Introduction
Percutaneous coronary intervention (PCI) has revolutionized the management of coronary artery disease (CAD), initially with balloon angioplasty (BA) and subsequently with coronary stenting both with bare-metal stents (BMSs) and with drug-eluting stents (DESs). The high incidence of coronary restenosis from neointimal coronary endothelial growth after BA prompted the clinical development and introduction of BMS placement. Although they represented a significant therapeutic advance, BMSs were still associated with coronary restenosis rates in excess of 10%. The second major significant reduction in coronary restenosis after PCI resulted from DESs that pharmacologically retard stent endothelialization and neointimal growth with antimitotic agents such as sirolimus, paclitaxel, everolimus, and zotarolimus. Because of slow release of these cytostatic agents, the risk of coronary restenosis with DESs has been significantly reduced to less than 10%. The newer generations of DESs have extended the outcome benefits even further as compared with the first generation of DESs with a 38% lower risk of clinically significant coronary restenosis, a 43% lower risk of stent thrombosis (ST), and a 23% lower risk of death.
Since the introduction of DESs, millions of these devices have been implanted worldwide. The prevention of coronary ST is of paramount importance because this complication has a high mortality rate. The risk of ST is particularly high before the coronary stent has been coated with endothelium (approximately 4 to 6 weeks for BMSs and at least 1 year for DESs). As a result, dual antiplatelet therapy with aspirin and clopidogrel has been recommended for at least 1 month after BMS placement and for at least 12 months after DES placement. Although premature discontinuation of antiplatelet therapy is a major risk for ST, there are multiple identified clinical and angiographic risk factors for ST ( Table 12-1 ).
Clinical Risk Factors | Angiographic Risk Factors |
---|---|
Cessation of platelet blockade | Thrombus-containing coronary lesions |
Advanced age | Multiple coronary lesions |
Diabetes | Overlapping coronary stents |
Low ejection fraction | Coronary ostial lesions |
Renal failure | Small-caliber coronary vessels |
Acute coronary syndrome | Complicated stent deployment |
Perioperative period | Coronary bifurcation lesions |
Malignancy | Inflow lesion proximal to coronary stent |
Peripheral arterial disease | Outflow lesion distal to coronary stent |
Smoking | Development of neoatheroma within coronary stent |
The perioperative period qualifies as a major risk factor for ST because noncardiac surgery (NCS) activates platelets and induces hypercoagulability. The significant risk of perioperative ST for BMSs was highlighted in a small case series that documented a 20% mortality rate in NCS within 6 weeks after BMS deployment. Furthermore, NCS after recent BA is not without risk of myocardial ischemia and perioperative mortality. In a case series of 350 patients who had NCS within 2 months after BA, the perioperative mortality rate was 0.9% (95% confidence interval [CI], 0.2% to 2.5%).
Given that up to 20% of patients with coronary stents require NCS within 3 years after PCI, the perioperative management of patients with recent PCI (BA, BMSs, DESs) is important because it concerns millions of patients who may be at significant perioperative risk of major adverse cardiovascular events. This chapter reviews the options, latest evidence, and current expert recommendations concerning the perioperative risk of recent PCI in NCS.
Options to Minimize Stent Thrombosis after Recent Percutaneous Coronary Intervention and Noncardiac Surgery
The perioperative options for limiting coronary thrombosis after recent PCI are presented in Table 12-2 . The evidence for each option will be reviewed. Recent expert recommendations will be presented according to the schema of the American Heart Association (AHA) and American College of Cardiology (ACC), as outlined in Tables 12-3A (classes of recommendations) and 12-3B (levels of evidence). The expert recommendations and corresponding levels of evidence have been summarized in Table 12-4 (class I recommendations), Tables 12-5A and 12-5B (classes IIa and IIb recommendations), and Table 12-6 (class III recommendations). The AHA/ACC guidelines for PCI (2011) and perioperative cardiovascular care for NCS surgery (2007) are available at www.americanheart.org (section on statements and practice guidelines; last accessed June 12, 2012.)
