Background:Obstructive coronary disease remains a leading cause of sudden cardiac death (SCD). The management of SCD therefore involves coronary angiography. Our aim was to evaluate whether the non-hyperemic angiography-derived microcirculatory resistance index (NH-IMRangio) could be an easy-to-use tool for identifying patients with electrical heart disease (EHD) from patients with other causes of SCD. Methods:A retrospective study was carried out on 30 patients who survived from SCD with no significant coronary lesions on coronary angiography. Etiological investigations enabled the classification of patients with myocardial disease (Group 1, n=20) and those with EHD without myocardial disease (Group 2, n=10). Myocardial disease was investigated by cardiac magnetic resonance imaging (CMR). NH-IMRangio was determined based on standard coronary angiographic views with 3-dimensional-modeling and computational analysis of the coronary flow. Results:Patients were 46.4±15.9 years old and mostly male (73%). Group 1 included patients with dilated cardiomyopathy (n=7), non-dilated left ventricular cardiomyopathy (n=6), hypertrophic cardiomyopathy (n=2), arrhythmogenic right ventricular cardiomyopathy (n=1), myocardial infarction with non-obstructive coronary arteries (MINOCA) disease due to vasospastic angina (n=1), myocarditis (n=2), chemotherapy-induced cardiomyopathy (n=1). Group 1 presented a significantly higher NH-IMR angio compared to group 2 (46.5±13.1 vs. 34.1±10.8, P<0.02). An NH-IMR angio cut-off of 41.5 enabled an optimal classification of patients with or without myocardial disease. Conclusions:A high NH-IMRangio could represent a useful tool for guiding the etiological diagnosis of SCD towards myocardial disease rather than EHD.
Objective Real-life management of patients with hypertension and chronic kidney disease (CKD) among European Society of Hypertension Excellence Centres (ESH-ECs) is unclear : we aimed to investigate it. Methods A survey was conducted in 2023. The questionnaire contained 64 questions asking ESH-ECs representatives to estimate how patients with CKD are managed. Results Overall, 88 ESH-ECS representatives from 27 countries participated. According to the responders, renin-angiotensin system (RAS) blockers, calcium-channel blockers and thiazides were often added when these medications were lacking in CKD patients, but physicians were more prone to initiate RAS blockers (90% [interquartile range: 70-95%]) than MRA (20% [10-30%]), SGLT2i (30% [20-50%]) or (GLP1-RA (10% [5-15%]). Despite treatment optimisation, 30% of responders indicated that hypertension remained uncontrolled (30% (15-40%) vs 18% [10%-25%]) in CKD and CKD patients, respectively). Hyperkalemia was the most frequent barrier to initiate RAS blockers, and dosage reduction was considered in 45% of responders when kalaemia was 5.5-5.9 mmol/L. Conclusions RAS blockers are initiated in most ESH-ECS in CKD patients, but MRA and SGLT2i initiations are less frequent. Hyperkalemia was the main barrier for initiation or adequate dosing of RAS blockade, and RAS blockers' dosage reduction was the usual management.
Objective: Real-life management of hypertensive patients with chronic kidney disease (CKD) is unclear. Methods: A survey was conducted in 2023 by the European Society of Hypertension (ESH) to assess management of CKD patients referred to ESH-Hypertension Excellence Centres (ESH-ECs) at first referral visit. The questionnaire contained 64 questions with which ESH-ECs representatives were asked to estimate preexisting CKD management quality. Results: Overall, 88 ESH-ECs from 27 countries participated (fully completed surveys: 66/88 [75.0%]). ESH-ECs reported that 28% (median, interquartile range: 1550%) had preexisting CKD, with 10% of them (5- 30%) previously referred to a nephrologist, while 30% (15-40%) had resistant hypertension. The reported rate of previous recent (<6 months) estimated glomerular filtration rate (eGFR) and urine albumin- creatinine ratio (UACR) testing were 80% (50- 95%) and 30% (15- 50%), respectively. The reported use of renin-angiotensin system blockers was 80% (70-90%). When a nephrologist was part of the ESH-EC teams the reported rates SGLT2 inhibitors (27.5% [20- 40%] vs. 15% [10-25], P = 0.003), GLP1-RA (10% [10- 20%] vs. 5% [5- 10%], P = 0.003) and mineralocorticoid receptor antagonists (20% [1030%] vs. 15% [10- 20%], P = 0.05) use were greater as compared to ESH-ECs without nephrologist participation. The rate of reported resistant hypertension, recent eGFR and UACR results and management of CKD patients prior to referral varied widely across countries. Conclusions: Our estimation indicates deficits regarding CKD screening, use of nephroprotective drugs and referral to nephrologists before referral to ESH-ECs but results varied widely across countries. This information can be used to build specific programs to improve care in hypertensives with CKD.
