{"product_id":"intravascular-imaging-guided-vs-angiography-guided-complex-pci-what-patients-need-to-know","title":"Intravascular Imaging-Guided vs. Angiography-Guided Complex PCI: What Patients Need to Know","description":"\u003cp\u003eIn a large randomized trial conducted at 20 centers in South Korea, patients with complex coronary-artery lesions underwent percutaneous coronary intervention (PCI, a procedure to open blocked heart arteries). Those whose procedures were guided by intravascular imaging had better outcomes than those whose procedures were guided by angiography alone. Over a median follow-up of 2.1 years, the primary composite endpoint occurred in 7.7% of the imaging-guided group versus 12.3% of the angiography-guided group. The primary composite endpoint was death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization (hazard ratio 0.64; 95% CI 0.45 to 0.89; P=0.008). The clinical trial enrolled 1,639 patients, a larger sample and longer follow-up than previous clinical trials comparing intravascular imaging-guided PCI with angiography-guided PCI.\u003c\/p\u003e\n\n\u003ch1\u003eIntravascular Imaging-Guided vs. Angiography-Guided Complex PCI: What Patients Need to Know\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 Research Matters\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#methods\"\u003eHow the Study Was Conducted\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#patients\"\u003ePatient Characteristics\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#procedural\"\u003eProcedural Details\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#findings\"\u003eKey Findings: What the Study Showed\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#subgroups\"\u003eSubgroup and Additional Analyses\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#safety\"\u003eSafety Outcomes\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#implications\"\u003eWhat This Means 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\"\u003eRecommendations\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 trial of 1,639 patients with complex coronary lesions, intravascular imaging-guided PCI reduced the combined risk of cardiac death, target-vessel heart attack, or repeat revascularization compared with angiography guidance.\u003c\/li\u003e\n\u003cli\u003eThe primary endpoint occurred in 7.7% of the imaging group versus 12.3% of the angiography group over a median of 2.1 years (hazard ratio 0.64).\u003c\/li\u003e\n\u003cli\u003eAdding intravascular imaging did not appear to increase procedure-related safety events, though procedures were longer and used slightly more contrast dye.\u003c\/li\u003e\n\u003cli\u003eThe trial was conducted in South Korea, so whether results apply equally to other populations and healthcare systems is uncertain.\u003c\/li\u003e\n\u003cli\u003ePatients should discuss with their doctor whether intravascular imaging will be used during their PCI for a complex coronary lesion.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eBackground: Why This Research Matters\u003c\/h2\u003e\n\n\u003cp\u003ePercutaneous coronary intervention (PCI) is a common procedure used to open narrowed or blocked heart arteries. During PCI, a small balloon is inflated to widen the artery, and a mesh tube called a stent is placed to keep the artery open. Modern drug-eluting stents (stents coated with medication to prevent re-narrowing) have greatly reduced complications compared with older stent types.\u003c\/p\u003e\n\n\u003cp\u003eHowever, patients with complex coronary-artery lesions still have worse outcomes after PCI than patients with simpler lesions. Complex lesions include blockages in multiple vessels, long blockages, severely calcified (hardened) blockages, and blockages at artery branch points.\u003c\/p\u003e\n\n\u003cp\u003eDuring PCI, doctors can use two types of intravascular imaging to see inside the artery. These are intravascular ultrasonography (IVUS, which uses sound waves) and optical coherence tomography (OCT, which uses light waves). These imaging tools provide detailed information about the blockage and help doctors choose the right stent size, position the stent correctly, and check whether the stent is fully expanded.\u003c\/p\u003e\n\n\u003cp\u003eA stent may not be well expanded. There may be a tear at the edge of the stent. Either problem increases the risk of stent thrombosis, which is a blood clot forming in the stent. The risk of myocardial infarction (heart attack) and repeat revascularization (needing another procedure to reopen the artery) also increases.\u003c\/p\u003e\n\n\u003cp\u003ePrevious randomized trials had shown lower rates of major adverse events with IVUS-guided PCI compared with angiography-guided PCI. However, those trials were not considered definitive because they had limited numbers of patients or included only highly selected lesion types.\u003c\/p\u003e\n\n\u003cp\u003eMedical guidelines address this issue. These guidelines come from the American College of Cardiology and the American Heart Association. They also come from the Society for Cardiovascular Angiography and Interventions. The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery also provide guidelines. These guidelines recommend that intravascular ultrasonography or OCT be considered in selected patients to optimize stent implantation.