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The bioresorbable Absorb scaffold considered the holy grail of coronary intervention is now being pulled out from the commercial market in Europe. The stunning news is the culmination of sticky data emerging from recent randomized trials assessing the bioresorbable vascular scaffold (BRS), that have revealed that with this generation of BRS both efficacy and safety are questionable.

 

The ABSORB II trial reported a significantly higher rate of target vessel myocardial infarction last year. The ABSORB III trial further dampened enthusiasm by showing significant increase in target lesion failure. The last randomized trial to be published was actually terminated early because of increased stent thrombosis including late stent (BRS) thrombosis.

 

The AIDA (Amsterdam Investigator Initiated Absorb Strategy All Comers Trial) investigators randomly assigned 1845 patients to either receive a BRS (924 patients) or a metallic stent (921). Median follow up was 707 days. Target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization) occurred in 105 patients with BRS and in 94 patients in the stent group. Target vessel MI occurred in 48 patients in the BRS group but in only 30 provided metallic stents. Definite or probable stent thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (3.5% vs. 0.9%; p<0.001). This was a single blind, multicenter, investigator initiated non-inferiority trial.

Continue reading “THE BIORESORBABLE SCAFFOLD OR THE “DISSOLVING STENT” IS NO LONGER PERMITTED FOR SALE IN EUROPE BECAUSE OF SAFETY CONCERNS”

 

 

 

 

 

I was taught  from my medical college undergraduate days that eating saturated fat was seeking trouble. Meat (red or white), cheese, butter and egg yolk were, for all practical purposes, proscribed. Repeated guidelines from the American Heart Association (AHA), American College of Cardiology and the World Health Organization were clear that fats in general and saturated fats in particular were to be strictly avoided in order to prevent a heart attack. The message was to reduce fats to less than 30% of total calories consumed in a day with saturated fats kept well below 10%. The entire planet followed these dietary commandments.

 

The  American Heart Association(AHA) declared way back in 1961 that saturated fats were bad because they increased blood cholesterol that in turn resulted in blockage of coronary arteries and heart attacks. The AHA astonishing conclusion was based upon the hypothesis of a single physiologist, without a shred of hard evidence. Ancel Benjamin Keys, who earned a PHD degree from Cambridge, was that single person. Keys successfully impressed Dr Paul Dudley White , a founder member of the AHA. Paul White was at that point looking after president Dwight Eisenhower who suffered his first heart attack in September 1955. Many middle aged Americans were succumbing to heart attacks in the 1950’s and the situation demanded answers from the health community. Eisenhower had been the Supreme Commander of NATO and before that was the Supreme Commander of the allied forces that had wrenched back Europe from the Germans in World War II. Eisenhower had famously warned the American public in his farewell address about the emerging “military-industrial complex”. President Eisenhower , however, had no clue of the rapidly developing “pharmaceutical –industrial complex.”

 

 

Keys was able to launch his Diet Heart Hypothesis because there was little science available in the 1950’s explaining the near epidemic of heart attack in middle-aged Americans. Keys presented his “Seven Countries Study” that displayed a clear association between eating saturated fats and deaths due to heart disease. The seven countries included USA, Japan, Yugoslavia, Netherlands, Italy, Greece, and Finland. There were however substantial flaws in the methodology of his paper.

 

 

 

Continue reading “THE MISLEADING ‘FATS’ IN THE DIET NARRATIVE”

 

 

 

The association between mental stress and heart disease, which was for long speculated but never proven has final been nailed to a large extent by a study, published in the Lancet this year. The researchers from Harvard Medical School report that heightened activity in the amygdala, which processes emotions such as anger and fear, plays a major role in development of atherosclerosis.

 

The amygdalae (there are 2 of them on either side of the brain) prepare us for reacting to strong emotional stimuli. The amygdala is responsible to responses to both pleasure and fear. Amygdala means almond in Latin and the term was first used in 1819.

Continue reading “BEATEN BRAIN ; BROKEN HEART”

The scientific community is undoubtedly guilty of sending erratic and confusing messages on dietary prevention of heart disease. The public has been informed that eggs are bad, then that they are good, and currently they are considered neutral. Fats were taught to be bad, but now the public is informed that some fats are good (omega-3 and omega-6 polyunsaturated fats), that animal data are neutral while trans fats are awful.

 

Despite repeated advice over the years by nutrition and health experts less than 0.5% of countries consume optimal fruits (300g a day) and vegetables (400 g a day) a day. More than 80% of countries consume more than the recommended red meat prescription of 100g per week.

