Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic.

Outcomes of Left Main Revascularization in Patients with Anemia: Gulf Left Main Registry.

INTRODUCTION: The aim of this study was to evaluate the effects of baseline anemia and anemia following revascularization on outcomes in patients with unprotected left main coronary artery (ULMCA) disease. METHODS: This was a retrospective, multicenter, observational study conducted between January 2015 and December 2019. The data on patients with ULMCA who underwent revascularization through percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) were stratified by the hemoglobin level at baseline into anemic and non-anemic groups to compare in-hospital events. The pre-discharge hemoglobin following revascularization was categorized into very low (<80 g/L for men and women), low (≥80 and ≤119 g/L for women and ≤129 g/L for men), and normal (≥130 g/L for men and ≥120 g/L for women) to assess impact on follow-up outcomes. RESULTS: A total of 2,138 patients were included, 796 (37.2%) of whom had anemia at baseline. A total of 319 developed anemia after revascularization and moved from being non-anemic at baseline to anemic at discharge. There was no difference in hospital major adverse cardiac and cerebrovascular event (MACCE) and mortality between CABG and PCI in anemic patients. At a median follow-up time of 20 months (interquartile range [IQR]: 27), patients with pre-discharge anemia who underwent PCI had a higher incidence of congestive heart failure (CHF) (p < 0.0001), and those who underwent CABG had significantly higher follow-up mortality (HR: 9.85 (95% CI: 2.53-38.43), p = 0.001). CONCLUSION: In this Gulf LM study, baseline anemia had no impact upon in-hospital MACCE and total mortality following revascularization (PCI or CABG). However, pre-discharge anemia is associated with worse outcomes after ULMCA disease revascularization, with significantly higher all-cause mortality in patients who had CABG, and a higher incidence of CHF in PCI patients, at a median follow-up time of 20 months (IQR: 27).

Left Main Coronary Artery Revascularization in Patients with Impaired Renal Function: Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting.

INTRODUCTION: The evidence about the optimal revascularization strategy in patients with left main coronary artery (LMCA) disease and impaired renal function is limited. Thus, we aimed to compare the outcomes of LMCA disease revascularization (percutaneous coronary intervention [PCI] vs. coronary artery bypass grafting [CABG]) in patients with and without impaired renal function. METHODS: This retrospective cohort study included 2,138 patients recruited from 14 centers between 2015 and 2,019. We compared patients with impaired renal function who had PCI (n= 316) to those who had CABG (n = 121) and compared patients with normal renal function who had PCI (n = 906) to those who had CABG (n = 795). The study outcomes were in-hospital and follow-up major adverse cardiovascular and cerebrovascular events (MACCE). RESULTS: Multivariable logistic regression analysis showed that the risk of in-hospital MACCE was significantly higher in CABG compared to PCI in patients with impaired renal function (odds ratio [OR]: 8.13 [95% CI: 4.19-15.76], p < 0.001) and normal renal function (OR: 2.59 [95% CI: 1.79-3.73]; p < 0.001). There were no differences in follow-up MACCE between CABG and PCI in patients with impaired renal function (HR: 1.14 [95% CI: 0.71-1.81], p = 0.585) and normal renal function (HR: 1.12 [0.90-1.39], p = 0.312). CONCLUSIONS: PCI could have an advantage over CABG in revascularization of LMCA disease in patients with impaired renal function regarding in-hospital MACCE. The follow-up MACCE was comparable between PCI and CABG in patients with impaired and normal renal function.

Effectiveness of digital health using the transtheoretical model to prevent or delay type 2 diabetes in impaired glucose tolerance patients: protocol for a randomized control trial.

