The circles are proportional to the population sizes .
“ I want to point out that in the intensive group , 62 % were below 120 . It wasn ’ t 80 % below 120 , but 80 % were below 130 ,” he said , adding later , “ I believe that SPRINT will change systolic blood pressure goal recommendations in hypertension guidelines . I ’ m not sure if those guidelines will decide for the goal to be less than 120 or less than 130 .”
He noted the lack of heterogeneity in all major subgroups , both for the primary endpoint and for allcause mortality , and the general indication that the benefits of more aggressive treatment outweighed “ the relatively small risk ” of adverse events .
After stating that his assigned task in the debate “ is to attack ,” Dr . Kjeldsen did so with gusto , not relenting before he presented strong criticisms of the trial ’ s design and interpretation , and even a suggestion of unethical behavior on the part of the researchers and others .
“ We had great expectations ,” he said about the SPRINT results when they were presented at last year ’ s AHA annual meeting . “ I was sitting there in the front row expecting something fantastic . I was deeply disappointed there and increasingly disappointed during the year since .”
Dr . Kjeldsen ’ s first complaint was that SPRINT used a novel and unvalidated BP measuring technique , namely a programmed automated monitor that allowed for unattended BP measurement so as to reduce white coat hypertension . This sounds like a good idea , but since unattended BP measurements can stand as much as 20 mm Hg lower than usual office BP , 6 he argued that the systolic target of 120 mm Hg used in SPRINT is really not as different as it sounds compared to the prevailing target of 140 mm Hg . ( In his counter-comments , Dr . Cushman suggested the BP difference is “ more on the order of 5 to 10 mm Hg , at the most , at least from most literature that I ’ m aware of .”)
Another issue raised was whether one of the main findings of SPRINT , the significant reduction seen in new onset HF with aggressive treatment , was really “ an artifact ” caused by up- and downtitration of diuretics in patients with very high risk of heart failure , as Dr . Kjeldsen suggested . ( Dr . Cushman countered that the control patients “ probably ” received more diuretic treatment than they had before the study , as evidenced by their lower BPs during the study , but he added that the investigators are still looking closely at the effects of drug choices on outcomes .)
Pulling no punches , Dr . Kjeldsen finished his comments by questioning the way in which the SPRINT results were first released , referring to the decision of a “ limited group of SPRINT investigators under the leadership of the NIH Director ” to release top-drawer findings from SPRINT 2 months before
For all the progress made in technical refinement and patient selection in TAVR , the issue of post-procedural anticoagulation remains a great unknown , with little or no high-quality evidence to guide clinicians .
the study ’ s publication and full release at the 2015 AHA meeting .
“ Is it an ethical issue to announce sensational new data in a press release and potentially misinform the world for 2 months prior to the release of the data which can then be inspected by other experts and the community ?” He went on to ask : “ Will NIH repair the damage and issue a neutralizing statement ?”
For all these reasons plus a few more , Dr . Kjeldsen concluded his comments by unequivocally stating that the SPRINT trial “ should have no implications for guidelines or clinical practice .”
“ We really do have to look at this data very carefully before we make big decisions about guidelines ,” said Dr . Williams in his concluding remarks , made after the audience voted with their thumbs and awarded the winner ’ s garland to Dr . Kjeldsen . Dr . Williams summed it all up thus : “ There is little doubt that more blood pressure lowering is better for patients at high risk because whatever the blood pressure was and whatever it ended up at , the people who got more of it , did better … The debate is how low should we go in the context of recommendations and guidelines ? My own view is that the guidelines should remain conservative in that you can ’ t advocate levels of treatment that are potentially harmful to some [ emphasis his ], even if it benefits others .”
He also sent a little criticism back to the crowd who were eager to debate how low to go , noting that we do a “ lamentable ” job of lowering blood pressure altogether with less than 50 % of patients achieving BP < 140 mm Hg , “ and we ’ re here arguing whether we should try to go below 120 . So , the first thing we should focus on is how to get blood pressure to 140 in the majority and then focus on getting it lower .”
Editor ’ s Note : You can access ACC ’ s comprehensive coverage and join the discussion of the SPRINT trial at ACC . org / Sprint .
Thromboembolic Prevention After TAVR : Antiplatelets or Anticoagulants
For all the progress made in technical refinement and patient selection in transcatheter aortic valve replacement ( TAVR , or TAVI with the I for implantation for the Europeans ), the issue of post-procedural anticoagulation remains a great unknown , with little or no high-quality evidence to guide clinicians .
While there is general consensus in the guidelines against long-term anticoagulation with a vitamin K antagonist ( VKA ) after TAVR , 7 , 8 VKA use is recommended in the first 3 months , which some argue is also not appropriate .
“ What we know is that we know very little about this issue ,” said Lars Sondergaard , MD , DMSc , from Rigshospitalet in Copenhagen , Denmark . Arguing against antiplatelet therapy alone after TAVR , Dr . Sondergaard suggested that an antiplatelet only strategy is “ too simple .”
In the opposite corner was Antonio Colombo , MD , from the Centro Cuore Columbus in Milan Italy , who was assigned to argue the “ all we need are antiplatelet agents ” side . Dr . Colombo started his remarks by saying , “ For those people who are in a rush , I ’ ll just say that we have no answer because if we had an answer we would not be doing trials .”
Post-TAVR pharmacotherapy primarily consists of dual antiplatelet therapy ( DAPT ) with aspirin and clopidogrel for 1 to 6 months after implantation , and aspirin for life . If a patient has a pre-existing indication for oral anticoagulation ( OAC ), they are generally prescribed OAC or a novel oral anticoagulant ( NOAC ) for 3 to 6 months plus antiplatelet therapy and continued anticoagulation ( with or without aspirin ) for life . Acknowledging the higher risk of ischemic stroke or peripheral embolism ( compared to the normal population ) in the first 90 days after valve replacement , the 2014 ACC / AHA guidelines assign a Class IIb recommendation for oral anticoagulation with a VKA to achieve a target international normalized ratio of 2.5 for the first 3 months after TAVR , even in the absence of other risk factors ( Level of Evidence : B ). 7
Arguing against current recommendations , Dr . Colombo cited a recent meta-analysis by Masri et al . that compared VKA anticoagulation to antiplatelet therapy or no therapy in patients undergoing bioprosthetic valve implantation , 95 % of which were aortic . 9 Reviewing a total of 14 studies comprising 31,740 patients , and including two randomized trials , the authors found no significant differences in thromboembolic events , all-cause mortality , or the need for repeat surgery between those given VKAs and those receiving an antiplatelet or no therapy . However , there were significantly more bleeding events in those treated with warfarin .
Dr . Colombo noted that the incidence of clinically relevant transcatheter heart valve thrombosis is not well defined but appears to be quite
30 CardioSource WorldNews November 2016