Heart surgery’s ben­e­fits ques­tioned

$100M study: Stents, by­pass are no more ef­fec­tive than drugs for clogged ar­ter­ies

Baltimore Sun Sunday - - FRONT PAGE - By Carolyn Y. John­son

A ma­jor fed­er­ally funded study shows stents, by­pass surg­eries are no more ef­fec­tive than drugs for clogged ar­ter­ies.

Some of the most com­mon in­va­sive heart pro­ce­dures in Amer­ica are no bet­ter at pre­vent­ing heart at­tacks and death in pa­tients with sta­ble heart disease than pills and life­style im­prove­ments alone, ac­cord­ing to a mas­sive fed­er­ally funded study de­signed to re­solve a long-stand­ing con­tro­versy in car­di­ol­ogy.

Re­searchers found that in­va­sive pro­ce­dures to un­clog blocked ar­ter­ies — in most cases, the in­ser­tion of a stent, a tiny mesh tube that props open a blood ves­sel af­ter artery-clear­ing an­gio­plasty — were mea­sur­ably bet­ter than pills at re­duc­ing pa­tients’ chest pain dur­ing ex­er­cise. But the study, called ISCHEMIA, found no dif­fer­ence in a con­stel­la­tion of ma­jor heart-disease out­comes, in­clud­ing car­diac death, heart at­tacks, heartre­lated hos­pi­tal­iza­tions and re­sus­ci­ta­tion af­ter car­diac ar­rest.

Over­all, the keenly an­tic­i­pated ISCHEMIA study re­sults sug­gest that in­va­sive pro­ce­dures, stents and by­pass surgery, should be used more spar­ingly in pa­tients with sta­ble heart disease and the de­ci­sion to use them should be less rushed, ex­perts said.

The $100 mil­lion trial, pre­sented Satur­day at the an­nual meet­ing of the Amer­i­can Heart As­so­ci­a­tion ahead of pub­li­ca­tion in a peer-re­viewed journal, is the lat­est en­try into a long and con­tentious ar­gu­ment over how to treat artery block­ages, one that has pit­ted pow­er­ful fac­tions of Amer­i­can heart spe­cial­ists against each other. It echoes a sim­i­lar study 12 years ago that was heav­ily dis­puted by in­ter­ven­tional car­di­ol­o­gists, the doc­tors per­form­ing the in­va­sive pro­ce­dures.

“This is a mile­stone study that peo­ple will talk about and write about for years to come,” said El­liott Ant­man, a car­di­ol­o­gist at Brigham and Women’s Hospi­tal who was not in­volved in the study and praised it for the wealth of in­for­ma­tion gath­ered and the rigor and so­phis­ti­ca­tion of the analy­ses.

The abil­ity to im­plant stents us­ing a catheter in­serted through blood ves­sels in the arm or groin has trans­formed car­di­ol­ogy over the past three decades. Stents have been clearly demon­strated to save lives in peo­ple who are suf­fer­ing from a heart at­tack.

But as heart medicines such as statins have im­proved, there has been ac­tive de­bate about whether stents and other in­va­sive pro­ce­dures are more ef­fec­tive for peo­ple who aren’t in the throes of a heart at­tack, but have sta­ble heart disease — gen­er­ally de­fined as hav­ing clogged ar­ter­ies, some­times ac­com­pa­nied by chest pain, or angina, when they ex­ert them­selves.

A ma­jor study more than a decade ago found stents didn’t work bet­ter than drugs, but it trig­gered crit­i­cism, and proper use of stents has be­come one of the most heated de­bates in medicine — in part be­cause so much is at stake. Coro­nary heart disease af­fects 17.6 mil­lion Amer­i­cans; com­pa­nies that make stents are multi­bil­lion-dol­lar en­ter­prises; the pro­ce­dures are a ma­jor in­come stream to in­ter­ven­tional car­di­ol­o­gists and hos­pi­tals; and many peo­ple who have stents credit their good health to the pro­ce­dure.

The new study was de­signed to fi­nally set­tle the ques­tion of whether stents are bet­ter for pa­tients with sta­ble heart disease — and it could change how tens of thou­sands of peo­ple are treated in hos­pi­tals, trans­form how car­di­ol­o­gists talk with pa­tients about their op­tions, and save hun­dreds of mil­lions of dol­lars in health-care spend­ing each year.

But the de­bate over the trial’s re­sults be­gan be­fore it even fin­ished. Crit­ics com­pared a change to the trial’s de­sign to mov­ing the goal posts mid­way through and wor­ried that it would make the re­sults of the trial hard to in­ter­pret.

The lead­ers of the trial fired back that the change was part of the orig­i­nal trial de­sign.

Now, the de­bate can be­gin about the ev­i­dence. More than 5,000 pa­tients with moder­ate to se­vere sta­ble heart disease from 320 sites in 37 coun­tries were ran­domly as­signed af­ter a stress test in­di­cated heart disease. Half re­ceived med­i­cal ther­apy and life­style coun­sel­ing alone, and the other half re­ceived stents or by­pass surgery plus medicine. Pa­tients were fol­lowed, on av­er­age, for four years. There was no dif­fer­ence in the two groups’ ex­pe­ri­ence of a com­pos­ite of five disease-re­lated events, in­clud­ing car­diac death, heart at­tack, hos­pi­tal­iza­tions for heart fail­ure and un­sta­ble angina, and re­sus­ci­ta­tion af­ter a car­diac event.

The new study, Ant­man said, will give pa­tients and doc­tors a solid frame­work to dis­cuss the ben­e­fits and risks. For ex­am­ple, an el­derly pa­tient with sta­ble heart disease who isn’t very ac­tive but suf­fers some chest pain may de­cide on drug ther­apy. A younger pa­tient who has more fre­quent chest pain that im­pedes ac­tive daily life could try med­i­cal ther­apy, and opt for a more in­va­sive strat­egy if their life­style is still lim­ited.

“We want pa­tients to un­der­stand that it’s OK to pause and it’s not ur­gent that they have a pro­ce­dure,” said David Maron, di­rec­tor of pre­ven­tive car­di­ol­ogy at Stan­ford Univer­sity, one of the study’s lead­ers. “It’s im­por­tant for physi­cians to un­der­stand how symp­to­matic a pa­tient is — and what is it worth to the pa­tient to go ahead and have a pro­ce­dure.”


The study pre­sented Satur­day sug­gests that in­va­sive pro­ce­dures should be used more spar­ingly in those with heart disease.

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