BACKGROUND: There is high prevalence of prediabetes and type 2 diabetes mellitus (T2DM) in Saudi Arabia that is still increasing. Early diagnosis of prediabetes, and immediate, effective intervention is yet unestablished. Conventional health promotion approaches are used to educate prediabetic patients. Behavior modification is very effective in prediabetics to delay T2DM. Thus, the main objective of this study is to examine the effect of the new behavioral model, the Transtheoretical Model short messages (text 4 change) to modify lifestyle to prevent or delay the onset of T2DM, through promotion of a healthy diet and increased physical activity, in impaired glucose tolerance patients. Another objective is to estimate the impact of this model on markers of cardiovascular and metabolic risks as T2DM is one of the modifiable risk factors to prevent cardiovascular diseases. METHODS: This is a randomized controlled trial. One thousand and sixteen, eligible Saudi adults will be recruited from the Heart Health Promotion study (HHP), which was conducted at the King Saud University from July 2013 to April 2014. These adults were at a higher risk of developing T2DM within 2-3 years. The research team's database has a contact list and they will recruit individuals over 6-8 weeks. All participants will be randomized at a 1:1 ratio into two groups, receive group education about lifestyle modifications and written information about diet and physical activity. Text 4 change SMS texts will be sent only to the intervention group. All participants will be assessed at baseline, 6, 12, 18, 24, 30, and 36 months for behavioral change using a World Health Organization (WHO) STEPS questionnaire and for glycated hemoglobin, biochemical and anthropometric measurements using standard methods. DISCUSSION: This new approach for promoting the importance of behavior modification in prediabetics is expected to delay and/or prevent the development of T2DM in Saudi Arabia, subsequently reducing the risk of cardiovascular morbidity and mortality too. Results from this study will promote an innovative and high-tech way to decrease the burden of cardiovascular diseases in Saudi Arabia. TRIAL REGISTRATION: International Standard Randomized Control Trial, registration number ISRCTN10857643. Registered 4 June, 2018.

Changes in dietary habits, physical activity and status of metabolic syndrome among expatriates in Saudi Arabia.

The aim of this paper is to assess the impact of living in Saudi Arabia on expatriate employees and their families' behavioural cardiovascular risk factors (BCVRFs), and to examine the association between changes in BCVRFs and metabolic syndrome (MetS). A cross-sectional study was conducted on 1437 individuals, aged ≥ 18 years, from King Saud University in Riyadh, Saudi Arabia. We used the World Health Organization STEPS questionnaire to ask every participant questions about BCVRFs twice: (1) to reflect their period of living in Saudi Arabia and (2) to shed light upon life in their country of origin. Their mean age was 40.9 (11.7) years. The prevalence of BCVRFs was as follows: tobacco use in 156 (11%), physical inactivity in 1049 (73%) low intake of fruit and vegetables in 1264 (88%) and MetS in 378 (26%). Residing in Saudi Arabia had reduced physical activity and intake of fruit and vegetables. There was also a significant increase in the fast food consumption. In conclusion, living in Saudi Arabia had a significant negative effect on BCVRFs. However, there was no statistically significant association between changes in fruit and vegetable intake and physical activity and MetS status, except that intake of fast food was lower among participants with MetS.

Toward Developing a Preventive MERS-CoV Vaccine-Report from a Workshop Organized by the Saudi Arabia Ministry of Health and the International Vaccine Institute, Riyadh, Saudi Arabia, November 14-15, 2015.

Middle East respiratory syndrome (MERS) remains a serious international public health threat. With the goal of accelerating the development of countermeasures against MERS coronavirus (MERS-CoV), funding agencies, nongovernmental organizations, and researchers across the world assembled in Riyadh, Saudi Arabia, on November 14-15, 2015, to discuss vaccine development challenges. The meeting was spearheaded by the Saudi Ministry of Health and co-organized by the International Vaccine Institute, South Korea. Accelerating the development of a preventive vaccine requires a better understanding of MERS epidemiology, transmission, and pathogenesis in humans and animals. A combination of rodent and nonhuman primate models should be considered in evaluating and developing preventive and therapeutic vaccine candidates. Dromedary camels should be considered for the development of veterinary vaccines. Several vaccine technology platforms targeting the MERS-CoV spike protein were discussed. Mechanisms to maximize investment, provide robust data, and affect public health are urgently needed.

Different impact of long-detection interval and anti-tachycardia pacing in reducing unnecessary shocks: data from the ADVANCE III trial.