PURPOSE:The objective of this study was to analyze the nycthemeral variations in blood pressure (BP) in individuals who presented with non-arteritic anterior ischemic optic neuropathy (NAION). METHODS:BP was recorded for 24 h (ambulatory blood pressure monitoring, ABPM) in 65 patients with acute NAION. Three definitions of nighttime periods were used: definition 1, 1 a.m.-6 a.m.; definition 2, 10 p.m.-7 a.m.; and definition 3, 10 p.m.-8 a.m. For each of these definitions, patients were classified according to the value of nocturnal reduction in BP into dippers (10-20%), mild dippers (0-10%), reverse dippers (< 0%), and extreme dippers (> 20%). RESULTS:The proportions of dippers, mild dippers, reverse dippers, and extreme dippers varied significantly depending on the definition chosen. We found the highest number of patients with extreme dipping (23%) when using the strictest definition of nighttime period (definition 1, 1 a.m.-6 a.m.), as compared with 6.2% and 1.5% for the other definitions, respectively. Overall, 13 of 33 patients without known systemic hypertension (39%) were diagnosed with hypertension after ABPM. No risk factor for NAION was associated with the extreme-dipping profile. Finally, the prevalence of systemic hypertension was high (69%). CONCLUSION:In our population of patients who had an episode of NAION, the proportion of extreme dippers was higher than that usually found in the literature. However, extreme dipping is not a frequent feature of patients with NAION as compared to patients with systemic hypertension. ABPM is recommended for all patients with NAION and unknown history of systemic hypertension.
Objective: Renal artery entrapment (RAE) is a rare cause of hypertension, and its management remains debated between surgical and endovascular approaches. The aim of this study was to propose an updated classification of RAEs. Design and method: This retrospective study included all patients referred to our center between 1995 and 2021 with a diagnosis of RAE confirmed by CT scan. The primary objective was to describe the type of renal artery (RA) compression (ostial or truncular location and focal or long extension). The association between the type of compression and age, side of compression and high origin of the RA was also evaluated. Results: Forty patients with 45 RAE were included. The compression was focal and ostial in 22 arteries (49%), long and truncular in 13 RA (29%) and focal and truncular in 10 RA (22%), of which 2 RA (4%) originated from the thoracic aorta with a transdiaphragmatic passage. From this distribution, an updated classification with 4 types of RAE was proposed including: type 1: ostial compression, type 2: long truncular compression, type 3: focal truncular entrapment and type 4: truncular entrapment with intrathoracic RA origin. There was no association between the type of RAE and the patient's age (p = 0.09) or the side of compression (p = 0.42). Type 2 and type 4 RAEs were associated with a higher origin of the compressed artery (p = 0.04). Conclusions: This study proposed an updated classification of RAE with four type of compressions. Knowledge of these conditions may be helpful for a future treatment algorithm.
Background Highly thrombotic coronary lesions continue to be a serious and clinically significant problem that is not effectively and completely addressed by current technology. Objectives We aimed to investigate whether a micro-net mesh (MNM) technology covering stent could preserve the index of microcirculatory resistance (IMR) after percutaneous coronary intervention (PCI) in patients with high thrombus burden. Methods and Results Fifty-two patients with non-ST elevation myocardial infarction or ST Elevation Myocardial Infarction and high thrombus burden (TIMI thrombus grade >= 3) were randomized into two groups, PCI with a MNM covering stent (MNM group, n = 25) and PCI with any commercially available stent (DES group, n = 27). As the primary endpoint, IMR was measured immediately after PCI using a pressure-temperature sensor-tipped coronary wire. The secondary endpoint was left ventricular ejection fraction (LVEF) at 6 months of follow-up. The IMR in the MNM group was significantly lower in comparison to the DES group (33.2 [21.3, 48.9] vs. 57.2 [39.9, 98.0], p = 0.005). No significant differences were observed in baseline LVEF (54.5 +/- 10.2% vs. 53.1 +/- 6.87%, p = .57), while LVEF was significantly improved at follow-up in the MNM group (61.1 +/- 7.1% vs. 53.9 +/- 6.35%, p = .0001). Conclusion MNM technology significantly improved coronary microvascular dysfunction after PCI in patient with acute coronary syndrome and appears as a useful technological option for thrombus management.
