Percutaneous Coronary Interventions in Elderly Patients: Experience from a Tertiary Care Center from Developing Country

Introduction

The study was conducted with an objective to assess the outcome of percutaneous coronary intervention in elderly with increasing aging population and wide used of PCI but less utilized in elder- ly, this study with reference to safety and complications in a Pa- kistani population. One of the major challenges in percutaneous coronary intervention (PCI) is bleeding complications. The con- tributing factors hypertension, females, cardiogenic shock use of GP11b/111a [1]. Some studies found that there is a difference in patients’ comorbid in Japan and USA for prediction of mortality [2]. Some authors found that lean patients are at higher risk com- pared to obese patients for bleeding complications after PCI for in hospital patients [3]. In an Australian study involving 37,866 patients undergoing PCI [4]. The researchers observed the cardi-ac and cerebrovascular adverse effects (MACCE) and bleeding. Major bleeding complications was uncommon while MACCE rate was higher. In another research the authors reported that access and non-access site bleeding occurred within 30 days of PCI and they were independently had a relationship with high risk of mor- tality within one year [5]. It was also reported that non-access site bleed was strongly correlated to mortality when compared with access site bleeding [6].

In meta-analysis of twenty-four randomized trials having 22,843 patients for coronary intervention, through femoral access or radial access [7]. It was found that mortality was less with radial access there was a reduction in vascular complications.

PCI is not widely used in older patients. The new anti-thrombot- ic therapy has played its role in this extensive use. This has re- duced the ischemic complications to a great level. The antiplatelet agents used earlier have more complications particularly in elderly patients having serious comorbidities [8,9]. During recent years treatment for ST-elevation myocardial infarction (STEMI) has un- dergone a vast evolution. This has led to significant improvement in techniques for timely access to PCI. In an Australian study the researcher recorded a low mortality (6.5% overall) during thir- ty-day period. This mortality rate compares favorably with oth- er studies [10]. In a study in Australia the authors concluded that bleeding is the result of poor clinical outcome and is responsible for increased hospitalization [10]. Hannan et al found that bleeding was higher in females after post PCI patients and were also related to late mortality [11]. However, the authors also concluded that gender was not assessed as an independent predictor for mortality. Bleeding evens have been associated with high risk in dying in patients undergoing successful PCI [12].

Due to the increasing complexity the occurrence of post PCI isch- emic stroke has increased over time. However, the data on the in- cidence in this regard are considered limited [13]. Acute coronary syndrome patients were at higher risk and more peri-procedural complications [14]. Elderly patients also suffering from comorbid- ity as well and were vulnerable to acute coronary syndrome. Mar- cus et al reported that for elderly patients of age more than eighty years undergoing PCI the risk of diabetes, renal failure impaired left ventricular function and three vessel coronary artery disease were higher in elderly Long-term mortality rate and in hospital death were higher in the elderly because of high risk patients with shock or STEMI underwent PCI [14]. Latest techniques in PCI use LV Support devices like LVAD has resulted in better outcomes after PCI in a study of PCI in elderly patients it was found that it is safe and effective for elderly patients to achieve complete myo- cardial revascularization, more so with the refined techniques and latest equipment. The need that a well-designed large randomized clinical trial comparing PCI, CABG and optimal medical therapy for the management of elderly patients should be done.

Methodology

This was a retrospective chart review of 887 cases of percutane- ous coronary intervention done at tertiary care hospital in Karachi, Pakistan. Karachi institute of heart diseases from 2015-2020. Con- secutive sampling strategy was used. The sample was divided into three groups

a. Younger (age <65 years n=592),

b. Older (age 65-75 years n=201) and

c. Elderly (76 years and above n= 94).

Charts with missing data on and patient lost to follow up were excluded from the study data collection was carried out through a Performa based on relevant study variables Data was double en- tered in Epi Data version 3.1 and analyzed using Statistical Pack- age for Social Sciences (SPSS) version 19.0 Categorical variables are described as percentages and compared using chi-square test or Fisher exact test as appropriated. Continuous variables were described as mean ± SD and compared using independent sample test. Multivariate logistic regression analysis was carried out to estimate the Odds Ratios (OR) and their 95% Confidence Inter- vals (CI) with p-value of 0.05 was considered significant. Study variables included sociodemographic, co morbid, and PCI details (complexity of lesion, number of vessels involved, number of stents placed, procedure type (emergency or elective), use of IV anti coagulation, associated diagnosis of MI/cardiogenic shock. Data collection points included immediate as well as six monthly outcomes.

