Summary
Background
Patients with renal failure (RF) have been systematically excluded from clinical trials; consequently their outcomes have not been well studied in the setting of percutaneous coronary intervention (PCI).
Aims
To compare cardiovascular outcomes after contemporary PCI in patients with versus without RF, according to clinical presentation (ST-segment elevation myocardial infarction [STEMI], acute coronary syndrome [ACS] or stable coronary artery disease [sCAD]).
Methods
Consecutive patients undergoing PCI with stent were prospectively included from 2007 to 2012. RF was defined as creatinine clearance < 60 mL/min. The primary endpoint was all-cause mortality; secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE: composite of cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and Academic Research Consortium definite/probable stent thrombosis (ST) at 1 year.
Results
Among 5337 patients, 23% had PCI for STEMI, 34% for ACS and 43% for sCAD, while 27% had RF. RF patients had a higher unadjusted death rate than those with preserved renal function (nRF) in all PCI indication groups (STEMI, 41% vs. 7.5%; ACS, 19% vs. 6%; sCAD, 10% vs. 3%; P < 0.0001 for all). The rate of MACCE was also higher in RF patients whatever the PCI indication (STEMI, 45% vs. 15%; ACS, 23% vs. 14%; sCAD, 14% vs. 9%; P < 0.05 for all). Rates of TLR (5.5–7.4%) and ST (< 2.5%) were similar ( P > 0.05 for both). sCAD-RF and STEMI-nRF patients had similar rates of mortality ( P = 0.209) and MACCE ( P = 0.658). RF was independently associated with mortality, with a doubled relative risk in STEMI versus ACS and sCAD groups (odds ratio 5.3, 95% confidence interval 3.627–7.821 vs. 2.1, 1.465–3.140 and 2.3, 1.507–3.469, respectively; P < 0.0001).
Conclusion
RF is a stronger independent predictor of death after PCI in STEMI than in ACS or sCAD patients. sCAD-RF and STEMI-nRF patients had similar prognoses.
Résumé
Contexte
Les patients insuffisants rénaux chroniques sont systématiquement exclus des études cliniques ; de ce fait, leur pronostic après angioplastie coronaire reste mal connu.
Objectif
Comparer les événements cardiovasculaires après angioplastie contemporaine chez les patients avec versus sans insuffisance rénale (IR) en fonction de la présentation clinique (infarctus du myocarde avec élévation du segment ST [STEMI], syndrome coronaire aigu [SCA], maladie coronaire stable [MCS]).
Méthodes
Tous les patients pris en charge pour angioplastie coronaire avec implantation de stent ont été prospectivement inclus de 2007 à 2012. L’IR était définie par une clairance de la créatinine < 60 mL/min. Le critère de jugement primaire était la mortalité toute cause ; les critères secondaires étaient les MACCE (mortalité cardiovasculaire/infarctus du myocarde/AVC/TLR), TLR (nouvelle revascularisation de la lésion cible) et les thromboses de stent (TS) certaines ou probables (ARC) à 1 an.
Résultats
Parmi 5337 patients, 23 % étaient dilatés pour un STEMI, 34 % pour un SCA, 43 % pour une MCS et 27 % avaient une IR. Les patients IR avaient des taux de mortalité supérieurs en cas de STEMI (41 % vs 7,5 %), SCA (19 % vs 6 %) et MCS (10 % vs 3 %) comparés aux patients normo-rénaux ( p < 0,0001 pour tous). Les MACCE étaient également supérieurs quelque soit l’indication d’angioplastie (STEMI, 45 % vs 15 % ; SCA, 23 % vs 14 % ; MCS, 14 % vs 9 % ; p < 0,05 pour tous). Le taux de TLR (5,5–7,4 %) et TS (< 2,5 %) étaient comparables ( p > 0,05 pour les 2). Les patients IR dilatés pour une MCS avaient un taux de mortalité ( p = 0,209) et de MACCE ( p = 0,658) comparables aux patients STEMI normo-rénaux. L’IR était un facteur prédictif indépendant de mortalité avec un sur-risque double en cas de STEMI versus SCA et MCS (OR 5,3, 95 % CI 3,627–7,821 vs 2,1, 1,465–3,140 et 2,3, 1,507–3,469, respectivement ; p < 0,0001).