ABPM is a great tool for GP's to characterise accurately BP profil, and improve follow up and monitoring of patients.
Coronary microvascular dysfunction (CMVD) is common and associated with poorer outcomes in patients with ST Segment Elevation Myocardial Infarction (STEMI). The index of microcirculatory resistance (IMR) and the index of hyperemic microvascular resistance (HMR) are both invasive indexes of microvascular resistance proposed for the diagnosis of severe CMVD after primary percutaneous coronary intervention (pPCI). However, these indexes are not routinely assessed in STEMI patients. Our main objective was to clarify the association between IMR or HMR and long-term major adverse cardiovascular events (MACE), through a systematic review and meta-analysis of observational studies. We searched Medline, PubMed, and Google Scholar for studies published in English until December 2020. The primary outcome was a composite of cardiovascular death, non-cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and rehospitalization for heart failure occurring after at least 6 months following CMVD assessment. We identified 6 studies, reporting outcomes in 1094 patients (mean age 59.7 ± 11.4 years; 18.2% of patients were women) followed-up from 6 months to 7 years. Severe CMVD, defined as IMR > 40 mmHg or HMR > 3mmHg/cm/sec was associated with MACE with a pooled HR of 3.42 [2.45; 4.79]. Severe CMVD is associated with an increased risk of long-term adverse cardiovascular events in patients with STEMI. Our results suggest that IMR and HMR are useful for the early identification of severe CMVD in patients with STEMI after PCI, and represent powerful prognostic assessments as well as new therapeutic targets for clinical intervention.
We aimed to investigate whether micro-net on stent could preserve the index of msicrocirculatory resistance (IMR) after primary percutaneous coronary intervention (PCI) in patients with acutemyocardial infarction (AMI). Fifty deux patients with AMI were randomized into two groups: primary PCI with micro-net on stent (MGUARD group, n = 25) and primary PCI with any commercially available (DES group, n = 27). As the primary endpoint, IMR was measured immediately after primary PCI using a pressure-temperature sensor-tipped coronary wire. The secondary endpoint was the left ventricular ejection fraction (LVEF) at six-month follow-up. The IMR in MGUARD group was significantly lower than in DES group (39.6 ± 26.2 U vs. 75.4 ± 60.5 U, P = 0.01). No significant differences in baseline EF (56.2 ± 10.3% vs. 54.9 ± 7.73%, P = 0.7), however, there were significant differences in follow-up EF (63.2 ± 3.8% vs. 54.7 ± 7.79%, P = 0.001). A micro-net on stent significantly improved CMVD compared with a traditional DES in primary PCI and appear as a useful technological option to manage the thrombus.