Definition of Outcome Variables

• Vascular complication defined as hematoma at the site of ar- terial puncture, classified according to the American College of Cardiology (ACC) classifications, large ≥10 cm and small <10cm.

• Major bleeding, according to criteria presented by CRU- SADE, retroperitoneal hemorrhage (without surgical correc- tion) major bleeding included those with hemodynamics in- stability defined by uncontrolled hypertension or hypotension, tachycardia or bradycardia or decreased oxygen saturation based on previous baseline parameters, surgical correction for any of the vascular complications of retroperitoneal hemor- rhage, pseudoaneurysm arteriovenous fistula formation [15].

• Perioperative Myocardial infarctions (MI) is classically de- fined as a characteristic rise and fall in cardiac troponin (cTn) levels with at least one value higher than the 99th percentile of the upper reference limit (UNL) (>0.014 ng/mL), with at least one of the following features: defined as Ischemic nature of the chest pain new ECG changes new regional wall motion abnormality on echocardiogram [16].

• Successful PCI: PCI success was defined as achievement of vessel patency with a residual stenosis of <20

• In hospital mortality is defined all-cause mortality includes cardiac and non-cardiac causes. Six monthly follow up out- comes compared between the groups.

Results

The baseline characteristics were shown in Table 1. Elderly more hypertensive than other groups 61% vs 49% with P value of 0.02, they had prior history of myocardial infarction 48% vs 26% with p value of 0,04, they had significant history of prior heart failure 2.1% vs 27% in elderly with value 0.05 Most elderly had previous coronary artery bypass surgery (CABG) and prior history of stroke 11% vs 1.5% p value 0.01, Elderly cohort was all high-risk feature

                                           Table 1: Bassline clinical and demographic characteristics in three cohorts

PCI chart in Table 2 PCI done for STEMI and cardiogenic shock in elderly with 11% vs 3.2% p value 0.01, elderly have more high- risk lesion defined as calcified, bifurcation ostial and long lesion greater than 10 mm in 78% of elderly group. Procedure success was same. In our study radial approach for PCI was used in 80% and femoral in 20%. Elderly has PCI was done by femoral in 30% while 70% were radial approach.

The relative risk of vascular complication in elderly n 23 with RR 4.3% with p value 0.5 not high as compares other cohorts. Vascu- lar complication in elderly included hematoma in elderly greater 10 mm in n=8 patient and minor bleeding as drop of Hb 2 gm in n=11 patients and pseudoaneurysm n=4 patients and 48% patients received GP11b/111a and 20% elderly were lean mean BMI 20 kg/ m2 and 34% of PCI were done for STEMI with increased used of unfractionated heparin.

                                              Table 2: PCI database showing indication, CAD complexity and success of PCI

The relative risk of perioperative myocardial infarction was not higher (OR ratio with 95% CI was 0.6 vs 0.3 vs 1.4 with p value 0.35). The need of repeat target revascularization was same in all the three groups with OR was (0.3 vs 0.2 vs 1.6 with p value 0.85). The relative risk of stroke following PCI was not high in elderly with OR (0.7 vs 0.4 vs 1.6 with p value 0.4). The in-hospital mor- tality was higher in elderly group of patients with relative risk (1% vs 2% vs 3.4% with p value of 0.03) in three groups.

The major cause of in hospital mortality in elderly was cardiac 42%, pneumonia 21% and Sepsis 22% and 15% Acute kidney in- jury. The six-month follow-up the total 84 patients were lost to fol- low up 12 patients from elderly group 24 from older group and 28 from younger group were lost to follow up and incomplete charts were found in 20 patients so analysis it was done in 803 patients. The outcome of repeat myocardial infarction in elderly was also not higher than group, (OR 95% CI 0.5 vs 0.6 vs 0.7 with p value 0.58) The need of repeat target revascularization was also not high in elderly as compared to other groups with OR (1 vs 2.5 vs 2 with p value of 0.6) The six months follow up mortality was higher in elderly group with relative risk of (1.5% vs 3.4% vs 4% and p value was 0.04) Six-month review of mortality in elderly n=88 patients was cardiac in 56% and non-cardiac 44%.

Discussion

our study showed that PCI was successful and complications are not high although in hospital mortality and six-month mortality was high like previous study [17]. In our study, the six month mortality rate elderly population a is consistent with the Abdul- lah study in which all-cause mortality in patient 65-74 years was 10.1% and 20.4% in patients ≥75 undergoing PCI in our study it was 3% vs 4.5% may be number of elderlies were 94 in our study and upon six month follow-up the mortality rate among the elderly was high which is not like 3-year mortality rates for elder- ly were comparable to previous studies in which 3-year all cause death in elderly patients with mean age of 88 years old treated with PCI were 33.3%, and treated with conservative management were 52.4% [18].

