Angel Sánchez Recalde

Thrombosis of Second-Generation Drug-Eluting Stents in Real Practice: Results From the Multicenter Spanish Registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2)

OBJECTIVES This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. BACKGROUND First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). METHODS A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. RESULTS From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). CONCLUSIONS In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis.

Comparison of Paclitaxel-Eluting Stents (Taxus) and Everolimus-Eluting Stents (Xience) in Left Main Coronary Artery Disease With 3 Years Follow-Up (from the ESTROFA-LM Registry)

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

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.

Utility of optical coherence tomography and intravascular ultrasound for the evaluation of coronary lesions

Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) are imaging methods used in the diagnosis of coronary lesions. IVUS is widely used in interventional cardiology laboratories, but OCT is now increasingly used. Conventional coronary angiography can identify different types of coronary lesions but sometimes is unable to diagnose them correctly. Both intravascular imaging methods are useful for better interpretation of these lesions, and can accurately diagnose ruptured plaques, thrombosis, stent restenosis and hazy images. However, the resolution of OCT is ten times higher than IVUS, and so an accurate diagnosis cannot always be achieved with ultrasound imaging. We present three cases in which IVUS was unable to identify the lesion causing the condition and OCT was required to obtain clearer images that helped to confirm the diagnosis. The advantages and disadvantages of each method are then discussed.

Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

INTRODUCTION AND OBJECTIVES The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.

Comparison of Paclitaxel and Everolimus-eluting Stents in ST-segment Elevation Myocardial Infarction and Influence of Thrombectomy on Outcomes. ESTROFA-IM Study

INTRODUCTION AND OBJECTIVES We sought to compare the long-term clinical outcome of with ST-segment elevation myocardial infarction treated with paclitaxel-eluting stents or everolimus-eluting stents and the influence of thrombectomy on outcomes. METHODS The ESTROFA-IM is a multicenter retrospective registry collecting consecutive patients with infarction treated with these stents in 16 centers. Propensity-score matching was performed to select comparable stent groups and comparable groups with and without thrombectomy. RESULTS After matching patients, 350 treated with everolimus-eluting stents and 350 with paclitaxel-eluting stents were included in the analysis. The clinical and angiographic characteristics were comparable in both groups. The 2-year incidence of death, infarction, and target lesion revascularization was 14.9% for paclitaxel-eluting stents and 11.5% for everolimus-eluting stents (P = .04) and the incidence of definite/probable thrombosis 4.3% and 1.4%, respectively (P = .01). The use of paclitaxel-eluting was an independent predictor for events (hazard ratio = 2.44, 95% confidence interval, 1.28-4.65; P = .006). The benefit of everolimus-eluting stents over paclitaxel-eluting stents regarding stent thrombosis was more evident in the nonthrombectomy subgroup (5.4% vs 1.4%; P = .01). A significant interaction was found in the subgroups with and without thombectomy in the comparison between paclitaxel-eluting stents and everolimus-eluting stents for the end-point of stent thrombosis (P = .039). CONCLUSIONS The results of this multicenter registry suggest better clinical outcomes with the everolimus-eluting stents in ST-segment elevation myocardial infarction. The lower risk of thrombosis with these stents could be more relevant in the absence of thrombectomy.

TCT-466 Clinical impact of the use of thrombus aspiration devices in primary angioplasty. Insights from the multicentric study ESTROFA-MI

Background: The occurrence, correlation and clinical outcome of intra-procedural stent thrombosis (IPST) in patients undergoing primary percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes (ACS) have not been previously described. Methods: This retrospective study comprised a review of 1901 consecutive ACS patients who received primary PCI in our center during the period of January 2006 to January 2011. IPST was defined as new, reappearing or increased (compared to baseline) thrombus within the deployed stent before the index PCI procedure was completed. All angiograms were independently reviewed frame-by-frame for the incidence of IPST. Patient demographics, coronary risk factors, follow-up visits, and all relevant information were retrieved from the hospital database. Patients with and without IPST were compared with respect to clinical characteristics, angiographic parameters and cardiac events at 1-year follow-up. Results: Overall, there were 23 cases of IPST detected in the study cohort, thus, the prevalence of IPST was 1.2% in this group. There were no significant differences in terms of baseline clinical characteristics between the two groups. Patients with compared to those without IPST had significantly more bifurcation lesions involved, and more thrombus burden at baseline. IPST group compared to no IPST group had 100% more major adverse events on 1-year follow-up (30.4% vs. 14.4%, P 0.02). Conclusions: IPST was a rare complication of PCI in the setting of ACS. It correlated with a few procedural factors and was more likely to cause cardiac events during 1-year follow-up.