms) were performed, representing a rate of 3014 diagnostic studies per million population. This year, the number of percutaneous coronary interventions increased to 67 611, giving a rate of 1447 interventions per million population. A total of 94 458 stents were implanted, including 64 057 drug-eluting stents and 2424 biodegradable intracoronary devices. Of the total number of percutaneous coronary interventions, 17 825 were in acute myocardial infarction, representing 26.4% of all coronary interventions. A radial approach was used in 74% of diagnostic procedures and in 70.4% of interventional procedures. The use of renal denervation decreased, whereas over 125 mitral leak closures were performed. Transcatheter aortic valve implantation procedures exceeded 1300 implantations per year, a 27% increase from 2013. CONCLUSIONS: The registry for 2014 shows a slight increase in coronary disease activity despite no increase in the management of ST-segment elevation myocardial infarction. Drug-eluting intracoronary devices now comprise over 70% of all intracoronary devices. A continual increase is only seen in certain structural interventional techniques, such as transcatheter aortic valve implantation and perivalvular leak closure.

Coronary artery perforation: don't rush, IVUS may be useful.

Coronary artery perforation (CAP) is a rare but potentially fatal complication of percutaneous coronary intervention. Polytetrafluoroethylene-covered stents prevent blood leakage between struts with a high rate of success. However, they lack elasticity and rapid and correct deployment is difficult. They have also a higher rate of stent restenosis and thrombosis. For these reasons, optimal deployment is essential. Although severe CAP needs an emergent solution, after stabilizing the patient, intracoronary imaging techniques may be useful to ensure correct expansion and reduce further adverse events. We present a case that shows the potential role of intravascular ultrasound in the resolution of a CAP.

Role of hydration in contrast-induced nephropathy in patients who underwent primary percutaneous coronary intervention.

To investigate the role of hydration to prevent contrast-induced nephropathy (CIN) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI), we prospectively included 408 consecutive patients who were randomly assigned to receive either hydration with isotonic saline (1 ml/kg/h since the beginning of the procedure and for 24 hours after it: NS+ group) or not (NS- group). All patients received an iso-osmolar nonionic contrast medium. The primary end point was the development of CIN: ≥25% or ≥0.5 mg/dl increase in serum creatinine within 3 days after the procedure. CIN was observed in 14% of patients: 21% in the NS- group and 11% in the NS+ group (p=0.016). CIN was significantly associated with death (15.2% vs 2.8%; p<0.0001) and need for dialysis (13.4% vs 0%; p<0.0001). In multivariate analysis, the only predictors of CIN were hydration (OR=0.29 [0.14 to 0.66]; p=0.003) and the hemoglobin before the procedure (OR=0.69 [0.59 to 0.88]; p<0.0001). In conclusion, intravenous saline hydration during PPCI reduced the risk of CIN to 48%. Patients with CIN had increased mortality and need for dialysis. Given the higher incidence of CIN in emergent procedures, and its morbidity and mortality, preventive hydration should be mandatory in them unless contraindicated.

2014 update on interventional cardiology.

This article reviews the most relevant publications and studies in the field of interventional cardiology in 2014. In the area of coronary interventional procedures, integrated treatment of acute coronary syndrome continues to be the subject of numerous studies that evaluate different devices and pharmacological and mechanical strategies that can be used without increasing the risk of hemorrhage or the need for reintervention. Certain anatomical substrates continue to generate a considerable number of publications, both on the outcomes with different stents and on the use of specific techniques. Bioabsorbable drug-eluting stents are used in increasingly complex lesions with promising results. The development of interventional procedures for structural heart disease continues to advance, with new evidence on percutaneously placed aortic valve prostheses, the outcome of percutaneous mitral valve repair, and the safety and efficacy of left atrial appendage occlusion. Finally, renal denervation has generated one of the major debates of the year.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 23rd official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2013).

INTRODUCTION AND OBJECTIVES: The Working Group on Cardiac Catheterization and Interventional Cardiology presents its yearly report on the data from the registry of the activity in Spain corresponding to 2013. METHODS: The centers introduce their data online voluntarily and the information is analyzed by the Steering Committee of the Working Group on Cardiac Catheterization. RESULTS: In 2013, 104 hospitals sent their data (72 public centers and 32 private). In all, 136 715 diagnostic studies were performed (120 358 coronary angiograms), with a slight decrease with respect to 2012, a reduction that was also observed in the rate, which was 2944 diagnostic studies per million population. A total of 65 912 interventional procedures were carried out during a phase of stability, for a rate of 1419 interventions per million population. Other techniques included the implantation of 99 417 stents and 1384 biodegradable intracoronary devices (64% of them drug-eluting devices). There were 18 337 procedures in acute myocardial infarction, for an increase of 7% with respect to 2012 and representing 27.8% of all the percutaneous coronary interventions. Radial access was the approach used in 71% of the diagnostic procedures and in 65% of the interventional procedures. The performance of renal denervation has nearly doubled with respect to 2012. For the first time, more than 1000 transcatheter aortic valve implantation procedures were carried out in 1 year, although the frequency increased only slightly (23%). CONCLUSIONS: There continued to be a slight increase in the activity in cardiac catheterization in association with ST-segment elevation myocardial infarction, whereas, with the exception of recently introduced, highly specific procedures, the use of the remainder of the procedures, among them transcatheter aortic valve implantation, leveled off.