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Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization.

ABSTRACT: Background There are still limited data about the differential effect of sex on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease. This extended follow-up study of the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry evaluated clinical outcomes beyond 10 years. Methods and Results Of 2240 patients with unprotected left main coronary artery disease (PCI=1102 and CABG=1138), all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization were separately evaluated in both sexes. Of 2240 patients, 631 (28.2%) were women and 1609 (71.8%) were men. Women had lower 10-year incidences of death and serious composite outcomes than men. The adjusted 10-year risks of adverse outcomes were similar in men. However, the adjusted 10-year risks were different according to a prespecified period in women. In the short-term (0-1 year) period, PCI had a significantly lower risk for serious composite outcomes (adjusted hazard ratio [HR], 0.41; 95% CI, 0.19-0.91; P=0.03) compared with CABG. The adjusted risks for death and serious composite outcomes were significantly higher after PCI than after CABG, during the midterm (1-5 years) period (death; adjusted HR, 3.99; 95% CI, 2.01-7.92; P<0.001 and composite outcome; adjusted HR, 2.93; 95% CI, 1.59-5.39; P=0.001). Beyond 5 years, adjusted risks were similar after PCI and CABG in women. Conclusions In this 10-year extended follow-up study of patients undergoing left main coronary artery revascularization, we observed a time-dependent impact of sex on the long-term outcomes after PCI and CABG, especially in women, with significant interactions. However, these results warrant confirmation on larger series of studies. Registration URl: https://www.clinicaltrials.gov; Unique identifier: NCT02791412.

SUBMITTER: Yoon YH

PROVIDER: S-EPMC9075067 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceThe optimal conduits for coronary artery bypass grafting (CABG) remain controversial in multivessel coronary artery disease.ObjectiveTo compare the long-term clinical outcomes of total arterial revascularization (TAR) vs non-TAR (CABG with at least 1 arterial and 1 saphenous vein graft) in a multicenter population-based study.Design, setting, and participantsThis multicenter population-based cohort study using propensity score matching took place from October 2008 to March 2017 in Ontario, Canada, with a mean and maximum follow-up of 4.6 and 9.0 years, respectively. Individuals with primary isolated CABG were identified, with at least 1 arterial graft. Exclusion criteria were individuals from out of province and younger than 18 years. Patients undergoing a cardiac reoperation or those in cardiogenic shock were also excluded because these conditions would potentially bias the surgeon toward not performing TAR. Analysis began April 2019.ExposuresTotal arterial revascularization.Main outcomes and measuresPrimary outcome was time to first event of a composite of death, myocardial infarction, stroke, or repeated revascularization (major adverse cardiac and cerebrovascular events). Secondary outcomes included the individual components of the primary outcome.ResultsOf 49 404 individuals with primary isolated CABG, 2433 (4.9%) received TAR, with the total number of bypasses being 2, 3, and 4 or more vessels in 1521 (62.5%), 865 (35.6%), and 47 individuals (1.9%), respectively. The mean (SD) age was 61.2 (10.4) years and 1983 (81.5%) were men. After propensity score matching, 2132 patient pairs were formed, with equal total number of bypasses (mean [SD], 2.4 [0.5]) but with more arterial grafts in the TAR group (mean [SD], 2.4 [0.5] vs 1.2 [0.4]; P < .01). In-hospital death (15 [0.7%] vs 21 [1.0%]; P = .32) did not differ between TAR vs non-TAR groups after propensity score matching. Throughout 8 years, TAR was associated with improved freedom from major adverse cardiac and cerebrovascular events (hazard ratio, 0.78; 95% CI, 0.68-0.89), death (hazard ratio, 0.80; 95% CI, 0.66-0.97), and myocardial infarction (hazard ratio, 0.69; 95% CI, 0.51-0.92). There was no difference in stroke and repeated revascularization.Conclusions and relevanceTotal arterial revascularization was associated with improved long-term freedom from major adverse cardiac and cerebrovascular events, death, and myocardial infarction and may be the procedure of choice for patients with reasonable life expectancy requiring CABG.

Project description:BackgroundWhether complete revascularization (CR) or incomplete revascularization (IR) may affect long-term outcomes after PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease is unclear.ObjectivesThe authors sought to assess the impact of CR or IR on 10-year outcomes after PCI or CABG for LMCA disease.MethodsIn the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) 10-year extended study, the authors evaluated the effect of PCI and CABG on long-term outcomes according to completeness of revascularization. The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE) (composite of mortality from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization).ResultsAmong 600 randomized patients (PCI, n = 300 and CABG, n = 300), 416 patients (69.3%) had CR and 184 (30.7%) had IR; 68.3% of PCI patients and 70.3% of CABG patients underwent CR, respectively. The 10-year MACCE rates were not significantly different between PCI and CABG among patients with CR (27.8% vs 25.1%, respectively; adjusted HR: 1.19; 95% CI: 0.81-1.73) and among those with IR (31.6% vs 21.3%, respectively; adjusted HR: 1.64; 95% CI: 0.92-2.92) (P for interaction = 0.35). There was also no significant interaction between the status of CR and the relative effect of PCI and CABG on all-cause mortality, serious composite of death, myocardial infarction, or stroke, and repeat revascularization.ConclusionsIn this 10-year follow-up of PRECOMBAT, the authors found no significant difference between PCI and CABG in the rates of MACCE and all-cause mortality according to CR or IR status. (Ten-Year Outcomes of PRE-COMBAT Trial [PRECOMBAT], NCT03871127; PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT], NCT00422968).

