Doc­tor may not say it’s un­likely you need a stent

The News & Observer (Sunday) - - Opinion - BY RITA F. REDBERG Los An­ge­les Times Rita F. Redberg is a car­di­ol­o­gist and pro­fes­sor at the UC San Fran­cisco School of Medicine.

For years, the usual pro­to­col in pa­tients with blocked ar­ter­ies has been for doc­tors to per­form an­gio­plasty, in­sert­ing a tiny mesh tube known as a stent to keep the artery open. The pro­ce­dure is per­formed nearly a mil­lion times a year in the U.S.

Like most in­va­sive pro­ce­dures, how­ever, this one comes with sig­nif­i­cant risks, in­clud­ing the po­ten­tial for heart at­tack, kid­ney fail­ure, stroke and bleed­ing. In ad­di­tion, in­sert­ing stents is ex­pen­sive: Medi­care spent more than $10 bil­lion last year on the pro­ce­dure.

The ex­pen­di­ture would be jus­ti­fied if stents were the only – or even the best – way to treat blocked ar­ter­ies. But re­search has now shown defini­tively that, ex­cept for peo­ple in the throes of a sud­den heart at­tack, an­gio­plasty and stents are no bet­ter at prevent­ing fu­ture heart at­tacks or keep­ing pa­tients alive than ad­min­is­ter­ing in­ex­pen­sive and safe med­i­ca­tions.

So, why is the pro­ce­dure so widely used? The rea­sons are com­pli­cated. The use of stents en­tered clin­i­cal prac­tice more than 40 years ago with­out any ev­i­dence from ran­dom­ized head-to­head com­par­isons of stents to med­i­ca­tions. Be­lief in their su­pe­ri­or­ity quickly be­came so great among the car­di­ol­o­gists per­form­ing the pro­ce­dure that there seemed no need to con­duct ran­dom­ized stud­ies.

Even­tu­ally, how­ever, such tri­als were done, and one af­ter an­other they found lit­tle or no dif­fer­ence in out­comes be­tween stents and med­i­ca­tion. But es­tab­lished prac­tice is slow to change.

The most re­cent trial should end de­bate. The well-de­signed, fed­er­ally funded so-called Is­chemia study fol­lowed more than 5,000 pa­tients with heart block­ages and chest pain over 3½ years, and it pro­vided con­clu­sive ev­i­dence that stents were no bet­ter than med­i­ca­tions in prevent­ing heart at­tacks or sav­ing lives.

De­spite this strong, high-qual­ity ev­i­dence, many pro­po­nents of stents jus­tify their con­tin­ued use cit­ing ev­i­dence that pa­tients who re­ceive stents have less chest pain. But a study from 2017 con­vinc­ingly re­futes this claim. A Bri­tish study com­pared pa­tients’ re­ported chest pain, tread­mill stam­ina and qual­ity of life be­tween one group who un­der­went an­gio­plasty and re­ceived stents, and a sec­ond “placebo con­trol” group that un­der­went anes­the­sia and all the other parts of the pro­ce­dure, but ac­tu­ally did not get a stent. Pa­tients who thought they got stents but did not scored the same in chest pain re­duc­tion, tread­mill tests and qual­ity of life as those who ac­tu­ally re­ceived stents, re­veal­ing that the pow­er­ful placebo ef­fect, long ob­served in drug tri­als, is plainly ev­i­dent in de­vice tri­als, too. In other words, it ap­pears that pain im­prove­ments that have been at­trib­uted to an­gio­plasty and stents are likely due to the placebo ef­fect of the pro­ce­dure.

Sev­eral stud­ies have shown that pa­tients aren’t told or don’t un­der­stand the risks or that stent­ing has been found no more ef­fec­tive than medicines in prevent­ing a heart at­tack or death. In my prac­tice, I find that pa­tients al­most al­ways pre­fer to avoid in­va­sive pro­ce­dures when they are fully in­formed that med­i­cal ther­apy will work equally well. More talk and less in­ter­ven­tion could save bil­lions of dol­lars on pro­ce­dures with less risk of harm­ing pa­tients.

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