Conclusion
L’IR est un facteur prédictif de surmortalité plus puissant après angioplastie pour un STEMI comparé à un SCA ou une MCS. Les patients IR dilatés pour une MCS avaient un pronostic comparable aux patients STEMI normo-rénaux.
Background
Coronary artery disease (CAD) is common in patients with renal failure (RF). The development of atherosclerotic cardiovascular disease probably begins during early renal insufficiency . In stable CAD (sCAD), RF is an independent predictor of death or non-fatal myocardial infarction . In acute coronary syndromes (ACS), impaired renal function is a common finding present in one out of three patients . RF in patients with ACS is also a marker of adverse baseline clinical characteristics and is independently associated with an increased risk of death and myocardial infarction . After percutaneous coronary intervention (PCI), RF is independently associated with mortality and other adverse events in patients with CAD . Patients undergoing PCI for ACS are known to have a poorer short-term prognosis compared with sCAD patients . RF is an independent predictor of all-cause mortality for both ACS and sCAD patients undergoing PCI . Because patients with RF have been systematically excluded from clinical trials , the prevalence and outcomes of patients with RF have not been well studied in the PCI setting. To our knowledge, no paper to date has evaluated in a direct manner the impact of RF on death and other important outcomes between different PCI cohorts.
The purpose of the present analysis was to evaluate cardiovascular outcomes in RF patients after contemporary PCI according to the indication (ST-segment elevation myocardial infarction [STEMI], ACS or sCAD).
Methods
Patients and procedures
Consecutive patients ( n = 5337) undergoing PCI with at least one stent were prospectively included from August 2007 to December 2012 in the Middle Care registry at Pitié-Salpêtrière Hospital. Patients treated by balloon angioplasty or without subsequent stent implantation ( n = 574, 9.7%) were excluded. In patients undergoing more than one revascularization procedure within 1 year after inclusion ( n = 598, 11%), subsequent PCIs were counted as outcomes.
PCI was performed by radial access whenever possible (routine use in first intention) using mostly 6 French sheaths with systematic stent implantation (unless considered inappropriate by the physician). Antiplatelet therapy, including aspirin and a P2Y 12 inhibitor, was started before or during PCI, with a 250 mg intravenous dose of aspirin and a loading dose of clopidogrel (300–900 mg), prasugrel (60 mg) or ticagrelor (180 mg). All patients, except those previously treated by vitamin K antagonists, but including patients on new oral anticoagulant drugs, received intravenous low molecular weight heparin during PCI (enoxaparin 0.5 mg/kg). Glycoprotein IIb/IIIa inhibitors were administered at the operator’s discretion. The usual aspirin maintenance dose was 75 mg/day, while the clopidogrel dose was 75–150 mg/day, the prasugrel dose was 5–10 mg/day and the ticagrelor dose was 180 mg/day. Dual antiplatelet therapy was maintained 12 months after acute coronary syndrome, 3–12 months after elective drug-eluting stent (DES) implantation, and could be switched to single antithrombotic therapy after 1 month after bare-metal stent (BMS) implantation in a non-urgent setting . Statins, beta-blockers and angiotensin-converting enzyme inhibitors were started as soon as possible according to haemodynamic status.
Definitions
We defined three patient groups according to the indication for PCI: STEMI, ACS and sCAD. STEMI was defined by the presence of the symptoms of myocardial ischaemia, with symptom onset to angiography time < 24 hours, associated with new ST-segment elevation (at least 0.1 mV in two or more standard leads or at least 0.2 mV in two or more contiguous precordial leads) or new left bundle branch block, and associated with later elevation of cardiac markers (creatine kinase and/or troponin I) at least three times above the upper limit of normal values.
ACS (non-ST-segment elevation myocardial infarction [NSTEMI] or unstable angina) was defined by the presence of at least two of the following criteria: symptoms of myocardial ischaemia (chest pain at rest, recent destabilization of previously stable angina or post-myocardial infarction angina); electrocardiographic ST-segment abnormalities (depression or transient elevation of ≥ 0.1 mV) or T-wave inversion in at least two contiguous leads; or an elevated cardiac troponin I value (above the upper limit of normal). STEMI late presenters (symptom onset to angiography time > 24 hours) were included in the ACS group.sCAD included patients with stable angina, silent ischaemia (positive functional test without angina), preoperative patients (mainly before peripheral vascular surgery) and coronary allograft vasculopathy (heart transplant patients with significant coronary stenosis).