Le cathétérisme des veines surrénaliennes (CVS) est le gold standard pour déterminer si un hyperaldostéronisme primaire (HAP) peut bénéficier d’une surrénalectomie unilatérale. La TDM est jugée inférieure, car non spécifique des adénomes secrétant de l’aldostérone. Cependant l’étude SPARTACUS a retrouvé un bénéfice identique aux surrénalectomies décidées sur la TDM ou le CVS. Ceci suggère que dans certains cas le CVS, habituellement normalisé par le cortisol, est inférieur à la TDM. Évaluer l’intérêt d’une normalisation du CVS par l’adrénaline. Un CVS avec mesure simultanée de l’aldostérone, cortisol et adrénaline a été réalisé chez 78 patients porteurs d’un HAP, dont 34 avec gradient latéral > ou = 4 ont bénéficié d’une surrénalectomie unilatérale. L’expression de CYP11B2, CYP11B1, CYP17 a été évaluée par immunohistochimie sur 9 adénomes. Les gradients normalisés par cortisol ou adrénaline étaient : – concordants dans 27/34 patients (groupe A) : 18 adénomes (moyenne 11 mm), 5 hyperplasies micro- et 2 macro-nodulaires, – latéralisés uniquement par l’adrénaline : 5/34 patients (groupe B), 3 adénomes (moyenne 21 mm) 2 hyperplasies micronodulaires, – latéralisés uniquement par le cortisol : 2/34 patients (groupe C), 2 microadénomes 8 et 6 mm. Le bénéfice tensionnel était similaire dans les 3 groupes. 5/9 adénomes, dont le seul du groupe B étudié, exprimaient CYP 11B2 et CYP11B1 et CYP17, en faveur d’une sécrétion adénomateuse d’aldostérone mais également de cortisol. Certains adénomes responsables d’HAP, bien visibles en TDM, sécrètent de l’aldostérone mais également du cortisol. Ils échappent au CVS normalisé par le cortisol, mais pas au CVS normalisé par l’adrénaline.
Clinic-ambulatory blood pressure (BP) difference is influenced by patients- and device-related factors and inadequate clinic-BP measurement. We investigated whether nonadherence to antihypertensive medications may also influence this difference in a post hoc analysis of the DENERHTN trial (Renal Denervation for Hypertension). We pooled the data of 77 out of 106 evaluable patients with apparent resistant hypertension who received a standardized antihypertensive treatment and had both ambulatory BP and drug-screening results available at baseline after 1 month of standardized triple therapy and at 6 months on a median of 5 antihypertensive drugs. After drug assay samplings on study visits, patients took their antihypertensive treatment under supervision immediately after the start of the ambulatory BP recording, and supine clinic BP was measured 24 hours post-dosing; both allowed to calculate the clinic minus daytime ambulatory systolic BP (SBP) difference (clinic-SBP-day-SBP). A total of 29 (37.7%) were found nonadherent to medications at baseline and 38 (49.4%) at 6 months. At baseline, the mean clinic-SBP-day-SBP difference in the nonadherent group was 12.7 mmHg (95% CI, 7.8-17.7 mmHg, P<0.001). In contrast, clinic SBP was almost identical to day-SBP in the adherent group (clinic-SBP-day-SBP difference, 0.1 mmHg; 95% CI, -3.3 to 3.5 mmHg; P=0.947). Similar observations were made at 6 months. Using receiver operating characteristics curves, we found that a 6 mmHg cutoff of clinic-SBP-day-SBP difference had 67% sensitivity and 69% specificity to predict nonadherence to the triple therapy at baseline. In conclusion, a large clinic-SBP-day-SBP difference may help discriminating between adherence and nonadherence to treatment in patients with resistant hypertension. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01570777.
Objective: Different types of pheochromocytoma-related cardiomyopathies have been described in literature, but predictive factors of their occurrence and evolution are not yet defined. Here are described two successive clinical cases concerning this issue. Design and method: Case-report 1: A 26 year-old woman was admitted for abdominal pain lasting for ten days. Blood pressure (BP) was 150/100 mmHg. The EKG presented negative T waves on the precordial leads, and the trans-thoracic echocardiography (TTE) revealed a severe left heart dysfunction (Left Ventricular Ejection Fraction (LVEF) 20%). There was no significant coronary artery stenosis but left ventricular apical ballooning resembling Takotsubo cardiomyopathy on the cardiac angiography. Plasma concentration of catecholamines was increased to over 26 times their normal values. A 60x58x58 mm right adrenal mass was detected on computer tomography (CT). A laparoscopic adrenalectomy was performed. The diagnosis was confirmed by histology. Thereafter, BP normalized and TTE control assessed complete recovery. Case-report 2: A 35 years old man presented clinical heart failure, his BP measured at 150/100 mmHg. Medical history revealed high blood pressure, which had been detected for a year, without specific therapy thus far. He also described the classic triad of head-aches, palpitations, and diaphoresis. Hypertrophic cardiomyopathy, evocated by negative T waves on anterior leads on the EKG, was confirmed on TTE with an altered ejection fraction of 30%. Coronary catheterization was normal. Explorations found elevated plasma catecholamines level and a right adrenal tumor of 65X55X50 mm on CT. Pathologic examination of the resection specimen affirmed the diagnosis of pheochromocytoma. The clinical follow-up showed BP normalization, but persistence of an altered LVEF. Results: The severe acute clinical presentation of the first patient led to early diagnosis and treatment, with complete recovery. For the second one, the long term evolution of the disease before treatment may explain the poor improvement of the myocardiopathy. Conclusions: These two case-reports suggest that the form and evolution of pheochromocytoma-related cardiomyopathies depend on duration of catecholamine exposure, possibly in close relation with the length of diagnosis delay. This hypothesis could be tested by a larger follow-up of multiple cases of pheochromocytoma-related cardiomyopathies.
