{"product_id":"stents-vs-bypass-surgery-for-three-vessel-heart-disease-what-the-fame-3-study-found","title":"Stents vs. Bypass Surgery for Three-Vessel Heart Disease: What the FAME 3 Study Found","description":"\u003cp\u003eIn patients with three-vessel coronary artery disease, blockages are present in all three main heart arteries. A stenting procedure guided by fractional flow reserve (FFR) did not match bypass surgery for preventing serious heart and brain events over one year. The FAME 3 trial randomly assigned 1,500 patients at 48 centers to either FFR-guided PCI (percutaneous coronary intervention, or stenting) or CABG (coronary-artery bypass grafting, or open-heart bypass surgery). After one year, 10.6% of the stenting group had died, had a heart attack, had a stroke, or needed another procedure. That is about 11 in 100 patients, compared with 6.9% of the bypass group, or about 7 in 100. The hazard ratio was 1.5. Bypass surgery caused more major bleeding, irregular heart rhythms, kidney injury, and longer hospital stays. But bypass surgery was clearly better at preventing the combined outcome the trial set out to measure.\u003c\/p\u003e\n\n\u003ch1\u003eFractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery FAME3\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n\u003cli\u003e\u003ca href=\"#background\"\u003eWhy This Research Matters\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#methods\"\u003eHow the Study Was Designed\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#participants\"\u003eWho Took Part in the Study\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#procedures\"\u003eWhat the Two Treatments Involved\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#endpoints\"\u003eWhat the Researchers Measured\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#statistics\"\u003eHow the Numbers Were Analyzed\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#results\"\u003eMain Results: The Primary End Point\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#components\"\u003eIndividual Outcomes and Repeat Procedures\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#safety\"\u003eSafety: Where Bypass Surgery Caused More Problems\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#implications\"\u003eWhat These Findings Mean for Patients\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#limitations\"\u003eLimitations of the Study\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#recommendations\"\u003ePractical Takeaways\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIn a 1,500-patient trial, FFR-guided stenting did not match bypass surgery for preventing death, heart attack, stroke, or repeat procedures at one year (10.6% vs 6.9%).\u003c\/li\u003e\n\u003cli\u003eBypass surgery caused more short-term problems: major bleeding, kidney injury, irregular heart rhythms, longer hospital stays, and more 30-day readmissions.\u003c\/li\u003e\n\u003cli\u003eStenting offered a faster, less invasive recovery, with a median hospital stay of 3 days versus 11 days for bypass surgery.\u003c\/li\u003e\n\u003cli\u003eThe trial included mostly men (81–83%) and mostly White patients (92–94%), so results may not fully apply to women or more diverse groups.\u003c\/li\u003e\n\u003cli\u003eResults cover one year only; longer follow-up is needed to see whether the gap between stenting and bypass narrows, widens, or stays the same.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eWhy This Research Matters\u003c\/h2\u003e\n\n\u003cp\u003eLarge randomized trials have already shown that open-heart bypass surgery produces better outcomes than percutaneous coronary intervention (PCI). Open-heart bypass surgery is also called coronary-artery bypass grafting, or CABG. Percutaneous coronary intervention (PCI) is the older approach of opening blockages with balloons and stents. These trials studied patients with three-vessel coronary artery disease. But those earlier trials had two important gaps.\u003c\/p\u003e\n\n\u003cp\u003eFirst, they rarely used the newer, second-generation drug-eluting stents. A drug-eluting stent is a tiny wire mesh tube coated with medication that slowly releases into the artery wall to stop the blockage from growing back. Second-generation versions have improved both early and late results. They cause less stent thrombosis, which is a blood clot forming inside the stent. They cause fewer heart attacks during and after procedures. They cause less restenosis, which is the artery narrowing again. They cause fewer deaths than the first-generation stents did.