Comparison of the Effects of Incomplete Revascularization on 12-Month Mortality in Patients <80 Compared With ≥80 Years Who Underwent Percutaneous Coronary Intervention




Although randomized trial data suggest that complete revascularization improves outcomes after percutaneous coronary intervention (PCI), the impact of differing revascularization strategies in octogenarians is not well defined. We performed a retrospective analysis, which was conducted of 9,628 consecutive patients who underwent PCI at a large UK center. Octogenarians were more likely to have significant co-morbidity, a higher Mehran bleed risk score (24.5 ± 6.8 vs 13.3 ± 7.4, p <0.0001), and more complex disease (baseline SYNTAX score 18.7 ± 11.0 vs 13.1 ± 8.9, p = 0.002) than younger patients. During PCI, octogenarians were more likely to undergo left main or proximal LAD intervention, but despite this, significantly less likely to receive drug-eluting stents (66.5% vs 80.1%, p <0.001). Postprocedurally, octogenarians had greater residual disease burden (residual SYNTAX score 10.1 ± 8.7 vs 1.6 ± 3.3, p <0.0001). At 12 months, adverse outcomes (definite stent thrombosis 3.3% vs 1.1%, p <0.001, clinically driven in-stent restenosis PCI 3.7% vs 2.6%, p = 0.005, and 12-month mortality 12.8% vs 4.2%, p <0.0001) were all more frequent in octogenarians. Although age, shock, diabetes, and BMS use were independently predictive of increased 12-month mortality, incomplete revascularization was not. In conclusion, octogenarians are a complex group to treat balancing high-risk bleeding profile and complex coronary disease. However, in multivariate analysis, incomplete revascularization was not independently predictive of adverse outcomes. These data support a conservative target lesion—only DES-driven revascularization strategy.


A recent analysis of global cardiovascular (CV) deaths found that although there was a 40% reduction in age-specific CV mortality, there was a 40% increase in the number of overall CV deaths because of the increasing age of the world’s population. Registry evidence revealing that patients >75 years now represent 27% to 34% of patients presenting with a non–ST-elevation myocardial infarction. However, patient >75 years are significantly less likely to be managed invasively and to receive revascularization. In the Global Registry of Acute Coronary Events (GRACE) registry, coronary angiography was performed in 67% of patients >70 years compared with only 33% in patients >80 years. In the same fashion, several registries reveal that increasing age was associated with a progressive decrease in percutaneous coronary intervention (PCI) rates. Although older patients are less likely to be managed using an early invasive strategy, data from several studies including the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS) trial-Thrombolysis In Myocardial Infarction (TIMI) 18 and the German Acute Coronary Syndromes registry reveal an improvement in short- and medium-term outcomes compared with a more conservative strategy in this cohort. Most recently, a randomized trial among patients ≥80 years with non-ST elevation acute coronary syndrome (NSTE-ACS) showed a significant reduction in recurrent MI and urgent revascularization procedures in the group treated with early revascularization versus a conservative strategy. In light of these data, the most recent European Society of Cardiology (ESC) non–ST-elevation myocardial infarction guidelines recommend that older patients should be considered for an invasive strategy and, if appropriate, revascularization after a careful weighing up of the potential risks and benefits. Although randomized trial data suggest that complete revascularization improves outcomes after PCI, the impact of differing revascularization strategies in octogenarians is not well defined. Therefore, in the present study, we examined the baseline demographics, procedural characteristics, and outcomes of a large cohort of octogenarians who underwent PCI.


Methods


Our institution provides cardiac care to a population of nearly 1.5 million and performs in excess of 1,600 PCI procedures a year. Patients who underwent PCI in a 6-year period (2008 to 2013) were studied. The baseline demographics, procedural characteristics, and 12-month outcomes of octogenarians who underwent PCI were then compared with younger patients (<80 years) who underwent PCI.


Patient demographics and procedural data were retrieved from the national British Cardiovascular Intervention Society Database Central Cardiac Audit (CCAD) database. The standard CCAD definitions of co-morbidity were used for the study purposes. Mortality was recorded from the Welsh Demographic Service database. Repeat revascularization data were derived from an internal angiographic database and the CCAD database. Clinical in-stent restenosis PCI was defined as repeat PCI to a stenosis >50% in a previously stented segment (+5 mm margins), which was performed because of presentation with recurrent angina with evidence of inducible ischemia or presentation with an acute coronary syndrome (non-ST or ST elevation). Stent thrombosis was defined as per the Academic Research Consortium (ARC) definite criteria.