Project description:BackgroundCoronary artery bypass graft (CABG) surgery has traditionally represented the standard of care for left main coronary artery (LMCA) disease. However, percutaneous coronary intervention with stent implantation (PCI) has more recently emerged as a valuable alternative. The long-time awaited results of the largest randomized trials on the long-term impact of PCI versus CABG in LMCA disease, the newly published NOBLE and EXCEL studies, revealed contrasting results. Thus, aim of the present meta-analysis was to review the most robust evidence from randomized comparisons of CABG versus PCI for revascularization of LMCA.MethodsRandomized studies comparing long-term clinical outcomes of CABG or Stent-PCI for the treatment of LMCA disease were searched for in PubMed, the Chochrane Library and Scopus electronic databases. A total of 5 randomized studies were selected, including 4499 patients.ResultsNo significant difference between CABG and PCI was found in the primary analysis on the composite endpoint of death, stroke and myocardial infarction (OR = 1·06 95% CI 0·80-1·40; p = 0·70). Similarly, no differences were observed between CABG and PCI for all-cause death (OR = 1·03 95% CI 0·81-1·32; p = 0·81). Although not statistically significant, a lower rate of stroke was registered in the PCI arm (OR = 0·86; p = 0·67), while a lower rate of myocardial infarction was found in the CABG arm (OR = 1·43; p = 0·17). On the contrary, a significantly higher rate of repeat revascularization was registered in the PCI arm (OR = 1·76 95% CI 1·45-2·13; p < 0·001).ConclusionsThe present meta-analysis, the most comprehensive and updated to date, including 5 randomized studies and 4499 patients, demonstrates no difference between Stent-PCI and CABG for the treatment of LMCA disease in the composite endpoint of death, stroke and myocardial infarction. Hence, a large part of patients with unprotected left main coronary artery disease can be managed equally well by means of both these revascularization strategies.

Project description:Background The degree of hospital-level variation in the ratio of percutaneous coronary interventions to coronary artery bypass grafting procedures (PCI:CABG) and the association of the PCI:CABG ratio with clinical outcome are unknown. Methods and Results In a multicenter population-based study conducted in Ontario, Canada, we identified 44 288 patients from 19 institutions who had nonemergent diagnostic angiograms indicating severe multivessel coronary artery disease (2013-2017) and underwent a coronary revascularization procedure within 90 days. Hospitals were divided into tertiles according to their adjusted PCI:CABG ratio into low (0.70-0.85, n=17 487), medium (1.01-1.17, n=15 275), and high (1.18-1.29, n=11 526) ratio institutions. Compared with low PCI:CABG ratio hospitals, hazard ratios (HRs) for major adverse cardiac and cerebrovascular events were higher at medium (HR, 1.19; 95% CI, 1.14-1.25) and high ratio (HR, 1.21; 95% CI, 1.15-1.27) hospitals during a median 3.3 (interquartile range 2.1-4.6) years follow-up. When interventional cardiologists performed the diagnostic angiogram, the odds of the patient receiving PCI was higher (odds ratio, 1.37; 95% CI, 1.23-1.52) than when it was performed by noninterventional cardiologists, after accounting for patient characteristics. Having the diagnostic angiogram at an institution without cardiac surgical capabilities was independently associated with a higher risk of major adverse cardiac and cerebrovascular events (HR, 1.07; 95% CI, 1.02-1.11), death (HR, 1.09; 95% CI, 1.02-1.18), and myocardial infarction (HR, 1.10; 95% CI, 1.03-1.17). Conclusions Patients undergoing diagnostic angiography in hospitals with higher PCI:CABG ratio had higher rates of adverse outcomes, including major adverse cardiac and cerebrovascular events, myocardial infarction, and repeat revascularization. Presence of on-site cardiac surgery was associated with better survival and lower major adverse cardiac and cerebrovascular events.

Project description:Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P<0.001) and had worse disease severity (Trans-Atlantic Inter-Society Consensus score [TASC] B and greater; atherectomy: 77%; PTA : 68%; stenting: 67%; P<0.001). The 5-year rate of major adverse limb events was 38% in patients receiving atherectomy versus 33% for PTA and 32% for stenting (log rank P<0.001). Controlling for unmeasured confounding using instrumental-variable analysis, patients treated with atherectomy experienced outcomes similar to those of patients treated with PTA , except for a higher risk of any amputation (hazard ratio: 1.51; 95% CI , 1.08-2.13). However, compared with stenting, atherectomy patients had a higher risk of major amputation (hazard ratio: 3.66; 95% CI , 1.72-7.81), any amputation (hazard ratio: 2.73; 95% CI , 1.60-4.76), and major adverse limb event (hazard ratio: 1.61; 95% CI , 1.10-2.38). Conclusions Atherectomy is used to treat severe femoropopliteal and tibial peripheral arterial disease even though long-term adverse outcomes occur more frequently after this treatment modality.

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Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization.

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