A sex stratified outcome analysis from the OPEN‐CTO registry

Abstract

Introduction: Women have been under-represented in trials. Due to the dearth of information about CTO-PCI in women and discordance of previous results, sex differences in outcomes in the OPEN-CTO Trial were investigated.Methods: OPEN-CTO is an investigator-initiated, multicenter, prospective observational registry of consecutive CTO patients undergoing PCI at 12 U.S. centers. The one-year outcomes of this trial stratified by sex were examined. Optimal propensity matching was performed to compare outcomes between sexes. Multivariate conditional logistic regression modeling for predictors of procedural success was performed.Results: Women represented 19.6% of the cohort (196/1,000 patients). Women were more likely to report dyspnea as their predominant symptom. Women reported statistically worse physical limitation and poorer quality of life as compared to men. J-CTO scores were similar in males and females. Technical, procedural success and MACE rates were similar in both sexes.Contrast and radiation doses were however significantly lower in women. The SAQ-summary score, RDS, EQ-5D VAS, PHQ-8 scores were all improved to the same degree at 1 year in women as compared to men. Predictors of procedural success revealed that younger age, lower J-CTO score and absence of prior CABG were predictors of procedural success. Sex did not predict procedural success or 1-year MACE in this regression model.Conclusion: This real-world registry revealed that women derive the same benefit from CTO-PCI as men without additional complications and with favorable health status outcomes at 1 year. Consideration of revascularization by PCI in symptomatic women should be considered as part of the treatment when appropriate. K E Y W O R D S CTO-PCI, females, health status 1 | INTRODUCTION Women have been under-represented in cardiovascular interventional trials. 1,2 This under-representation is evident in the chronic total occlusion (CTO) literature. Due to the low number of women enrolled in clinical trials, evaluating outcomes after CTO-PCI in women has been difficult. Women have a similar prevalence of CTO's as men. 3 Time to presentation for invasive treatment is usually later than men and presentation symptoms in women with CTO's are often different. 4 When compared with men, women have smaller coronary vessels and this has been considered to be an important basis for sex differences in outcomes despite lesser plaque volume in women. Nonetheless, when controlled for body surface area (BSA), women have similar vessel sizes as men. 5 Women also have increased bleeding risks and vascular complication after PCI 6,7 and may impact outcomes in CTO. CTO's have different angiographic characteristics in women. 8 Despite favorable angiographic characteristics, the impact of sex on outcomes of CTO-PCI in women has been mixed. 9 Due to the relative Women derived the same benefit from CTO-PCI as men in this multicenter, core lab adjudicated prospective registry. The procedural success and complications in females were the same as in men. At 1 year...

Impact of sex on outcomes of percutaneous coronary intervention for chronic total occlusion: A meta‐analysis

“…A total of 14 observational studies were included in the analysis with 75% males and 25% females. 4,8,10,[18][19][20][21][22][23][24][25][26][27][28] Of the 14 included studies, 6 were multicenter and S2.…”

“…7 However, among women with CTOs, the time from initial presentation to invasive treatment is longer due to presentation at an older age and higher prevalence of comorbidities such as hypertension (HTN) and diabetes mellitus (DM). 4,[8][9][10] Physicians may be more likely to treat women with conservative medical management instead of referring them for revascularization. Studies focusing on periprocedural complications and long-term outcomes of CTO-PCI in women are limited, yielding inconclusive results.…”

“…Women are underrepresented in clinical studies evaluating the outcomes of CTO‐PCI 5,6 although literature shows similar prevalence of CTO in both women and men 7 . However, among women with CTOs, the time from initial presentation to invasive treatment is longer due to presentation at an older age and higher prevalence of co‐morbidities such as hypertension (HTN) and diabetes mellitus (DM) 4,8–10 . Physicians may be more likely to treat women with conservative medical management instead of referring them for revascularization.…”

Predictors for Target Vessel Failure after Recanalization of Chronic Total Occlusions in Patients Undergoing Surveillance Coronary Angiography

“…Larger prospective randomized studies with defined protocol, including intracoronary imaging or flow measurements, for surveillance coronary angiography would be desirable. Furthermore, patients with female gender were relevantly underrepresented (15.1%), yet at a comparable extent to most published CTO registries [11,12,[14][15][16].…”

“…In our analysis, we identified female gender as a risk factor for TVF. Although some registries generated evidence that women derive the same benefit from CTO-PCI as men in regard to clinical benefit [14], female gender was found to be a predictor of PCI-related complications as well as MACEs in other retrospective studies too [12,15,16]. The reason for this observation remains unclear Figure 1.…”