\u003c\/p\u003e\n\n\u003cp\u003eSecond, the older trials did not routinely measure a value called fractional flow reserve to guide the stenting. FFR is measured with a thin coronary pressure wire threaded into the artery. It gives a more accurate picture of how much a blockage actually restricts blood flow than an angiogram (an X-ray dye picture of the arteries) does on its own. A low FFR means the blockage is truly limiting blood flow; a high FFR means it is not.\u003c\/p\u003e\n\n\u003cp\u003ePCI guided by FFR leads to better short-term and long-term outcomes than PCI guided by angiography alone, or than treating with medication only. The FAME 3 investigators therefore set out to test whether FFR-guided PCI using current-generation drug-eluting stents could hold its own against bypass surgery in patients with three-vessel disease.\u003c\/p\u003e\n\n\u003ch2 id=\"methods\"\u003eHow the Study Was Designed\u003c\/h2\u003e\n\n\u003cp\u003eFAME 3 was an investigator-initiated, multicenter, international, randomized, controlled trial run at 48 sites. It was designed as a \"noninferiority\" trial. That means the researchers were not trying to prove stenting was better than surgery — they were testing whether stenting was no worse than surgery by more than a pre-agreed amount.\u003c\/p\u003e\n\n\u003cp\u003eThe trial was supported by research grants to Stanford University from Medtronic and Abbott Vascular. Neither company had any role in designing the trial, running it, or preparing the manuscript. Stanford University oversaw the trial.\u003c\/p\u003e\n\n\u003cp\u003ePatients were assigned in a 1:1 ratio — half to CABG, half to FFR-guided PCI. Assignment was done through a web-based system and was stratified by diabetes status and by trial site, so that each group would be balanced on those two factors.\u003c\/p\u003e\n\n\u003cp\u003eThe main requirement to join the study was three-vessel coronary artery disease. Three-vessel coronary artery disease was defined as at least 50% narrowing (diameter stenosis) in each of the three major heart vessels or their major side branches. This was judged by visual estimation. The left main coronary artery could not be involved. The blockages also had to be treatable by either PCI or CABG, as decided by the heart team at each site.\u003c\/p\u003e\n\n\u003cp\u003ePeople were excluded if they had a recent ST-segment elevation myocardial infarction (STEMI), the most severe type of heart attack. People were excluded if they had cardiogenic shock, the heart failing so badly it cannot pump enough blood for the body. People were excluded if they had a left ventricular ejection fraction below 30%. Ejection fraction is the percentage of blood in the heart's main pumping chamber that is pushed out with each beat; below 30% indicates a seriously weakened heart.\u003c\/p\u003e\n\n\u003cp\u003eThe trial protocol was approved by the relevant institutional review boards or ethics committees, and every participant gave written informed consent.\u003c\/p\u003e\n\n\u003ch2 id=\"participants\"\u003eWho Took Part in the Study\u003c\/h2\u003e\n\n\u003cp\u003eA total of 1,500 patients were enrolled: 757 assigned to PCI and 743 to CABG. The two groups were well matched at the start.\u003c\/p\u003e\n\n\u003cp\u003eThe average age was about 65 years (65.2 years in the PCI group and 65.1 in the CABG group). Most patients were men: 81.4% in the PCI group and 83.3% in the CABG group. About 94% of patients in the PCI group and 92% in the CABG group were White. Average body-mass index was 28.6 in the PCI group and 28.7 in the CABG group.\u003c\/p\u003e\n\n\u003cp\u003eOther baseline characteristics were closely similar between the groups:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiabetes:\u003c\/strong\u003e 28.3% of the PCI group and 28.8% of the CABG group. About 7–8% of patients in each group needed insulin (7.3% vs 8.2%).