What Are the Role and Management of Percutaneous Coronary Intervention for Noncardiac Surgery?


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). Historically, the high incidence of coronary restenosis from neointimal coronary endothelial growth plagued success rates for BA and prompted the clinical development and introduction of BMSs. Although a significant therapeutic advance, BMSs were still associated with coronary restenosis rates in excess of 20% in long-term follow-up studies . , The second major significant reduction in coronary restenosis after PCI came from DESs, which pharmacologically retard smooth muscle proliferation and migration with antimitotic agents, the main mechanisms behind in-stent restenosis. Despite this advantage, later follow-up studies found that there is a trade-off of an increase in the risk for stent thrombosis (ST) in first-generation DESs, which include the sirolimus- and pacitaxel-eluting stents, largely because of polymer-induced inflammation and thicker strut designs. Specifically, although the risks for early ST (within 30 days of implantation) in BMSs and first-generation DESs are similar, the risk for very late stent thrombosis (>1 year after implantation) was higher in these DESs. This heightened risk meant that patients receiving DESs would be consigned to an increase in dual antiplatelet therapy (DAPT) intensity and duration. Newer generations of DESs address these safety issues and have a 38% lower risk for clinically significant coronary restenosis, a 43% lower risk for ST, and a 23% lower risk for death compared with the older DESs. ,

Since the introduction of second-generation DESs in 2008, millions of these devices have been implanted worldwide and have largely supplanted first-generation products. In a large cohort, the cumulative incidence of ST after 3 years was 1.5% in patients receiving BMS, 2.2% with first-generation DESs, and 1.0% in second-generation DESs. Nevertheless, the prevention of coronary ST in patients receiving any type of stent is of paramount importance because this complication has a high mortality rate. As a result, DAPT with aspirin and a P2Y 12 inhibitor has been recommended for at least 1 month after BMS placement or for at least 6 months after DES placement in patients being treated for stable ischemic heart disease and for at least 1 year using the more potent P2Y 12 inhibitors ticagrelor or prasugrel in patients receiving treatment for acute coronary syndrome (ACS). ,

Although premature discontinuation of antiplatelet therapy is a major risk factor for ST, there are multiple other identified clinical and angiographic ischemic risk factors ( Table 11.1 ). , , , The perioperative period qualifies as a major risk factor for ST and other types of myocardial ischemia because noncardiac surgery (NCS) activates platelets and induces hypercoagulability. , For example, cardiac risk was 27 times higher in the week after NCS (hazard ratio [HR]: 27.3; 95% confidence interval [CI]: 10.0–74.2; p < .001) in a large registry study. More recent observational data from Japan of 2398 patients found a 0.4% incidence of definite or probable stent thrombosis in the 30 days post-NCS, and a 3.2% composite rate of death, myocardial infarction (MI), and ST. Unfortunately, patients with coronary stents frequently require NCS. , Most of these surgeries are performed after the 1-year mark, although many surgeries are still necessary soon after stent implantation, as the cumulative incidence of surgery in a large multicenter trial was 3.6% at 30 days, 9.4% at 6 months, 14.3% at 1 year, and 40% at 5 years.

TABLE 11.1
Identified Risk Factors for Increased Ischemic Risk Including Stent Thrombosis After PCI
Clinical Risk Factors PCI-Related Risk Factors
Cessation of platelet blockade Number of implanted stents (>3)
Advanced age (>75 years) Multiple coronary lesions (> 3)
Diabetes Overlapping coronary stents
Low ejection fraction (<40%) Coronary ostial lesions
Chronic kidney disease (eGFR < 60 mL/min) Small-caliber coronary vessels
Recent acute coronary syndrome (<1 year) Complicated stent deployment
Perioperative period Coronary bifurcation lesions
Prior history of myocardial infarctions Long total stent length (>60 mm)
Peripheral arterial disease Treatment of last remaining patent coronary artery
Current smoker Treatment of in-stent restenosis
Anemia Treatment of chronic total occlusion
First-generation DES
Long time from PCI to surgery
DES , Drug-eluting stent; eGFR , estimated glomerular filtration rate; PCI , percutaneous coronary intervention.

