{"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\u003ePatients with severe blockages in all three major heart arteries face an important treatment decision: minimally invasive stenting or open-heart bypass surgery. The FAME 3 study followed 1,500 such patients for one year and found that 10.6% of those who received stents guided by fractional flow reserve (FFR) experienced a major heart-related event, compared with 6.9% of those who underwent bypass surgery. This difference meant that the stent procedure did not meet the study's pre-defined criteria to be considered \"not worse than\" surgery. However, patients who received stents had significantly fewer short-term complications, including major bleeding, irregular heart rhythms, and kidney injury.\u003c\/p\u003e\n\n\u003ch1\u003eStents vs. Bypass Surgery for Three-Vessel Heart Disease: What the FAME 3 Study Found\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\"\u003eBackground: Why This Study Matters\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#understanding-treatments\"\u003eUnderstanding the Two Treatment Approaches\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#study-design\"\u003eHow the Study Was Designed (Methods)\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#study-patients\"\u003eWho Took Part in the Study\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#procedures\"\u003eWhat Treatments Patients Actually Received\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#primary-results\"\u003eKey Findings: The Primary Result\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#secondary-results\"\u003eDetailed Results: Individual Events\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#safety-results\"\u003eSafety: Short-Term Complications\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#subgroup-analyses\"\u003eSubgroup Analyses: Who Benefits From Which?\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#clinical-implications\"\u003eWhat This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#limitations\"\u003eStudy Limitations\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations for Patients\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 1,500 patients with three-vessel disease, bypass surgery led to fewer major heart events at 1 year than FFR-guided stenting: 6.9% versus 10.6%.\u003c\/li\u003e\n\u003cli\u003eStenting failed to meet the noninferiority threshold; the hazard ratio was 1.5 (95% CI 1.1–2.2), favoring surgery.\u003c\/li\u003e\n\u003cli\u003eBypass surgery had more short-term complications: major bleeding 3.8% vs 1.6%, arrhythmia 14.1% vs 2.4%, and higher 30-day readmissions.\u003c\/li\u003e\n\u003cli\u003eFFR-guided stenting avoided stenting 24% of blockages that did not limit blood flow, yet still resulted in more repeat revascularizations.\u003c\/li\u003e\n\u003cli\u003eResults were consistent across subgroups including age, sex, diabetes, and SYNTAX score; no subgroup favored stenting over surgery.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eBackground: Why This Study Matters\u003c\/h2\u003e\n\n\u003cp\u003eCoronary artery disease occurs when plaque builds up inside the arteries that supply blood to the heart muscle. When blockages develop in all three of the major heart arteries — a condition called \u003cstrong\u003ethree-vessel coronary artery disease\u003c\/strong\u003e — the heart's blood supply is seriously compromised. Without treatment, patients face a high risk of heart attacks, heart failure, and death.\u003c\/p\u003e\n\n\u003cp\u003eFor decades, doctors have known that \u003cstrong\u003ecoronary-artery bypass grafting (CABG)\u003c\/strong\u003e, commonly called bypass surgery, produces better long-term outcomes than \u003cstrong\u003epercutaneous coronary intervention (PCI)\u003c\/strong\u003e, commonly called angioplasty or stenting, for patients with three-vessel disease. Earlier large, randomized trials consistently showed that patients who received bypass surgery had lower rates of death, heart attacks, and the need for repeat procedures compared with those who received stents.\u003c\/p\u003e\n\n\u003cp\u003eBut those older trials had two important limitations. First, they rarely used second-generation drug-eluting stents — newer stents that slowly release medication to prevent scar tissue from blocking the artery again. Second, they did not routinely use a measurement called \u003cstrong\u003efractional flow reserve (FFR)\u003c\/strong\u003e to guide stent placement. The FAME 3 trial was designed specifically to address these gaps and to answer a modern question: With today's best stent technology and FFR guidance, can stenting match the results of bypass surgery?