Antonio Serra

Retrograde Recanalization of Chronic Total Occlusions in Europe: Procedural, In-Hospital, and Long-Term Outcomes From the Multicenter ERCTO Registry

BACKGROUNDnA retrograde approach improves the success rate of percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs).nnnOBJECTIVESnThe authors describe the European experience with and outcomes of retrograde PCI revascularization for coronary CTOs.nnnMETHODSnFollow-up data were collected from 1,395 patients with 1,582 CTO lesions enrolled between January 2008 and December 2012 for retrograde CTO PCI at 44 European centers. Major adverse cardiac and cerebrovascular events were defined as the composite of cardiac death, myocardial infarction, stroke, and further revascularization.nnnRESULTSnThe mean patient age was 62.0 ± 10.4 years; 88.5% were men. Procedural and clinical success rates were 75.3% and 71.2%, respectively. The mean clinical follow-up duration was 24.7 ± 15.0 months. Compared with patients with failed retrograde PCI, successfully revascularized patients showed lower rates of cardiac death (0.6% vs. 4.3%, respectively; pxa0< 0.001), myocardial infarction (2.3% vs. 5.4%, respectively; pxa0= 0.001), further revascularization (8.6% vs. 23.6%, respectively; pxa0< 0.001), and major adverse cardiac and cerebrovascular events (8.7% vs. 23.9%, respectively; pxa0< 0.001). Female sex (hazard ratio [HR]: 2.06; 95% confidence interval [CI]: 1.33 to 3.18; pxa0= 0.001), prior PCIxa0(HR: 1.73; 95% CI: 1.16 to 2.60; pxa0= 0.011), low left ventricular ejection fraction (HR: 2.43; 95% CI: 1.22 to 4.83; pxa0=xa00.011), J-CTO (Multicenter CTO Registry in Japan) scorexa0≥3 (HR: 2.08; 95% CI: 1.32 to 3.27; pxa0= 0.002), and procedural failure (HR: 2.48; 95% CI: 1.72 to 3.57; pxa0< 0.001) were independent predictors of major adverse cardiac andxa0cerebrovascular events at long-term follow-up.nnnCONCLUSIONSnThe number of retrograde procedures in Europe has increased, with high percents of success, low rates of major complications, and good long-term outcomes.

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

BACKGROUNDnData for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.nnnMETHODSnIn the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087.nnnFINDINGSn1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047).nnnINTERPRETATIONnOur findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction.nnnFUNDINGnSpanish Heart Foundation.

Comparison of Newer-Generation Drug-Eluting With Bare-Metal Stents in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Pooled Analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) Trials

OBJECTIVESnThis study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI).nnnBACKGROUNDnAmong patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES.nnnMETHODSnIndividual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year.nnnRESULTSnNewer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS.nnnCONCLUSIONSnAmong patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

Percutaneous mitral valvuloplasty in surgical high risk patients

Among 126 consecutive patients undergoing percutaneous mitral valvuloplasty, 34 were judged to be at high risk for surgery on the basis of age greater than 70 years (n = 13), New York Heart Association functional class IV (n = 11), ejection fraction less than or equal to 35% (n = 3), severe pulmonary hypertension (n = 7), need for associated coronary bypass (n = 4) or additional valve surgery (n = 20) or severe pulmonary disease (n = 3). Baseline features of the high risk group were substantially worse than those of the other patients: age (65 +/- 11 versus 49 +/- 12 years; p = 0.0001) and echocardiographic score (9.4 +/- 1.8 versus 8.2 +/- 1.5; p = 0.005) were higher, whereas cardiac output (2.9 +/- 0.9 versus 4.1 +/- 1.2 liters/min; p = 0.0001) and mitral valve area (0.9 +/- 0.4 versus 1.1 +/- 0.3 mm2; p = 0.002) were lower. Three high risk patients experienced technical failures and three others had major complications. Among the remaining 28 patients, 18 (65%) had a complete hemodynamic success, 4 (14%) an incomplete success and 6 (21%) hemodynamic failure. Stepwise logistic regression analysis retained echocardiographic score as the only factor independently predictive of success. The percent increase in mitral valve area also correlated with echocardiographic score (r = 0.51, p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Multicenter Study of 19 Aortopulmonary Window Parathyroid Tumors: The Challenge of Embryologic Origin