RF was defined as creatinine clearance (CrCl) < 60 mL/min/1.73 m 2 using the Cockcroft formula. Patients in each PCI group were compared according to their renal function: preserved (nRF) versus impaired (RF).
Endpoints
The primary endpoint was all-cause mortality at 1-year. Death was defined as death from any cause. The secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE: a composite of cardiovascular death, myocardial infarction, stroke and target lesion revascularization [TLR]), TLR and Academic Research Consortium definite or probable stent thrombosis (ST) at 1 year.
Death was adjudicated as cardiovascular death if, when patients died suddenly, an autopsy failed to reveal another cause, or if death was associated with documented myocardial infarction or other cardiac causes, such as congestive heart failure and arrhythmia. Myocardial infarction was defined as recurrent chest pain and/or electrocardiogram changes with at least one of the following criteria: creatine kinase or troponin I ≥ two times the upper limit of normal with an increase of > 50% over the previous value and/or the appearance of new left bundle branch block or new Q waves. Stroke was defined as an acute neurological deficit lasting for > 24 hours, as classified by a physician, with supporting information, including brain images and neurological/neurosurgical evaluation. Clinical TLR was defined as new revascularization of the index lesion mandated by clinical symptoms or documented ischaemia. ST was defined as definite or probable ST according to the Academic Research Consortium criteria .
One-year follow-up was obtained from outpatient clinic visits, review of medical records or telephone interview with the patient or their family. Informed consent was obtained from each patient, and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki, as reflected in a priori approval by the institution’s human research committee.
Statistical analyses
Continuous variables are expressed as means ± standard deviations and were compared by the t -test. Categorical variables are expressed as numbers and percentages and were compared by the χ 2 test. Kaplan–Meier curves were drawn using Prism 5 software (GraphPad Software, Inc., La Jolla, CA, USA). Among all baseline clinical and procedural characteristics, variables with a P value < 0.05 in univariate analyses were included in multivariable logistic regression models to determine the independent factors for 1-year mortality and 1-year MACCE. The statistical analyses were performed with SPSS software for Windows, version 15.0 (SPSS, Inc., Chicago, IL, USA). A P value < 0.05 was considered to indicate statistical significance.
Results
Baseline characteristics
Among 5337 consecutive patients who underwent PCI with stent in our institution, 1219 (23%), 1837 (34%) and 2281 (43%) patients had STEMI, ACS and sCAD, respectively. Nearly one third of PCI patients had RF (27%); among them, 126 (9%) had dialysis, 156 (11%) had severe RF (CrCl < 30 mL/min) and 1176 (80%) had moderate RF (CrCl 30–60 mL/min).
Patients with RF were older (74 vs. 62 years old), more likely to be women (35% vs. 17%) and had more hypertension (72% vs. 54%), history of stroke (10% vs. 5%) and multivessel disease (60% vs. 50%), with a lower rate of DES use (51% vs. 64%) in all groups. These patients were less likely to be current smokers (13% vs. 34%) or to have a family history of CAD (11% vs. 21%) ( P < 0.0001, for all comparisons).
Baseline clinical and procedural characteristics according to PCI indication and renal function are shown in Table 1 ; 23% of STEMI patients and 29% of both ACS and sCAD patients had RF ( P = 0.0002). At admission, RF patients were more likely to present with out-of-hospital cardiac arrest or cardiogenic shock in the STEMI and ACS groups. The radial artery was the main access for PCI (4861, 91%), although radial PCI was used less frequently in STEMI patients with RF versus nRF (79% vs. 92%; P < 0.0001). In the overall patient population, the radial approach was less accessible in RF versus nRF patients (88% vs. 92%; P < 0.0001). In STEMI patients, the number of stents implanted and the total stent length were slightly higher, while the average stent diameter was lower in RF than in nRF patients.