Options | Considerations within the Option |
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Minimize preoperative PCI |
|
Consider type of PCI |
|
Optimize platelet blockade |
|
Education and collaboration |
|
Clinical Recommendations | Definition of Recommendation Class |
---|---|
Class I | The procedure/treatment should be performed (benefit far outweighs the risk) |
Class IIa | It is reasonable to perform the procedure/treatment (benefit still clearly outweighs the risk) |
Class IIb | It is not unreasonable to perform the procedure/treatment (benefit probably outweighs the risk) |
Class III | The procedure/treatment should not be performed because it is not helpful and may be harmful (risk may outweigh the benefit) |
Level of Evidence | Definition of Recommendation Class |
---|---|
Level A | Sufficient evidence from multiple randomized trials or meta-analyses |
Level B | Limited evidence from a single randomized trial/multiple nonrandomized studies |
Level C | Case studies and/or expert opinion |
Recommendation | Class and Evidence |
---|---|
PCI before NCS is indicated in appropriate patients with stable angina who have two-vessel disease with significant proximal left anterior descending artery stenosis and either an ejection fraction less than 50% or demonstrable ischemia on noninvasive testing | I (level A) |
PCI before NCS is recommended for appropriate patients with high-risk unstable angina or non–ST-segment elevation myocardial infarction | I (level A) |
PCI before NCS is recommended in appropriate patients with ST-segment elevation myocardial infarction | I (level A) |
Recommendation | Class and Evidence |
---|---|
In patients who require PCI to alleviate myocardial ischemia and who require elective NCS in the following 12 mo, the recommended strategy is balloon angioplasty or bare-metal stent placement followed by 4-6 wk of dual antiplatelet therapy (aspirin and clopidogrel) | IIa (level B) |
In patients who have drug-eluting coronary stents and who require emergency NCS that mandates discontinuation of clopidogrel, it is reasonable to continue aspirin therapy and restart clopidogrel as soon as clinically possible | IIa (level C) |
Recommendation | Class and Evidence |
---|---|
The benefit of PCI before NCS is not established in high-risk ischemic patients (e.g., five or more wall motion abnormalities during dobutamine stress echocardiography) | IIb (level C) |
The benefit of PCI before NCS is not established in low-risk ischemic patients (e.g., one to four wall motion abnormalities during dobutamine stress echocardiography) | IIb (level B) |
Recommendation | Class and Evidence |
---|---|
Routine PCI in patients with stable coronary artery disease is not recommended before NCS | III (level B) |
Elective NCS that requires perioperative discontinuation of clopidogrel or aspirin and clopidogrel is not recommended within 4-6 wk of bare-metal coronary stent deployment | III (level B) |
Elective NCS that requires perioperative discontinuation of clopidogrel or aspirin and clopidogrel is not recommended within 12 mo of drug-eluting coronary stent deployment | III (level B) |
Elective NCS is not recommended within 4 wk of coronary revascularization with balloon angioplasty | III (level B) |
Evidence
Minimize Preoperative Percutaneous Coronary Intervention
Patients with CAD will often not benefit from coronary revascularization with PCI before NCS. The Coronary Artery Revascularization Prophylaxis (CARP) trial randomly assigned 510 patients with angiographically proved CAD to coronary revascularization or medical management before elective major vascular surgery (33% abdominal aortic aneurysm repair; 67% infrainguinal vascular bypass). The exclusion criteria included significant left main coronary stenosis, unstable CAD syndromes, aortic stenosis, and severe cardiomyopathy (defined as a left ventricular ejection fraction < 20%). Coronary revascularization was achieved surgically in 41% and with PCI in 59% of enrolled subjects. Patients with or without preoperative revascularization had a similar incidence of postoperative myocardial infarction (8.4% versus 8.4%, p = 0.99) and a similar 27-month survival rate (78% versus 77%, p = 0.98). Therefore this landmark study suggests that preoperative PCI for stable CAD may not be required before NCS. Of all patients screened for the CARP trial, 4.6% had clinically important left main coronary disease. Even though this subset was excluded from the CARP trial, it was the only subset who demonstrated a survival benefit from preoperative coronary revascularization. Further analysis of the CARP dataset has also revealed that although postoperative cardiac complications are accurately predicted by the revised cardiac risk index (odds ratio [OR], 1.73; 95% CI, 1.26 to 2.38; p < 0.001), preoperative coronary revascularization was unable to reduce these complications in high-risk subgroups identified by the revised cardiac risk index (OR, 0.86; 95% CI, 0.50 to 1.49; p = 0.60). Interestingly, patients in the CARP trial who underwent preoperative revascularization had better protection from subsequent myocardial infarction from surgical revascularization as compared with PCI (6.6% versus 16.8%; p = 0.024).
