Journal scan 2016

Sajan Ahmad


  1. DANISH Trial – [August 28,2016, at]

-      Multicenter, randomized, unblinded, controlled trial to assess the efficacy of ICDs in patients with non-ischemic systolic heart failure on mortality.

-      Patients with symptomatic systolic heart failure (left ventricular ejection fraction, ≤35%) not caused by coronary artery disease were assigned to receive an ICD or usual clinical care (control group).

-      There was no significant reduction in all cause mortality as well as cardiovascular death in the ICD group during a median follow up of 67.6 months.

-      The risk of sudden cardiac death was halved with an ICD.

-      There was significant survival benefit in younger patient (age < 68 yrs)  in association with ICD implantation.

NOTE – In the elderly non ischemic cardiomyopathy rethink before ICD implantation. ICD implantation is beneficial in younger patients with non ischemic cardiomyopathy.

  1. NORSTENT Trial [August 30,2016, at]

-      Randomized trial to evaluate  the long-term risks and benefits of the use of drug eluting stents versus bare-metal stents in patients presented with stable angina or an acute coronary syndrome. The median follow up of 5 years.

-      No significant difference in the 6-year rates of death or spontaneous myocardial infarction between patients receiving DES Vs BMS.

-      There was significant reduction in the rate of revascularization in the DES group with absolute risk reduction of 3.3 percentage.

-      The rate of stent thrombosis was lower with the use of drug-eluting stents.

NOTE – This study gives hope to use of BMS in indicated cases.



  1. FIRE AND ICE Trial [April 4, 2016,at]


-      A multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation.

-      A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation) and the mean duration of followup was 1.5 years.

-      The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation and the primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events.

-      There was no significant difference in the  primary efficacy end point occurred in the cryoballoon group and the radiofrequency group [hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for non inferiority]. The safety endpoints were also comparable between the groups.

-      The cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy and no significant difference in overall safety for the treatment of patients with drug-refractory paroxysmal atrial fibrillation.

NOTE – This study promotes the use of Cryoballoon ablation for drug refractory atrial fibrillation, which needs lesser expertise. 

  1.    VANISH Trial [NEJM - July 14, 2016 vol. 375 no. 2]

-      A multicenter, randomized, controlled trial comparing catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group) in patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite the use of antiarrhythmic drugs.

-      In the escalated therapy group, amiodarone was initiated if another agent had been used previously or the dose of amiodarone was increased if it had been less than 300 mg per day or mexiletine was added if the dose was already at least 300 mg per day.

-      During a mean follow up of 27.9±17.1 months, the primary outcome  [a composite of death, three or more documented episodes of VT within 24 hours (VT storm), or appropriate ICD shock] occurred in 59.1% of patients in the ablation group and 68.5% of those in the escalated-therapy group (hazard ratio in the ablation group, 0.72; 95% confidence interval, 0.53 to 0.98; P=0.04).

-      Catheter ablation was more effective than escalated AAD therapy in reducing the rate of the primary outcomes, while neither of the two treatment group showed superiority with respect to mortality.

-      No significant difference in the primary outcome was observed among patients who were previously on non-amiodarone antiarrhythmic drug therapy.

NOTE - Skilled electrophysiologists can now feel confident offering ablation over escalation of medical therapy in patients with VT and ischemic cardiomyopathy especially who were already on amiodarone.


  1.     GARFIELD AF Registry – [ European Heart Journal June 29, 2016]

-      An ongoing, observational, worldwide study of adults with newly diagnosed non valvular AF.

-      A total of 17162 patients was followed up for 2 years.

-      The most frequent cause of cardiovascular death was congestive heart failure (CHF).

-      The rate of death was three-fold higher than the rate of stroke/SE and more than five-fold higher than the rate of major bleeding.

-      Anticoagulant therapy was associated with a 35% lower risk of death.

-      Anticoagulant therapy was not prescribed in 36.9% of patients with CHA2DS2-VASc ≥2. Patients not receiving anticoagulant therapy tended to be younger age group, those with paroxysmal AF, low CHA2DS2-VASc score and high HAS BLED score.

NOTE - GARFIELD-AF have identified substantial gaps between antithrombotic prescribing in the real world and guideline recommendations.


  1.     SAVE Trial [ Sleep Apnea Cardiovascular Endpoints ]  

    [ August 28, 2016 at]

-      A multicenter, randomized, open-label trial, with blinded end-point assessment to assess the effect of continuous positive airway pressure (CPAP) in preventing major cardiovascular events in patients with moderate to- severe obstructive sleep apnea and coronary or cerebrovascular disease.

-      2717 eligible adults between 45 and 75 years of age received CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group) with a mean follow up of 3.7 years.

