Impact of systolic dominant pulmonary venous flow morphology on outcomes after mitral transcatheter edge-to-edge repair.

BACKGROUND: The prognostic significance of intraprocedural pulsed-wave Doppler analysis of pulmonary venous flow (PVF) during mitral transcatheter edge-to-edge repair (TEER) remains understudied. We aimed to investigate the prognostic value of systolic dominant-PVF (SD-PVF) morphology post-TEER. METHODS: In a retrospective analysis from December 2019 to December 2022, patients undergoing mitral TEER were categorized into SD-PVF and systolic blunting (SB)-PVF groups based on post-TEER morphology. The primary endpoint was a composite of all-cause mortality or heart failure hospitalization at 1 year. We investigated the association of PVF morphology post-TEER with the primary endpoint at 1 year using Cox regression and compared the prognostic accuracy of PVF variables through receiver operating characteristic (ROC) curve analysis. RESULTS: Among 187 patients (mean age 76.4 ± 10.5 years, 51.3% primary etiology), residual mitral regurgitation (MR) ≤mild was observed in 147 (82.4%) patients and 105 (56.2%) had SD-PVF post-TEER. Patients with SD-PVF had a lower incidence of >2+ residual MR after clip deployment, at 30 days (2.1% vs. 13.1%; p = 0.005) and at 1 year (1.4% vs. 9%; p = 0.08). SD-PVF post-TEER was independently associated with the primary endpoint (HR = 0.59, 95% CI = 0.39-0.87; p = 0.009). ROC curve analysis of the prognostic accuracy of SD-PVF demonstrated an AUC of 0.64 (95% CI = 0.54-0.73), comparable to other quantitative measures of PVF. CONCLUSION: Assessing PVF morphology after clip deployment offers a simple prognostic tool for patients undergoing mitral TEER. Multicenter cohorts will be necessary to further investigate its prognostic value.

Association of Baseline Tricuspid Regurgitation With Health Status and Clinical Outcomes After TAVR and Mitral TEER.

BACKGROUND: Tricuspid regurgitation (TR) is associated with worse clinical outcomes after transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (M-TEER), but little is known about its association with health status outcomes. OBJECTIVES: The aims of this study were to explore, using the Society of Thoracic Surgeons and American College of Cardiology TVT (Transcatheter Valve Therapy) Registry, the association between baseline TR and health status after TAVR and M-TEER and to determine if baseline TR was associated with clinical endpoints. METHODS: Health status was assessed using Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score in patients enrolled in the TVT Registry who underwent isolated TAVR or M-TEER between January 2019 and June 2021. The association among baseline TR and KCCQ-OS score, being alive and well, and clinical outcomes was examined. RESULTS: In total, 130,097 TAVR patients (13.1% with moderate TR, 2.3% with severe TR) and 19,593 M-TEER patients (33.2% with moderate TR, 14.7% with severe TR) were included. Mean KCCQ-OS scores were lower with severe vs moderate vs none to mild TR at baseline prior to TAVR (39.4 ± 24.2 vs 45.2 ± 24.7 vs 51.3 ± 25.3; P < 0.01) or M-TEER (38.1 ± 23.9 vs 41.9 ± 24.7 vs 45.4 ± 25.2; P < 0.01) and similarly at 30 days and 1 year. The odds of being alive and well at 1 year were lower with moderate or severe TR before TAVR (adjusted OR: 0.79 [95% CI: 0.74-0.85] and adjusted OR: 0.81 [95% CI: 0.70-0.94], respectively) and severe TR before M-TEER (adjusted OR: 0.53; 95% CI: 0.40-0.71). Furthermore, moderate or severe TR before TAVR was associated with higher 1-year mortality and readmission, whereas moderate or severe TR before M-TEER was associated with higher 1-year mortality. CONCLUSIONS: In a large cohort of U.S. patients who underwent TAVR or M-TEER, greater baseline TR was associated with worse health status and clinical outcomes. Understanding adverse outcomes of TR in patients with coexisting valvular abnormalities is important, especially with rapidly evolving transcatheter tricuspid valve interventions.

3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.