\u003c\/p\u003e\n\n\u003cp\u003ePrevious research had already shown that second-generation drug-eluting stents lead to lower rates of stent thrombosis (blood clots inside the stent), procedure-related and spontaneous heart attacks, re-narrowing of the treated artery (restenosis), and death compared with first-generation stents. Similarly, FFR-guided PCI produces better short-term and long-term outcomes than angiography-guided PCI (where decisions are made based only on X-ray images) or medical therapy alone.\u003c\/p\u003e\n\n\u003ch2 id=\"understanding-treatments\"\u003eUnderstanding the Two Treatment Approaches\u003c\/h2\u003e\n\n\u003cp\u003eTo understand this study, it helps to know how the two procedures differ.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eCoronary-artery bypass grafting (CABG)\u003c\/strong\u003e is open-heart surgery. The surgeon takes a healthy blood vessel from another part of the body — most commonly the left internal thoracic artery from the chest wall, or a leg vein — and attaches it to the heart artery beyond the blockage, creating a \"bypass\" so blood can flow around the narrowed area. In this study, 97% of patients who had CABG received a left internal thoracic artery graft, which is considered the gold-standard bypass vessel.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePercutaneous coronary intervention (PCI)\u003c\/strong\u003e is far less invasive. A thin tube called a catheter is threaded through an artery in the wrist or groin up to the heart. A tiny balloon is inflated inside the narrowed artery to compress the plaque, and a mesh tube called a \u003cstrong\u003estent\u003c\/strong\u003e is left in place to keep the artery open. The procedure requires no surgical incision in the chest and typically involves a hospital stay of only a few days.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFractional flow reserve (FFR)\u003c\/strong\u003e is a technique used during PCI. A very thin wire with a pressure sensor is passed into the heart artery. The wire measures blood pressure just before and just after a blockage while the heart is stressed with a medication called adenosine. The ratio of these pressures — the FFR value — tells doctors how severely the blockage restricts blood flow. An FFR of 1.0 means no obstruction at all, while lower numbers mean more significant blockage. In this study, and in standard clinical practice, a cutoff of \u003cstrong\u003e0.80 or lower\u003c\/strong\u003e was used to decide that a blockage was significant enough to deserve a stent. This approach prevents unnecessary stenting of blockages that are not actually limiting blood flow — blockages that respond just as well to medications alone.\u003c\/p\u003e\n\n\u003ch2 id=\"study-design\"\u003eHow the Study Was Designed (Methods)\u003c\/h2\u003e\n\n\u003cp\u003eThe FAME 3 trial (formally called the \u003cstrong\u003eFractional Flow Reserve versus Angiography for Multivessel Evaluation 3\u003c\/strong\u003e trial) was an investigator-initiated, multicenter, international, randomized, controlled trial. The study was conducted at 48 medical centers across multiple countries.\u003c\/p\u003e\n\n\u003cp\u003ePatients with three-vessel coronary artery disease that did not involve the left main coronary artery were randomly assigned in a 1:1 ratio to receive either CABG or FFR-guided PCI — much like flipping a coin to decide which treatment each patient received. Randomization was performed using a Web-based system and was \u003cstrong\u003estratified according to diabetes status and trial site\u003c\/strong\u003e, which means researchers made sure the two groups were balanced in terms of these important factors.\u003c\/p\u003e\n\n\u003cp\u003eThe major inclusion criterion was the presence of three-vessel coronary artery disease, defined as \u003cstrong\u003eat least 50% narrowing (diameter stenosis)\u003c\/strong\u003e of each of the three major epicardial arteries or their major side branches, as judged by visual inspection of the angiogram. The narrowing also had to be treatable by either PCI or CABG, as determined by a \"heart team\" at each trial site.