BJA Advance Access published online on March 1, 2008
British Journal of Anaesthesia, doi:10.1093/bja/aen033
Drug-eluting stent thrombosis in patients undergoing non-cardiac surgery: is it always a problem?
Department of Anesthesiology and Critical Care, Centre Hospitalo-Universitaire Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France
* Corresponding author. Département d’Anesthésie Réanimation 2, Hôpital Pontchaillou, CHU Rennes, 2 rue Henri Le Guilloux, 35033 Rennes Cedex 9, France. E-mail: gilles.godet{at}chu-rennes.fr
Accepted for publication January 30, 2008.
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Abstract |
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Background: Recent publications have reported high incidence of perioperative complications in patients with drug-eluting stent (DES). The recommendations for bare-metal stents (BMS) are not applicable to DES. In fact, large evidence-based studies are lacking on which to base a consensus for the perioperative management of patients with DES. The aim of the present study is to evaluate the postoperative cardiac risk associated with DES.
Methods: Prospectively collected data were examined for the rate of postoperative cardiac complications in 96 consecutive patients with DES who underwent digestive, urologic, orthopaedic, or vascular surgery. The average delay between revascularization and non-cardiac surgery was 14 (11) months (extremes 1 week and 36 months). The occurrence of postoperative troponin release (troponin I 
0.15 ng ml–1) and the rate of in-stent thrombosis were analysed.
Results: Twelve patients (12%) presented a postoperative troponin release, without EKG abnormalities in 10 cases (83%). Two patients (2%) developed an in-stent thrombosis. None of the patients had excessive postoperative blood loss.
Conclusions: Patients with DES are at higher risk of postoperative cardiac complications. Nevertheless, the specific thrombotic complications of the DES were uncommon in this series and this is in contrast to previous alarming reports. A balanced perioperative management of anti-platelet agents, considering both risk for bleeding and risk of thrombotic complications, in patients with DES, is associated with a low risk of thrombosis in the postoperative period. The rate of cardiac complications remains high in these patients due to co-morbidities.
Keywords: cardiac troponin I; complications, myocardial infarction; coronary artery disease; drug-eluting stents; surgery, non-cardiac
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Introduction |
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Several case reports have recently been published describing catastrophic perioperative complications in patients with drug-eluting stent (DES), undergoing non-cardiac surgery.1–4 Even more worrying is the fact that a large proportion of reported cases had DES implantation over 6 months and even 12 months in advance to surgery.2 It is therefore apparent that the recommendations of previous studies on bare-metal stents (BMS) are not applicable to DES.5 6
To date, there is little information on the recommended perioperative management of anti-coagulation, in patients taking one or two anti-platelet agents for the prevention of DES thrombosis. Likewise, it is not known when it is safe to discontinue these medications permanently. Furthermore, taking into consideration the specific and elevated risks of thrombosis in the postoperative period, it is not clear how soon after DES implantation it is possible to safely conduct surgery. The AHA/ACC has released a scientific advisory recommending delaying all elective surgery within 12 months of DES placement.7 8 Currently, high-level evidence is lacking in the literature to support strong recommendations on the perioperative use of anti-platelet agents in patients with BMS9 or DES. Major thrombotic complications such as in-stent thrombosis and haemorrhagic complications have to be taken into account to propose strategy.
For ethical and methodological reasons, further prospective and randomized studies are quite uncertain. Furthermore, establishment of a national registry might be difficult, and a long delay may elapse before clear recommendations can be made for anaesthesiologists and physicians.
It is the reason why, recently, a multidisciplinary group of French experts (cardiologists, haematologists, surgeons, and anaesthesiologists) met in December 2005 to review the state-of-the-art in the field and to produce recommendations on appropriate clinical practice. In view of the paucity of evidence-based data, the recommendations, recently published,10 11 are based in large part on agreement among the members of the task force. In fact, continuation of dual anti-platelet therapy is recommended if at all possible by the AHA/ACC.
The aim of our study was to evaluate the incidence of postoperative cardiac complications of all consecutive patients with a DES who underwent non-cardiac surgery in four different units of our hospital.
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Patient characteristics
Using a prospective registry describing clinical and surgical characteristics of all patients undergoing orthopaedic, urologic, digestive, or vascular surgery at the institution, we reviewed the database for records of all patients with a DES during a 1 yr period. As part of our departmental policy, all outcomes were prospectively noted with respect to: the perioperative strategy in the management of anti-coagulation, details of surgery, complications, biochemical analysis, and follow-up details.