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHigh blood pressure (hypertension):\u003c\/strong\u003e 71.2% vs 75.0%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAbnormal cholesterol levels (dyslipidemia):\u003c\/strong\u003e 68.9% vs 71.7%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCurrent tobacco use:\u003c\/strong\u003e 19.2% vs 18.4%; former smokers made up 39.2% vs 39.9%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFamily history of coronary artery disease:\u003c\/strong\u003e 32.5% vs 28.8%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrevious heart attack:\u003c\/strong\u003e 33.3% vs 33.5%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrevious PCI:\u003c\/strong\u003e 13.0% vs 14.0%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrior transient ischemic attack (TIA) or stroke (cerebrovascular accident):\u003c\/strong\u003e 6.5% vs 7.6%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eKidney disease\u003c\/strong\u003e (defined as an estimated glomerular filtration rate below 60 ml per minute per 1.73 m² of body-surface area): 4.9% vs 5.9%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReduced left ventricular ejection fraction (50% or less):\u003c\/strong\u003e 18.2% vs 17.6%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHospitalized with a non–ST-segment elevation acute coronary syndrome:\u003c\/strong\u003e 39.7% vs 38.7%.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eOn the angiograms, patients had a mean of 4.3 blockages (lesions). Twenty-two percent had at least one completely blocked vessel (chronic total occlusion), and 68% had at least one bifurcation lesion — a blockage at a point where one artery splits into two. The mean SYNTAX score, which grades how complex the coronary disease is, was 26. Lower SYNTAX scores indicate simpler disease and predict a better outcome with stenting.\u003c\/p\u003e\n\n\u003ch2 id=\"procedures\"\u003eWhat the Two Treatments Involved\u003c\/h2\u003e\n\n\u003cp\u003eBypass surgery was performed according to the standard practice at each participating center. Complete arterial revascularization was strongly recommended. This means surgeons were encouraged to use arteries rather than veins for the grafts. Measuring FFR to guide the surgery was not required, but if it had already been done during the diagnostic angiogram, the surgeon could use that information.\u003c\/p\u003e\n\n\u003cp\u003eEveryone assigned to PCI first had FFR measured with a coronary pressure wire (Abbott Vascular) using adenosine given intravenously or directly into the coronary artery. Only blockages with an FFR of 0.80 or lower were treated with a stent. Stenting used durable-polymer zotarolimus-eluting stents (Resolute Integrity or Resolute Onyx, Medtronic). Measuring FFR again after stenting was encouraged, and intravascular imaging was used when the treating physician felt it was needed.\u003c\/p\u003e\n\n\u003cp\u003eAll patients in both groups were to receive aspirin, a high-dose statin, and guideline-directed medical therapy. Patients who had PCI also took a second antiplatelet medication for at least 6 months afterward. Follow-up visits took place at hospital discharge and at 1, 6, and 12 months.\u003c\/p\u003e\n\n\u003cp\u003eHow the procedures compared in practice:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTime to the procedure:\u003c\/strong\u003e a median of 4 days after randomization for PCI (interquartile range 1 to 13 days) versus 13 days for CABG (interquartile range 6 to 26 days).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedure duration:\u003c\/strong\u003e a median of 87 minutes for PCI (67 to 113 minutes) versus 197 minutes for CABG (155 to 239 minutes).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHospital stay:\u003c\/strong\u003e a median of 3 days for PCI (1 to 7) versus 11 days for CABG (7 to 16).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStents:\u003c\/strong\u003e an average of 3.7 stents per patient (plus or minus 1.9), with a median total stented length of 80 mm (52 to 116 mm). Twenty-two percent of PCI patients needed a staged procedure — a second session on another day.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eBypass grafts:\u003c\/strong\u003e an average of 3.4 distal anastomoses (graft connections) per patient; 97% received a left internal thoracic artery graft, and 24.5% received multiple arterial grafts. About 24% had off-pump surgery, meaning the heart was not stopped and no heart-lung machine was used.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntravascular imaging during PCI:\u003c\/strong\u003e used in about 12% of cases.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eFFR was actually measured in 82% of the blockages in the PCI group. The most common reason for skipping it was that the vessel was subtotally or completely blocked. The mean FFR was 0.70. Of the lesions that had been intended for treatment, 24% turned out to have an FFR greater than 0.80. This means they were not significantly limiting blood flow and were left alone. FFR was measured again after stenting in 60% of the treated blockages, with a mean value of 0.88, indicating that blood flow had been restored. In the CABG group, FFR was measured before surgery in 10% of patients.