AIMS: A long-detection interval (LDI) (30/40 intervals) has been proved to be superior to a standard-detection interval (SDI) (18/24 intervals) in terms of reducing unnecessary implantable cardioverter defibrillator (ICD) therapies. To better evaluate the different impact of LDI and anti-tachycardia pacing (ATP) on reducing painful shocks, we assessed all treated episodes in the ADVANCE III trial. METHODS AND RESULTS: A total of 452 fast (200 ms < cycle length ≤ 320 ms) arrhythmic episodes were recorded: 284 in 138 patients in the SDI arm and 168 in 82 patients in the LDI arm (106/452 inappropriate detections). A total of 346 fast ventricular tachycardias (FVT) were detected in 169 patients: 208 in 105 patients with SDI and 138 in 64 patients with LDI. Setting LDI determined a significant reduction in appropriate but unnecessary therapies [208 in SDI vs. 138 in LDI; incidence rate ratio (IRR): 0.61 (95% CI 0.45-0.83), P = 0.002]. Anti-tachycardia pacing determined another 52% reduction in unnecessary shocks [208 in SDI with hypothetical shock-only programming vs. 66 in LDI with ATP; IRR: 0.37 (95% CI 0.25-0.53, P < 0.001)]. The efficacy of ATP in terminating FVT was 63% in SDI and 52% in LDI (P = 0.022). No difference in the safety profile (acceleration/degeneration and death/cardiovascular hospitalizations) was observed between the two groups. CONCLUSION: The combination of LDI and ATP during charging is extremely effective and significantly reduces appropriate but unnecessary therapies. The use of LDI alone yielded a 39% reduction in appropriate but unnecessary therapies; ATP on top of LDI determined another 52% reduction in unnecessary shocks. The strategy of associating ATP and LDI could be considered in the majority of ICD recipients.

Quality of assessment and counselling offered by community pharmacists and medication sale without prescription to patients presenting with acute cardiac symptoms: a simulated client study.

PURPOSE: Self-medication is common worldwide. However, the prevalence of sale of prescription medications without prescription and the quality of assessment and counselling provided by community pharmacists to cardiac patients is unknown. We sought to determine the prevalence of prescription medication sales and explore how pharmacists assess and counsel patients with acute cardiac conditions. METHODS: Six hundred community pharmacies in the two largest cities in Saudi Arabia were selected. Two simulated clients presented either an acute coronary syndrome (ACS) scenario or an acute heart failure (AHF) scenario to the pharmacists. Descriptive statistics and regression models were used to analyse and present the collected data. RESULTS: Of 600 pharmacies, 379 (63.2%) sold various prescription medications to simulated patients without prescription. Assessment and counselling provided by pharmacists were inadequate. Almost a quarter of pharmacists did not ask simulated patients any questions; 52% asked one or two questions; and only 24% asked three or more questions. Only 28 pharmacists (4.7%) inquired about drug allergies; 48.5% instructed simulated patients on the dosage and frequency of the sold medications; 21.6% provided instruction on treatment duration; and 19.4% gave instructions on dose, frequency, and duration of treatment. Compared to AHF, ACS simulated patients were more likely to be asked about other symptoms and comorbidities (59.7% vs. 48.7%, p = 0.007 and 46.3% vs. 37.3%, p = 0.005, respectively) and were more likely to be advised to go to hospital (70.3% vs. 56.3%, p < 0.001). CONCLUSIONS: The sale of prescription medications by community pharmacists to simulated cardiac patients without prescription is very common; assessment and counselling qualities are suboptimal.

Acute heart failure with and without acute coronary syndrome: clinical correlates and prognostic impact (From the HEARTS registry).