In our study elderly have more comorbid like heart failure, pri- or myocardial infarction their presentation and PCI data showed more high risk lesion, three vessel diseases and mostly PCI done in emergency as compared to elective with cardiogenic shock, and STEMI which have effect on in hospital and six month mortality results similarly Previous studies showed that preoperative factors influencing mortality in elderly treated with invasive or conserva- tive strategy are cardiogenic shock, previous cardiac surgery, renal failure, age, hypertension, heart rate and anemia [19]. Our study elderly although lean there was no significant post PCI vascular complication because of radial approach reported study reported same results [20]. Shashank et al study the effect of bleeding se- verity in PCI and effect on mortality according to their study no major bleeding [21]. Procedure success and complication were not different from other group like TIMI III flow no post procedure MI and stroke similarly results were reported from Japanese largest PCI registry on octogenarians [22].

Our results are in line with previous findings by showing that the elderly patients can get benefit of PCI not only at in hospital but-year but also six-years. Recently a randomized study aimed to investigate whether elderly patients with NSTEMI or unsta- ble angina would benefit from an early invasive strategy versus a conservative strategy and showed similar results as ours [23]. In our study STEMI is a large proportion of the total PCI in elder- ly. Second, as many other trials randomized study was subject to many exclusions such as cardiogenic shock, continuing bleeding problems, short life expectancy [24]. This was not the case in our study. Therefore, our study is closer to the “real world” of the clin- ical practice. The decision to proceed with a PCI procedure in the elderly is influenced by numerous factors. Non-cardiac comorbid- ities include renal, cerebral, pulmonary and vascular disease were often considered prior to decision making for PCI [25].

In our study was retrospective review of PCI in elderly and co- hort were high risk but success of PCI was reflected in our cohort of elderly patients. The all-cause mortality in hospital and at six months may be confounded by high-risk elderly we need large ran- domized study with long follow up with matched risk factors to recommend the PCI is safe option in elderly as compare managing on medicines

Limitations and strengths: Despite our effort include as much information as possible in medical records, and despite we cannot rule out potential confounding from unmeasured variables. Many patients are lost to follow up. Nevertheless, our data are encourag- ing and serve as the basis for randomized trials in the future. One of the main strengths is that all patients were included from our daily clinical practice, and therefore representative.

Conclusion

The procedure success in elderly patients was same as compared to younger patients but in hospital and six months follow up mor- tality rate was higher in elderly as compared to young groups. This could be underlying high risk presentation at the time of PCI.