\u003c\/p\u003e\n\n\u003cp\u003ePatients were excluded if they had a recent \u003cstrong\u003eST-segment elevation myocardial infarction (STEMI)\u003c\/strong\u003e — the most serious type of heart attack — or \u003cstrong\u003ecardiogenic shock\u003c\/strong\u003e (when the heart fails to pump enough blood to the body). Patients with a \u003cstrong\u003eleft ventricular ejection fraction of less than 30%\u003c\/strong\u003e (severely weakened heart-pumping function) were also excluded.\u003c\/p\u003e\n\n\u003cp\u003eFor patients assigned to PCI, the protocol required that FFR be measured using a coronary pressure wire (Abbott Vascular) with intravenous or intracoronary adenosine. Only blockages with an FFR of \u003cstrong\u003e0.80 or lower\u003c\/strong\u003e were to be treated with stents. The stents used were current-generation \u003cstrong\u003ezotarolimus-eluting stents\u003c\/strong\u003e (Resolute Integrity or Resolute Onyx, made by Medtronic). These stents slowly release the drug zotarolimus to prevent the artery from re-narrowing. Measuring FFR after stent placement was encouraged but not required. Intravascular imaging (using sound waves or light to see inside the artery) was used at the discretion of the treating physician.\u003c\/p\u003e\n\n\u003cp\u003eFor patients assigned to CABG, surgery was performed according to standard practice at each center, with \u003cstrong\u003ecomplete arterial revascularization strongly recommended\u003c\/strong\u003e. FFR testing to guide CABG was not required, but if it had been performed during the diagnostic angiogram, the surgeon could use that information.\u003c\/p\u003e\n\n\u003cp\u003eAll patients in both groups received aspirin, a high-dose statin (cholesterol-lowering medication), and guideline-directed medical therapy for their heart disease. Patients who underwent PCI were required to take a second antiplatelet medication (to prevent blood clots) for at least 6 months after the procedure.\u003c\/p\u003e\n\n\u003cp\u003ePatients were followed at hospital discharge and then at 1, 6, and 12 months after their procedure.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eThe primary end point\u003c\/strong\u003e — the main outcome the study was measuring — was the occurrence within 1 year of a \u003cstrong\u003emajor adverse cardiac or cerebrovascular event\u003c\/strong\u003e, defined as:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eDeath from any cause\u003c\/li\u003e\n  \u003cli\u003eMyocardial infarction (heart attack)\u003c\/li\u003e\n  \u003cli\u003eStroke\u003c\/li\u003e\n  \u003cli\u003eRepeat revascularization (needing another procedure to restore blood flow)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eHeart attacks were classified as either procedural (related to the procedure itself) or spontaneous (occurring on their own later). For procedural heart attacks after stenting or surgery, the definition required a rise in the cardiac troponin level (a protein released when heart muscle is damaged) to \u003cstrong\u003emore than 10 times the 99th percentile of the upper reference limit\u003c\/strong\u003e within 72 hours after the procedure, plus at least one additional finding: new abnormal Q waves on the electrocardiogram, a new left bundle-branch block, proof of a new blockage in a graft or major native coronary artery, or imaging evidence of new loss of viable heart muscle or a new regional wall-motion abnormality. This definition aligns with a \u003cstrong\u003etype 5 myocardial infarction\u003c\/strong\u003e (post-bypass surgery heart attack) according to the Third and Fourth Universal Definitions of Myocardial Infarction.\u003c\/p\u003e\n\n\u003cp\u003eSpontaneous heart attacks were defined as a rise or fall in troponin with at least one value above the 99th percentile upper reference limit, together with evidence of myocardial ischemia (inadequate blood flow to heart muscle), such as symptoms of ischemia, electrocardiographic changes, new Q waves, or imaging evidence of new loss of viable muscle.\u003c\/p\u003e\n\n\u003cp\u003eAn independent clinical events committee reviewed and adjudicated (officially judged) all events in a blinded fashion — meaning they did not know which treatment each patient had received.