BACKGROUND: Little is know about the outcomes of acute heart failure (AHF) with acute coronary syndrome (ACS-AHF), compared to those without ACS (NACS-AHF). METHODS: We conducted a prospective registry of AHF patients involving 18 hospitals in Saudi Arabia between October 2009 and December 2010. In this sub-study, we compared the clinical correlates, management and hospital course, as well as short, and long-term outcomes between AHF patients with and without ACS. RESULTS: Of the 2609 AHF patients enrolled, 27.8 % presented with ACS. Compared to NACS-AHF patients, ACS-AHF patients were more likely to be old males (Mean age = 62.7 vs. 60.8 years, p = 0.003, and 73.8 % vs. 62.7 %, p < 0.001, respectively), and to present with De-novo heart failure (56.6 % vs. 28.1 %, p < 0.001). Additionally they were more likely to have history of ischemic heart disease, diabetes, dyslipidemia, and less likely to have chronic kidney disease (p < 0.001 for all comparisons). The prevalence of severe LV systolic dysfunction (EF < 30 %) was higher in ACS-AHF patients. During hospital stay, ACS-AHF patients were more likely to develop shock (p < 0.001), recurrent heart failure (p = 0.02) and needed more mechanical ventilation (p < 0.001). ß blockers and Angiotensin Converting Enzyme inhibitors were used more often in ACS-AHF patients (p = 0.001 and, p = 0.004 respectively). ACS- AHF patients underwent more coronary angiography and had higher prevalence of multi-vessel coronary artery disease (p < 0.001 for all comparisons). The unadjusted hospital and one-month mortality were higher in ACS-AHF patients (OR = 1.6 (1.2-2.2), p = 0.003 and 1.4 (1.0-1.9), p = 0.026 respectively). A significant interaction existed between the level of left ventricular ejection fraction and ACS-AHF status. After adjustment, ACS-AHF status was only significantly associated with hospital mortality (OR = 1.6 (1.1-2.4), p = 0.019). The three-years survival following hospital discharge was not different between the two groups. CONCLUSION: AHF patients presenting with ACS had worse hospital prognosis, and an equivalent long-term survival compared to AHF patients without ACS. These findings underscore the importance of timely recognition and management of AHF patients with concomitant ACS given their distinct presentation and underlying pathophysiology compared to other AHF patients.

Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial.

BACKGROUND: Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator (ICD) therapy in primary prevention patients. Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) was the only trial that enrolled both primary and secondary prevention patients. METHODS AND RESULTS: Of the 1902 patients enrolled in the ADVANCE III trial, 477 received a defibrillator for secondary prevention; 248 patients were randomly assigned to a long detection setting (30 of 40 intervals) and 229 to the nominal setting (18 of 24 intervals) for ventricular arrhythmias with cycle length ≤ 320 ms. Eight-five percent of patients were men, with a mean age of 65 ± 12 years, a previous history of ventricular fibrillation in 37% of the cases, and a mean ejection fraction of 38 ± 13%. The ICD device mix was 37% single chamber, 47% dual chamber, and 16% triple chamber. Over a median period of 12 months, the long detection period was associated with a 25% reduction in the number of overall therapies (115.6 versus 86.8 per 100 patient-years; incidence rate ratio, 0.75; 95% confidence interval, 0.61-0.93; P=0.008) and a 34% reduction in the number of shocks (rate per 100 patient-years, 51.2 versus 38.1; incidence rate ratio, 0.66; 95% confidence interval, 0.48-0.89; P=0.007). Appropriate therapies (89.7 versus 67.7; incidence rate ratio, 0.77; 95% confidence interval, 0.60-0.97; P=0.029) and appropriate shocks (37.1 versus 28.1; incidence rate ratio, 0.64; 95% confidence interval, 0.45-0.93; P=0.018) were also reduced. CONCLUSIONS: ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients. These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging. CLINICAL TRIAL REGISTRATION URL: http://www/clinicaltrials.gov. Unique identifier: NCT00617175.

The Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes.