To assess baseline bleeding risk, we used the Mehran score. For SYNTAX score, we used the Web site http://ir-nwr.ru/calculators/syntaxscore.htm . The patients’ angiograms were scored in a blinded fashion by 4 experienced interventional cardiologists. To calculate baseline SYNTAX score, the pre-PCI angiograms were assessed and scored. To calculate residual SYNTAX score, the final post-PCI angiogram was scored to assess untreated disease. As with previous SYNTAX studies, scores were categorized into low (<22), intermediate (23 to 32), and high (≥33). Baseline and residual disease refers to the number of main coronary arteries with a >75% stenosis.


Continuous data were expressed as mean (SD), and comparison between groups was performed using Student’s t test. Categorical data are presented as frequencies and percentages and were compared using chi-square table statistics. Logistic regression analysis was performed on Minitab (V16) and collinearity was confirmed using principal component analysis and inspection of loading plots. The variables included in multivariate logistic regression for incomplete revascularization were age, gender, cardiogenic shock, clinical syndrome, New York Heart Association and Canadian Cardiovascular Society (CCS) class, previous MI, previous CABG, diabetes, history of peripheral vascular disease, history of stroke, and presence of renal disease. The variables included in multivariate logistic regression for mortality were age, presentation, shock, previous MI, diabetes, ejection fraction, history of CVA, history of PVD, chronic kidney disease, stent type, and completeness of revascularization. Analyses were run in the octogenarian cohort for patients with and without cardiogenic shock. Goodness of fit for the binary logistic regression analyses were examined using the Pearson, Deviance, and Hosmer–Lemeshow tests. The results are presented as odds ratios (ORs) and 95% confidence intervals. The null hypothesis was rejected at p <0.05.




Results


In all, 9,628 patients underwent PCI with the mean age of the whole patient cohort increasing from 62.4 ± 11.4 years in 2008 to 64.8 ± 11.8 years in 2014 ( Figure 1 ). Of the whole cohort, 727 were aged ≥80 years (7.6%) with 5.4% ≥80 years in 2008 versus 10.2% in 2014 (p <0.0001, Figure 1 ). The baseline demographics of the 2 cohorts are presented in Table 1 . Octogenarians were more likely to be female and to have significant co-morbidity including hypertension (71.5% vs 62.8%, p <0.0001), chronic kidney disease (7.9% vs 2.8%, p <0.0001), peripheral vascular disease (5.9% vs 3.1%, p <0.001), or history of stroke (3.6% vs 2.1%, p <0.05) and more likely to present with ST depression (19.6% vs 14.3%, p = 0.003) or cardiogenic shock (5.1% vs 2.4%, p <0.0001) than younger patients. The overall and components of the modified Mehran bleed risk score are presented in Table 2 . The bleeding risk was significantly higher in octogenarians treated versus younger patients (24.5 ± 6.8 vs 13.3 ± 7.4, p <0.0001) with this difference being driven by all components of the Mehran score apart from white blood cell count. The breakdown of quartiles of risk groups is presented in Figure 2 with 81.5% of the octogenarians categorized as very high risk for subsequent bleeding compared with only 18.8% in the general cohort.




Figure 1


(A) Increasing age of 9,700 consecutive patients who underwent PCI from 2008 to 2014; (B) Increasing percentage of center volume aged >80 years who underwent PCI during the same period. p <0.0001 for trends in both figures.