\u003c\/p\u003e\n\n\u003ch3\u003eUnderstanding the Statistical Approach\u003c\/h3\u003e\n\n\u003cp\u003eThis was a \u003cstrong\u003enoninferiority trial\u003c\/strong\u003e, which means the goal was to determine whether FFR-guided PCI is \"not worse than\" CABG by more than a certain pre-specified amount. This is different from a standard \"superiority\" trial, which asks whether one treatment is actually better than the other.\u003c\/p\u003e\n\n\u003cp\u003eInitially, the researchers estimated that 12% of CABG patients would have a primary end-point event within 1 year, based on previous trials. They originally planned to declare noninferiority if the \u003cstrong\u003eupper boundary of the 95% confidence interval was less than 1.45\u003c\/strong\u003e for the hazard ratio. With that criterion, they calculated they would need 712 patients per group (1,424 total) to achieve 90% power.\u003c\/p\u003e\n\n\u003cp\u003eHowever, during recruitment and without knowledge of event rates, the trial's steering committee decided to change the noninferiority margin to an upper boundary of \u003cstrong\u003eless than 1.65\u003c\/strong\u003e. This decision was based on newly published trials comparing CABG with PCI, which reported major adverse cardiac or cerebrovascular events in no more than 10% of CABG patients and used similar noninferiority margins. With the wider margin, only 645 patients per group (1,290 total) would be needed for 90% power. Nevertheless, the committee chose to complete the planned enrollment of 1,500 patients.\u003c\/p\u003e\n\n\u003cp\u003eThe primary analysis was conducted on an \u003cstrong\u003eintention-to-treat basis\u003c\/strong\u003e, meaning patients were analyzed in the group to which they were randomly assigned, regardless of what treatment they actually received. This approach preserves the benefits of randomization and reflects real-world practice.\u003c\/p\u003e\n\n\u003ch2 id=\"study-patients\"\u003eWho Took Part in the Study\u003c\/h2\u003e\n\n\u003cp\u003eA total of \u003cstrong\u003e1,500 patients\u003c\/strong\u003e were enrolled at 48 centers and underwent randomization. Of these, \u003cstrong\u003e757 were assigned to receive FFR-guided PCI\u003c\/strong\u003e and \u003cstrong\u003e743 were assigned to receive CABG\u003c\/strong\u003e.\u003c\/p\u003e\n\n\u003cp\u003eBecause of randomization, the two groups were very similar in their characteristics. Here is a detailed breakdown of the patients in each group:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAge:\u003c\/strong\u003e 65.2 ± 8.6 years in the PCI group vs. 65.1 ± 8.3 years in the CABG group (mean age overall: 65 years)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eMale sex:\u003c\/strong\u003e 81.4% (616 patients) in the PCI group vs. 83.3% (619 patients) in the CABG group\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eWhite race:\u003c\/strong\u003e 93.9% (711 patients) vs. 92.3% (686 patients)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eBody-mass index (BMI):\u003c\/strong\u003e 28.6 ± 4.5 vs. 28.7 ± 4.3 (both groups were in the overweight range)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDiabetes:\u003c\/strong\u003e 28.3% (214 patients) vs. 28.8% (214 patients) — overall, 29% of all study participants had diabetes\n    \u003cul\u003e\n      \u003cli\u003eInsulin-dependent diabetes: 7.3% (55 patients) vs. 8.2% (61 patients)\u003c\/li\u003e\n      \u003cli\u003eNon-insulin-dependent diabetes: 21.0% (159 patients) vs. 20.6% (153 patients)\u003c\/li\u003e\n    \u003c\/ul\u003e\n  \u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eHypertension:\u003c\/strong\u003e 71.2% vs. 75.0%\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDyslipidemia (abnormal cholesterol):\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%\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003ePrevious tobacco use:\u003c\/strong\u003e 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 (myocardial infarction):\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\u003eHistory of transient ischemic attack (TIA) or stroke:\u003c\/strong\u003e 6.5% vs. 7.6%\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eKidney disease:\u003c\/strong\u003e 4.9% vs. 5.9% (defined as an estimated glomerular filtration rate below 60 ml per minute per 1.73 m²)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003ePositive noninvasive test for ischemia:\u003c\/strong\u003e 41.1% vs. 40.6%\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eLeft ventricular ejection fraction (LVEF) ≤ 50%:\u003c\/strong\u003e 18.2% vs. 17.6% — meaning most patients had relatively preserved