INTRODUCTION: Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA. METHODS: This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates. The data collection occurred at enrollment (baseline) and after 6- and 12-months (follow-up). Baseline data included demographics, AF characteristics, medical history, and anti-thrombotic treatment patterns. Clinical events, healthcare resource utilization, and direct costs were collected at follow-up. RESULTS: The study enrolled a total of 1418 patients (52.7% males and 47.3% females). The mean age of the patients was 64.5 years and 90.6% were white. The mean (standard deviation) CHA2DS2-VASc and HAS-BLED risk scores were 2.7 (1.6) and 1.6 (1.2), respectively. Non-vitamin K antagonist oral anticoagulants, antiplatelet therapy, and vitamin K antagonists were prescribed to 65.8%, 16.4%, and 12.9% patients, respectively. During follow-up, the following rates of clinical outcomes were observed: bleeding events (1.7%), transient ischemic attack (1.7%), all-cause mortality (1.7%), stroke (0.6%), myocardial infarction (0.2%), and systemic embolism (0.08%). CONCLUSIONS: This MENA patient population was younger and had lower mean baseline CHA2DS2-VASc and HAS-BLED scores. The rates of clinical outcomes over 1-year in this study were low. Longer follow-up is required to comprehensively assess clinical outcomes in this patient population.

Does Gender Affect the Outcomes of Myocardial Revascularization for Left-Main Coronary Artery Disease?

Currently, gender is not considered in the choice of the revascularization strategy for patients with unprotected left main coronary artery (ULMCA) disease. This study analyzed the effect of gender on the outcomes of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG) in patients with ULMCA disease. Females who had PCI (n = 328) were compared with females who had CABG (n = 132) and PCI in males (n = 894) was compared with CABG (n = 784). Females with CABG had higher overall hospital mortality and major adverse cardiovascular events (MACE) than females with PCI. Male patients with CABG had higher MACE; however, mortality did not differ between males with CABG vs PCI. In female patients, follow-up mortality was significantly higher in CABG patients, and target lesion revascularization was higher in patients with PCI. Male patients had no difference in mortality and MACE between groups; however, MI was higher with CABG, and congestive heart failure was higher with PCI. In conclusion, women with ULMCA disease treated with PCI could have better survival with lower MACE compared with CABG. These differences were not evident in males treated with either CABG or PCI. PCI could be the preferred revascularization strategy in women with ULMCA disease.

Single Versus Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting for Unprotected Left-Main Coronary Disease.

BACKGROUND: The use of dual antiplatelet therapy (DAPT) after coronary revascularization for left-main disease is still debated. The study aimed to characterize patients who received dual versus single antiplatelet therapy (SAPT) after coronary artery bypass grafting (CABG) for unprotected left-main disease and compare the outcomes of those patients. RESULTS: This multicenter retrospective cohort study included 551 patients who were grouped into 2 groups: patients who received SAPT (n = 150) and those who received DAPT (n = 401). There were no differences in age ( P = 0.451), gender ( P = 0.063), smoking ( P = 0.941), diabetes mellitus ( P = 0.773), history of myocardial infarction ( P = 0.709), chronic kidney disease ( P = 0.615), atrial fibrillation ( P = 0.306), or cerebrovascular accident ( P = 0.550) between patients who received SAPT versus DAPT. DAPTs were more commonly used in patients with acute coronary syndrome [87 (58%) vs. 273 (68.08%); P = 0.027], after off-pump CABG [12 (8%) vs. 73 (18.2%); P = 0.003] and in patients with radial artery grafts [1 (0.67%) vs. 32 (7.98%); P < 0.001]. While SAPTs were more commonly used in patients with low ejection fraction [55 (36.67%) vs. 61 (15.21%); P < 0.001] and in patients with postoperative acute kidney injury [27 (18%) vs. 37 (9.23%); P = 0.004]. The attributed treatment effect of DAPT for follow-up major adverse cerebrovascular and cardiac events was not significantly different from that of SAPT [ß, -2.08 (95% confidence interval (CI), -20.8-16.7); P = 0.828]. The attributed treatment effect of DAPT on follow-up all-cause mortality was not significantly different from that of SAPT [ß, 4.12 (CI, -11.1-19.32); P = 0.595]. There was no difference in bleeding between groups ( P = 0.666). CONCLUSIONS: DAPTs were more commonly used in patients with acute coronary syndrome, after off-pump CABG, and with radial artery grafts. SAPTs were more commonly used in patients with low ejection fraction and acute kidney injury. Patients on DAPT after CABG for left-main disease had comparable major adverse cerebrovascular and cardiac events and survival to patients on SAPT, with no difference in bleeding events.

Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial.

IMPORTANCE: Using more intervals to detect ventricular tachyarrhythmias has been associated with reducing unnecessary implantable cardioverter-defibrillator (ICD) therapies. OBJECTIVE: To determine whether using 30 of 40 intervals to detect ventricular arrhythmias (VT) (long detection) during spontaneous fast VT episodes reduces antitachycardia pacing (ATP) and shock delivery more than 18 of 24 intervals (standard detection). DESIGN, SETTING, AND PARTICIPANTS: Randomized, single-blind, parallel-group trial that enrolled 1902 primary and secondary prevention patients (mean [SD] age, 65 [11] years; 84% men; 75% primary prevention ICD) with ischemic and nonischemic etiology undergoing first ICD implant at 1 of 94 international centers (March 2008-December 2010). INTERVENTIONS: Patients were randomized 1:1 to programming with long- (n = 948) or standard-detection (n = 954) intervals. MAIN OUTCOMES AND MEASURES: Total number of ATPs and shocks delivered for all episodes (primary outcomes) and inappropriate shocks, mortality, and syncopal rate (secondary outcomes). RESULTS: During a median follow-up of 12 months (interquartile range, 11-13), long-detection group had 346 delivered therapies (42 therapies per 100 person-years, 95% CI, 38-47) vs 557 in the standard-detection group (67 therapies per 100 person-years [95% CI, 62-73]; incident rate ratio [IRR], 0.63 [95% CI, 0.51-0.78]; P < .001). The long- vs the standard-detection group experienced 23 ATPs per 100 person-years (95% CI, 20-27) vs 37 ATPs per 100 person-years (95% CI, 33-41; IRR, 0.58 [95% CI, 0.47-0.72]; P < .001); 19 shocks per 100 person-years (95% CI, 16-22) vs 30 shocks per 100 person-years (95% CI, 26-34; IRR, 0.77 [95% CI, 0.59-1.01]; P = .06), with a significant difference in the probability of therapy occurrence (P < .001); and a reduction in first occurrence of inappropriate shock (5.1 per 100 patient-years [95% CI, 3.7-6.9] vs 11.6 [95% CI, 9.4-14.1]; IRR, 0.55 [95% CI, 0.36-0.85]; P = .008). Mortality (5.5 [95% CI, 4.0-7.2] vs 6.3 [95% CI, 4.8-8.2] per 100 patient-years; HR, 0.87; P = .50) and arrhythmic syncope rates (3.1 [95% CI, 2.6-4.6] vs 1.9 [95% CI, 1.1-3.1] per 100 patient-years; IRR, 1.60 [95% CI, 0.76-3.41]; P = .22) did not differ significantly between groups. CONCLUSIONS AND RELEVANCE: Among patients receiving an ICD, the use of a long- vs standard-detection interval resulted in a lower rate of ATP and shocks, and inappropriate shocks. This programming strategy may be an appropriate alternative. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00617175.

One Versus Two Stents Strategies for Unprotected Left Main Intervention: Gulf Left Main Registry.

The optimal stenting strategy for unprotected left main coronary artery (ULMCA) disease remains debated. This retrospective observational study (Gulf Left Main Registry) analyzed the outcomes of 1 vs 2 stents in patients with unprotected left main percutaneous coronary intervention (PCI). Overall, 1222 patients were evaluated; 173 had 1 stent and 1049 had 2 stents. The 2-stent group was older with more comorbidities, higher mean SYNTAX scores, and more distal bifurcation lesions. In the 1-stent group, in-hospital events were significant for major bleeding, and better mean creatinine clearance. At median follow-up of 20 months, the 1-stent group was more likely to have target lesion revascularization (TLR). Total mortality was numerically lower in the 1-stent group (.00% vs 2.10%); however, this was not statistically significant (P=.068). Our analysis demonstrates the benefits of a 2-stent approach for ULMCA patients with high SYNTAX scores and lesions in both major side branches, while the potential benefit of a 1-stent approach for less complex ULMCA was also observed. Further studies with longer follow-up are needed to definitively demonstrate the optimal approach.