The DECREASE-II trial evaluated preoperative cardiac testing in major vascular surgical patients who had intermediate cardiac risk factors and who received adequate beta-blocker therapy. This trial demonstrated that preoperative coronary revascularization did not significantly improve the 30-day outcome in patients with extensive ischemia (OR, 0.78; 95% CI, 0.28 to 2.1; p = 0.62).
The DECREASE-V pilot study randomly assigned 101 vascular surgical patients with extensive ischemia (defined as five or more ischemic segments during dobutamine stress echocardiography or at least three ischemic segments identified by dipyrimadole perfusion scintigraphy) to preoperative coronary revascularization versus best medical therapy. Coronary revascularization was achieved surgically in 35% and with PCI in 65% of enrolled subjects. The composite primary outcome (perioperative death and myocardial infarction) was similar between study groups (43% for revascularization versus 33% for medical therapy; OR, 1.4; 95% CI, 0.7 to 2.8; p = 0.30). The incidence of death and myocardial infarction at 1 year was high at 47% but similar in both groups (49% for revascularization and 44% for medical therapy; OR, 1.2; 95% CI, 0.7 to 2.3; p = 0.48).
Taken together, these three important clinical trials (CARP, DECREASE-II, and DECREASE-V) point to a more limited role for PCI in stable CAD before NCS. Their cumulative evidence forms the basis of the expert recommendations relating to PCI before elective NCS in stable CAD (see Tables 12-4 to 12-6 ).
In unstable angina or myocardial infarction, PCI is indicated in appropriate patients for management of the acute coronary syndrome in its own right. Firstly, PCI before NCS is recommended for appropriate patients with high-risk unstable angina or non–ST-segment elevation myocardial infarction (class I recommendation; level A evidence). Secondly, PCI before NCS is also recommended in appropriate patients with ST-segment elevation myocardial infarction (class I recommendation; level A evidence).
In the setting of stable CAD, PCI has a more limited role, as explained earlier. Routine PCI in patients with stable CAD is not recommended before NCS (class III recommendation; level B evidence). The benefit of PCI before NCS is not established in high-risk ischemic patients, for example, with five or more wall motion abnormalities during dobutamine stress echocardiography (class IIb recommendation; level C evidence). The benefit of PCI before NCS is also not established in low-risk ischemic patients, for example, with one to four wall motion abnormalities during dobutamine stress echocardiography (class IIb recommendation; level B evidence). PCI before NCS surgery, however, is indicated in appropriate patients with stable angina who have two-vessel disease with significant proximal left anterior descending (LAD) artery stenosis and either an ejection fraction less than 50% or demonstrable ischemia on noninvasive testing (class I recommendation; level A evidence).
Type of Percutaneous Coronary Intervention
Balloon Angioplasty
Seven retrospective studies have examined cardiovascular outcome after coronary BA before NCS. The main features of these studies are summarized in Table 12-7 . Five of the seven studies are limited by factors such as a small sample size, a long interval between coronary angioplasty and surgery, or a control group with coronary stents. The remaining two studies suggest that NCS after BA is safe, particularly if surgery occurs at least 2 weeks after coronary intervention. This minimum time period allows the coronary injury at the BA site to heal and thus not be at risk for perioperative thrombosis.