-     In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea–hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up.

-    The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack.

-      There was no significant difference in the primary endpoints between the two groups. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood.

-      Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease.

NOTE – CPAP therapy in patients with moderate to severe obstructive sleep apnea had no reduction in the incidence of cardiovascular events.


  1.    HOPE – 3 Trial (Heart Outcomes Prevention Evaluation)                                  (NEJM May 26, 2016 vol. 374 no. 21)

-      A randomized trial with 2-by-2 factorial design evaluating the long term effects of rosuvaststin(10mg/day), candesarten(16 mg / day) with hydrochlorthiazide(12.5 mg/ day) and combination of both in intermediate risk for cardiovascular events who did not have cardiovascular disease.

-      12,705 participants ( men ≥ 55 years and women ≥ 65 years with atleast one cardiovascular risk factor ) were randomized, of these 3180 were assigned to candesartan–hydrochlorothiazide plus rosuvastatin (combined therapy), 3181 to rosuvastatin plus placebo, 3176 to candesartan–hydrochlorothiazide plus placebo, and 3168 to placebo plus placebo. The median follow up was 5.6 years.

-      The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization.

-      The trial evaluating cholesterol lowering with rosuvastatin found that there is a significant reduction in the first coprimary outcomes as well as second coprimary outcomes in the rosuvastatin arm.

-     The number needed to treat with rosuvastatin to prevent one first coprimary outcome event was 91 and one second coprimary event was 73.

-      There was significant reduction in the number of myocardial infarctions, coronary revascularizations, hospitalization for cardiovascular causes and stroke in the rosuvastatin group when compared to the placebo, with a slight increase in the number of hemorrhagic stroke.

-      There was no significant difference between the two groups in the number of new onset diabetes mellitus.

-      Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease.

-      In the study evaluating blood-pressure–lowering therapy with a fixed-dose combination of candesarten (16 mg / day) with hydrochlorthiazide (12.5 mg/ day), there were no significant differences between the active-treatment group and the placebo group in the incidence of the first coprimary outcome and second coprimary outcomes.

-      In the subgroup analysis participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg; mean, 154.1±8.9 mm Hg) who were in the active-treatment group had significantly lower rates than those in the placebo group with respect to the first and second coprimary outcomes.

-      In the study to assess the effect of rosuvastatin plus candesarten with hydrochlorthiazide (n – 3180) versus dual placebo( n- 3168) in preventing cardiovascular events, there is a significant decrease in the first and second coprimary outcomes in the combined treatment group.

NOTE – This study showed a clear benefit of giving rosuvastatin for patients with intermediate risk for CV events. Rosuvastatin plus candesarten with hydrochlorthiazide also showed significant reduction in the outcomes. Candesarten with hydrochlorthiazide has showen no benefits in normotensive patients with intermediate risk, but there is significant reduction in the CV outcome in patients with high blood pressure.


  1.      PARTNER 2A Trial – [NEJM. 2016. 374(17):1609-20.]


-      A randomized trial were TAVR with a second-generation valve system         was compared with conventional surgery in patients with severe aortic stenosis and intermediate- risk clinical profiles [STS risk score 4-8%].

-      The study enrolled 2032 patients with severe aortic stenosis and cardiac symptoms at 57 centers in the United States and Canada.

-      Patients were stratified in cohorts according to access route (transfemoral or transthoracic) and were then randomly assigned (in a 1:1 ratio) to undergo either transcatheter or surgical aortic-valve replacement.

-      The primary end point was a non-hierarchical composite of death from any cause or disabling stroke at 2 years.

-      There was no significant difference in the primary end point of death from any cause or disabling stroke at 2 years between the TAVR group and the surgery group.

-       The risk ratio at 2 years for the primary end point in the TAVR group as compared with the surgery group met the criterion for noninferiority.

-      In the transfemoral-access cohort, TAVR resulted in a statistically significant reduction in the primary outcomes when compared to surgical cohort, whereas there was no significant difference in the transthoracic access cohort.

-      Major vascular complications were more frequent in the TAVR group than in the surgery group while life-threatening bleeding, acute kidney injury, and new-onset atrial fibrillation were more in surgical group.

-      The need for permanent pacemaker at 30 days and rehospitalisation at 2 years was similar in both groups.

-      The improvements in aortic-valve areas and gradients at all time points were significantly greater after TAVR than after surgery while the frequency and severity of paravalvular aortic regurgitation were greater after TAVR than after surgery.

-      Moderate or severe paravalvular aortic regurgitation at 30 days was noted in 3.7% in TAVR group and these group had higher mortality at 2 years.

NOTE – In near future TAVR may replace surgical AVR in patients with intermediate surgical risk.


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