heart-pumping function\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eHospitalized with non-ST-segment elevation acute coronary syndrome (NSTE-ACS):\u003c\/strong\u003e 39.7% vs. 38.7% — meaning about 39% of patients in each group had been admitted to the hospital for unstable angina or a milder form of heart attack\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe severity of the patients' coronary disease was also similar between groups. On average, patients had \u003cstrong\u003e4.3 blockages\u003c\/strong\u003e in their heart arteries. About 22% of patients had at least one artery that was completely blocked (a \u003cstrong\u003echronic total occlusion\u003c\/strong\u003e), and 68% had at least one \u003cstrong\u003ebifurcation lesion\u003c\/strong\u003e (a blockage at a point where an artery divides into two branches).\u003c\/p\u003e\n\n\u003cp\u003eThe average \u003cstrong\u003eSYNTAX score\u003c\/strong\u003e — an angiography-based scoring system that evaluates the severity and complexity of coronary artery disease (the lowest score is 0 and there is no upper limit; lower scores indicate less complex disease and predict better outcomes with PCI) — was 26 in both groups, indicating a moderate-to-high level of disease complexity.\u003c\/p\u003e\n\n\u003ch2 id=\"procedures\"\u003eWhat Treatments Patients Actually Received\u003c\/h2\u003e\n\n\u003cp\u003eThe procedures the patients received differed substantially between the two groups, as expected.\u003c\/p\u003e\n\n\u003ch3\u003eTiming and Hospital Stay\u003c\/h3\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eTime to procedure:\u003c\/strong\u003e The median time from randomization to the procedure was 4 days (interquartile range 1–13 days) for PCI vs. 13 days (6–26 days) for CABG.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eProcedure duration:\u003c\/strong\u003e The median procedure time was 87 minutes (67–113 minutes) for PCI vs. 197 minutes (155–239 minutes) for CABG.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eHospital stay:\u003c\/strong\u003e The median length of hospitalization was 3 days (1–7 days) for PCI vs. 11 days (7–16 days) for CABG.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eDetails of the PCI Procedures\u003c\/h3\u003e\n\u003cp\u003eAmong the 757 patients assigned to FFR-guided PCI, the average number of blockages treated per patient was 4.3, and a mean of \u003cstrong\u003e3.7 ± 1.9 stents\u003c\/strong\u003e were implanted per patient. The median total length of stents placed was \u003cstrong\u003e80 mm\u003c\/strong\u003e (52–116 mm). 22.1% of patients (166 of 750) had the procedure done in stages (more than one session).\u003c\/p\u003e\n\n\u003cp\u003eFFR was successfully measured in \u003cstrong\u003e82% of all blockages\u003c\/strong\u003e. The most common reason FFR was not measured was that the artery was subtotally or completely blocked — in these cases, the blockage was clearly significant and FFR measurement would not add useful information. The mean FFR value was \u003cstrong\u003e0.70\u003c\/strong\u003e, confirming that most treated blockages were indeed severely limiting blood flow.\u003c\/p\u003e\n\n\u003cp\u003eImportantly, \u003cstrong\u003e24% of the blockages that were originally intended for treatment had an FFR greater than 0.80\u003c\/strong\u003e, meaning they were not actually limiting blood flow. Under the study protocol, these blockages were \u003cstrong\u003enot stented\u003c\/strong\u003e — demonstrating how FFR guidance prevents unnecessary procedures. After stenting, FFR was re-measured in 60% of treated blockages, with a mean value of \u003cstrong\u003e0.88\u003c\/strong\u003e, confirming that stent placement successfully restored blood flow.\u003c\/p\u003e\n\n\u003cp\u003eIntravascular imaging was used in only \u003cstrong\u003e11.7% of cases\u003c\/strong\u003e (87 of 744 patients) — meaning most stent placements were guided by angiography and FFR alone.\u003c\/p\u003e\n\n\u003ch3\u003eDetails of the CABG Procedures\u003c\/h3\u003e\n\u003cp\u003eAmong the 743 patients assigned to CABG, the average number of blockages was 4.2, and patients received a mean of \u003cstrong\u003e3.4 ± 1.0 distal anastomoses\u003c\/strong\u003e (the surgical connections that create the bypass pathways). Notably:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003e97.0%\u003c\/strong\u003e of patients (684 of 705) received a \u003cstrong\u003eleft internal thoracic artery graft\u003c\/strong\u003e — the key arterial graft that provides the most durable bypass.