\u003c\/p\u003e\n\n\u003cp\u003eThe RENOVATE-COMPLEX-PCI trial was designed to provide definitive evidence about whether intravascular imaging-guided PCI improves clinical outcomes compared with angiography-guided PCI in patients with complex coronary-artery lesions.\u003c\/p\u003e\n\n\u003ch2 id=\"methods\"\u003eHow the Study Was Conducted\u003c\/h2\u003e\n\n\u003cp\u003eThis was an investigator-initiated, prospective, multicenter, randomized, open-label trial conducted at 20 sites in South Korea. \"Randomized\" means patients were assigned to treatment groups by chance, like flipping a coin. \"Open-label\" means both doctors and patients knew which treatment was being used.\u003c\/p\u003e\n\n\u003cp\u003eThe trial protocol was approved by the institutional review board at each participating site. All patients provided written informed consent before randomization. A data and safety monitoring board oversaw the trial, and an independent clinical-event adjudication committee whose members were unaware of the trial-group assignments assessed all clinical events.\u003c\/p\u003e\n\n\u003cp\u003eThe funders of the trial were Abbott Vascular and Boston Scientific. These companies had no role in the trial design, in the collection, analysis, or interpretation of the data, or in the writing of the manuscript.\u003c\/p\u003e\n\n\u003ch3\u003eWhich Patients Were Eligible?\u003c\/h3\u003e\n\n\u003cp\u003ePatients 19 years of age or older who were undergoing PCI for complex coronary-artery lesions were candidates for enrollment. Complex coronary-artery lesions were defined as any of the following:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003eTrue bifurcation lesions (blockages at artery branch points) with a side-branch diameter of at least 2.5 mm\u003c\/li\u003e\n\u003cli\u003eChronic total occlusion (a complete blockage that has been present for some time)\u003c\/li\u003e\n\u003cli\u003eUnprotected left main coronary artery disease (narrowing in the main artery supplying the left side of the heart)\u003c\/li\u003e\n\u003cli\u003eLong coronary-artery lesions requiring an expected stent length of at least 38 mm\u003c\/li\u003e\n\u003cli\u003eMultivessel PCI involving at least two major epicardial coronary arteries treated at the same time\u003c\/li\u003e\n\u003cli\u003eLesions requiring at least three planned stents\u003c\/li\u003e\n\u003cli\u003eLesions involving in-stent restenosis (re-narrowing inside a previously placed stent)\u003c\/li\u003e\n\u003cli\u003eSeverely calcified lesions (blockages with extensive calcium deposits)\u003c\/li\u003e\n\u003cli\u003eOstial lesions of a major epicardial coronary artery (blockages at the origin of a major artery)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003ePatients were excluded if they had coronary lesions not appropriate for PCI as determined by the operator. Patients were also excluded if they had cardiogenic shock (Killip class IV, a severe state where the heart cannot pump enough blood) at presentation. Patients were excluded if they had a known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, everolimus, or contrast medium. Pregnant or breast-feeding patients were also excluded.\u003c\/p\u003e\n\n\u003ch3\u003eHow Were Patients Assigned to Treatment?\u003c\/h3\u003e\n\n\u003cp\u003eEligible patients were randomly assigned in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI after diagnostic coronary angiography. This means that for every two patients assigned to imaging guidance, one patient was assigned to angiography guidance.\u003c\/p\u003e\n\n\u003cp\u003eRandomization was performed using a Web-based randomization program with permuted blocks of six. The randomization was stratified according to clinical presentation (stable ischemic heart disease or acute coronary syndrome) and participating center.\u003c\/p\u003e\n\n\u003ch3\u003eWhat Happened During the Procedures?\u003c\/h3\u003e\n\n\u003cp\u003ePCI was performed using standard techniques for coronary-artery-lesion preparation and stent implantation, selected at the discretion of the operator. The drug-eluting stents implanted were either biodegradable or biocompatible polymer-coated everolimus-eluting stents.\u003c\/p\u003e\n\n\u003cp\u003eFor patients assigned to the intravascular imaging group, the choice between intravascular ultrasonography and OCT was made at the operators' discretion. Intravascular imaging could be used at any time during the PCI procedure but was mandated after stent implantation to determine whether the stented segment was optimized.\u003c\/p\u003e\n\n\u003cp\u003eStent optimization was defined as sufficient stent expansion without major stent malapposition (stent not properly touching the vessel wall) or edge dissection (tear at the stent edge). The criteria for sufficient stent expansion included:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003eA residual stenosis diameter (remaining narrowing) of less than 10% of the reference-vessel diameter for the target lesion as assessed on angiography\u003c\/li\u003e\n\u003cli\u003eA minimum stent area of more than 80% of the mean reference lumen area, or an absolute minimum stent area of more than 5.5 mm² on the basis of intravascular ultrasonography\u003c\/li\u003e\n\u003cli\u003eAn absolute minimum stent area of more than 4.5 mm² on the basis of OCT for stenoses not in the left main coronary artery\u003c\/li\u003e\n\u003cli\u003eFor stenoses in the left main coronary artery, an absolute minimum stent area of more than 7 mm² is required for the distal left main coronary artery. An absolute minimum stent area of more than 8 mm² is required for the proximal left main coronary artery.