\u003c\/p\u003e\n\n\u003ch2 id=\"endpoints\"\u003eWhat the Researchers Measured\u003c\/h2\u003e\n\n\u003cp\u003eThe primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event. This was defined as any one of the following: death from any cause, myocardial infarction (heart attack), stroke, or repeat revascularization (another procedure to reopen or bypass arteries).\u003c\/p\u003e\n\n\u003cp\u003eHeart attacks were classified as either procedural or spontaneous. In both groups, a procedural heart attack was defined by a rise in cardiac troponin within 72 hours after the procedure. Cardiac troponin is a protein released when heart muscle is damaged. The rise had to be to more than 10 times the 99th percentile of the upper reference limit. This applied to patients whose troponin was normal beforehand. For patients whose troponin was already elevated, the threshold was an increase of more than 20%. In addition, at least one of these had to be present. One was new pathologic Q waves on the electrocardiogram or a new left bundle-branch block. One was angiographic proof of a new graft or major native coronary blockage. One was imaging showing new loss of viable heart muscle or a new regional wall-motion abnormality. This definition matches the type 5 category (post-bypass procedural heart attack) in the Third and Fourth Universal Definitions of Myocardial Infarction.\u003c\/p\u003e\n\n\u003cp\u003eSpontaneous heart attack was defined as a rise or fall in troponin with at least one value above the 99th percentile of the upper reference limit. There also had to be evidence of reduced blood supply to the heart. That evidence had to be shown by at least one of the following. One was symptoms of ischemia, such as chest pain or its equivalents. One was electrocardiographic changes indicating new ischemia. One was development of pathologic Q waves. One was imaging evidence of new loss of viable heart muscle or a new regional wall-motion abnormality.\u003c\/p\u003e\n\n\u003cp\u003eSecondary end points included the composite of death, heart attack, or stroke, along with safety outcomes. An independent clinical events committee reviewed and adjudicated all events without knowing which treatment each patient had received.\u003c\/p\u003e\n\n\u003ch2 id=\"statistics\"\u003eHow the Numbers Were Analyzed\u003c\/h2\u003e\n\n\u003cp\u003eThe main analysis followed the intention-to-treat principle, meaning patients were analyzed in the group they were originally assigned to, whether or not they received that treatment.\u003c\/p\u003e\n\n\u003cp\u003eThe researchers initially assumed that 12% of patients assigned to CABG would have a primary end-point event within 1 year. They also assumed that PCI patients would not be at higher risk than CABG patients. Under those assumptions, they used a noninferiority boundary of less than 1.45 for the upper end of the 95% confidence interval of the hazard ratio. They calculated that 712 patients per group would be needed. That is 1,424 patients in total. This would give 90% statistical power to claim noninferiority.\u003c\/p\u003e\n\n\u003cp\u003eDuring enrollment, and without knowing what the actual event rates were, the trial steering committee decided to relax the noninferiority margin to less than 1.65. They judged this more appropriate based on newly published trials comparing CABG with PCI. Those trials reported major adverse cardiac or cerebrovascular events in no more than 10% of patients assigned to bypass surgery. Those trials used noninferiority margins similar to a hazard ratio of 1.65. With the wider margin, only 645 patients per group (1,290 total) were needed for 90% power. Even so, the committee completed the scheduled enrollment of 1,500 patients.\u003c\/p\u003e\n\n\u003cp\u003eBetween-group differences were shown with cumulative-incidence curves and estimated with a Cox proportional hazards model. That model adjusted for the stratification factors by including baseline diabetes status and by allowing the baseline risk to vary from site to site. Each component of the primary end point was compared separately. Safety end points were compared using chi-square or Fisher's exact tests as appropriate. The proportional hazards assumption was checked with a two-sided score test of the scaled Schoenfeld residuals at the 0.05 level. Noninferiority was assessed with a Wald test at the 0.025 significance level.