Table 1

Baseline demographics of both study groups










































































































Variable Age (years) p
<80
(n=8901)
≥80
(n=727)
Women 24.6% 34.8% <0.0001
Weight (kg±SD) 84.2 72.5 <0.0001
Body Mass Index kg/m 2 (±SD) 28.9±5.8 25.9±4.3 <0.0001
Diabetes mellitus 18.8% 15.2% 0.019
Smoker 70.2% 54.8% <0.0001
Hypertension history 62.8% 71.5% <0.0001
Chronic kidney disease 2.8% 7.9% <0.0001
Previous cerebrovascular accident 2.1% 3.6% 0.011
History peripheral vascular disease 3.1% 5.9% 0.0003
EF <30% 6.9% 12.5% 0.0004
CCS class (±SD) 2.72±1.17 2.87±1.11 0.0003
NYHA class (±SD) 1.62±0.86 1.90±0.96 <0.0001
Previous MI 27.8% 35.8% <0.0001
Previous CABG 6.0% 9.6% 0.0003
Previous PCI 20.6% 21.0% 0.81
Q wave on ECG 12.1% 13.2% 0.372
ACS presentation 66.1% 70.5% 0.016
Shock 2.4% 5.1% <0.0001
ST depression 14.3% 19.6% 0.003


Table 2

Overall and individual components of the modified Mehran bleeding risk score for both study groups














































Variable Age (years) p
<80
(n=8901)
≥80
(n=727)
Age years (±SD) 62.7±10.9 84.9±3.9 <0.0001
Women 24.6% 34.8% <0.0001
ST elevation MI 23.5% 34.1% 0.027
Haemoglobin (g/l, ±SD) 136.1±15.8 123.9±15.7 <0.0001
White blood cell (10 9 /l, ±SD) 8.9±2.7 9.0±3.8 0.451
Creatinine (mg/dl, ±SD) 0.99±0.48 1.22±0.98 0.0002
Total Mehran score (±SD) 13.3±7.4 24.5±6.8 <0.0001



Figure 2


Modified Mehran bleeding risk score for patients ≥80 vs patients <80 years.


The baseline coronary disease data are presented in Table 3 . Octogenarians presented more often with proximal left coronary disease, with more lesions and vessels diseased, and were more likely to have a chronic total occlusion (CTO) of at least 1 artery. The baseline SYNTAX score was significantly greater in patients ≥80 versus patients <80 years (18.7 ± 11.0 vs 13.1 ± 8.9, p = 0.002; Figure 3 ).



Table 3

Baseline and residual disease severity for both study groups































































































Variable Age (years) p
<80
(n=8901)
≥80
(n=727)
Baseline disease severity
Left main stenosis >75% in diameter 3.1% 9.7% <0.0001
Proximal LAD stenosis >75% in diameter 35.3% 47.8% <0.0001
No. stenosed vessels present (±SD) 1.46±0.79 1.85±0.93 <0.0001
No. of vessels attempted (±SD) 1.27±0.53 1.32±0.59 0.006
No. of lesions attempted (±SD) 1.63±0.89 1.77±0.99 <0.0001
CTO present 30.5% 43.0% <0.0001
CTO attempted by total procedures 9.7% 8.4% 0.59
Attempt at CTO if present 26.8% 18.9% 0.004
Baseline SYNTAX score (±SD) 13.1±8.9 18.7±11.0 0.002
Residual disease severity
No. of vessels not attempted (±SD) 0.19±0.12 0.53±22 <0.0001
≥1 residual untreated vessels 23.3% 48.2% <0.0001
≥2 residual untreated vessels 6.5% 19.5% <0.0001
≥3 residual untreated vessels 1.3% 4.7% <0.0001
≥4 residual untreated vessels 0.2% 0.8% 0.009
All patients with residual CTO 20.6% 36.0% <0.0001
Residual SYNTAX score (±SD) 1.6±3.3 10.1±8.7 <0.0001



Figure 3


(A) Baseline SNYTAX scores in patients ≥80 vs those <80 years who underwent PCI; (B) residual SNYTAX scores in patients ≥80 versus those <80 years who underwent PCI.