Perioperative management
After operation, patients were transferred to the post-anaesthesia care unit (PACU). Postoperative hypertension (systolic arterial pressure >30% of baseline value) was treated by i.v. bolus of nicardipine 1 mg, or by clonidine (150 µg s.c.). Tachycardia (heart rate >80 beats min–1) was treated with i.v. beta-adrenergic receptor blocking drugs (propanolol or atenolol). The target heart rate was 70 beats min–1. Postoperative analgesia included i.v. morphine followed by s.c. morphine administration. Beta-blockers and statins were never discontinued and both were resumed the evening after surgery for patients receiving this therapy before surgery.
Blood was obtained for measurement of cardiac troponin I (cTnI) in all patients 6 h after the end of the surgery, and on the first, second, and third postoperative days. This measurement was performed using an immunoenzymofluorometric assay on a Stratus autoanalyser (Dade-Behring, Paris La Défense, France). An ECG was performed on arrival into the PACU, and on the first, second, and third postoperative days, and in the presence of clinical abnormalities or if there were increased cTnI values.
Perioperative administration of anti-coagulation
The perioperative management of anti-coagulation varied according to the type of surgery, the associated risk of perioperative haemorrhage, and the associated risk of DES thrombosis [site as bifurcation, multiple stenting, size (length and diameter), stenting in emergency after acute coronary syndrome, and residual dissection]. This perioperative management was discussed for each patient between the surgeon and the anaesthesiologist in charge of the patient, with advice of a referent cardiologist.
Aspirin was wished to be continued for all peripheral surgery, but both aspirin and clopidogrel were stopped before surgery considered as high risk for haemorrhagic complications (such as aortic surgery). The preoperative delay to stop one or both anti-platelet agents was at the discretion of the team in charge of the patient.
Anti-platelet agents and low molecular weight heparin (LMWH) were restarted after operation as sought by both surgeon and anaesthesiologist.
Ninety-six patients with DES were included. The characteristics of surgery, stent type, and interval plus complication rates are outlined in Table 1. The relationship between anti-coagulation therapy and the incidence of complications is outlined in Table 2.
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Sixty-eight patients received both aspirin and clopidogrel before operation. In 22 of the cases among 72 chronically treated with clopidogrel, clopidogrel was stopped 7 days or less before surgery; in 13 cases, it was stopped more than 7 days in advance; in 37 cases, clopidogrel was continued perioperatively, whereas aspirin was continued in 67 cases, stopped less than 5 days in advance in 13 cases, between 6 and 8 days in six cases, and stopped more than 8 days in advance in four cases.
In 25 cases, aspirin or clopidogrel or both were replaced by LMWH [85–100 IU antiXa per kg for 12 h (nine patients), for 24 h (16 patients)]; in three cases, aspirin was replaced by flurbiprofen (50 mgx2).
All patients received LMWH in the immediate perioperative period, which was continued until clopidogrel was reintroduced. Aspirin was restarted on day of surgery in 22 patients, on day 1 after operation in 23 cases, never more than four postoperative days in the remaining cases.
End points
In-stent thrombosis was defined as a documented (coronarography, 64-slice CT-scan or autopsy) occlusion of a DES with EKG sign (ST-T elevation). Postoperative troponin release was defined as an abnormal cTnI value at any time during the postoperative period. The cutoff used during the study period to define normality was 0.15 ng ml–1, which was the 99th percentile threshold for our laboratory during the study period. Death was defined as death from any cause occurring during hospitalization or within 30 days after surgery.
Statistical analysis
Data are expressed as mean (SD). Comparison of two means was performed using t-test or U-test of Mann and Whitney, according to the distribution of the variables. Qualitative variables were analysed using Fisher's exact test. All statistical comparisons were two-tailed and a P-value of <0.05 was considered significant. Statistical analysis was performed using SPSS version 13.0 software (SPSS Inc., Chicago, IL, USA).
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None of the patients had abnormal postoperative blood loss regarding the type of surgery. Three of the patients who underwent a carotid endarterectomy while taking clopidogrel and aspirin had a moderate haematoma after operation, but there was no airway compromise and no surgical intervention was necessary.
Overall several patients suffered major complications:
- 12 patients presented a postoperative troponin release, without EKG abnormalities in 10 cases.
- 8 out of these 12 patients had a troponin leak lower than 1.5 µg litre–1.
- one of the vascular patients had a troponin leak (peak of 1.63 µg litre–1), on day 2 and was admitted to a coronary care unit but recovered uneventfully and the subsequent coronary angiography on day 5 revealed no new abnormality. He underwent another procedure 7 months later with similar anti-coagulation prophylaxis without any complications.