  Continue reading “WE INDIANS NEED TO FOLLOW THE CHINESE MODEL OF LIFESTYLE MODIFICATION TO PREVENT HEART ATTACKS AND STROKE”

 

 

 

Atrial fibrillation (AF) is the commonest arrhythmia carrying the burden of cerebral embolus (CE), systemic embolus (SE) and aggravation of heart failure (HF). The risk of emboli is increased in persona with risk factors detailed by CHADS-VASc (Congestive heart failure, Hypertension, Age more than 75 years, Diabetes, Stroke, Vascular disease, Age between 65 and 74 Years, Sex category) score of 2 or more.

 

Traditionally the risk of embolism with subsequent morbidity and mortality has been managed by Warfarin, a vitamin K antagonist (VKA). Warfarin has always plagued treating physicians with a narrow therapeutic index, drug interactions, and need for repeated monitoring of efficacy by the International Normalized Ratio (INR). The ROCKET AF trial reported that only 55% of patients in the warfarin arm were in the INR therapeutic range.

Continue reading “ORAL ANTICOAGULANTS CONTINUE TO BE UNDER-UTILISED IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION”

 

 

Repeat coronary revascularization has always been found to be increased by routine follow up coronary angiography (FUCAG) in randomized trials done in the era of balloon angioplasty and percutaneous coronary intervention (PCI) with bare metal stents. But there was never any reduction in major clinical events. Myocardial infarction was reduced with angiographic follow up (AF) than with clinical follow up (CF) in BAAS (Balloon Angioplasty and Anticoagulation Study) and TAXUS –IV trials. Previous studies included low risk patients and hence impact of FUCAG in high-risk patients was unclear.

 

Continue reading “ROUTINE FOLLOW-UP CORONARY ANGIOGRAPHY AFTER INDEX PCI MAY BE UNNECESSARY”

 

 

 

 

Treatment of high blood pressure reduces mortality, heart failure and heart attacks. The American Association of Physicians recently stated in their guidelines on treatment of hypertension in people over 60 years that it was enough to bring down blood pressure below 150 mm Hg to reduce risk of death, stroke and cardiac events. If a 60 year old has had a stroke or TIA then the target should be below 140 mm Hg to prevent another stroke, similarly in a patient with diabetes, metabolic syndrome or chronic kidney disease the target should be below 140 mm Hg.

 

All guidelines advocate lowering of high cholesterol and low-density lipoprotein (LDL) to reduce cardiac events, stroke and mortality. Numerous randomized trials have concluded that lowering LDL levels are beneficial for clinical outcomes.

Continue reading “LOWERING BLOOD GLUCOSE IS NOT ENOUGH TO PREVENT CARDIOVASCULAR RISKS OR MORTALITY IN TYPE 2 DIABETES MELLITUS”

 

 

 

 

It does not necessarily mean that if both your parents or a parent died of a heart attack in their forties you too are going to suffer one. Researchers have identified about 50 genes associated with heart disease. But even if you carry all the 50 genes you can still substantially reduce your risk of a heart attack by employing simple life style measures. Healthy life style behaviour that includes not smoking, not acquiring too much weight, moderate exercise and eating healthy food is terrific strategy to improve cardiovascular health in the general population.

 

A recent study (NEJM 2016; 375:2349) analyzed data for participants in 3 prospective cohort trials and one cross-sectional study to test the theory that life style modification despite high-risk genes can cut down rates of a heart attack.

Continue reading “BAD GENES, DO NOT WORRY, EXERCISE A LITTLE AND EAT WELL.”

 

 

In the din of demonetization with its befuddling changing goal posts the dropping dead on a morning run of one of the leading gynecologists’ of Mumbai went largely unnoticed. True to form, the print and electronic media hardly raised a whisper on why a middle aged man who had numerous marathons under his belt and who regularly ran 10 kilometers every morning collapse and die whilst happily engaged in his morning run? There have been of course equally if not more serious issues to be dilated upon, ranging from lakhs of workers being waylaid and scores of people perishing while waiting their turn to draw their own money from the bank or an ATM machine. No serious commentary has emerged on the tantalizing reasons for the untimely death of a seemingly superbly fit leading gynecologist.

 

Physicians have for decades advised exercise as the best antidote for prevention of ill health, apart from statins, ACE inhibitors and beta-blockers. The Potsdam study unequivocally demonstrated that a healthy life consisting of moderate exercise and decent diet substantially cut down development of heart attack, stroke, diabetes and even cancer. Marathon running was considered by researchers to be the best immunization against atherosclerosis.

Continue reading “TOO MUCH EXERCISE MAY KILL; DEATH IN MARATHONERS.”