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eMajor stent malapposition was defined as an acute malapposition with a distance between the coronary-artery vessel wall and the stent of at least 0.4 mm. The length of the malapposition had to be more than 1 mm. Major edge dissection was defined as a dissection occurring within 5 mm from the edge of the stent and extending to the medial layer of the vessel. The dissection had a dissection angle of at least 60 degrees of the circumference of the vessel or a length of the dissection flap of at least 3 mm.\u003c\/p\u003e\n\n\u003cp\u003eIf stent optimization did not occur, additional dilation of the stent or additional stent implantation was recommended, and repeat evaluation on intravascular imaging was mandated.\u003c\/p\u003e\n\n\u003cp\u003eIn patients assigned to the angiography group, stent optimization was determined on the basis of angiographic findings. The stented segment was considered optimized if the residual stenosis diameter on angiography was less than 10% of the reference-vessel diameter based on visual estimation. The stented segment was also considered optimized if there was no flow-limiting coronary-artery dissection.\u003c\/p\u003e\n\n\u003cp\u003eAll angiograms and intravascular imaging data were analyzed by independent core laboratories after the completion of the PCI procedure.\u003c\/p\u003e\n\n\u003ch3\u003eWhat Was Measured?\u003c\/h3\u003e\n\n\u003cp\u003eThe primary endpoint was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. The primary endpoint was assessed in the intention-to-treat population (all patients who underwent randomization) during the overall trial period.\u003c\/p\u003e\n\n\u003cp\u003eSecondary endpoints included the individual components of the primary endpoint. Secondary endpoints also included target-vessel failure without procedure-related myocardial infarction, a composite of target-vessel-related myocardial infarction or death from cardiac causes, and definite stent thrombosis.\u003c\/p\u003e\n\n\u003cp\u003eSerious adverse events related to PCI or intravascular imaging were monitored. These included coronary perforation, emergency reintervention, congestive heart failure, cardiogenic shock, anaphylactic reaction to the contrast agent, and cardiac tamponade. These also included bleeding related to the access site or other bleeding, arterial dissection at the vascular access site, or arrhythmia.\u003c\/p\u003e\n\n\u003cp\u003eClinical follow-up was conducted during outpatient clinic visits scheduled at 1 month, 6 months, and 12 months and yearly thereafter. Patients unable to attend outpatient clinical visits were contacted by telephone. Cross-validation of survival status was performed using the Korean National Health Insurance database.\u003c\/p\u003e\n\n\u003ch3\u003eStatistical Analysis\u003c\/h3\u003e\n\n\u003cp\u003eThe researchers estimated that a sample size of 1,620 would provide the trial with at least 90% power, at a two-sided significance level of 5%, to reject the null hypothesis. The null hypothesis was that there would be no between-group difference for the primary composite endpoint.\u003c\/p\u003e\n\n\u003cp\u003eThe annual incidence of the primary endpoint was expected to be 3.6% in the intravascular imaging group and 6.0% in the angiography group. These estimates were based on the results of previous studies. No interim analysis was planned.\u003c\/p\u003e\n\n\u003cp\u003eAll analyses were performed on an intention-to-treat basis. The primary endpoint analysis included an estimation of the cumulative-incidence function of target-vessel failure. The analysis also included a comparison of the randomized groups using the method of Fine and Gray to adjust for the potential competing risk of death from non-cardiac causes.\u003c\/p\u003e\n\n\u003cp\u003eAs a sensitivity analysis, Kaplan-Meier analyses were performed for time-to-event endpoints with treatment effects estimated using Cox proportional-hazards regression models. Subgroup analysis of the primary endpoint was performed according to the type of intravascular imaging device and clinical factors. All models were adjusted for the patient's clinical presentation and for participating centers.\u003c\/p\u003e\n\n\u003cp\u003eBecause the statistical analysis plan did not include a provision for correction for multiplicity when tests for secondary endpoints were conducted, results are reported as point estimates with 95% confidence intervals. The widths of the confidence intervals have not been adjusted for multiplicity, so they should not be used to infer definitive treatment effects for secondary endpoints.\u003c\/p\u003e\n\n\u003ch2 id=\"patients\"\u003ePatient Characteristics\u003c\/h2\u003e\n\n\u003cp\u003eFrom May 2018 through May 2021, a total of 1,639 patients with complex coronary-artery lesions underwent randomization. Of these, 1,092 patients were assigned to undergo intravascular imaging-guided PCI, and 547 to undergo angiography-guided PCI.\u003c\/p\u003e\n\n\u003cp\u003eIntravascular imaging devices were not used in 14 patients in the intravascular imaging group. This was owing to failure to pass the device across the lesion, failed PCI, or hemodynamic instability during the procedure. In 13 patients in the angiography group, intravascular imaging devices were used during the procedure. Patients with protocol violations were included in the analysis as part of the intention-to-treat population.