BACKGROUND: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited. OBJECTIVES: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study. METHODS: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S. CENTERS: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR. CONCLUSIONS: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance.

Impact of Left Atrial Pressure on Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Increased left atrial pressure (LAP) has been associated with adverse outcomes after mitral transcatheter edge-to-edge repair (M-TEER). We sought to evaluate outcomes based on differences in postprocedural LAP measured after the final clip deployment. METHODS: We included consecutive patients who underwent M-TEER at our institution between 2014 and 2022 with LAP monitoring. Patients were stratified into 3 groups according to tertiles of post-TEER mean LAP. Outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazards models. RESULTS: We included 273 patients (mean age, 76.8±10.8 years; 42.5% women; 78.4% White). The mean post-TEER LAP was 8.7±1.7 mm Hg in tertile 1 (n=85), 14.4±1.6 mm Hg in tertile 2 (n=95), and 21.9±3.8 mm Hg in tertile 3 (n=93). In comparison with tertile 1, both tertiles 2 and 3 were associated with increased risk of all-cause mortality or heart failure hospitalization at 2 years (adjusted hazard ratio [adjHR], 2.27 [95% CI, 1.25-4.12] and adjHR, 3.00 [95% CI, 1.59-5.64], respectively). Among patients with primary mitral regurgitation, higher LAP was associated with increased risk of 2-year all-cause mortality or heart failure hospitalization (tertile 2 versus 1: adjHR, 3.00 [95% CI, 1.37-6.56]; tertile 3 versus 1: adjHR, 5.52 [95% CI, 2.04-14.95]). However, in patients with secondary mitral regurgitation, neither being in tertile 2 (adjHR, 1.53 [95% CI, 0.55-4.24]) nor tertile 3 (adjHR, 2.18 [95% CI, 0.82-5.77]) were associated with the composite outcome compared with tertile 1. Any degree of LAP reduction following M-TEER was associated with lower mortality or heart failure hospitalization compared with no LAP reduction (adjHR, 0.59 [95% CI, 0.39-0.88]). CONCLUSIONS: Elevated LAP after M-TEER was associated with increased 2-year risk of mortality or heart failure hospitalization. Exploration of reasons for elevated LAP after M-TEER and ways to lower it warrant further investigation.

Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

Prognostic Value of Right Ventricular Afterload in Patients Undergoing Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Pulmonary hypertension (PH) and secondary mitral regurgitation (MR) are associated with adverse outcomes after mitral transcatheter edge-to-edge repair. We aim to study the prognostic value of invasively measured right ventricular afterload in patients undergoing mitral transcatheter edge-to-edge repair. METHODS AND RESULTS: We identified patients who underwent right heart catheterization ≤1 month before transcatheter edge-to-edge repair. The end points were all-cause mortality and a composite of mortality and heart failure hospitalization at 2 years. Using the receiver operating characteristic curve-derived threshold of 0.6 for pulmonary effective arterial elastance ([Ea], pulmonary artery systolic pressure/stroke volume), patients were stratified into 3 profiles based on PH severity (low elastance [HE]: Ea <0.6/mean pulmonary artery pressure (mPAP)) <35; High Elastance with No/Mild PH (HE-): Ea ≥0.6/mPAP <35; and HE with Moderate/Severe PH (HE+): Ea ≥0.6/mPAP ≥35) and MR pathogenesis (Primary MR [PMR])/low elastance, PMR/HE, and secondary MR). The association between this classification and clinical outcomes was examined using Cox regression. Among 114 patients included, 50.9% had PMR. Mean±SD age was 74.7±10.6 years. Patients with Ea ≥0.6 were more likely to have diabetes, atrial fibrillation, New York Heart Association III/IV status, and secondary MR (all P<0.05). Overall, 2-year cumulative survival was 71.1% and was lower in patients with secondary MR and mPAP ≥35. Compared with patients with low elastance, cumulative 2-year event-free survival was significantly lower in HE- and HE+ patients (85.5% versus 50.4% versus 41.0%, respectively, P=0.001). Also, cumulative 2-year event-free survival was significantly higher in patients with PMR/low elastance when compared with PMR/HE and patients with secondary mitral regurgitation (85.5% versus 55.5% versus 46.1%, respectively, P=0.005). CONCLUSIONS: Assessment of the preprocedural cardiopulmonary profile based on mPAP, MR pathogenesis, and Ea guides patient selection by identifying hemodynamic features that indicate likely benefit from mitral-transcatheter edge-to-edge repair in PH or lack thereof.

Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis.

BACKGROUND: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited. OBJECTIVES: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR. METHODS: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR. RESULTS: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41). CONCLUSIONS: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.

Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients.

BACKGROUND: Symptomatic patients with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR) sustain comparable improvements in health status over 5 years after transcatheter aortic valve replacement (TAVR) or SAVR. Whether a similar long-term benefit is observed among intermediate-risk AS patients is unknown. OBJECTIVES: The purpose of this study was to assess health status outcomes through 5 years in intermediate risk patients treated with a self-expanding TAVR prosthesis or SAVR using data from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. METHODS: Intermediate-risk patients randomized to transfemoral TAVR or SAVR in the SURTAVI trial had disease-specific health status assessed at baseline, 30 days, and annually to 5 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Health status was compared between groups using fixed effects repeated measures modelling. RESULTS: Of the 1,584 patients (TAVR, n = 805; SAVR, n = 779) included in the analysis, health status improved more rapidly after TAVR compared with SAVR. However, by 1 year, both groups experienced large health status benefits (mean change in KCCQ-Overall Summary Score (KCCQ-OS) from baseline: TAVR: 20.5 ± 22.4; SAVR: 20.5 ± 22.2). This benefit was sustained, albeit modestly attenuated, at 5 years (mean change in KCCQ-OS from baseline: TAVR: 15.4 ± 25.1; SAVR: 14.3 ± 24.2). There were no significant differences in health status between the cohorts at 1 year or beyond. Similar findings were observed in the KCCQ subscales, although a substantial attenuation of benefit was noted in the physical limitation subscale over time in both groups. CONCLUSIONS: In intermediate-risk AS patients, both transfemoral TAVR and SAVR resulted in comparable and durable health status benefits to 5 years. Further research is necessary to elucidate the mechanisms for the small decline in health status noted at 5 years compared with 1 year in both groups. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Percutaneous coronary intervention before transcatheter aortic valve implantation: A propensity score matched analysis.

BACKGROUND: The role of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) who subsequently undergo transcatheter aortic valve replacement (TAVR) remains uncertain. Therefore, we conducted this study to assess the association of PCI before TAVR with mortality and cardiovascular outcomes. METHODS: We used the TriNetX database (Jan 2012 - Aug 2022) and grouped patients into PCI (3 months or less) before TAVR and no PCI. We performed propensity score matched (PSM) analyses for outcomes at 30 days and 1 year. RESULTS: Of 17,120 patients undergoing TAVR, 2322 (14 %) had PCI, and 14,798 (86 %) did not have PCI before TAVR. In the PSM cohort (2026 patients in each group), PCI was not associated with lower all-cause mortality at 30 days (HR: 1.25, 95 % CI: 0.82-1.90) or 1 year (HR: 1.02, 95 % CI: 0.83-1.24). Frequency of repeat PCI after TAVR was low in both no PCI vs. PCI (2.4 % vs. 1.2 %) at 1 year; PCI was associated with a lower rate of repeat PCI (HR: 0.49, 95 % CI: 0.30-0.80). Sensitivity analysis revealed an E-value of 3.5 for repeat PCI (E-value for lower CI for HR: 1.81). PCI was not linked to reductions in MI, heart failure exacerbation, all-cause hospitalization, major bleeding, or permanent pacemaker/implantable cardioverter defibrillator. CONCLUSION: This analysis showed that PCI prior to TAVR was not associated with improvement in all-cause mortality. However, PCI was associated with a reduced rate of repeat PCI at 1 year.

