Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial.

IMPORTANCE: The occurrence of new-onset migraine attacks is a complication of transcatheter atrial septal defect (ASD) closure. It has been suggested that clopidogrel may reduce migraine attacks after ASD closure. OBJECTIVE: To assess the efficacy of clopidogrel, used in addition to taking aspirin, for the prevention of migraine attacks following ASD closure. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind clinical trial performed in 6 university hospitals in Canada. Participants were 171 patients with an indication for ASD closure and no history of migraine. INTERVENTIONS: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin + clopidogrel [the clopidogrel group], n = 84) vs single antiplatelet therapy (aspirin + placebo [the placebo group], n = 87) for 3 months following transcatheter ASD closure. The first patient was enrolled in December 2008, and the last follow-up was completed in February 2015. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the monthly number of migraine days within the 3 months following ASD closure in the entire study population. The incidence and severity of new-onset migraine attacks, as evaluated by the Migraine Disability Assessment questionnaire, were prespecified secondary end points. A zero-inflated Poisson regression model was used for data analysis. RESULTS: The mean (SD) age of the participants was 49 (15) years and 62% (106) were women. Patients in the clopidogrel group had a reduced mean (SD) number of monthly migraine days within the 3 months following the procedure (0.4 [95% CI, 0.07 to 0.69] days) vs the placebo group (1.4 [95% CI, 0.54 to 2.26] days; difference, -1.02 days [95% CI, -1.94 to -0.10 days]; incident risk ratio [IRR], 0.61 [95% CI, 0.41 to 0.91]; P = .04) and a lower incidence of migraine attacks following ASD closure (9.5% for the clopidogrel group vs 21.8% for the placebo group; difference, -12.3% [95% CI, -23% to -1.6%]; odds ratio [OR], 0.38 [95% CI, 0.15 to 0.89]; P = .03). Among patients with migraines, those in the clopidogrel group had less-severe migraine attacks (zero patients with moderately or severely disabling migraine attacks vs 37% [7 patients] in the placebo group; difference, -36.8% [95% CI, -58.5% to -15.2%]; P = .046). There were no between-group differences in the rate of patients with at least 1 adverse event (16.7% [14 patients] in the clopidogrel group vs 21.8% [19 patients] in the placebo group; difference, -5.2% [95% CI, -17% to 6.6%]; P = .44). CONCLUSIONS AND RELEVANCE: Among patients who underwent transcatheter ASD closure, the use of clopidogrel and aspirin, compared with aspirin alone, resulted in a lower monthly frequency of migraine attacks over 3 months. Further studies are needed to assess generalizability and durability of this effect. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00799045.

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial.

Importance: Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown. Objective: To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure. Design, Setting, and Participants: This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019. Interventions: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued. Main Outcomes and Measures: Incidence and severity of migraine attacks at 6- and 12-month follow-up. Results: The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P = .03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P < .001). The severity of migraine attacks progressively decreased over time; no moderate or severe attacks occurred at 6 and 12 months (vs 3 months: P < .001). There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure. Only 2 patients (1.2%; 1 patient per group) presented with new-onset migraine attacks after 3 months. Conclusions and Relevance: New-onset migraine attacks after ASD closure improved or resolved spontaneously within 6 to 12 months in most patients. No significant rebound effect was observed after clopidogrel cessation at 3 months. These results demonstrate a low rate of migraine events beyond 3 months following transcatheter ASD closure and support the early discontinuation of clopidogrel therapy if administered. Trial Registration: ClinicalTrials.gov Identifier: NCT00799045.

The Transcatheter Aortic Valve Implantation (TAVI) Quality Report: A Call to Arms for Improving Quality in Canada.

Transcatheter aortic valve implantation (TAVI) is a disruptive technology that has dramatically changed the way clinicians care for patients with aortic stenosis. In 15 short years, this technology has progressed from first-in-human to the standard of care for high-risk and inoperable patients with aortic stenosis. In 2016 the Canadian Cardiovascular Society published the first ever report of quality of care for TAVI in Canada. This report provided multiple insights into evaluating such care delivered to Canadians and the challenges that lie ahead. In this article, we summarize these challenges and encourage cardiologists to join the call to arms for improving quality of TAVI care in Canada.