\u003c\/p\u003e\n\n\u003cp\u003eThe clinical characteristics of the patients at baseline appeared to be similar in the two groups:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAge:\u003c\/strong\u003e Average age was 65.6 ± 10.2 years overall (65.3 ± 10.3 in the imaging group and 66.0 ± 10.0 in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMale sex:\u003c\/strong\u003e 1,300 patients (79.3%) overall (79.6% in the imaging group and 78.8% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStable ischemic heart disease:\u003c\/strong\u003e 807 patients (49.2%) overall (48.7% in the imaging group and 50.3% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAcute coronary syndrome:\u003c\/strong\u003e 832 patients (50.8%) overall (51.3% in the imaging group and 49.7% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUnstable angina:\u003c\/strong\u003e 534 patients (32.6%) overall (33.1% in the imaging group and 31.6% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAcute myocardial infarction:\u003c\/strong\u003e 298 patients (18.2%) overall (18.2% in the imaging group and 18.1% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNon-STEMI:\u003c\/strong\u003e 258 patients (15.7%) overall (15.7% in the imaging group and 15.9% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSTEMI:\u003c\/strong\u003e 40 patients (2.4%) overall (2.6% in the imaging group and 2.2% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eMedical history at baseline included:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eHypertension:\u003c\/strong\u003e 1,005 patients (61.3%) overall (62.5% in the imaging group and 59.0% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiabetes mellitus:\u003c\/strong\u003e 617 patients (37.6%) overall (36.1% in the imaging group and 40.8% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInsulin-treated diabetes mellitus:\u003c\/strong\u003e 51 patients (3.1%) overall (2.6% in the imaging group and 4.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDyslipidemia (abnormal cholesterol levels):\u003c\/strong\u003e 840 patients (51.3%) overall (51.3% in the imaging group and 51.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCurrent smoking:\u003c\/strong\u003e 307 patients (18.7%) overall (19.4% in the imaging group and 17.4% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eChronic renal insufficiency (kidney problems):\u003c\/strong\u003e 296 patients (18.1%) overall (18.6% in the imaging group and 17.0% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrevious PCI:\u003c\/strong\u003e 395 patients (24.1%) overall (24.5% in the imaging group and 23.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrevious myocardial infarction:\u003c\/strong\u003e 117 patients (7.1%) overall (6.9% in the imaging group and 7.7% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrevious stroke:\u003c\/strong\u003e 112 patients (6.8%) overall (6.4% in the imaging group and 7.7% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePeripheral arterial disease:\u003c\/strong\u003e 44 patients (2.7%) overall (2.5% in the imaging group and 3.1% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLeft ventricular ejection fraction (a measure of heart pumping function):\u003c\/strong\u003e 58.7 ± 11.6% overall (58.4 ± 11.9% in the imaging group and 59.3 ± 11.0% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eMedications at discharge were similar between groups:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eAspirin:\u003c\/strong\u003e 1,606 patients (98.0%) overall (97.9% in the imaging group and 98.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eP2Y12 inhibitor (antiplatelet medication):\u003c\/strong\u003e 1,603 patients (97.8%) overall (97.7% in the imaging group and 98.0% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClopidogrel:\u003c\/strong\u003e 1,216 patients (74.2%) overall (73.2% in the imaging group and 76.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTicagrelor:\u003c\/strong\u003e 209 patients (12.8%) overall (13.6% in the imaging group and 11.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrasugrel:\u003c\/strong\u003e 178 patients (10.9%) overall (11.0% in the imaging group and 10.6% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOral anticoagulant:\u003c\/strong\u003e 75 patients (4.6%) overall (4.2% in the imaging group and 5.3% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStatin:\u003c\/strong\u003e 1,567 patients (95.6%) overall (95.3% in the imaging group and 96.2% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eBeta-blocker:\u003c\/strong\u003e 710 patients (43.3%) overall (42.7% in the imaging group and 44.6% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eACE inhibitor or ARB:\u003c\/strong\u003e 945 patients (57.7%) overall (57.0% in the imaging group and 59.0% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"procedural\"\u003eProcedural Details\u003c\/h2\u003e\n\n\u003cp\u003eThe characteristics of the coronary-artery target lesion and the PCI procedures appeared to be well balanced between the two groups. This included the types of complex coronary-artery lesions treated with PCI and the severity of coronary artery disease as assessed on angiography.