References

1. Numasawa Y, Kohsaka S, Ueda I, Miyata H, Sawano M, et al. (2017) Incidence and predictors of bleeding complications af- ter percutaneous coronary intervention. Journal of cardiology 69: 272-279.
2. Kohsaka S, Miyata H, Ueda I, Masoudi FA, Peterson ED, et al. (2015) An international comparison of patients undergoing percutaneous coronary intervention: a collaborative study of the National Cardiovascular Data Registry (NCDR) and Japan Cardiovascular Database-Keio interhospital Cardiovascular Studies (JCD-KiCS). American heart journal 170: 1077-1085.
3. Numasawa Y, Kohsaka S, Miyata H, Kawamura A, Noma S, et al. (2015) Impact of body mass index on in-hospital com- plications in patients undergoing percutaneous coronary in- tervention in a Japanese real-world multicenter registry. PloS One 10: e0124399.
4. Ndrepepa G, Neumann FJ, Richardt G, Schulz S, Tölg R, et al. (2013) Prognostic value of access and non-access sites bleed- ing after percutaneous coronary intervention. Circulation: Cardiovascular Interventions 6: 354-361.
5. Bellemain-Appaix A, Brieger D, Beygui F, Silvain J, Pena A, et al. (2010) New P2Y12 inhibitors versus clopidogrel in per- cutaneous coronary intervention: a meta-analysis. Journal of the American College of Cardiology 56: 1542-1551.
6. Ferrante G, Rao SV, Jüni P, Da Costa BR, Reimers B, et al. (2016) Radial versus femoral access for coronary interven- tions across the entire spectrum of patients with coronary artery disease: a meta-analysis of randomized trials. JACC: Cardiovascular Interventions 9: 1419-1434.
7. Gao Y, Zhang F, Li C, Dai Y, Qu YN, et al. (2019) Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main cor- onary artery occlusion (OPTIMAL): study protocol for a ran- domised controlled trial. Trials 20: 1-8.
8. Doyle BJ, Rihal CS, Gastineau DA, Holmes DR (2009) Bleed- ing, blood transfusion, and increased mortality after percuta- neous coronary intervention: implications for contemporary practice. Journal of the American College of Cardiology 53: 2019-2027.
9. Biswas S, Duffy SJ, Lefkovits J, Andrianopoulos N, Brennan A, et al. (2018) Australian trends in procedural characteris- tics and outcomes in patients undergoing percutaneous coro- nary intervention for ST-elevation myocardial infarction. The American journal of cardiology 121: 279-288.
10. Wlodarczyk J, Ajani AE, Kemp D, Andrianopoulos N, Bren- nan AL, et al. (2016) Incidence, predictors and outcomes of major bleeding in patients following percutaneous coronary interventions in Australia. Heart, Lung and Circulation 25: 107-117.
11. Idris H, French JK, Shugman IM, Hopkins AP, Juergens CP, et al. (2017) Influence of age and gender on clinical outcomes following percutaneous coronary intervention for acute cor- onary syndromes. Heart, Lung and Circulation 26: 554-565.
12. Redfors B, Généreux P, Witzenbichler B, Kirtane AJ, McAn- drew T, et al. (2018) Bleeding severity after percutaneous cor-onary intervention. Circulation: Cardiovascular Interventions 11: e005542.
13. Alkhouli M, Alqahtani F, Tarabishy A, Sandhu G, Rihal CS (2019) Incidence, predictors, and outcomes of acute ischemic stroke following percutaneous coronary intervention. JACC: Cardiovascular Interventions 12: 1497-1506.
14. Iverson A, Stanberry LI, Tajti P, Garberich R, Antos A, et al. (2019) Prevalence, trends, and outcomes of higher-risk percu- taneous coronary interventions among patients without acute coronary syndromes. Cardiovascular Revascularization Med- icine 20: 289-292.
15. Subherwal S, Bach RG, Chen AY, Gage BF, Rao SV, et al. (2009) Baseline risk of major bleeding in non-ST-segment-el- evation myocardial infarction: the CRUSADE (can rapid risk stratification of unstable angina patients suppress Adverse outcomes with early implementation of the ACC/AHA guide- lines) bleeding score. Circulation 119: 1873-1882.
16. Landesberg G, Beattie WS, Mosseri M, Jaffe AS, Alpert JS(2009) Perioperative myocardial infarction. Circulation 119:2936-2944.
17. Avezum A, Makdisse M, Spencer F, Gore JM, Fox KA, et al. (2005) Impact of age on management and outcome of acute coronary syndrome: observations from the Global Registry of Acute Coronary Events (GRACE). American heart journal 149: 67-73.
18. Damluji AA, Bandeen-Roche K, Berkower C, Boyd CM, Al-Damluji MS, et al. (2019) Percutaneous coronary inter- vention in older patients with ST-segment elevation myocar-dial infarction and cardiogenic shock. Journal of the American College of Cardiology 73: 1890-1900.
19. Barywani SB, Li S, Lindh M, Ekelund J, Petzold M, et al. (2015) Acute coronary syndrome in octogenarians: associa- tion between percutaneous coronary intervention and long- term mortality. Clinical interventions in aging 10: 1547-1553.
20. Völz S, Angerås O, Koul S, Haraldsson I, Sarno G, et al. (2019) Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART. Euro- pean Heart Journal: Acute Cardiovascular Care 8: 510-519.
21. Murali S, Vogrin S, Noaman S, Dinh DT, Brennan AL, et al. (2020) Bleeding Severity in Percutaneous Coronary Interven- tion (PCI) and Its Impact on Short-Term Clinical Outcomes. Journal of clinical medicine 9: 1426.
22. Sawano M, Yamaji K, Kohsaka S, Inohara T, Numasawa Y, et al. (2020) Contemporary use and trends in percutaneous cor- onary intervention in Japan: an outline of the J-PCI registry. Cardiovascular intervention and therapeutics 35: 218-226.
23. Navarese EP, Rao SV, Krucoff MW (2019) Age, STEMI, and Cardiogenic Shock: Never Too Old for PCI? Journal of the American College of Cardiology 73: 1901-1904.
24. Kumar S, McDaniel M, Samady H, Forouzandeh F (2020) Contemporary revascularization dilemmas in older adults. Journal of the American Heart Association 9: e014477.
25. Shanmugam VB, Harper R, Meredith I, Malaiapan Y, Psaltis PJ (2015) An overview of PCI in the very elderly. Journal of geriatric cardiology: JGC 12: 174-184.