\u003c\/p\u003e\n\n\u003cp\u003eSubgroup analyses used the same Cox proportional hazards framework and were displayed as a forest plot for these prespecified characteristics: age (under 65 vs. 65 or older), sex, presence or absence of diabetes, presence or absence of acute coronary syndrome, left ventricular ejection fraction (above 50% vs. 50% or below), previous PCI, and core laboratory–assessed SYNTAX score. A post hoc sensitivity analysis used an alternative definition of procedure-related clinically relevant heart attack proposed by the Society for Cardiovascular Angiography and Interventions. Analyses were independently reproduced within the statistical team using SAS version 9.4 and R version 4.0.15.\u003c\/p\u003e\n\n\u003ch2 id=\"results\"\u003eMain Results: The Primary End Point\u003c\/h2\u003e\n\n\u003cp\u003eFollow-up at 1 year was completed in 99.7% of patients — an exceptionally high rate that makes the results highly reliable.\u003c\/p\u003e\n\n\u003cp\u003eFFR-guided PCI did not meet the trial's definition of noninferiority. At 1 year, the primary end point had occurred in 80 of 757 PCI patients (10.6%, about 11 in 100) and in 51 of 743 CABG patients (6.9%, about 7 in 100). The hazard ratio was 1.5, with a 95% confidence interval of 1.1 to 2.2. The P value for noninferiority was 0.35.\u003c\/p\u003e\n\n\u003cp\u003eIn plain terms, that P value means the result failed the statistical test required to declare stenting \"no worse\" than surgery. The confidence interval is also informative. Even the most optimistic end of the range (1.1) is above 1.0. The entire range sits well above the pre-specified noninferiority boundary of 1.65 only at its lowest end. It does not. When a confidence interval does not fall entirely below the noninferiority limit, noninferiority cannot be claimed.\u003c\/p\u003e\n\n\u003ch2 id=\"components\"\u003eIndividual Outcomes and Repeat Procedures\u003c\/h2\u003e\n\n\u003cp\u003eWhen the researchers looked at each piece of the primary end point separately, there was no clear evidence of a difference between the groups. The numbers were as follows:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeath from any cause:\u003c\/strong\u003e 1.6% with PCI (about 2 in 100) vs. 0.9% with CABG (about 1 in 100); hazard ratio 1.7 (95% CI, 0.7 to 4.3).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeath from cardiac causes:\u003c\/strong\u003e 0.8% vs. 0.5%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eHeart attack (myocardial infarction):\u003c\/strong\u003e 5.2% vs. 3.5%; hazard ratio 1.5 (95% CI, 0.9 to 2.5). Of these, spontaneous heart attacks occurred in 3.3% vs. 2.3%, and procedural heart attacks in 1.7% vs. 1.2%.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStroke:\u003c\/strong\u003e 0.9% with PCI vs. 1.1% with CABG; hazard ratio 0.9 (95% CI, 0.3 to 2.4).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCombined death, heart attack, or stroke:\u003c\/strong\u003e 7.3% with PCI (about 7 in 100) vs. 5.2% with CABG (about 5 in 100); hazard ratio 1.4 (95% CI, 0.9 to 2.1).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRepeat revascularization:\u003c\/strong\u003e 5.9% with PCI vs. 3.9% with CABG; hazard ratio 1.5 (95% CI, 0.9 to 2.3). Of these repeat procedures, 5.2% vs. 3.5% were repeat PCIs, and 0.8% vs. 0.4% were repeat bypass operations.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe authors note an important caution here. The confidence intervals for these secondary end points were not adjusted for multiple comparisons. So they should not be interpreted as definitive proof of a treatment effect on any single component.\u003c\/p\u003e\n\n\u003cp\u003eThere were no obvious differences between the groups in the medications patients were taking at 1 year. The one exception was that more patients in the FFR-guided PCI group were still on dual antiplatelet therapy and nitrate therapy.\u003c\/p\u003e\n\n\u003ch2 id=\"safety\"\u003eSafety: Where Bypass Surgery Caused More Problems\u003c\/h2\u003e\n\n\u003cp\u003eThe safety picture ran in the opposite direction from the effectiveness picture. Patients randomly assigned to CABG had longer hospital stays and higher rates of several complications. Patients lost to follow-up before the end of the first year were excluded from these comparisons.