\u003c\/p\u003e\n\n\u003cp\u003eTypes of complex coronary lesions treated:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTrue bifurcation lesion:\u003c\/strong\u003e 359 patients (21.9%) overall (21.3% in the imaging group and 23.0% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eChronic total occlusion:\u003c\/strong\u003e 319 patients (19.5%) overall (20.1% in the imaging group and 18.1% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUnprotected left main coronary artery disease:\u003c\/strong\u003e 192 patients (11.7%) overall (12.6% in the imaging group and 9.9% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiffuse long coronary-artery lesion:\u003c\/strong\u003e 898 patients (54.8%) overall (56.5% in the imaging group and 51.4% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMultivessel PCI involving at least two major coronary arteries:\u003c\/strong\u003e 622 patients (37.9%) overall (37.5% in the imaging group and 38.9% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLesion necessitating use of at least three stents:\u003c\/strong\u003e 305 patients (18.6%) overall (19.0% in the imaging group and 17.7% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLesion with in-stent restenosis:\u003c\/strong\u003e 236 patients (14.4%) overall (14.5% in the imaging group and 14.3% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSeverely calcified lesion:\u003c\/strong\u003e 231 patients (14.1%) overall (14.4% in the imaging group and 13.5% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOstial lesions of major coronary artery:\u003c\/strong\u003e 251 patients (15.3%) overall (16.7% in the imaging group and 12.6% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAt least three complex coronary lesions:\u003c\/strong\u003e 505 patients (30.8%) overall (32.2% in the imaging group and 28.0% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eNumber of vessels with disease:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eOne vessel:\u003c\/strong\u003e 526 patients (32.1%) overall (31.3% in the imaging group and 33.6% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTwo vessels:\u003c\/strong\u003e 621 patients (37.9%) overall (38.5% in the imaging group and 36.7% in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThree vessels:\u003c\/strong\u003e 492 patients (30.0%) overall (30.2% in the imaging group and 29.6% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eProcedural characteristics:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal number of target lesions treated:\u003c\/strong\u003e 1.5 ± 0.7 in both groups\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntravascular imaging device used:\u003c\/strong\u003e 1,091 of 1,639 patients (66.6%) overall; 1,078 of 1,092 (98.7%) in the imaging group and 13 of 547 (2.4%) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIntravascular ultrasonography:\u003c\/strong\u003e 813 of 1,091 (74.5%) overall; 800 of 1,078 (74.2%) in the imaging group and 13 of 13 (100%) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOptical coherence tomography:\u003c\/strong\u003e 278 of 1,091 (25.5%) overall; 278 of 1,078 (25.8%) in the imaging group and 0 of 13 (0%) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVolume of contrast media used:\u003c\/strong\u003e 207.3 ± 116.5 ml overall (214.2 ± 118.5 ml in the imaging group and 193.7 ± 111.3 ml in the angiography group)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMedian procedural time:\u003c\/strong\u003e 65 minutes (interquartile range, 47 to 89) overall; 70 minutes (interquartile range, 51 to 95) in the imaging group and 53.5 minutes (interquartile range, 40 to 75) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedural success:\u003c\/strong\u003e 1,613 patients (98.4%) overall (98.3% in the imaging group and 98.7% in the angiography group)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eAmong the 1,092 patients in the intravascular imaging group, 800 (73.3%) underwent imaging with intravascular ultrasonography and 278 (25.5%) underwent imaging with OCT. The majority of the PCI procedures were performed by means of radial-artery access, and coronary-artery lesions were treated with drug-eluting stents with procedural success in 1,613 of 1,639 patients (98.4%).\u003c\/p\u003e\n\n\u003cp\u003eThe baseline severity of the coronary-artery lesions, assessed on the basis of the minimum lumen diameter and the percent diameter stenosis, did not appear to differ between the two groups.\u003c\/p\u003e\n\n\u003cp\u003eUse of intravascular imaging resulted in more frequent use of adjunctive balloon dilation of the stent with noncompliant balloons (ultra-high-strength balloons that accommodate high pressure without changing diameter). After PCI, the mean minimum lumen diameter was 2.8 ± 0.5 mm in the intravascular imaging group and 2.7 ± 0.5 mm in the angiography group.\u003c\/p\u003e\n\n\u003ch2 id=\"findings\"\u003eKey Findings: What the Study Showed\u003c\/h2\u003e\n\n\u003cp\u003eAt a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0 years), the primary endpoint event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group. The primary endpoint event had occurred in 60 patients (cumulative incidence, 12.3%) in the angiography group. This difference was statistically significant (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008).