Echocardiographic Profiling Predicts Clinical Outcomes After Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Prior studies investigating the impact of residual mitral regurgitation (MR), tricuspid regurgitation (TR), and elevated predischarge transmitral mean pressure gradient (TMPG) on outcomes after mitral transcatheter edge-to-edge repair (TEER) have assessed each parameter in isolation. We sought to examine the prognostic value of combining predischarge MR, TR, and TMPG to study long-term outcomes after TEER. METHODS AND RESULTS: We reviewed the records of 291 patients who underwent successful mitral TEER at our institution between March 2014 and June 2022. Using well-established outcomes-related cutoffs for predischarge MR (≥moderate), TR (≥moderate), and TMPG (≥5 mm Hg), 3 echo profiles were developed based on the number of risk factors present (optimal: 0 risk factors, mixed: 1 risk factor, poor: ≥2 risk factors). Discrimination of the profiles for predicting the primary composite end point of all-cause mortality and heart failure hospitalization at 2 years was examined using Cox regression. Overall, mean age was 76.7±10.6 years, 43.3% were women, and 53% had primary MR. Two-year event-free survival was 61%. Predischarge TR≥moderate, MR≥moderate, and TMPG≥5 mm Hg were risk factors associated with the primary end point. Compared with the optimal profile, there was an incremental risk in 2-year event-rate with each worsening profile (optimal as reference; mixed profile: hazard ratio (HR), 2.87 [95% CI, 1.71-5.17], P<0.001; poor profile: HR, 3.76 [95% CI, 1.84-6.53], P<0.001). Echocardiographic profile was statistically associated with the 2-year mortality end point (optimal as reference; mixed profile: HR, 3.55 [95% CI, 1.81-5.96], P<0.001; poor profile: HR, 3.39 [95% CI, 2.56-7.33], P=0.02). CONCLUSIONS: The echocardiographic profile integrating predischarge TR, MR, and TMPG presents a novel prognostic stratification tool for patients undergoing mitral TEER.

Impact of transcatheter heart valve type on outcomes of surgical explantation after failed transcatheter aortic valve replacement: the EXPLANT-TAVR international registry.

BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Intravascular imaging guided versus coronary angiography guided percutaneous coronary intervention: systematic review and meta-analysis.

OBJECTIVE: To assess the absolute treatment effects of intravascular imaging guided versus angiography guided percutaneous coronary intervention in patients with coronary artery disease, considering their baseline risk. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed/Medline, Embase, and Cochrane Library databases up to 31 August 2023. STUDY SELECTION: Randomized controlled trials comparing intravascular imaging (intravascular ultrasonography or optical coherence tomography) guided versus coronary angiography guided percutaneous coronary intervention in adults with coronary artery disease. MAIN OUTCOME MEASURES: Random effect meta-analysis and GRADE (grading of recommendations, assessment, development, and evaluation) were used to assess certainty of evidence. Data included rate ratios and absolute risks per 1000 people for cardiac death, myocardial infarction, stent thrombosis, target vessel revascularization, and target lesion revascularization. Absolute risk differences were estimated using SYNTAX risk categories for baseline risks at five years, assuming constant rate ratios across different cardiovascular risk thresholds. RESULTS: In 20 randomized controlled trials (n=11 698), intravascular imaging guided percutaneous coronary intervention was associated with a reduced risk of cardiac death (rate ratio 0.53, 95% confidence interval 0.39 to 0.72), myocardial infarction (0.81, 0.68 to 0.97), stent thrombosis (0.44, 0.27 to 0.72), target vessel revascularization (0.74, 0.61 to 0.89), and target lesion revascularization (0.71, 0.59 to 0.86) but not all cause death (0.81, 0.64 to 1.02). Using SYNTAX risk categories, high certainty evidence showed that from low risk to high risk, intravascular imaging was likely associated with 23 to 64 fewer cardiac deaths, 15 to 19 fewer myocardial infarctions, 9 to 13 fewer stent thrombosis events, 28 to 38 fewer target vessel revascularization events, and 35 to 48 fewer target lesion revascularization events per 1000 people. CONCLUSIONS: Compared with coronary angiography guided percutaneous coronary intervention, intravascular imaging guided percutaneous coronary intervention was associated with significantly reduced cardiac death and cardiovascular outcomes in patients with coronary artery disease. The estimated absolute effects of intravascular imaging guided percutaneous coronary intervention showed a proportional relation with baseline risk, driven by the severity and complexity of coronary artery disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023433568.