- one patient died on day 1 after operation. This patient had chronic obstructive airways disease necessitating oxygen therapy at home. In the immediate postoperative period, he suffered from a hypoxic respiratory arrest during fibreoptic bronchoscopy. A pre-mortem cTnI was at 11.7 µg litre–1.
- one patient with 11 stents (3 DES and 8 BMS) underwent urologic surgery after a discontinuation of its chronic anti-platelet agents (respectively, 8 days for aspirin and 12 days for clopidogrel. He had a troponin leak (peak of 34.24 µg litre–1) with an ST-T elevation. A coronary angiography pointed out an in-BMS thrombosis. He had later uneventful recovery.
- one patient, with 2 DES (left main and circumflex arteries) inserted 32 months previously, was operated on a complex lower limb revascularization, after a short discontinuation of both clopidogrel (5 days) and aspirin (3 days). He suffered from a chest pain at recovery, 1 h after end of surgery, with an ST-T elevation. A coronary angiography on H+2 after the end of surgery revealed an in-stent thrombosis of the DES of the circumflex artery. A new angioplasty with a BMS placing was achieved. Patient developed a left ventricular insufficiency with a peak of cTnI at 324 µg litre–1 on POD2. He recovered uneventfully and was discharged from the cardiologic intensive care at POD4.
- a patient died 4 weeks after a femoral-popliteal bypass requiring subsequent amputation of toes. Death occurred after discharge, in the nephrology unit, caused by sepsis and anuria, with a late increase of cTnI (peak at 11.53 µg litre–1 on the day before death).
- three patients experienced a surgical complication: one colic necrosis on POD7 and two leg prosthesis thrombosis, all three complications needing redo surgery. All patients had later uneventful recovery.
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Our findings do not support previous reports that patients with DES who undergo surgery are at an increased risk of cardiac complications whether their regular anti-thrombotic treatment is continued or stopped for a few days.1–5 In this series of high-risk patients undergoing non-cardiac surgery, mainly vascular, we observed 12% of postoperative troponin release. Only two of them had significant EKG modifications and the all-cause mortality was 2%, none being related to a cardiac cause.
Moreover, one out of 96 patients experienced a DES thrombosis (the second in-stent thrombosis observed in this study occurs on a BMS in a patient with BMS and DES), suggesting that with a protective anti-thrombotic agents management, the frequency remains low.
The most important difference that must be taken into account remains the definition of the postoperative cardiac event. One could use postoperative troponin release as primary endpoint,12 but postoperative troponin release is also observed in patients without any stent, and most of the cases are not associated with coronary thrombosis. In the present study, postoperative troponin release was observed in 12% of the cases, the frequency predicted for patients with the same preoperative risk remains not significantly different. This suggests that most of the cases of postoperative troponin release observed are not related to in-stent thrombosis.
More than 1.5 million people benefit each year from percutaneous coronary revascularization with stent insertion in a large proportion of cases. Since early 2002, a substantial proportion of stents inserted are pharmacologically active. Initially CYPHER® (sirolimus) stents were used, but since 2003, TAXUS® (paclitaxel) stents represent the mainstay of treatment.4 As DES are associated with a significant reduction in restenosis compared with BMS, the proportion of patients with DES presenting for surgery in the future is likely to increase. However, there have been no studies to date to explore the actual incidence of DES thrombosis perioperatively nor have any perioperative management guidelines been established. Additionally, sirolimus and paclitaxel stents exert their effect by different mechanisms, and thus it may be necessary to establish separate protocols.
Sirolimus is regarded as a cytostatic drug, as it arrests the cell before it enters the dividing cycle and a significant portion of its efficacy is probably due to a pronounced anti-inflammatory action, whereas paclitaxel interrupts cell division during the mitotic phase and is thus classified as a cytotoxic drug.13 These discrete differences may also be associated with different clinical efficacy profiles with paclitaxel stents being associated with twice the number of major cardiac adverse effects at 9 months in one follow-up study.14 In fact, total occlusion as a result of restenosis has been shown to occur twice as often with paclitaxel stents than sirolimus stents,13 and the duration of anti-thrombotic treatment needed is longer. It is noteworthy that both of the complications in our cohort occurred in patients with a paclitaxel stent. This raises the question if both DES are equally safe in the perioperative period. However, other reviews have not borne out these differences.15 16
Likewise, continuation of aspirin perioperatively may not abolish the risk of postoperative cardiac complications when clopidogrel treatment is stopped. On the other hand, if anti-thrombotic treatment is continued, there is a risk of haemorrhage with haemodynamic instability and increased transfusion requirements (and the associated complications), which in themselves augment the likelihood of adverse cardiac events.