Structural Heart Disease Intervention: The Canadian Landscape.

Cardiovascular disease encompasses coronary artery disease and valvular heart disease, and the prevalence of both increases with age. Over the past decade, the landscape of interventional cardiology has evolved to encompass a new set of percutaneous procedures outside the coronary tree, including transcatheter aortic valve implantation, transcatheter mitral valve repair, and left atrial appendage occlusion. These interventions have sparked a new discipline within interventional cardiology referred to as structural heart disease (SHD) intervention. The access to and numbers of such procedures performed in Canada is currently unknown. This "first of its kind" survey of structural interventions provides insight into the landscape of SHD intervention in Canada and the challenges faced by cardiologists to deliver this important care.

Drug eluting stents: data from a clinical registry.

OBJECTIVE: To assess the characteristics and short-term outcome of patients, undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES), in routine clinical practice. DESIGN: Observational study. PLACE AND DURATION OF STUDY: The Aga Khan University Hospital, from 2002 to 2003. PATIENTS AND METHODS: All the patients who underwent PCI with DES at cath lab, AKUH, during the year 2002 and 2003 were included. Data was collected from database and by reviewing clinical records. Follow-up data for a period of 6-9 months was collected from the clinical records and by a telephone interview where required. RESULTS: A total of 141 patients underwent PCI with DES at AKUH during the year 2002 and 2003. This study was predominantly male dominated (approximately 77%), with a mean age of 55+/-11 years. Thirty-nine percent were diabetics, and 53% were hypertensives. Twelve percent of patients had prior coronary artery bypass graft surgery (CABG) and 17% had prior PCI. Two or more than two lesions were attempted in 55% of patients. Majority (84.4%) of lesions were moderate to high risk category. Six to nine months follow-up was available in 133 (94%) patients. The only death was due to heart failure in the presence of a patent stent. Nearly 8% had clinical angina and 3.8% had myocardial infarction (MI) during follow-up. Target lesion revascularization (TLR) was performed in 4.6%. Major adverse cardiac events (MACE), defined as death, MI, and TLR occurred in 6.8% of patients. CONCLUSION: This data shows that DES are being used in a broad variety of clinical settings in routine or real life clinical practice. The outcome is excellent and comparable to randomized trials.

Initial experience with pre-activation of the cardiac catheterization lab and emergency room bypass for patients with ST-elevation myocardial infarction in Halifax, Nova Scotia.

BACKGROUND: To determine whether pre-activation of the cardiac catheterization lab by Emergency Health Services (EHS) with a single call system in the field was associated with reduced time to reperfusion in patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). METHODS: Consecutive STEMI patients identified by EHS and subsequently taken to the Queen Elizabeth II Health Sciences Center (QEIIHSC) for PPCI between February 1, 2011 and January 30, 2013 were examined. Patients who had pre-activation of the catheterization lab from the field (pre-act group) after the acquisition of the LifeNet® system (Physio Control, Redmond Washington) were compared to those who had usual activation (routine group) prior to the acquisition of the LifeNet® system, for outcomes including treatment timeline data and mortality. RESULTS: 271 patients were included in the analysis, 149 patients in the pre-act group and 122 patients in the routine group. Door-to-device (DTD) times of less than 90min were achieved more frequently in the Pre-act group (91.9% vs. 62.2%; P<0.001). DTD time was shorter in the Pre-act group (48min IQR: 38 to 63min vs. 78min IQR: 64-101min; p=0.001) as was first medical contact-to-device (FMCTD) time (91min IQR: 78 to 106min vs. 115min IQR: 90 to 139min; P<0.001). False activation of the catheterization lab was infrequent (1.3%). CONCLUSIONS: Implementation of catheterization lab pre-activation using the LifeNet® system was associated with more efficient reperfusion times as measured by reduced FMCTD and DTD times without excess false activation rates.

Survival of patients treated with intra-aortic balloon counterpulsation at a tertiary care center in Pakistan - patient characteristics and predictors of in-hospital mortality.