| STEMI ( n = 1219) | ACS ( n = 1837) | sCAD ( n = 2281) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| RF ( n = 278, 23%) | nRF ( n = 941, 77%) | P | RF ( n = 527, 29%) | nRF ( n = 1310, 71%) | P | RF ( n = 653, 29%) | nRF ( n = 1628, 71%) | P | |
| Age (years) | 74 ± 13 | 58 ± 12 | < 0.0001 | 75 ± 10 | 61 ± 12 | < 0.0001 | 73 ± 10 | 64 ± 10 | < 0.0001 |
| Men | 161 (58) | 772 (82) | < 0.0001 | 340 (64) | 1072 (82) | < 0.0001 | 446 (68) | 1376 (84) | < 0.0001 |
| BMI (kg/m 2 ) | 26 ± 13 | 27 ± 10 | 0.185 | 24 ± 4 | 27 ± 11 | < 0.0001 | 25 ± 8 | 28 ± 17 | < 0.0001 |
| CrCl (mL/min) | 43 ± 12 | 108 ± 35 | < 0.0001 | 40 ± 14 | 101 ± 32 | < 0.0001 | 43 ± 14 | 94 ± 28 | < 0.0001 |
| Dialysis | 5 (1.8) | – | – | 57 (11) | – | – | 64 (10) | – | – |
| Diabetes | 65 (23) | 163 (17) | 0.023 | 186 (35) | 321 (24) | < 0.0001 | 212 (32) | 550 (34) | 0.546 |
| Dyslipidaemia | 113 (41) | 361 (38) | 0.492 | 280 (53) | 680 (52) | 0.635 | 399 (61) | 1047 (64) | 0.150 |
| Current smoker | 53 (19) | 489 (52) | < 0.0001 | 74 (14) | 473 (36) | < 0.0001 | 64 (10) | 355 (22) | < 0.0001 |
| Hypertension | 168 (60) | 368 (39) | < 0.0001 | 403 (76) | 707 (54) | < 0.0001 | 482 (74) | 1033 (63) | < 0.0001 |
| Family history of CAD | 17 (6) | 212 (22) | < 0.0001 | 52 (10) | 282 (21) | < 0.0001 | 87 (13) | 336 (21) | < 0.0001 |
| History of MI | 29 (10) | 66 (7) | 0.062 | 101 (19) | 250 (19) | 0.968 | 119 (18) | 382 (23) | 0.006 |
| History of PCI | 30 (11) | 79 (8) | 0.219 | 157 (29) | 338 (26) | 0.114 | 235 (36) | 640 (39) | 0.140 |
| History of CABG | 13 (5) | 14 (1.5) | 0.002 | 61 (12) | 86 (7) | < 0.0001 | 60 (9) | 157 (10) | 0.738 |
| History of stroke | 19 (7) | 26 (3) | 0.002 | 67 (13) | 71 (5) | < 0.0001 | 56 (9) | 98 (6) | 0.028 |
| Cardiac arrest | 43 (15) | 66 (7) | < 0.0001 | 12 (2.3) | 10 (0.8) | 0.007 | 0 (0) | 0 (0) | – |
| Cardiogenic shock | 60 (22) | 44 (5) | < 0.0001 | 17 (3.7) | 18 (1.4) | 0.009 | 0 (0) | 0 (0) | – |
| Radial access | 220 (79) | 865 (92) | < 0.0001 | 471 (89) | 1209 (92) | 0.043 | 589 (90) | 1507 (93) | 0.061 |
| DES | 52 (19) | 382 (41) | < 0.0001 | 290 (55) | 884 (67) | < 0.0001 | 403 (62) | 1211 (74) | < 0.0001 |
| Multivessel CAD | 169 (61) | 420 (45) | < 0.0001 | 326 (62) | 663 (51) | < 0.0001 | 378 (58) | 856 (53) | 0.022 |
| Number of stents/patient | 1.63 ± 0.88 | 1.49 ± 0.75 | 0.012 | 1.68 ± 0.95 | 1.67 ± 0.97 | 0.868 | 1.68 ± 0.93 | 1.62 ± 0.93 | 0.059 |
| Average stent diameter/patient (mm) | 2.82 ± 0.46 | 2.92 ± 0.47 | 0.001 | 2.83 ± 0.53 | 2.86 ± 0.51 | 0.301 | 2.81 ± 0.48 | 2.82 ± 0.46 | 0.796 |
| Total stent length/patient (mm) | 30 ± 18 | 27 ± 16 | 0.035 | 28 ± 18 | 29 ± 20 | 0.308 | 27 ± 18 | 27 ± 19 | 0.891 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