\u003c\/p\u003e\n\n\u003cp\u003eIn plain language, this means that patients in the imaging-guided group had a 36% lower relative risk of experiencing the combined primary endpoint compared with patients in the angiography-guided group. The absolute risk reduction was 4.6 percentage points (12.3% minus 7.7%).\u003c\/p\u003e\n\n\u003cp\u003eWhen the individual components of the primary endpoint were examined separately:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eDeath from cardiac causes:\u003c\/strong\u003e Occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTarget-vessel-related myocardial infarction:\u003c\/strong\u003e Occurred in 38 patients (cumulative incidence, 3.7%) in the intravascular imaging group and in 30 patients (cumulative incidence, 5.6%) in the angiography group\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClinically driven target-vessel revascularization:\u003c\/strong\u003e Occurred in 32 patients (cumulative incidence, 3.4%) in the intravascular imaging group and in 25 patients (cumulative incidence, 5.5%) in the angiography group\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThere were no apparent between-group differences in the incidence of procedure-related safety events.\u003c\/p\u003e\n\n\u003ch2 id=\"subgroups\"\u003eSubgroup and Additional Analyses\u003c\/h2\u003e\n\n\u003cp\u003eThe researchers performed a prespecified subgroup analysis to examine whether the benefit of intravascular imaging was consistent across different types of patients and lesions. The results of the unadjusted analysis were consistent with those of the primary analysis.\u003c\/p\u003e\n\n\u003cp\u003eIn an exploratory analysis, the cumulative incidence of the primary endpoint was 6.0% in one subgroup examined. The document also reports that definite stent thrombosis occurred in 0.1% of the intravascular imaging-guided group and 0.7% of the angiography group (hazard ratio, 0.25; 95% confidence interval, 0.02 to 2.75).\u003c\/p\u003e\n\n\u003cp\u003eThe subgroup analysis examined outcomes according to the type of intravascular imaging device used (intravascular ultrasonography versus OCT) and various clinical factors. The consistency of benefit across these subgroups supports the broad applicability of the findings.\u003c\/p\u003e\n\n\u003ch2 id=\"safety\"\u003eSafety Outcomes\u003c\/h2\u003e\n\n\u003cp\u003eThe trial assessed safety by monitoring serious adverse events related to PCI or intravascular imaging. These included coronary perforation, emergency reintervention, congestive heart failure, cardiogenic shock, anaphylactic reaction to the contrast agent, and cardiac tamponade. These also included bleeding related to the access site or other bleeding, arterial dissection at the vascular access site, and arrhythmia.\u003c\/p\u003e\n\n\u003cp\u003eThere were no apparent between-group differences in the incidence of procedure-related safety events. This means that adding intravascular imaging to the PCI procedure did not introduce additional safety risks compared with angiography guidance alone.\u003c\/p\u003e\n\n\u003cp\u003eThe median procedural time was longer in the intravascular imaging group (70 minutes versus 53.5 minutes). The volume of contrast media used was slightly higher in the imaging group (214.2 ml versus 193.7 ml). However, these differences did not translate into worse safety outcomes.\u003c\/p\u003e\n\n\u003ch2 id=\"implications\"\u003eWhat This Means for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThis trial provides strong evidence that intravascular imaging-guided PCI improves clinical outcomes for patients with complex coronary-artery lesions compared with angiography-guided PCI. The findings are particularly important because previous trials had not been considered definitive due to limited sample size or highly selected patient populations.\u003c\/p\u003e\n\n\u003cp\u003eFor patients undergoing PCI for complex coronary lesions, the use of intravascular imaging (either intravascular ultrasonography or OCT) during the procedure may reduce the risk of:\u003c\/p\u003e\n\n\u003cul\u003e\n\u003cli\u003eDeath from cardiac causes (1.7% vs. 3.8% cumulative incidence)\u003c\/li\u003e\n\u003cli\u003eTarget-vessel-related myocardial infarction (3.7% vs. 5.6% cumulative incidence)\u003c\/li\u003e\n\u003cli\u003eClinically driven target-vessel revascularization (3.4% vs. 5.5% cumulative incidence)\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eThe number needed to treat can be estimated from the data. This would prevent one primary endpoint event over 2.1 years. This is based on the absolute risk reduction of 4.6 percentage points.\u003c\/p\u003e\n\n\u003cp\u003eThe trial included a broad range of complex lesion types. These included bifurcation lesions, chronic total occlusions, unprotected left main disease, long lesions, multivessel PCI, lesions requiring multiple stents, in-stent restenosis, severely calcified lesions, and ostial lesions. This suggests that the benefits of intravascular imaging guidance apply across the spectrum of complex coronary interventions.\u003c\/p\u003e\n\n\u003cp\u003eBoth intravascular ultrasonography and OCT were used in the trial, with intravascular ultrasonography being more common (73.3% of imaging procedures) and OCT used in 25.5%. The choice between the two imaging modalities was left to the operator's discretion, and both appeared to be associated with benefit.