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003e24.5%\u003c\/strong\u003e of patients (173 of 705) received \u003cstrong\u003emultiple arterial grafts\u003c\/strong\u003e — meaning more than one artery was used as a bypass vessel. The study protocol strongly recommended complete arterial revascularization, but this was achieved in only about a quarter of patients.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003e24.1%\u003c\/strong\u003e of operations (168 of 698) were performed \u003cstrong\u003eoff-pump\u003c\/strong\u003e — meaning without the use of a heart-lung bypass machine.\u003c\/li\u003e\n  \u003cli\u003eFFR was measured before CABG in only \u003cstrong\u003e10.0%\u003c\/strong\u003e of patients (72 of 718), since FFR guidance for bypass surgery is not standard practice.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"primary-results\"\u003eKey Findings: The Primary Result\u003c\/h2\u003e\n\n\u003cp\u003eFollow-up at 1 year was completed in \u003cstrong\u003e99.7% of patients\u003c\/strong\u003e — an exceptionally high rate that makes the results highly reliable.\u003c\/p\u003e\n\n\u003cp\u003eThe study's central finding is clear: \u003cstrong\u003eFFR-guided PCI did NOT meet the criteria for noninferiority to CABG.\u003c\/strong\u003e In other words, the study could not confirm that stenting was \"not worse than\" bypass surgery for patients with three-vessel coronary artery disease.\u003c\/p\u003e\n\n\u003cp\u003eAt 1 year, the incidence of the primary end point (death from any cause, heart attack, stroke, or repeat revascularization) was:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003e10.6%\u003c\/strong\u003e in the FFR-guided PCI group (80 of 757 patients)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003e6.9%\u003c\/strong\u003e in the CABG group (51 of 743 patients)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eHazard ratio: 1.5\u003c\/strong\u003e (95% confidence interval [CI], 1.1 to 2.2)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eP = 0.35 for noninferiority\u003c\/strong\u003e — meaning the results did not meet the statistical requirement to declare PCI \"not worse than\" CABG\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eTo understand why this failed, it helps to understand the numbers. A \u003cstrong\u003ehazard ratio of 1.5\u003c\/strong\u003e means that patients who received PCI had a 50% higher risk of experiencing a major adverse event during the year compared with patients who received CABG. The 95% confidence interval (1.1 to 2.2) provides a range of plausible values for the true risk; since \u003cstrong\u003eboth the lower bound (1.1) and the upper bound (2.2) are above 1.0\u003c\/strong\u003e, the difference between the groups was statistically significant in favor of CABG. Moreover, the upper bound of 2.2 exceeded the pre-specified noninferiority threshold of 1.65, meaning the results were not even close to declaring PCI \"not worse\" — they actually suggested CABG was better.\u003c\/p\u003e\n\n\u003cp\u003eThe study's original assumption that 12% of CABG patients would have an event within 1 year turned out to be too pessimistic — the actual rate was 6.9%, meaning CABG performed even better than expected.\u003c\/p\u003e\n\n\u003ch2 id=\"secondary-results\"\u003eDetailed Results: Individual Events\u003c\/h2\u003e\n\n\u003cp\u003eWhen the researchers broke down the primary end point into its individual components, no single outcome was dramatically different between the two groups on its own, but the pattern consistently favored CABG:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDeath from any cause:\u003c\/strong\u003e 1.6% (12 patients) in the PCI group vs. 0.9% (7 patients) in the CABG group (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% (6 patients) vs. 0.5% (4 patients)\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eMyocardial infarction (heart attack):\u003c\/strong\u003e 5.2% (39 patients) vs. 3.5% (26 patients) (hazard ratio, 1.5; 95% CI, 0.9 to 2.5)\n    \u003cul\u003e\n      \u003cli\u003eSpontaneous heart attacks: 3.3% (25 patients) vs. 2.3% (17 patients)\u003c\/li\u003e\n      \u003cli\u003eProcedural heart attacks: 1.7% (13 patients) vs. 1.2% (9 patients)\u003c\/li\u003e\n    \u003c\/ul\u003e\n  \u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eStroke:\u003c\/strong\u003e 0.9% (7 patients) vs. 1.1% (8 patients) (hazard ratio, 0.9; 95% CI, 0.3 to 2.4) — this was the only component where the two treatments came close to equal\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eRepeat revascularization:\u003c\/strong\u003e 5.9% (45 patients) vs. 3.9% (29 patients) (hazard ratio, 1.5; 95% CI, 0.9 to 2.3)\n    \u003cul\u003e\n      \u003cli\u003eRepeat PCI: 5.2% (39 patients) vs. 3.5% (26 patients)\u003c\/li\u003e\n      \u003cli\u003eRepeat CABG: 0.8% (6 patients) vs. 0.4% (3 patients)\u003c\/li\u003e\n    \u003c\/ul\u003e\n  \u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe composite of \u003cstrong\u003edeath, heart attack, or stroke\u003c\/strong\u003e (excluding repeat revascularization) occurred in \u003cstrong\u003e7.3%\u003c\/strong\u003e of PCI patients (55 patients) vs. \u003cstrong\u003e5.2%\u003c\/strong\u003e of CABG patients (39 patients) — a hazard ratio of 1.4 (95% CI, 0.9 to 2.1). While this difference was not statistically significant on its own, it followed the same direction as the overall result.\u003c\/p\u003e\n\n\u003cp\u003eAn important note: the confidence intervals for these secondary end points were not adjusted for multiple comparisons, so they should not be interpreted as definitive evidence of treatment effects for individual outcomes. However, the consistency of the pattern is telling.\u003c\/p\u003e\n\n\u003cp\u003eAt 1 year, there were no obvious differences between the groups regarding medical therapy, with one exception: a higher percentage of patients in the FFR-guided PCI group were receiving dual antiplatelet therapy and nitrate medication.\u003c\/p\u003e\n\n\u003ch2 id=\"safety-results\"\u003eSafety: Short-Term Complications\u003c\/h2\u003e\n\n\u003cp\u003eWhile CABG was more effective at preventing major cardiac events at 1 year, the \u003cstrong\u003esafety profile\u003c\/strong\u003e of the two procedures was quite different. Bypass surgery is a major operation, and it comes with substantially higher risks of certain complications in the early post-procedure period:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eMajor bleeding (BARC type 3–5):\u003c\/strong\u003e 1.6% (12 patients) in the PCI group vs. \u003cstrong\u003e3.8%\u003c\/strong\u003e (28 patients) in the CABG group (P = 0.009) — meaning major bleeding was more than twice as common after bypass surgery\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAcute kidney injury:\u003c\/strong\u003e 0.1% (1 patient) vs. \u003cstrong\u003e0.9%\u003c\/strong\u003e (7 patients) (P = 0.04) — defined as a rise in serum creatinine of at least 0.3 mg per deciliter within 48 hours, or a 1.5-fold increase from baseline, or reduced urine output\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAtrial fibrillation or clinically significant arrhythmia:\u003c\/strong\u003e 2.4% (18 patients) vs. \u003cstrong\u003e14.1%\u003c\/strong\u003e (105 patients) (P \u0026lt; 0.001) — irregular heart rhythms were nearly six times more common after bypass surgery\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eRehospitalization within 30 days:\u003c\/strong\u003e 5.5% (42 patients) vs. \u003cstrong\u003e10.2%\u003c\/strong\u003e (76 patients) (P \u0026lt; 0.001) — patients who had bypass surgery were nearly twice as likely to be readmitted to the hospital within a month\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThere were also procedure-specific complications unique to each approach:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDefinite stent thrombosis\u003c\/strong\u003e (a blood clot forming inside a newly placed stent) occurred in \u003cstrong\u003e0.8%\u003c\/strong\u003e of PCI patients (6 patients).\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDefinite symptomatic graft occlusion\u003c\/strong\u003e (a bypass graft becoming blocked) occurred in \u003cstrong\u003e1.3%\u003c\/strong\u003e of CABG patients (10 patients).\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThese safety data highlight the trade-off that lies at the heart of this study. Bypass surgery may provide more durable, complete revascularization — leading to fewer heart attacks, deaths, and repeat procedures at 1 year — but it comes at the cost of a more invasive procedure with significantly higher rates of short-term complications like bleeding, kidney injury, arrhythmia, and hospital readmission.