BackgroundEctopic abnormal parathyroid glands are relatively common in the superior mediastinum but are rarely situated in the aortopulmonary window (APW). The embryological origin of these abnormal parathyroid glands is controversial. The purpose of this investigation was to investigate the embryological origin and the surgical management of abnormal parathyroid glands situated in the APW.MethodsThe databases of patients operated on for primary, secondary, and tertiary hyperparathyroidism at eight European medical centers with a special interest in endocrine surgery were reviewed to identify those with APW adenomas. Demographic features, localization procedures, and perioperative and pathology findings were documented. The embryological origin was determined based on the number and position of identified parathyroid glands.ResultsNineteen (0.24%) APW parathyroid tumors were identified in 7,869 patients who underwent an operation for hyperparathyroidism (HPT) and 181 patients (2.3%) with mediastinal abnormal parathyroid glands. Ten patients had primary, eight had secondary, and one had tertiary HPT. Sixteen patients had undergone previous unsuccessful cervical exploration. In three patients, an APW adenoma was suspected by preoperative localization studies and was cured at the initial operation. Sixteen patients had persistent HPT of whom 15 were reoperated, resulting in 6 failures. Evaluation of 17 patients who had bilateral neck exploration allowed us to determine the most probable origin of the APW parathyroid tumors: 12 were supernumerary, 4 appeared to originate from a superior, and 1 from an inferior gland.ConclusionsAbnormal parathyroid glands situated in the APW are rare and usually identified after an unsuccessful cervical exploration. Preoperative imaging of the mediastinum and neck are essential. The origin of these ectopically situated tumors is probably, as suggested by our data, from a supernumerary fifth parathyroid gland or from abnormal migration of a superior parathyroid gland during the embryologic development.

Causes and Treatment of Recurrent Hyperparathyroidism After Subtotal Parathyroidectomy in the Presence of Multiple Endocrine Neoplasia 1

BackgroundSubtotal parathyroidectomy (SPTX) is the treatment of choice for hyperparathyroidism in a patient with multiple endocrine neoplasia type 1 (HPT-MEN-1). There are scarce data on the causes, timing, and appropriate surgical treatment of patients with recurrent HPT-MEN-1. The aim of this study was to investigate the timing, causes, site of recurrence, and surgical treatment of recurrent HPT-MEN-1 in patients who underwent SPTX.MethodsThe study was a retrospective review of prospectively collected data on patients with HPT-MEN-1 with SPTX at two referral institutions. The data collected included the following: demographics, duration of follow-up, weight of resected parathyroid tissue, type of remnant, time to reoperation, cause/site of recurrence, and surgical treatment. We studied prognostic factors of recurrence.ResultsA total of 69 patients underwent SPTX and were followed for a mean of 75.3xa0months. After the surgery, 15 patients were left with a single “normal” gland and 54 with a 50- to 70-mg remnant of a partially excised abnormal gland. Nine patients (13%) had a recurrence within a mean of 85xa0months (12–144xa0months). Patients with a recurrence had been followed longer (115 vs. 66xa0months; pxa0=xa00.005). Five recurrences occurred in a parathyroid remnant, 3 in a previously “normal” gland; the fifth recurrence was in both a hyperplastic remnant and a fifth gland. Remedial surgery included five subtotal resections and four immediate parathyroid autotransplantations. Two patients had a second recurrence due to a supernumerary gland. Factors related with recurrence are the follow-up time (pxa0<xa00.01) and thymectomy (pxa0<xa00.003).ConclusionsRecurrence of HPTP-MEN-1 usually is located in preserved parathyroid tissue with no preference for a previously normal gland or a remnant. A second recurrence is most likely seen in a supernumerary gland. Recurrence is associated with the follow-up time and thymectomy.

The EXTREME registry: Titanium-nitride-oxide coated stents in small coronary arteries†

Objectives: We sought to explore the immediate results of Titan2® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background: The safety of Titan2® stent has been confirmed in several studies in real‐life unselected populations. Methods: We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results: The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions: Titan2® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up.

Procedural and Long-Term Outcomes of Bioresorbable Scaffolds Versus Drug-Eluting Stents in Chronic Total Occlusions

Background—There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions. Methods and Results—We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight–adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69–3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS. Conclusions—Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

OBJECTIVESnThe aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions.nnnBACKGROUNDnPolyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.nnnMETHODSnPatients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death,xa0myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumenxa0loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trialsxa0of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis.nnnRESULTSnOf 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events.nnnCONCLUSIONSnThe COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was anxa0excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials.

AIMSnThe aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI).nnnMETHODS AND RESULTSnIndividual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35, 95% CI: 0.16-0.74) and any TLR (OR 0.34, 95% CI: 0.21-0.54).nnnCONCLUSIONSnKillip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00962416. The EXAMINATION trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00828087.