Dr Mark Eisenberg, professor of medicine at Jewish General University Hospital in Montreal, presented the EVITA trial[1] this morning. By his description, this was "the highest-risk population ever exposed to varenicline [Chantix/Champix, Pfizer]" in the history of smoking-cessation data. These were the sickest of the sick. All had experienced a heart attack in the past 48 hours. Some suffered from ischemic cardiomyopathy, exhibited heart failure, or had no targets for revascularization. One patient was so ill that he needed a transplant, was denied it, and subsequently died before he left the hospital. When the investigators chose this population, they weren't fooling around.
There is hardly anything negative any non–tobacco-industry-employed individual can say about this trial. Researchers enrolled cohorts without heavy exclusionary criteria but did exclude those with a significant psychiatric history. They randomized cohorts to on-drug therapy vs placebo and followed them for 6 months. By avoiding intense proselytizing, the bias of counseling was not injected into the trial data. Amazingly, in this population of hardened smokers whose vessels were no doubt crusty from the ravages of one-pack-per-day smoking for 3 decades, cessation rates at 24 weeks were impressive. Both encouraging and reassuring, a 50% abstinence rate was achieved in the treatment population vs one-third of the placebo-treated group.
Reassuring as well, major adverse cardiovascular events (MACE) were similar on and off therapy. There was a definite increase in vivid dreams at 15% on treatment vs 3 % on placebo. I often point out to concerned patients who are considering this therapy that brain metastasis and oxygen dependence are nightmares from which most will never awaken. I'd personally take my chances with varenicline, and for a few patients I offered to swallow a pill right along with their first one. I'm not afraid of varenicline.
Perhaps the most impressive statistic gleaned from these data is a dreamy number needed to treat (NNT) of 6.8. If we as clinicians will just pitch a Chantix prescription at nearly all of our smoking ACS patients, we will create one nonsmoker. We know this will translate into more grandparents living to see their grandchildren. We will help put back $8500 every 5 years into the family budget, not to mention the reduction in the incidence of cancer and COPD. Add the positive health benefits of reduction in smoke exposure for those who cohabitate with these patients, and it's a win-win. Reduce the world's burden of expenditures for preventable tobacco-related illnesses, and we could feed the masses.
The tobacco industry, of course, will be the only ones who cry foul (or they will hire someone to do it for them). They are fighting to preserve their financial stability at the detriment of the world's population. The two CV deaths noted in this trial included a patient who was denied a heart transplant. The other presented with an LVEF of 20% and other comorbidities. A third patient died of a perforated gastric ulcer weeks following discharge. In 300 post-MI patients, 85% of whom underwent PCI and 10% who underwent CABG, one would unfortunately expect some deaths in this population.
The holy grail of smoking-cessation therapy is efficacy. and efficacy was well demonstrated here today. Perhaps with more data, registries and regulatory agencies will someday add a check box for discharge planning right under aspirin, prn nitro, beta-blockers, and statins for a specific varenicline discussion (instead of the usual general smoking-cessation option).
Since the smoking habit is the most lethal pastime for ACS patients, perhaps slightly less than playing Russian roulette or driving at 100 mph blind-folded sans seatbelt, we as clinicians and researchers are desperate to find something to help. For some of these unfortunate patients, despite the number of zippers on their sternums, the number of limbs lost or strokes suffered, the call of addiction never sleeps. To date, we've not known for certain that we had anything that could really help them. Sounds like we finally have something that really does.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Melissa Walton-Shirley. New ACS Cocktail: ASA, Antiplatelets, Beta-blockers, and Now Varenicline? - Medscape - Nov 10, 2015.
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