\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eMajor bleeding\u003c\/strong\u003e (Bleeding Academic Research Consortium type 3 to 5, meaning severe bleeding): 1.6% with PCI (about 2 in 100) vs. 3.8% with CABG (about 4 in 100); P = 0.009.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAcute kidney injury:\u003c\/strong\u003e 0.1% with PCI (about 1 in 1,000) vs. 0.9% with CABG (about 1 in 100); P = 0.04. Acute kidney injury was defined as a rise in serum creatinine of at least 0.3 mg per deciliter (26.5 micromoles per liter) within 48 hours. Acute kidney injury was also defined as a rise to at least 1.5 times a known or presumed baseline within the previous 7 days. Acute kidney injury was also defined as urine output below 0.5 ml per kilogram of body weight per hour for 6 hours.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAtrial fibrillation or clinically significant arrhythmia (irregular heart rhythm):\u003c\/strong\u003e 2.4% with PCI (about 2 in 100) vs. 14.1% with CABG (about 14 in 100); P \u0026lt; 0.001. This was the largest safety difference in the trial.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDefinite stent thrombosis:\u003c\/strong\u003e 0.8% in the PCI group (6 patients); not applicable to the CABG group.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDefinite symptomatic graft occlusion:\u003c\/strong\u003e 1.3% in the CABG group (10 patients); not applicable to the PCI group.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRehospitalization within 30 days:\u003c\/strong\u003e 5.5% with PCI (about 6 in 100) vs. 10.2% with CABG (about 10 in 100); P \u0026lt; 0.001.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"implications\"\u003eWhat These Findings Mean for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThe headline conclusion is straightforward. In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG. This applied to preventing the combined outcome of death, heart attack, stroke, or repeat revascularization at 1 year.\u003c\/p\u003e\n\n\u003cp\u003eThe authors point out that these results align with earlier trials comparing CABG with PCI. But there is one important difference. In this trial, FFR was measured routinely to guide the stenting, with the expectation that this would lead to more judicious use of stents. The idea was that an FFR-guided strategy would treat only the blockages that genuinely restricted blood flow. Those blockages are known to cause more adverse events when treated with medication alone. The strategy would also avoid stenting blockages that were not limiting flow. Those blockages would respond just as well to medication.\u003c\/p\u003e\n\n\u003cp\u003eEven with that more selective approach and with modern drug-eluting stents, stenting still fell short of surgery on the trial's primary measure. That makes the finding especially meaningful. The advantage of bypass surgery in this patient group does not appear to be explained away by older stent technology. The advantage also does not appear to be explained away by stenting blockages that did not need stents.\u003c\/p\u003e\n\n\u003cp\u003eAt the same time, the two treatments carry very different risk profiles, and patients and their care teams must weigh both sides. Bypass surgery involved a longer wait to treatment (median 13 days vs. 4), a longer operation (median 197 minutes vs. 87), a longer hospital stay (median 11 days vs. 3), more severe bleeding (3.8% vs. 1.6%), far more irregular heart rhythms (14.1% vs. 2.4%), more kidney injury (0.9% vs. 0.1%), and more readmissions within 30 days (10.2% vs. 5.5%). Stenting, on the other hand, carried a higher rate of the combined serious-event outcome over the first year.\u003c\/p\u003e\n\n\u003cp\u003eThis means the decision is genuinely a trade-off. For patients with three-vessel disease, surgery lowered the combined risk of death, heart attack, stroke, or repeat procedures at 1 year, although the difference was not clear for any one of these outcomes on its own. But surgery comes at the cost of a harder recovery and more short-term complications. Stenting offers a faster, less invasive recovery, but with a higher risk of needing another procedure or having a serious event in the first year.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eLimitations of the Study\u003c\/h2\u003e\n\n\u003cp\u003eSeveral aspects of this trial deserve careful thought before drawing broad conclusions.\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eThe results cover one year only.\u003c\/strong\u003e Longer-term follow-up will be needed to see whether the gap between the two treatments narrows, widens, or stays the same over 5 or 10 years.