5 results on '"Malik FTN"'
Search Results
2. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis
- Author
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Valgimigli, Marco, Smits, Pieter C, Frigoli, Enrico, Bongiovanni, Dario, Tijssen, Jan, Hovasse, Thomas, Mafragi, Al, Ruifrok, Willem Theodoor, Karageorgiev, Dimitar, Aminian, Adel, Garducci, Stefano, Merkely, Bela, Routledge, Helen, Ando, Kenji, Diaz Fernandez, Josè Francisco, Cuisset, Thomas, Nesa Malik, Fazila Tun, Halabi, Majdi, Belle, Loic, Din, Jehangir, Beygui, Farzin, Abhyankar, Atul, Reczuch, Krzysztof, Pedrazzini, Giovanni, Heg, Dik, Vranckx, Pascal, MASTER DAPT Investigators, Cardiology, ACS - Heart failure & arrhythmias, Valgimigli, M, Smits, PC, Frigoli, E, Bongiovanni, D, Tijssen, J, Hovasse, T, Mafragi, A, Ruifrok, WT, Karageorgiev, D, Aminian, A, Garducci, S, Merkely, B, Routledge, H, Ando, K, Fernandez, JFD, Cuisset, T, Malik, FTN, Halabi, M, Belle, L, Din, J, Beygui, F, Abhyankar, A, Reczuch, K, Pedrazzini, G, Heg, D, and VRANCKX, Pascal
- Subjects
animal structures ,Aspirin ,Myocardial Infarction ,Hemorrhage ,Percutaneous coronary intervention ,Stroke ,Treatment Outcome ,Complex intervention ,Dual antiplatelet therapy ,Humans ,Drug Therapy, Combination ,Acute Coronary Syndrome ,High bleeding risk ,610 Medizin und Gesundheit ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors - Abstract
Aim To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). Methods and results In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69–1.52, and HR: 1.24, 95% CI: 0.79–1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71–1.15, and HR: 0.91, 95% CI: 0.69–1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42–0.98, and HR: 0.70; 95% CI: 0.55–0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. Conclusion In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. Clinical Trial Registration This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.
- Published
- 2022
3. Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.
- Author
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Landi A, Alasnag M, Heg D, Frigoli E, Malik FTN, Gomez-Blazquez I, Pourbaix S, Chieffo A, Spaulding C, Sainz F, Routledge H, Andò G, Testa L, Sciahbasi A, Contractor H, Jepson N, Mieres J, Imran SS, Noor H, Smits PC, and Valgimigli M
- Subjects
- Male, Humans, Female, Aged, Platelet Aggregation Inhibitors therapeutic use, Hemorrhage chemically induced, Hemorrhage epidemiology, Ischemia chemically induced, Percutaneous Coronary Intervention methods, Drug-Eluting Stents, Myocardial Infarction epidemiology, Myocardial Infarction drug therapy, Stroke epidemiology, Stroke etiology, Stroke prevention & control
- Abstract
Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI)., Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR., Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022., Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups., Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB)., Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI., Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events., Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.
- Published
- 2024
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4. Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.
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Kadavil RM, Abdullakutty J, Patel T, Rathnavel S, Singh B, Chouhan NS, Malik FTN, Hiremath S, Gunasekaran S, Kalarickal SM, Kumar V, and Subban V
- Abstract
Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking., Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI., Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR., Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%., Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions., Competing Interests: The authors have no conflicts of interest to declare.
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- 2023
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5. Under-utilization of pacemaker therapy for sinus node dysfunction - Real world data from South Asia.
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Narasimhan C, Sanyal J, Sethi R, Kothari Y, Malik FTN, Pandurangi U, Khan N, Sahu S, Lande J, Sachanandani H, and Naik A
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- Asia epidemiology, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Prospective Studies, Sick Sinus Syndrome epidemiology, Sick Sinus Syndrome physiopathology, Time Factors, Cardiac Pacing, Artificial statistics & numerical data, Heart Rate physiology, Outcome Assessment, Health Care, Pacemaker, Artificial statistics & numerical data, Product Surveillance, Postmarketing methods, Sick Sinus Syndrome therapy
- Abstract
Objective: Chronic symptomatic sinus node dysfunction (SND), the most common bradyarrhythmia, can be effectively managed by permanent cardiac pacing. Yet the care pathway and barriers to adoption of pacing therapy are not well understood - particularly in low volume implanting countries. The IMPROVE Brady study is a quality improvement initiative being conducted at centers in South Asia, Latin America, and Russia. We assessed the rates of SND diagnosis and pacemaker treatment for SND in the South Asia cohort., Methods: The prospective study enrolled patients with heart rate of ≤50 beats per minute presenting with symptoms including syncope, dizziness, and/or dyspnea from ten centers in India and Bangladesh. Patients were followed to identify the proportion diagnosed with SND and subsequently treated with pacemaker therapy., Results: A total of 508 patients meeting criteria were enrolled and followed on average for 8.3±8.0months. Patients were on average 58 years of age, 77% were male, and 91% had completed at least primary education. An SND diagnosis was made in 368 (72%) of patients, with the majority (80%) of diagnoses occurring within 1 month of enrollment. Of the patients with an SND diagnosis, 63 (17%) were treated with a pacemaker. Reasons for not receiving treatment were: subject refusal or deferred decision (45%), unaffordability (34%), physician determined - not-indicated (20%), and other (1%). Older age, female gender, history of hypertension, lower resting heart rate, and syncopal or pre-syncopal symptoms were associated with a higher probability of implant., Conclusions: In a care pathway assessment for the diagnosis and treatment of symptomatic SND in South Asia only 1 in 6 patients received pacemaker indicated therapy, largely due to patient refusal and physician decision. Phase II of the study will be aimed to improve this treatment rate., (Copyright © 2017. Published by Elsevier B.V.)
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- 2017
- Full Text
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