\u003c\/p\u003e\n\n\u003ch2 id=\"subgroup-analyses\"\u003eSubgroup Analyses: Who Benefits From Which?\u003c\/h2\u003e\n\n\u003cp\u003eThe researchers also examined whether the results were consistent across different types of patients. They pre-specified the following subgroup categories to analyze:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eAge group: under 65 years vs. 65 years or older\u003c\/li\u003e\n  \u003cli\u003eSex: male vs. female\u003c\/li\u003e\n  \u003cli\u003ePresence or absence of diabetes\u003c\/li\u003e\n  \u003cli\u003ePresence or absence of acute coronary syndrome at presentation\u003c\/li\u003e\n  \u003cli\u003eLeft ventricular ejection fraction: above 50% vs. 50% or below\u003c\/li\u003e\n  \u003cli\u003ePrevious PCI: yes vs. no\u003c\/li\u003e\n  \u003cli\u003eSYNTAX score category: low (0–22), intermediate (23–32), or high (\u0026gt;32)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe results of these subgroup analyses were displayed in a forest plot, and they showed that the treatment effect was \u003cstrong\u003egenerally consistent across all subgroups\u003c\/strong\u003e. That is, the pattern of CABG being associated with fewer events than PCI held across different age groups, in men and women, in patients with and without diabetes, across different levels of heart function, and regardless of previous PCI history. No subgroup was found in which PCI clearly matched or surpassed CABG's results.\u003c\/p\u003e\n\n\u003cp\u003eThis consistency\n\n\u003c!-- ddn:faq:start --\u003e\n\u003c\/p\u003e\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is three-vessel coronary artery disease?\u003c\/h3\u003e\n\u003cp\u003eThree-vessel coronary artery disease means blockages develop in all three major heart arteries, seriously reducing blood supply to the heart muscle. Without treatment, patients face a high risk of heart attacks, heart failure, and death. This condition was the focus of the FAME 3 study, which compared two treatment approaches.\u003c\/p\u003e\n\u003ch3\u003eWhat are the two treatment options for three-vessel heart disease?\u003c\/h3\u003e\n\u003cp\u003eThe two options are coronary-artery bypass grafting (CABG), which is open-heart surgery that creates bypass pathways around blockages, and percutaneous coronary intervention (PCI), commonly called stenting, which uses a catheter to place a mesh tube inside the artery. The FAME 3 trial compared these approaches in 1,500 patients.\u003c\/p\u003e\n\u003ch3\u003eWhat is fractional flow reserve (FFR) and why does it matter?\u003c\/h3\u003e\n\u003cp\u003eFFR is a technique used during stenting to measure blood pressure before and after a blockage using a thin wire. A value of 0.80 or lower means the blockage limits blood flow and deserves a stent. FFR guidance prevents unnecessary stenting of blockages that are not actually restricting blood flow.\u003c\/p\u003e\n\u003ch3\u003eWhat were the main results of the FAME 3 study?\u003c\/h3\u003e\n\u003cp\u003eAt one year, 10.6% of patients who received FFR-guided stents had a major heart-related event (death, heart attack, stroke, or repeat procedure) compared with 6.9% who had bypass surgery. The stent procedure did not meet the study's criteria to be considered not worse than surgery.\u003c\/p\u003e\n\u003ch3\u003eWhat short-term complications were more common with bypass surgery?\u003c\/h3\u003e\n\u003cp\u003eBypass surgery had significantly higher rates of major bleeding, acute kidney injury, atrial fibrillation or irregular heart rhythms, and rehospitalization within 30 days. For example, major bleeding occurred in 3.8% of surgery patients versus 1.6% of stent patients, and irregular rhythms in 14.1% versus 2.4%.\u003c\/p\u003e\n\u003ch3\u003eWho was included in the FAME 3 study?\u003c\/h3\u003e\n\u003cp\u003eThe study included 1,500 patients with blockages in all three major heart arteries, without left main disease. Patients were randomly assigned to stenting or bypass surgery. About 29% had diabetes, average age was 65 years, and most were male. Patients with recent severe heart attacks or severely weakened pumping function were excluded.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47427812196508,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/diagnosticdetectives.fr\/products\/stents-vs-bypass-surgery-for-three-vessel-heart-disease-what-the-fame-3-study-found","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}