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThe noninferiority margin was changed mid-trial.\u003c\/strong\u003e The steering committee widened the acceptable margin from a hazard ratio below 1.45 to below 1.65 while enrollment was ongoing. Even with the wider margin, the trial still failed to show noninferiority — which strengthens rather than weakens the conclusion, but the change should be noted.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThe secondary end points were not adjusted for multiple comparisons.\u003c\/strong\u003e The authors explicitly warn that these confidence intervals should not be used to make definitive claims about individual outcomes such as death or stroke.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCertain patients were excluded.\u003c\/strong\u003e People with recent STEMI heart attacks, cardiogenic shock, or an ejection fraction below 30% were not included, so the findings may not apply to the sickest patients.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThe population was mostly male (about 81–83%) and mostly White (about 92–94%).\u003c\/strong\u003e Results may not generalize fully to women or to more diverse populations.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFFR was measured before CABG in only 10% of patients\u003c\/strong\u003e, so the bypass procedures were largely not guided by flow measurement, unlike the PCI procedures.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003ch2 id=\"recommendations\"\u003ePractical Takeaways\u003c\/h2\u003e\n\n\u003cp\u003eIf you or someone you care for has blockages in all three main heart arteries, here is what this trial suggests.\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eAsk whether your case has been reviewed by a heart team.\u003c\/strong\u003e In this trial, both PCI and CABG had to be technically feasible, as judged by a multidisciplinary team. That same discussion is the right setting for your decision.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUnderstand that both options are legitimate, but they carry different risks.\u003c\/strong\u003e Bypass surgery gave better protection against the combined outcome of death, heart attack, stroke, or repeat procedures at 1 year. Stenting gave a far easier short-term course, with fewer rhythm problems, less bleeding, less kidney injury, and shorter hospital stays.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWeigh the recovery period honestly.\u003c\/strong\u003e In this trial, bypass patients stayed in the hospital a median of 11 days, compared with 3 days for stenting. They were also more than twice as likely to be readmitted within 30 days (10.2% vs. 5.5%).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFollow the medication plan closely, whichever procedure you have.\u003c\/strong\u003e Everyone in this trial was expected to take aspirin, a high-dose statin, and guideline-directed medical therapy. PCI patients also took a second antiplatelet drug for at least 6 months.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eKeep your follow-up appointments.\u003c\/strong\u003e The trial's high follow-up rate (99.7% at 1 year) is part of why its results are trustworthy. Regular visits at discharge and at 1, 6, and 12 months help catch problems early.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTalk with your cardiologist and cardiac surgeon about your personal risk factors\u003c\/strong\u003e — diabetes, kidney function, ejection fraction, and how complex your blockages are (the SYNTAX score) — since these influence which approach is likely to serve you best.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is FFR-guided stenting?\u003c\/h3\u003e\n\u003cp\u003eFFR (fractional flow reserve) is measured with a thin pressure wire in the artery to show how much a blockage limits blood flow. In FFR-guided stenting, only blockages with an FFR of 0.80 or lower are treated with a stent. A low FFR means the blockage truly restricts flow; a high FFR means it does not.\u003c\/p\u003e\n\u003ch3\u003eWho was included in the FAME 3 trial?\u003c\/h3\u003e\n\u003cp\u003eThe trial enrolled 1,500 patients with three-vessel coronary artery disease. This means at least 50% narrowing in each of the three main heart arteries or their major branches, with the left main artery not involved. Blockages had to be treatable by either stenting or bypass. People with recent severe heart attack, cardiogenic shock, or ejection fraction below 30% were excluded.