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eLimitations of the Study\u003c\/h2\u003e\n\n\u003cp\u003eSeveral important limitations should be considered when interpreting these results:\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eOpen-label design:\u003c\/strong\u003e Both doctors and patients knew which treatment was being used. This could potentially influence decisions about subsequent treatments or procedures, although an independent committee unaware of treatment assignments assessed all clinical events.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGeographic limitation:\u003c\/strong\u003e The trial was conducted entirely in South Korea at 20 sites. Whether the results apply equally to other populations and healthcare systems is uncertain.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOperator discretion:\u003c\/strong\u003e The choice between intravascular ultrasonography and OCT was left to the operator, and the specific imaging protocols were not standardized across all sites.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSecondary endpoints:\u003c\/strong\u003e The statistical analysis plan did not include correction for multiple comparisons when testing secondary endpoints. Therefore, the results for individual components of the primary endpoint and other secondary endpoints should be considered exploratory and not definitive.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFollow-up duration:\u003c\/strong\u003e The median follow-up was 2.1 years. Longer-term outcomes beyond this period are not known.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProtocol violations:\u003c\/strong\u003e Fourteen patients in the intravascular imaging group did not receive imaging, and 13 patients in the angiography group did receive imaging. These patients were included in the intention-to-treat analysis.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFunding:\u003c\/strong\u003e The trial was supported by Abbott Vascular and Boston Scientific, although these companies had no role in trial design, data collection, analysis, interpretation, or manuscript writing.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations\u003c\/h2\u003e\n\n\u003cp\u003eBased on the findings of this trial, the following recommendations can be made for patients with complex coronary-artery lesions who are undergoing PCI:\u003c\/p\u003e\n\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiscuss imaging guidance with your doctor:\u003c\/strong\u003e If you are scheduled for PCI for a complex coronary lesion, ask your interventional cardiologist whether intravascular imaging (intravascular ultrasonography or OCT) will be used during your procedure.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUnderstand your lesion complexity:\u003c\/strong\u003e Complex lesions include blockages at branch points, chronic total occlusions, left main disease, long lesions requiring stents of at least 38 mm, multivessel disease, lesions requiring multiple stents, in-stent restenosis, severely calcified lesions, and ostial lesions.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecognize the benefits:\u003c\/strong\u003e Intravascular imaging guidance during PCI for complex lesions reduces the risk of cardiac death, heart attack related to the treated vessel, and the need for repeat procedures to reopen the artery.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eKnow the safety profile:\u003c\/strong\u003e Adding intravascular imaging to PCI does not appear to increase procedure-related safety events, although it may slightly lengthen the procedure time and require slightly more contrast dye.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFollow medication recommendations:\u003c\/strong\u003e Nearly all patients in this trial were discharged on aspirin (98.0%), a P2Y12 inhibitor (97.8%), and a statin (95.6%). These medications are essential for preventing future cardiovascular events after PCI.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAttend follow-up visits:\u003c\/strong\u003e Regular follow-up at 1 month, 6 months, 12 months, and yearly thereafter is important for monitoring your heart health and detecting any problems early.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003ePatients should discuss the specific risks and benefits of intravascular imaging-guided PCI with their healthcare team. This discussion should take into account their individual medical history. It should also take into account the complexity of their coronary lesions and other factors.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is intravascular imaging and how is it used during a PCI procedure?\u003c\/h3\u003e\n\u003cp\u003eIntravascular imaging uses either sound waves (intravascular ultrasonography) or light waves (optical coherence tomography) to see inside the artery during PCI. It helps doctors choose the right stent size, position the stent correctly, and check whether the stent is fully expanded. In a trial of 1,639 patients with complex coronary lesions, imaging was mandated after stent implantation to confirm the stented segment was optimized.\u003c\/p\u003e\n\u003ch3\u003eWhat does a 36% lower relative risk mean for me?\u003c\/h3\u003e\n\u003cp\u003eIn a trial of 1,639 patients with complex coronary lesions, those whose PCI was guided by intravascular imaging had a 36% lower relative risk of the combined endpoint of cardiac death, target-vessel heart attack, or repeat target-vessel revascularization over a median of 2.1 years. The absolute risk reduction was 4.6 percentage points. This does not mean an individual patient's risk drops by exactly 36%.