Our findings confirm the importance of vigilance when managing the patient with a DES perioperatively.17 The decision to proceed with surgery and if so, whether to continue anti-thrombotic treatment or not, should be seriously weighed up against the risk of an adverse cardiac event. Consultation with the cardiologist in charge should be pursued, in order to facilitate the minimum disruption of anti-coagulant treatment and to further delineate the cardiac risks of stopping this treatment. Furthermore, clear documentation of clarification of all risks must be included in the patient’s chart—as part of the modern day concept of informed consent. Close monitoring with ECG and serial cTnI measurements is essential, and the patient and surgeon must be well informed of the risks of stopping anti-coagulation.
This highlights that aspirin therapy in the absence of clopidogrel does not completely protect the patient from the risk of adverse events and that the perioperative management of anti-coagulation in these patients is difficult. Drugs incorporated in DES are utilized to retard and hopefully prevent neointimal hyperplasia, by inhibiting cellular proliferation on the stent wall. As such, they may be associated with prolonged delays in re-endothelialization. By the very nature of their action in delaying intimal healing, they increase the risk of thrombosis in the absence of anti-platelet treatment. In studies to date, the anti-platelet regimen has not been uniform and the duration of prophylactic treatment with aspirin and clopidogrel was significantly longer in patients with paclitaxel stents. Thus, despite the low quoted incidence of thrombosis near to 1%, it is difficult to establish if paclitaxel stents are not inherently associated with an augmented risk of thrombosis.7 Despite the fact that the rate of DES thrombosis is comparable with that seen in BMS, it should be remembered that few studies have been performed on the incidence of late DES thrombosis. The current recommendations are to continue lifelong aspirin therapy and at a minimum clopidogrel for 3 months (after sirolimus stent insertion) and 6 months (after paclitaxel stent insertion) with increasing opinion that thienopyridine treatment should be continued for no less than 12 months.7 18 19
The absence of treatment by a thienopyridine is the most striking factor associated with the risk of DES thrombosis.20 The other contributing factors being: bifurcation stenting, multiple stenting, long stent lengths, smaller minimum stent diameters, and residual dissection.21 The risk factor that has not been studied is how surgery affects the incidence of DES thrombosis. It is well known that surgical interventions are associated with sympathetic surges which predispose the patient with unstable coronary artery disease to myocardial infarction. The delay in re-endothelialization seen post-DES insertion results in an unstable coronary lesion and ought to be treated with a high index of suspicion.22 The risk of perioperative thrombosis is further augmented by the pro-coagulant effects of surgery, and the anti-platelet treatment is often completely stopped at this time in order to avoid the risk of significant bleeding.23
No studies define the optimum period of delay between DES insertion and elective surgery. Moreover randomized controlled trials with clear-cut results allowing high-degree evidence-based guidelines, which clarifies the risk of perioperative stent thrombosis, are missing. Likewise, no recommendations have been proposed to guide appropriate management of perioperative anti-thrombotic treatment. In a recent paper, Schouten and colleagues24 reported a series of 99 patients with DES, operated on within 2 yr after stenting, either receiving aspirin and clopidogrel throughout the surgical procedure or with a 1 week discontinuation of anti-thrombotic agents. This author observed three major adverse cardiac events, with a DES thrombosis in two of the three patients, probably in relation to a larger incidence and a longer time for discontinuation of anti-thrombotic agents. These are all areas that need urgent assessment as paradoxically, many patients and their treating doctors may be lulled into a false sense of security after successful DES placement. Owing to the favourable long-term outcomes reported, the inherent risks that surgery presents may easily go ignored and result in catastrophic outcomes.
In conclusion, our results confirm that perioperative modification of anti-platelet therapy in patients with DES is associated with a real risk of adverse cardiac events, but rarely specifically related to the DES thrombosis. Furthermore, EKG is a tool of major importance to survey these patients, because ST-T segment abnormalities must conduct to coronary angiography in emergency. Angiographic diagnosis of an in-stent thrombosis may conduct to a new angioplasty. The increasing number of patients with DES presenting for surgery and the important nature of potential complications when anti-thrombotic treatment is disrupted necessitate further investigations, in order to establish appropriate recommendations.25 Since aspirin alone or in combination with LMWH does not necessarily eradicate the risk of complications, it is likely that it will be difficult to establish the optimal guidelines for perioperative anti-coagulation.
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Departmental sources.
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