 

 

Dual antiplatelet therapy (DAPT) is considered standard treatment after percutaneous coronary intervention (PCI) accompanied by stent deployment. The optimal duration of DAPT after a drug eluting stent (DES) remains controversial. Six months of DAPT is the minimum duration recommended by all professional cardiology guidelines with a DES implantation.

 

Diabetes is associated with increased platelet and thrombin reactivity and decreased response to treatment. Diabetes is well known to trigger atherosclerosis and restenosis after PCI. It is unclear whether diabetes mandates a different protocol in DAPT duration. It has been suggested that patients with diabetes may require prolonged DAPT.

Continue reading “DURATION OF DUAL ANTI PLATELET THERAPY AFTER PCI WITH DRUG ELUTING STENT”

 

 

 

Current guidelines on treating patients with non-ST segment elevation myocardial infarction ( NSTEMI) recommend an invasive strategy because this reduces the risk of death and myocardial infarction ( MI) compared with a conservative or selectively invasive approach. The timing of the invasive strategy still remains controversial. The current European Society of Cardiology guidelines are based on old trials and a meta analysis published in 2013. The TIMACS trial including more than 3000 patients has been the largest trial on the subject to date. The study was stopped prematurely because of difficulty in enrolment and it did not meet its primary endpoint.

 

A meta analysis conducted in 2013 that included randomized and observational trials, comparing early invasive with delayed invasive strategies recorded nonsignificant reduction in mortality in the early invasive strategy group in the randomized trials and significant reduction in mortality in the observational data. There was however an increased rate of myocardial infarction in the early strategy group which was not significant.

 

The most recent meta analysis has added 3 more randomized studies to previous studies in order to better determine timing of intervention in NSTEMI. The median time between randomisation and angiography ranged from 0.5 to 14 hours in the early group, and from 18 to 86 hours in the delayed group. The researchers found in their meta analysis of 10 randomized trials that an early invasive strategy did not result in mortality benefit compared to a delayed approach. It is unlikely that a small delay in intervention would result in increased deaths in patients with NSTEMI ( J Am Coll Cardiol Intv 2016;9:2267-2276).

Continue reading “EARLY INVASIVE STRATEGY IN PATIENTS WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION IS SAFE AND EFFECTIVE”

 

 

 

About 5-8% of patients undergoing percutaneous coronary intervention also suffer from atrial fibrillation (AF). Oral anticoagulation with a vitamin K antagonist is better than dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor in preventing stroke in a patient with AF. On the other hand DAPT is superior to oral anticoagulation in reducing the risk of stent thrombosis with first generation stents.

 

Treatment in a patient with AF who has undergone PCI must balance the risk of bleeding with that of stent thrombosis and ischemic stroke. Triple therapy consisting of DAPT and oral anticoagulation may result in bleeds with rates of 2% in the first month and 4%-12% within the first year of treatment.

Continue reading “LOW DOSE RIVAROXABAN IS SAFE AND EFFECTIVE IN PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING PCI WITH CORONARY STENTING.”

 

The theoretical advantages  of the fully bioresorbable scaffolds (BRSs) include, to begin, with the ability to dissolve after some months, restoration of vasomotion of the coronary artery, improbability of late stent thrombosis because of absence of a pro-inflammatory polymer, no hindrance during future MRI or other imaging, and avoiding jailing of a side branch.

Continue reading “NO LATE CLINICAL GAINS WITH THE BIORESORBABLE SCAFFOLD ; ABSORB II TRIAL.”

 

 

Thiazide type diuretics are known to improve bone strength and reduce risk of fractures. Many observational studies have suggested this advantage of diuretics regarding bone strength. There is probably a positive effect on calcium balance and direct stimulation of osteoblasts. Beta-blockers may also reduce fracture risk but the jury is till out on the mechanism. Studies have shown that ACE inhibitors by blocking local angiotensin production that increases osteoclast activity increase bone strength. Some studies suggest lower fracture risk with ACE inhibitors but all do not agree. Little data is available on effect of calcium channel blockers on bone durability.

Continue reading “DIURETICS REDUCE HIP FRACTURES IN HYPERTENSION”

 

 

In an international prospective cohort study more than 14,000 patients undergoing non cardiac surgery were studied ( Vascular Events in Noncardiac Surgery Patients Cohort Events Evaluation-VISION). There were 4802 patients who were using an ACE inhibitor or an angiotensin II receptor blocker who were 45 years or older. The researchers studied the ramifications of withholding the ACE inhibitor / ARB a day before surgery. Compared to patients who continued with the ACE inhibitor/ ARB , the 1245 (26%) patients who stopped the drugs 24 hours before surgery had lower adverse events. The composite of death, ischemia induced injury(assessed by troponin) or strike were less (125/1245;12%) was less than in those who continued (459/3557;12.9%). There was an absolute reduction of 0.9% and relative reduction of 18% (p <0.01). Post operative hypotension was similar in both groups ( Anesthesiology; October 2016).