\u003c\/p\u003e\n\u003ch3\u003eWhat were the main results at one year?\u003c\/h3\u003e\n\u003cp\u003eAt one year, 10.6% of the stenting group (about 11 in 100) had died, had a heart attack, had a stroke, or needed another procedure, compared with 6.9% of the bypass group (about 7 in 100). The hazard ratio was 1.5. Stenting did not meet the trial's definition of noninferiority to bypass surgery.\u003c\/p\u003e\n\u003ch3\u003eWhat does a hazard ratio of 1.5 mean?\u003c\/h3\u003e\n\u003cp\u003eA hazard ratio of 1.5 means that, over the same period, the risk of the combined outcome was about 50% higher in the stenting group than in the bypass group. The 95% confidence interval was 1.1 to 2.2, meaning the data are consistent with a risk increase somewhere between 10% and 120%.\u003c\/p\u003e\n\u003ch3\u003eHow did recovery compare between stenting and bypass?\u003c\/h3\u003e\n\u003cp\u003eIn this trial, stenting was faster: median time to procedure was 4 days versus 13 for bypass, procedure duration was 87 minutes versus 197, and hospital stay was 3 days versus 11. Bypass patients were more than twice as likely to be readmitted within 30 days (10.2% versus 5.5%).\u003c\/p\u003e\n\u003ch3\u003eWhat should patients discuss with their care team?\u003c\/h3\u003e\n\u003cp\u003eAsk whether your case has been reviewed by a heart team, since both stenting and bypass had to be technically feasible in this trial. Discuss your personal risk factors, including diabetes, kidney function, ejection fraction, and how complex your blockages are (the SYNTAX score), because these influence which approach may serve you better.\u003c\/p\u003e\n\u003ch3\u003eWhen should a patient with three-vessel coronary artery disease seek a second opinion about stenting versus bypass surgery?\u003c\/h3\u003e\n\u003cp\u003eWhen you have blockages of at least 50% in all three main heart arteries and both stenting and bypass are technically possible, a second opinion can help you weigh the trade-off. FFR-guided stenting did not match bypass surgery at one year for death, heart attack, stroke, or repeat procedures (10.6% versus 6.9%). Bypass caused more bleeding, irregular rhythms, kidney injury, and longer hospital stays. A second review can check whether your case was assessed by a heart team and how your diabetes, kidney function, ejection fraction, and SYNTAX score fit. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\n\u003cp\u003e\u003cstrong\u003eOriginal article title:\u003c\/strong\u003e Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery FAME3\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e W.F. Fearon, F.M. Zimmermann, B. De Bruyne, Z. Piroth, A.H.M. van Straten, L. Szekely, G. Davidavičius, G. Kalinauskas, S. Mansour, R. Kharbanda, N. Östlund‑Papadogeorgos, A. Aminian, K.G. Oldroyd, N. Al‑Attar, N. Jagic, J.‑H.E. Dambrink, P. Kala, O. Angerås, P. MacCarthy, O. Wendler, F. Casselman, N. Witt, K. Mavromatis, S.E.S. Miner, J. Sarma, T. Engstrøm, E.H. Christiansen, P.A.L. Tonino, M.J. Reardon, D. Lu, V.Y. Ding, Y. Kobayashi, M.A. Hlatky, K.W. Mahaffey, M. Desai, Y.J. Woo, A.C. Yeung, and N.H.J. Pijls, for the FAME 3 Investigators\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublication:\u003c\/strong\u003e \u003cem\u003eThe New England Journal of Medicine\u003c\/em\u003e, 2022; volume 386, pages 128–137. Published online November 4, 2021; updated January 13, 2022. DOI: 10.1056\/NEJMoa2112299. Copyright © 2021 Massachusetts Medical Society.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c\/strong\u003e Medtronic and Abbott Vascular provided research grants to Stanford University. The funders had no role in the design or conduct of the trial or in the preparation of the manuscript.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c\/strong\u003e FAME 3, ClinicalTrials.gov number NCT02100722.\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research. It is intended for educational purposes and does not replace personalized medical advice from your own care team.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47427812196508,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0599\/5449\/5644\/files\/ddn-medical-article-stents-vs-bypass-surgery-for-three-vessel-heart-disease-what-the-fame-3-study-found-hero.png?v=1790203952","url":"https:\/\/diagnosticdetectives.com\/sv\/products\/stents-vs-bypass-surgery-for-three-vessel-heart-disease-what-the-fame-3-study-found","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}