Percutaneous coronary intervention vs. coronary artery bypass grafting in emergency and non-emergency unprotected left-main revascularization.

BACKGROUND: The optimal revascularization strategy in patients with left main coronary artery (LMCA) disease in the emergency setting is still controversial. Thus, we aimed to compare the outcomes of percutaneous coronary interventions (PCI) vs. coronary artery bypass grafting (CABG) in patients with and without emergent LMCA disease. METHODS: This retrospective cohort study included 2138 patients recruited from 14 centers between 2015 and 2019. We compared patients with emergent LMCA revascularization who underwent PCI (n = 264) to patients who underwent CABG (n = 196) and patients with non-emergent LMCA revascularization with PCI (n = 958) to those who underwent CABG (n = 720). The study outcomes were in-hospital and follow-up all-cause mortality and major adverse cardiovascular and cerebrovascular events (MACCE). RESULTS: Emergency PCI patients were older and had a significantly higher prevalence of chronic kidney disease, lower ejection fraction, and higher EuroSCORE than CABG patients. CABG patients had significantly higher SYNTAX scores, multivessel disease, and ostial lesions. In patients presenting with arrest, PCI had significantly lower MACCE (P = 0.017) and in-hospital mortality (P = 0.016) than CABG. In non-emergent revascularization, PCI was associated with lower MACCE in patients with low (P = 0.015) and intermediate (P < 0.001) EuroSCORE. PCI was associated with lower MACCE in patients with low (P = 0.002) and intermediate (P = 0.008) SYNTAX scores. In non-emergent revascularization, PCI was associated with reduced hospital mortality in patients with intermediate (P = 0.001) and high (P = 0.002) EuroSCORE compared to CABG. PCI was associated with lower hospital mortality in patients with low (P = 0.031) and intermediate (P = 0.001) SYNTAX scores. At a median follow-up time of 20 months (IQR: 10-37), emergency PCI had lower MACCE compared to CABG [HR: 0.30 (95% CI 0.14-0.66), P < 0.003], with no significant difference in all-cause mortality between emergency PCI and CABG [HR: 1.18 (95% CI 0.23-6.08), P = 0.845]. CONCLUSIONS: PCI could be advantageous over CABG in revascularizing LMCA disease in emergencies. PCI could be preferred for revascularization of non-emergent LMCA in patients with intermediate EuroSCORE and low and intermediate SYNTAX scores.

Impact of left ventricular ejection fraction on outcomes after left main revascularization: g-LM Registry.

AIMS: The impact of left ventricular dysfunction on clinical outcomes following revascularization is not well established in patients with unprotected left main coronary artery disease (ULMCA). In this study, we evaluated the impact of left ventricular ejection fraction (LVEF) on clinical outcomes of patients with ULMCA requiring revascularization with percutaneous coronary intervention (PCI) compared with coronary artery bypass graft (CABG). METHODS: The details of the design, methods, end points, and relevant definitions are outlined in the Gulf Left Main Registry: a retrospective, observational study conducted between January 2015 and December 2019 across 14 centres in 3 Gulf countries. In this study, the data on patients with ULMCA who underwent revascularization through PCI or CABG were stratified by LVEF into three main subgroups; low (l-LVEF <40%), mid-range (m-LVEF 40-49%), and preserved (p-LVEF ≥50%). Primary outcomes were hospital major adverse cardiovascular and cerebrovascular events (MACCE) and mortality and follow-up MACCE and mortality. RESULTS: A total of 2137 patients were included; 1221 underwent PCI and 916 had CABG. During hospitalization, MACCE was significantly higher in patients with l-LVEF [(10.10%), P = 0.005] and m-LVEF [(10.80%), P = 0.009], whereas total mortality was higher in patients with m-LVEF [(7.40%), P = 0.009] and p-LVEF [(7.10%), P = 0.045] who underwent CABG. There was no mortality difference between groups in patients with l-LVEF. At a median follow-up of 15 months, there was no difference in MACCE and total mortality between patients who underwent CABG or PCI with p-LVEF and m-LVEF. CONCLUSION: CABG was associated with higher in-hospital events. Hospital mortality in patients with l-LVEF was comparable between CABG and PCI. At 15 months' follow-up, PCI could have an advantage in decreasing MACCE in patients with l-LVEF.