\u003c\/p\u003e\n\u003ch3\u003eWhat are complex coronary-artery lesions and was I eligible for this trial?\u003c\/h3\u003e\n\u003cp\u003eIn the trial, complex lesions included blockages at artery branch points, chronic total occlusions, unprotected left main disease, long lesions needing stents of at least 38 mm, multivessel PCI, lesions requiring at least three stents, in-stent restenosis, severely calcified lesions, and ostial lesions. Patients were 19 or older and excluded if they had cardiogenic shock or certain medication allergies.\u003c\/p\u003e\n\u003ch3\u003eDoes adding intravascular imaging to PCI increase procedure risks?\u003c\/h3\u003e\n\u003cp\u003eIn the trial of 1,639 patients, there were no apparent between-group differences in procedure-related safety events such as coronary perforation, emergency reintervention, heart failure, shock, contrast reaction, tamponade, bleeding, access-site dissection, or arrhythmia. However, the imaging group had a longer median procedure time (70 vs. 53.5 minutes) and slightly more contrast media used (214.2 ml vs. 193.7 ml).\u003c\/p\u003e\n\u003ch3\u003eWhat medications will I need after PCI for a complex lesion?\u003c\/h3\u003e\n\u003cp\u003eIn the trial, nearly all patients were discharged on aspirin (98.0%), a P2Y12 inhibitor such as clopidogrel, ticagrelor, or prasugrel (97.8%), and a statin (95.6%). These medications are essential for preventing future cardiovascular events after PCI. Your own medication plan should be discussed with your healthcare team, as it depends on your individual medical history and other factors.\u003c\/p\u003e\n\u003ch3\u003eHow long is follow-up needed after PCI for complex coronary lesions?\u003c\/h3\u003e\n\u003cp\u003eIn the trial, clinical follow-up was scheduled at 1 month, 6 months, and 12 months, and yearly thereafter. Patients unable to attend clinic visits were contacted by telephone. The median follow-up in the trial was 2.1 years, so longer-term outcomes beyond that period are not known. Regular follow-up helps monitor heart health and detect problems early.\u003c\/p\u003e\n\u003ch3\u003eWhat is the number needed to treat and what does it mean?\u003c\/h3\u003e\n\u003cp\u003eThis estimate comes from the absolute risk reduction of 4.6 percentage points (12.3% minus 7.7%) observed in the trial of 1,639 patients.\u003c\/p\u003e\n\u003ch3\u003eIf I'm scheduled for PCI for a complex coronary lesion, when should I get a second opinion about whether intravascular imaging will be used?\u003c\/h3\u003e\n\u003cp\u003eA second opinion is reasonable when you are scheduled for PCI for a complex lesion and imaging guidance has not been discussed. Complex lesions include blockages at branch points, chronic total occlusions, left main disease, long lesions needing stents of at least 38 mm, multivessel disease, lesions requiring multiple stents, in-stent restenosis, severely calcified lesions, and ostial lesions. In a large randomized trial, imaging-guided PCI reduced the combined endpoint of cardiac death, target-vessel heart attack, or repeat revascularization from 12.3% to 7.7%. 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 Intravascular ImagingGuided or Angiography-Guided Complex PCI NEJM 2023\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e \u003ca href=\"https:\/\/doi.org\/10.1056\/NEJMoa2216607\" target=\"_blank\" rel=\"noopener\"\u003e10.1056\/NEJMoa2216607\u003c\/a\u003e\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e J.M. Lee, K.H. Choi, Y.B. Song, J.-Y. Lee, S.-J. Lee, S.Y. Lee, S.M. Kim, K.H. Yun, J.Y. Cho, C.J. Kim, H.-S. Ahn, C.-W. Nam, H.-J. Yoon, Y.H. Park, W.S. Lee, J.-O. Jeong, P.S. Song, J.-H. Doh, S.-H. Jo, C.-H. Yoon, M.G. Kang, J.-S. Koh, K.Y. Lee, Y.-H. Lim, Y.-H. Cho, J.-M. Cho, W.J. Jang, K.-J. Chun, D. Hong, T.K. Park, J.H. Yang, S.-H. Choi, H.-C. Gwon, and J.-Y. Hahn, for the RENOVATE-COMPLEX-PCI Investigators\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublication:\u003c\/strong\u003e New England Journal of Medicine, 2023;388:1668-79\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e 10.1056\/NEJMoa2216607\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublished:\u003c\/strong\u003e March 5, 2023 (online), May 4, 2023 (print issue)\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eClinicalTrials.gov Number:\u003c\/strong\u003e NCT03381872\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c\/strong\u003e Supported by Abbott Vascular and Boston Scientific\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research published in the New England Journal of Medicine. The information presented here is for educational purposes and should not replace consultation with a qualified healthcare provider. Patients should discuss their individual medical situation with their doctor.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47919014510748,"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-intravascular-imaging-guided-vs-angiography-guided-complex-pci-what-patients-need-to-know-hero.png?v=1793341270","url":"https:\/\/diagnosticdetectives.com\/sv\/products\/intravascular-imaging-guided-vs-angiography-guided-complex-pci-what-patients-need-to-know","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}