 

ACE inhibitors and ARB’s are known to produce intraoperative hypotension but thus is the first time adverse clinical effects have been recorded. It is not clear as to why the 26% patients stopped ACE inhibitor/ARB prior to non cardiac surgery. There was significantly less intraoperative hypotension in those who did stop the drugs.

Continue reading “DISCONTINUE BOTH ACE INHIBITOR/ARB OR BETA BLOCKER BEFORE NON CARDIAC SURGERY”

 

 

 

About 5% of patients undergoing coronary angiography are found to have left main coronary artery (LMCA) disease. Left main disease has proved to be lethal because the left main coronary artery supplies 100% of the left ventricle (LV) myocardium in a left dominant system, and 80% of LV myocardium in a right dominant system. Surgical revascularization has been the mainstay of treatment of LMCA disease for long. The SYNTAX trial however demonstrated that patients with LMCA could be managed with paclitaxel eluting stent in patients with low and intermediate coronary artery complexity (SYNTAX score <32). The study showed similar rates of death up to 5 years with percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG). There were similar rates in major adverse cardiac events at 12 months and at 5 years (Circulation 2014;129:2388-94).

 

 

Continue reading “THE ‘EXCEL’ AND NOBLE LEFT MAIN TRIALS GET FINALLY PRESENTED”

 

 

It is not uncommon to come across a patient brought into the emergency for syncope. Experienced clinicians are well aware that often despite extensive examination and investigations the cause cannot be confirmed. A recent paper has studied the prevalence of pulmonary embolism in patients admitted for syncope (NEJM 2016; 375:1524-31).

Continue reading “SYNCOPE DUE TO PULMONARY EMBOLISM IS NOT RARE”

 

 

 

The Mayo Clinic has published a paper on the surgical approach in patients hypertrophic obstructive cardiomyopathy (HOCM) accompanied by mitral regurgitation (MR). The study has confirmed what is already well known that MR in HOCM is dependent upon systolic anterior motion (SAM) and in most patients this can be corrected by extended myectomy alone.

 

 

Hypertrophic cardiomyopathy (HCM) is characterized by asymmetrical myocardial hypertrophy plus fiber fibrosis and disarray. About one third of HCM patients have resting left ventricular outflow tract obstruction (LVOTO) with >30 mm gradient at rest. Another third have a resting gradient < 30 mm but obstruction can be triggered by exertion, increased myocardial contractility or afterload.

Continue reading “SURGERY IN HOCM ACCOMPANIED BY MITRAL REGURGITATION”

The mandarins in the Indian health ministry have decided to include coronary stents in the National List of Essential Medicines (NLEM) to bring down the pricing by a staggering 50%. There were almost 500,00 coronary stents inserted across India in 2015. More than 60% of these stents were imported while the remainder were made in India. Health ministry officials insist that Indian stents are equal in efficacy and safety as compared to foreign stents, without a single head to head comparison of the device. But then one should never expect common sense or scientific temper from the bureaucrats hunched in Nirman Bhawan, Delhi.

 

Heart disease continues to be the biggest killer of the globe; more than 17.5 million die in a year. Millions of patients with heart disease get treated by coronary stents; including patients with stable angina and acute coronary syndrome. It is well recognized that drug eluting stents (DES) are more effective than bare metal stents (BMS) in preventing restenosis, and the newer generation DES have the lowest rate of stent thrombosis (ST). It has been suggested that the newer generation DES would therefore have the advantage of reduced rates of death and myocardial infarction.

Continue reading “IS THIS THE NEW BEGINNING FOR THE BARE METAL STENT ?”

 

 

We now  know that elections and are being rigged, both in the developing world, and in the first world. This realization is no longer the monopoly of conspiracy theorists. More startling however is the gradual clearing away of the fog over the publication of manifestly tailored scientific data that have been going around for quite a few years with the active connivance of leading medical journal editors. It has now become imperative to scrutinize every bit of the methods employed in a study, and the results presented to draw ones own conclusion, which more often than not may vary considerably from that of the researchers. Most, if not all, of these trials are industry sponsored and therefore guarantee reprint orders to the tune of hundreds of thousands of dollars. There is an extra-ordinary grip by the corporates on the major medical journals of the world. The main stream media have been all along unwittingly or by choice, pliable.

 

 

Continue reading “ANOTHER INDUSTRY SPONSORED TRIAL ON A NEW ANTI- DIABETES DRUG THAT EXAGGERATES EFFICACY REGARDING CARDIOVASCULAR SYSTEM”