Outcomes of Myocardial Revascularization in Diabetic Patients With Left Main Coronary Artery Disease: A Multicenter Observational Study From Three Gulf Countries.

BACKGROUND: Real-world data for managing patients with diabetes and left main coronary artery (LMCA) disease are scarce. We compared percutaneous coronary intervention (PCI) outcomes versus coronary artery bypass grafting (CABG) in diabetes and LMCA disease patients. METHODS: We retrospectively studied patients with LMCA presented to 14 centers from 2015 to 2019. The study included 2138 patients with unprotected LMCA disease; 1468 (68.7 %) had diabetes. Patients were grouped into; diabetes with PCI (n = 804) or CABG (n = 664) and non-diabetes with PCI (n = 418) or CABG (n = 252). RESULTS: In diabetes, cardiac (34 (5.1 %) vs. 22 (2.7 %); P = 0.016), non-cardiac (13 (2 %) vs. 6 (0.7 %); P = 0.027) and total hospital mortality (47 (7.1 %) vs. 28 (3.5 %); P = 0.0019), myocardial infarction (45 (6.8 %) vs. 11 (1.4 %); P = 0.001), cerebrovascular events (25 (3.8 %) vs. 12 (1.5 %); P = 0.005) and minor bleeding (65 (9.8 %) vs. 50 (6.2 %); P = 0.006) were significantly higher in CABG patients compared to PCI; respectively. The median follow-up time was 20 (10-37) months. In diabetes, total mortality was higher in CABG (P = 0.001) while congestive heart failure was higher in PCI (P = 0.001). There were no differences in major adverse cerebrovascular events and target lesion revascularization between PCI and CABG. Predictors of mortality in diabetes were high anatomical SYNTAX, peripheral arterial disease, chronic kidney disease, and cardiogenic shock. CONCLUSIONS: In this multicenter retrospective study, we found no significant difference in clinical outcomes during the short-term follow-up between PCI with second-generation DES and CABG except for lower total mortality and a higher rate of congestive heart failure in PCI group of patients. Randomized trials to characterize patients who could benefit from each treatment option are needed.

Unprotected Left Main Revascularization in the Setting of Non-coronary Atherosclerosis: Gulf Left Main Registry.

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in revascularization of left main coronary artery (LMCA) disease has been evaluated in previous studies. However, there has been minimal study of the relationship between co-existing non-coronary atherosclerosis (NCA) and LMCA disease revascularization. We aim to examine this relationship. The Gulf-LM study is a retrospective analysis of unprotected LMCA revascularization cases undergoing PCI with second generation drug-eluting stent vs CABG across 14 centers within 3 Gulf countries between January 2015 and December 2019. A total of 2138 patients were included, 381 with coexisting NCA and 1757 without. Outcomes examined included major adverse cardiovascular and cerebrovascular events (MACCE), cardiac and non-cardiac death, and all bleeding. In patients with NCA, preexisting myocardial infarction and congestive heart failure were more common, with PCI being the most common revascularization strategy. A statistically significant reduction in in-hospital MACCE and all bleeding was noted in patients with NCA undergoing PCI as compared to CABG. At a median follow-up of 15 months, MACCE and major bleeding outcomes continued to favor the PCI group, though no such difference was identified between revascularization strategies in patients without NCA.In this multicenter retrospective study of patients with and without NCA who require revascularization (PCI and CABG) for unprotected LMCA disease, PCI demonstrated a better clinical outcome in MACCE both in-hospital and during the short-term follow-up in patients with NCA. However, no such difference was observed in patients without NCA.