Despite the significant excess of mean number of vessels diseased in the octogenarian cohort (delta 0.39 vessels), there was only a small increase in the number of vessels treated (delta 0.05 vessels, p <0.0001, Table 3 ). Additionally, although a CTO was more likely to be present in octogenarians, it was less likely to be treated. During PCI consistent with the anatomy and baseline characteristics octogenarians were more likely to undergo left main, proximal LAD graft intervention ( Table 4 ). However, operators were more likely to resort to atherectomy use or intra-aortic balloon pump support but less likely to use aspiration thrombectomy, intracoronary imaging, or a glycoprotein receptor inhibitor. Because of the slight excess of vessels treated, octogenarians received more stents that the younger cohort. Despite this observation, the increased complexity of the intervention and the greater likelihood of proximal left coronary intervention, octogenarians were significantly less likely to receive a drug-eluting stent (65.5% vs 80.1%, p <0.001, Table 4 ) despite similar vessel size and shorter stent lengths used. Additionally, there was a close age-related association of DES use with the highest use in the 80- to 81-year-old group (70.3%) and lowest in the >90-year group (45.2%, p <0.001 for trend). Immediate procedural success and complications were similar between these 2 groups.



Table 4

PCI procedural data for both study groups










































































































Variable Age (years) p
<80
(n=8901)
≥80
(n=727)
Femoral access 9.3% 16.8% <0.0001
Left main stem intervention 3.3% 9.5% <0.0001
Bypass graft intervention 3.7% 5.4% 0.034
Proximal LAD intervention 31.4% 35.2% 0.042
Diagnostic device used 13.0% 9.8% 0.011
Atherectomy device used 3.1% 9.6% <0.0001
Aspiration use if PPCI case 52.1% 40.1% 0.004
IABP use if shock present 20.3% 18.2% 0.843
Stent used 93.9% 94.5% 0.567
Largest balloon used (mm, ±SD) 3.36±0.59 3.40±1.71 0.061
Longest stent (mm, ±SD) 23.2±8.2 22.1±8.2 0.0002
No. stents per case (±SD) 1.74±1.17 1.87±1.25 0.001
DES usage 80.1% 65.5% <0.001
No. DES used per case (±SD) 1.37±1.24 1.24±1.33 0.003
No. DES used if DES used (±SD) 1.85±1.09 1.98±1.17 0.005
No. BMS uses if BMS used (±SD) 1.43±0.89 1.65±1.01 0.0003
Glycoprotein inhibitor used 14.0% 8.5% <0.0001
TIMI flow <3 at procedure end 3.7% 4.3% 0.492
Procedural complication 3.5% 3.5% 1.0

BMS = bare metal stent; DES = drug-eluting stent; LAD = left anterior descending artery.


Post-procedure, octogenarians had greater residual disease burden. As is demonstrated in Table 3 , the number of vessels not attempted, the number of residual vessels, and the likelihood of a residual CTO being present were all significantly greater in octogenarians. The residual SYNTAX was also significantly higher than in younger patients (10.1 ± 8.7 vs 1.6 ± 3.3, p <0.0001; Figure 3 ). The independent predictors of incomplete revascularization are detailed in Table 5 with the most powerful predictors including age, female sex, previous CABG, and shock.



Table 5

Independent predictors of incomplete revascularization












































All patients
OR (95% CI)
p
Age per year 1.03 (1.03-1.04) <0.0001
Previous CABG 5.10 (4.09-6.36) <0.0001
Peripheral vascular disease 1.65 (1.26-2.16) <0.0001
Cardiogenic shock 1.62 (1.20-2.18) 0.002
Left main stenosis >75% 1.51 (1.15-1.98) <0.0001
Previous MI 1.34 (1.19-1.51) <0.0001
NYHA class 1.19 (1.12-1.26) <0.0001
CCS class 1.09 (1.04-1.14) <0.0001
Male sex 0.71 (0.63-0.80) <0.0001


All clinical end points were more likely in the octogenarian cohort ( Table 6 ). ARC definite stent thrombosis (1.1% vs 3.3%, p <0.001) and clinically driven in-stent restenosis PCI (3.7% vs 2.6%, p = 0.005) were more frequent and 30-day (6.6% vs 1.9%, p <0.0001) and 12-month mortality (12.8% vs 4.2%, p <0.0001) were higher. Consistent with the incomplete revascularization during the index procedure, the octogenarian cohort were less likely to have further nontarget vessel PCI during follow up.


Nov 25, 2016 | Posted by in CARDIOLOGY | Comments Off on Comparison of the Effects of Incomplete Revascularization on 12-Month Mortality in Patients <80 Compared With ≥80 Years Who Underwent Percutaneous Coronary Intervention

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