BACKGROUND: Intra-aortic balloon counterpulsation (IABC) has an established role in the treatment of patients presenting with critical cardiac illnesses, including cardiogenic shock, refractory ischemia and for prophylaxis and treatment of complications of percutaneous coronary interventions (PCI). Patients requiring IABC represent a high-risk subset with an expected high mortality. There are virtually no data on usage patterns as well as outcomes of patients in the Indo-Pakistan subcontinent who require IABC. This is the first report on a sizeable experience with IABC from Pakistan. METHODS: Hospital charts of 95 patients (mean age 58.8 (+/- 10.4) years; 78.9% male) undergoing IABC between 2000-2002 were reviewed. Logistic regression was used to determine univariate and multivariate predictors of in-hospital mortality. RESULTS: The most frequent indications for IABC were cardiogenic shock (48.4%) and refractory ischemia (24.2%). Revascularization (surgical or PCI) was performed in 74 patients (77.9%). The overall in-hospital mortality rate was 34.7%. Univariate predictors of in-hospital mortality included (odds ratio [95% CI]) age (OR 1.06 [1.01-1.11] for every year increase in age); diabetes (OR 3.68 [1.51-8.92]) and cardiogenic shock at presentation (OR 4.85 [1.92-12.2]). Furthermore, prior CABG (OR 0.12 [0.04-0.34]), and in-hospital revascularization (OR 0.05 [0.01-0.189]) was protective against mortality. In the multivariate analysis, independent predictors of in-hospital mortality were age (OR 1.13 [1.05-1.22] for every year increase in age); diabetes (OR 6.35 [1.61-24.97]) and cardiogenic shock at presentation (OR 10.0 [2.33-42.95]). Again, revascularization during hospitalization (OR 0.02 [0.003-0.12]) conferred a protective effect. The overall complication rate was low (8.5%). CONCLUSIONS: Patients requiring IABC represent a high-risk group with substantial in-hospital mortality. Despite this high mortality, over two-thirds of patients do leave the hospital alive, suggesting that IABC is a feasible therapeutic device, even in a developing country.

Relationship between exercise induced dyspnea and functional capacity with doppler-derived diastolic function'.

BACKGROUND: Dyspnea is the frequent cause of exercise intolerance and physical inactivity among patients referred for exercise tolerance test. Diastolic dysfunction has shown significant correlation with exercise capacity and exercise induced dyspnea. To find out the frequency of diastolic dysfunction (DD) and the relationships between impaired exercise capacity and exercise induced dyspnea with DD by Doppler-derived indices among patients referred for stress test in a tertiary care hospital of Karachi. METHODS: For this study 135 consecutive patients who were referred for stress test at our non-invasive lab were screened for eligibility. Patients with valvular pathology, atrial fibrillation (AF) and coronary artery disease (CAD) were excluded. Stress test was performed on treadmill using Bruce protocol. Assessment of diastolic function as determined by trans-mitral flow velocity pattern was carried at baseline and at peak exercise. We evaluated impaired exercise capacity and exercise induced dyspnea using validated Borg Scale among study subjects. RESULTS: Study subjects 88% were males, mean age was 46 ± 16 years, BMI 27 ± 5 kg/m2, prevalence of diabetes mellitus (DM) 15%, hypertension 28% and smoking 21%. Exercise induced DD occurred among 44.6%. Patients with exercise induced DD had lower exercise capacity (9.2 vs. 10.2 METS; p = 0.04) and higher Borg Scale (5.2 vs. 4.0; p < 0.001). DD at baseline was present in 25(26%) of patients so they were excluded from the study. Five patients develop ischemia during stress test so were also excluded. So final analysis was done on 105 patients. Among patients without DD at baseline, there was significant vicariate linear inverse correlation between post exercise E/A ratio and Borg scale (r = -0.23; p = 0.02) and exercise capacity was assessed by exercise duration and MET (r-0.825; p = 0.04). Multivariate regression analysis revealed post exercise E/A ratio as an independent determinant of severity of exercise induced dyspnea and impaired exercise tolerance. CONCLUSION: DD is significantly associated with impaired functional capacity and dyspnea among patients referred for exercise tolerance test.