Objective: To analyze discordances between lateralization predicted by CT scan or by adrenal venous sampling (AVS) in patients with primary aldosteronism (PA) and a unilateral adrenal mass. Design and method: Monocentric retrospective analysis of data of 33 selective AVS in patients with primary aldosteronism (PA) and a unilateral adrenal mass. In our center AVS is performed simultaneously on both adrenal veins (AV) without stimulation and analyzed not only with cortisol but also epinephrine as a reference for selectivity and lateralization. lateralization index (LI) > 4 is considered significant. Immunohistochemical analysis of CYP11B1, CYP11B2 and CYP17 was performed in the adrenal adenoma of one patient. Results: One patient with severe hypertension and hypokalemia showed PA, no hypercortisolism and a 2 cm right adrenal mass. AVS was selective in both AV and cortisol-normalized AVS showed right/left LI = 0.8, ruling out lateralization, despite the fact that absolute values of aldosterone, but also cortisol, were higher in the right AV. By contrast epinephrine-normalized AVS showed right/left LI = 6.25 as absolute values of epinephrine were similar in both AV. The patient was treated medically but showed poor tolerance of anti-aldosterone treatment and eventually underwent right adrenalectomy, resulting in normalization of blood pressure and remission of PA. Immunochemical analysis of his right adrenal adenoma showed expression of CYP11B2 but also CYP11B1 and CYP17. Analysis of the 32 other patients identified 5 discordances between cortisol-normalized AVS lateralization and epinephrine-normalized AVS, with 2/5 patients showing concordance in epinephrine-normalized AVS and CT scan. These 2 patients were not operated as cortisol-normalized AVS was still considered the standard. Conclusions: Cortisol-normalized AVS can fail to detect lateralization of aldosterone secretion by Conn's adenoma expressing not only CYP11B2 but also CYP11B1 and CYP17, which must allow secretion of not only aldosterone but also cortisol, without being necessary responsible for hypercortisolism. In these adenoma cortisol measurements during AVS is not a reliable reference to normalize aldosterone, as it is produced by both the normal adrenal gland and the adenoma.
Background The DENERHTN (Renal Denervation for Hypertension) trial confirmed the efficacy of renal denervation (RDN) in lowering daytime ambulatory systolic blood pressure when added to standardized stepped‐care antihypertensive treatment (SSAHT) for resistant hypertension at 6 months. Methods and Results This post hoc exploratory analysis assessed the impact of abdominal aortic calcifications (AAC) on the hemodynamic and renal response to RDN at 6 months. In total, 106 patients with resistant hypertension were randomly assigned to RDN plus SSAHT or to the same SSAHT alone (control group). Total AAC volume was measured, with semiautomatic software and blind to randomization, from the aortic hiatus to the iliac bifurcation using the prerandomization noncontrast abdominal computed tomography scans of 90 patients. Measurements were expressed as tertiles. The baseline‐adjusted difference in the change in daytime ambulatory systolic blood pressure from baseline to 6 months between the RDN and control groups was −10.1 mm Hg ( P =0.0462) in the lowest tertile and −2.5 mm Hg ( P =0.4987) in the 2 highest tertiles of AAC volume. Estimated glomerular filtration rate remained stable at 6 months for the patients in the lowest tertile of AAC volume who underwent RDN (+2.5 mL/min per 1.73 m 2 ) but decreased in the control group (−8.0 mL/min per 1.73 m 2 , P =0.0148). In the 2 highest tertiles of AAC volume, estimated glomerular filtration rate decreased similarly in the RDN and control groups ( P =0.2640). Conclusions RDN plus SSAHT resulted in a larger decrease in daytime ambulatory systolic blood pressure than SSAHT alone in patients with a lower AAC burden than in those with a higher AAC burden. This larger decrease in daytime ambulatory systolic blood pressure was not associated with a decrease in estimated glomerular filtration rate. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01570777.
Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure (BP) lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report here the effect of denervation on 24-hour BP and its variability and look for parameters that predicted the BP response. Patients with resistant hypertension were randomly assigned to denervation plus stepped-care treatment or treatment alone (control). Average and standard deviation of 24-hour, daytime, and nighttime BP and the smoothness index were calculated on recordings performed at randomization and 6 months. Responders were defined as a 6-month 24-hour systolic BP reduction ≥20 mm Hg. Analyses were performed on the per-protocol population. The significantly greater BP reduction in the denervation group was associated with a higher smoothness index (P=0.02). Variability of 24-hour, daytime, and nighttime BP did not change significantly from baseline to 6 months in both groups. The number of responders was greater in the denervation (20/44, 44.5%) than in the control group (11/53, 20.8%; P=0.01). In the discriminant analysis, baseline average nighttime systolic BP and standard deviation were significant predictors of the systolic BP response in the denervation group only, allowing adequate responder classification of 70% of the patients. Our results show that denervation lowers ambulatory BP homogeneously over 24 hours in patients with resistant hypertension and suggest that nighttime systolic BP and variability are predictors of the BP response to denervation.CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01570777.
Fibromuscular dysplasia (FMD) commonly affects the renal and cervical arteries but has been described to affect other vascular beds as well. The prevalence of and clinical characteristics associated with multisite FMD (string-of-beds or focal stenoses affecting at least 2 vascular beds) are not known. In the prospective ARCADIA registry (Assessment of Renal and Cervical Artery Dysplasia), symptomatic patients with renal artery (RA) FMD underwent tomographic- or magnetic resonance-angiography from the aortic arch to the intracranial arteries and those with cervical FMD from the diaphragm to the pelvis. Of 469 patients (84.0% women), 225 (48.0%) had multisite FMD. In addition, 86 of 244 patients with single-site disease had dissections or aneurisms affecting other vascular beds, totaling 311 patients (66.3%) with lesions in >1 vascular bed. Among patients with a cerebrovascular presentation, the prevalence of RA lesions was higher in patients with than in those without hypertension (odds ratio, 3.4; 95% confidence interval, 1.99–6.15). Among patients with a renal presentation, the prevalence of cervical lesions was higher in patients with bilateral than in those with unilateral RA lesions (odds ratio, 1.9; 95% confidence interval, 0.99–3.57). In conclusion, FMD is a systemic arterial disease. At least 2 vascular beds were affected by dysplastic stenoses in 48.0% of cases and by dysplastic stenoses, aneurysms, and dissections in 66.1% of cases. RA imaging should be proposed to hypertensive patients with a cerebrovascular presentation. Cervical artery imaging should be considered in patients with a renal presentation and bilateral RA lesions. Clinical Trial Registration— URL: www.Clinicaltrials.gov . Unique identifier: NCT02884141.
Objective: Asprin resistance is more frequent in diabetes and is associated with a poor health outcome. Intermitent hypoxemia in patient with obstructive sleep apnea (OSA) is associated with platelet activation. OSA is frequent in patient with diabetes mellitus. The aim of this study was to investigate the role of the OSA in aspirin resistance in diabetes. Design and method: Patients with diabetes mellitus, taking aspirin for primary prevention or stable atherothrombotic disease, underwent overnight, in-lab polysomnography. The following morning we used the VerifyNow aspirin system to evaluate the efficacy of aspirin. Patients with at least an apnea-hypopnea index of 30 events/hours were diagnosed with severe OSA. Results: The preliminary result of the fifty first consecutive patients included in the study is presented:Conclusions: In these preliminary results, the OSA seems not be influence the aspirin response in patients with diabetes.
OBJECTIVES The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is non-inferior to 24-month DAPT in aspirin-sensitive patients.BACKGROUND The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component.RESULTS Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6-versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding.CONCLUSIONS Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT. (C) 2017 by the American College of Cardiology Foundation.