Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

OBJECTIVES: To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population. BACKGROUND: Long lesions are considered difficult technically and in terms of achieving successful clinical outcomes. With first generation DES, MACE can be as high as 10% at a short-medium term follow-up. There are a few data available in this subset regarding the use of second generation DES METHODS: A prospective, multicenter registry of consecutive patients (aged 64.8 ± 11.2 years, 77% men and 33% diabetics) in 29 tertiary hospitals with de novo > 24 mm lesions in vessels of 2.25-4 mm was performed. The primary and secondary endpoints were major adverse cardiac events (MACE; cardiac death, myocardial infarction, and target lesion revascularization) and stent thrombosis (ST) at 1, 12, and 24 months. Patients were on dual antiplatelet therapy during 12 months. RESULTS: A total of 610 patients with 705 long lesions were included (1.2 per patient). Lesion length was 34.59 ± 11.17 mm and vessel size 2.93 ± 0.41 mm. Stented length was 39.83 ± 14.08 mm (1.4 stents per lesion). Predilatation/postdiltatation was performed in 75 and 33% of the cases, intravascular ultrasound in 15%. The device success rate was 99.1%. MACE and ST rates at 1, 12, and 24-months follow-up were 0.3, 2.1, and 5.4% and 0.2, 0.7, and 1.5%, respectively. CONCLUSION: In this real-world population, the Xience Prime EES performs extremely well in long lesions, with a very low rate of both MACE and ST.

Procedural resources utilization and clinical outcomes with bioresorbable everolimus-eluting scaffolds and Pt-Cr everolimus-eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial.

OBJECTIVES: We sought to compare the procedural implications of using bioresorbable everolimus-eluting scaffolds (BVS) and Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy). BACKGROUND: There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes. METHODS: A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose-area product, contras agent volumen, and peri-procedural troponin release. RESULTS: A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose-area product (20%), and contrast volume (10%). Post-procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri-procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy. CONCLUSIONS: The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.

[Influence of clinical and anatomical factors on the outcome of percutaneous coronary interventions]. / Importancia de los factores clínicos y anatómicos en el intervencionismo coronario.

The outcome of percutaneous coronary interventions depends on several factors. Some relate to the patient's clinical characteristics, in particular, to the presence of diabetes, renal failure, or unstable syndromes, the number of diseased vessels, and the level of left ventricular function. Others are linked to the anatomical characteristics of the lesion. Firstly, whether it is located in the left main coronary artery or in a coronary ostium, whether there is a saphenous vein graft, and whether the lesion is bifurcated or involves small-diameter arteries. Secondly, whether lesion morphology is characterized by heavy calcification or severe occlusion. Therapy using coronary stents has become the standard approach. Angiographically, results are good but some problems occur over the long term, such as restenosis. The recent introduction of stents coated in drugs that inhibit intimal proliferation, which have been shown to reduce the restenosis rate dramatically, is certain to increase and alter the range of applications of percutaneous coronary interventions.

Effectiveness and safety beyond 10 years of percutaneous transluminal septal ablation in hypertrophic obstructive cardiomyopathy.

INTRODUCTION AND OBJECTIVES: Percutaneous transluminal septal ablation is an alternative treatment in patients with hypertrophic obstructive cardiomyopathy. However, due to the relatively new introduction of this technique, there is no information on its very long term results (>10 years). METHODS: The present study included consecutive patients treated in 5 centers between 1998 and 2003. We analyzed clinical, hemodynamic, and echocardiographic data at baseline and follow-up. RESULTS: A total of 45 patients were included; there were 31 (69%) women, the mean age was 62.4 (14) years, and 39 patients (86.6%) showed functional class III or IV. Septal thickness was 21.8 (3.5) mm, the peak resting gradient on echocardiography was 77 (39) mmHg, and mitral regurgitation was at least moderate in 22 patients (48.8%). During hospitalization, permanent pacemaker implantation was required in 3 patients and ventricular perforation (by pacing lead) occurred in 1 patient, requiring surgery. After a follow-up of 12.3 years (11.0-13.5 years), 2 patients (4.4%) died from cardiac causes (heart failure and posttransplantation), 3 patients required an implantable cardioverter-defibrillator (1 for primary prevention and 2 due to sustained ventricular tachycardia after cardiac surgery), and 2 underwent cardiac surgery (due to endocarditis and mitral regurgitation). In the last clinical review, functional class was I-II in 39 patients (86.6%) (P<.0001), the peak resting gradient was 16 (23) mmHg (P<.0001), and mitral regurgitation was absent or mild in 34 patients (75.5%) (P<.03). CONCLUSIONS: The results of this study suggest that septal ablation is safe and effective in the very long term. The procedure was not associated with a significant incidence of sudden death or symptomatic ventricular arrhythmias.

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries.

OBJECTIVES: This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES). BACKGROUND: Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy. METHODS: We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance. RESULTS: A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02). CONCLUSIONS: The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES.

Clinical outcomes after intravascular ultrasound and fractional flow reserve assessment of intermediate coronary lesions. Propensity score matching of large cohorts from two institutions with a differential approach.

AIMS: Assessment of intermediate coronary lesions can be done with fractional flow reserve (FFR) and intravascular ultrasound (IVUS). There are no randomised trials and only a small registry from one centre is available but this is subject to important bias. We sought to evaluate the clinical outcomes of an FFR strategy compared with an IVUS strategy for intermediate lesion assessment. METHODS AND RESULTS: We compared the outcome of patients assessed with FFR and IVUS in two centres with a differential approach. After propensity score matching 400 pairs of patients were included. Revascularisation was done when FFR was <0.75 or minimum lumen area was <4 mm2 in vessels >3 mm, and <3.5 mm2 in vessels 2.5-3 mm, along with plaque burden >50%. After FFR and IVUS, 72% and 51.2% of lesions, respectively, were left untreated (p<0.001). At one and two years no significant differences in MACE-free survival were observed in overall groups (97.7% at one year and 93.1% at two years in the FFR group and 97.7% at one year and 95.6% at two years in the IVUS group; p=0.35) and among those with deferred intervention (97.9% at one year and 94.2% at two years in the FFR group and 96.5% at one year and 93.6% at two years in the IVUS group; p=0.7). CONCLUSIONS: IVUS and FFR may be safely used to defer revascularisation of intermediate lesions. IVUS induces a higher degree of revascularisation but much lower than previously reported and does not affect the clinical outcome.