{"id":7249,"date":"2011-03-30T10:28:22","date_gmt":"2011-03-30T14:28:22","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=7249"},"modified":"2011-07-19T17:45:18","modified_gmt":"2011-07-19T21:45:18","slug":"acc-preview-a-stich-in-time","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/03\/30\/acc-preview-a-stich-in-time\/","title":{"rendered":"ACC Preview: A STICH in Time"},"content":{"rendered":"

Eric Velazquez is the principal investigator of the STICH (Surgical Treatment for Ischemic Heart Failure) trial. He will present the main results of the trial at the Late’Breaking Clinical Trials II session on Monday morning. Velazquez relates the origins of STICH more than a decade ago and discusses some of the fascinating challenges of completing such a unique trial.<\/em><\/p>\n

________________________________________________<\/p>\n

Next week, I will present results of the Surgical Revascularization Hypothesis of the\u00a0Surgical Treatment for Ischemic Heart Failure,\u00a0or STICH, trial at the ACC. The trial’s origins go back more than a decade and emanated from three related clinical observations:<\/p>\n

1.\u00a0Heart failure patients were commonly\u00a0referred\u00a0for noninvasive testing to determine whether they should be considered candidates for CABG. For many physicians, those test results drove decision making<\/p>\n

2. Although,\u00a0overall, CABG rates were flat, or at some centers even decreasing, the proportion of patients with heart failure and left ventricular dysfunction who were referred\u00a0for CABG was rising.<\/p>\n

3. The Coronary Artery Surgery Study (CASS)\u00a0 and other randomized clinical trials that\u00a0informed the formulation of CABG guidelines excluded heart failure patients. These studies were performed in the 1970s,\u00a0before the initiation of\u00a0contemporary evidence-based medical therapy, leaving substantial clinical uncertainty regarding the incremental value of CABG for such patients.<\/p>\n

Medical therapy and CABG have improved dramatically since then for heart failure patients. For instance, aspirin was used in less than a quarter of CASS patients, beta blockers were contraindicated\u00a0for heart failure, and ACE inhibitors didn’t even exist. In surgery, the internal mammary artery was used in only 11% of cases.<\/p>\n

We’ve also changed our interpretation of earlier results. We now believe that CABG benefits those with the highest risk, and\u00a0we don’t remember that in the CASS trial and in the CASS registry reports, the presence of HF symptoms with no angina suggested no benefit from CABG. Clinical practice has\u00a0changed: PCI is used preferentially in lower-risk coronary cohorts while CABG is increasingly used in people with low EFs. In the New York database, for instance, upwards of 40% of the population who received\u00a0CABG had an EF that would have excluded them from previous randomized trials of CABG versus medical therapy.<\/p>\n

Beginning in 2000, in response to\u00a0these developments, we submitted an investigator-initiated request to the NIH\u00a0to evaluate the role of surgical revascularization in patients with heart failure. We were also\u00a0interested in, and have previously reported on,\u00a0the effect of adding SVR to CABG. We enrolled patients\u00a0whose physicians held in genuine equipoise the\u00a0question of whether continuing medical therapy or CABG was in that patient’s\u00a0best long-term interest. This enrollment strategy was challenging,\u00a0because many patients, cardiologists, and surgeons had preformed ideas\u00a0on the issue and\u00a0were hesitant to leave a decision regarding surgery to randomized assignment, but that’s what was needed to clearly answer the question.<\/p>\n

With the help of 1212 patients\u00a0enrolled by 99 clinical investigative teams in 22 countries, the STICH trial went forward. I remember presenting cases at some of\u00a0 the best surgical investigative\u00a0sites in the world, and watching the debate unfold regarding the best strategy for a particular patient. It was not unusual for several physicians\u00a0to present completely different perspectives on how\u00a0the patients should be evaluated and treated. These debates brought home to me that the answers were critically needed, despite\u00a0any difficulties. There is\u00a0tremendous heterogeneity in how heart failure patients with similar baseline features are evaluated and treated by excellent, well-intentioned physicians\u00a0who are\u00a0hampered by the lack of adequate data and evidence.<\/p>\n

We achieved excellent follow-up and are excited to present these results early next week at ACC. Following my presentation of the main results of the trial, Bob Bonow will present the results of an important substudy of patients who had SPECT or dobutamine.<\/p>\n

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Eric Velazquez is the principal investigator of the STICH (Surgical Treatment for Ischemic Heart Failure) trial. He will present the main results of the trial at the Late’Breaking Clinical Trials II session on Monday morning. Velazquez relates the origins of STICH more than a decade ago and discusses some of the fascinating challenges of completing […]<\/p>\n","protected":false},"author":454,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,14,9],"tags":[231,287,762],"class_list":["post-7249","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-heart-failure","category-interventional-cardiology","tag-cabg","tag-heart-failure-2","tag-stich"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7249","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/454"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=7249"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7249\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=7249"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=7249"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=7249"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}