The danger of the perioperative period after recent PCI was known even in the early era of PCIs, highlighted in a small case series that documented a 20% mortality rate at 2 weeks in patients undergoing NCS within 40 days after BMS deployment, primarily from MI because of ST. Subsequently, in a large multicenter retrospective cohort of cases from 2000 to 2010, those who underwent NCS within 24 months of stent placement had higher rates of major adverse cardiac events (MACE) in the 30 days after surgery compared with those with stents who did not undergo surgery (3.1% versus 1.9%; risk difference [RD]: 1.3%; 95% CI: 1.0%–1.5%; p < .001). This risk difference was highest in the first 6 weeks after stent implantation (2.8%; 95% CI: 0.8%–4.8%). Thus the timing and management of perioperative patients with recent PCI is an important risk-benefit calculation. This chapter reviews the options, latest evidence, and current expert recommendations concerning the perioperative risk for 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 11.2 . , 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 11.3A (classes of recommendations) and 11.3B (levels of evidence). The expert recommendations and corresponding levels of evidence have been summarized in Tables 11.4 (class I recommendations), 11.5 (classes IIa and IIb recommendations), and 11.6 (class III recommendations). , The AHA/ACC guideline-focused update on duration of antiplatelet therapy in patients with coronary artery disease (2016) and perioperative cardiovascular care for NCS surgery (2014) are available at www.americanheart.org (section on guidelines and statements; last accessed May 1, 2021).

TABLE 11.2
Options for Limiting Coronary Thrombosis after Noncardiac Surgery and Recent PCI
Options Considerations within the Option
Minimize preoperative PCI
  • 1.

    Limit preoperative PCI in stable coronary disease

  • 2.

    PCI for unstable coronary syndromes

Consider type of PCI
  • 1.

    Bare-metal stents

  • 2.

    Drug-eluting stents

Optimize platelet blockade
  • 1.

    Continue aspirin and clopidogrel

  • 2.

    Perioperative bridging with intravenous platelet blockade

  • 3.

    Continue aspirin only

Education and collaboration
  • 1.

    Surgeon

  • 2.

    Cardiologist

  • 3.

    Surgery at center with primary PCI availability

PCI , Percutaneous coronary intervention.

TABLE 11.3A
Definition of Classification Scheme for Clinical Recommendations
Clinical Recommendations Class (Strength) of Recommendation
Class I (Strong) Suggested phrases for writing recommendations:

  • Is recommended

  • Is indicated/useful/effective/beneficial

  • Should be performed/administered/other

  • Treatment A should be chosen over treatment B.

Class IIa (Moderate) Suggested phrases for writing recommendations:

  • Is reasonable

  • Can be useful/beneficial/effective

  • It is reasonable to choose treatment A over treatment B.

Class IIb (Weak) Suggested phrases for writing recommendations:

  • May/might be reasonable

  • May/might be considered

  • Usefulness/effectiveness is unknown/unclear/uncertain or not well established.

Class III No Benefit (Moderate) Suggested phrases for writing recommendations:

  • Is not recommended

  • Is not indicated/useful/beneficial/effective

  • Should not be performed/administered/other

Class III Harm (Strong) Suggested phrases for writing recommendations:

  • Potentially harmful

  • Causes harm

  • Associated with excess morbidity/mortality

  • Should not be performed/administered/other

Adapted from Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circ. 2016;133(11):1135–1147.

TABLE 11.3B
Classification Scheme for Supporting Evidence for Clinical Recommendations
Level of Evidence Definition of Recommendation Class
Level A
  • High-quality evidence from more than one RCT

  • Meta-analyses of high-quality RCTs

  • One or more RCTs corroborated by high-quality registry studies

Level B-R
(Randomized)
  • Moderate-quality evidence from one or more RCTs

  • Meta-analyses of moderate-quality RCTs

Level B-NR
(Nonrandomized)
  • Moderate-quality evidence from one or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies

  • Meta-analyses of such studies

Level C-LD
(Limited Data)
  • Randomized or nonrandomized observational or registry studies with limitations of design or execution

  • Meta-analyses of such studies

  • Physiologic or mechanistic studies in human subjects

Level C-EO
(Expert Opinion)
  • Consensus of expert opinion based on clinical experience

RCT , Randomized controlled trial.
Adapted from Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circ. 2016;133(11):1135–1147.

TABLE 11.4
Class I Recommendations for PCI and NCS
Recommendation Class and Evidence
Elective noncardiac surgery should be delayed 30 days after BMS implantation and optimally 6 months after DES implantation I (B-NR)
Elective noncardiac surgery should be delayed 14 days after balloon angioplasty I (C-EO)
Revascularization before noncardiac surgery is recommended when indicated by existing CPGs I (C-EO)
Continue DAPT in patients undergoing urgent noncardiac surgery during the first 4–6 weeks after BMS or DES implantation, unless the risk for bleeding outweighs the benefit of stent thrombosis prevention I (C-LD)
In patients treated with DAPT after coronary stent implantation who must undergo surgical procedures that mandate the discontinuation of P2Y 12 inhibitor therapy, it is recommended that aspirin be continued if possible and the P2Y 12 platelet receptor inhibitor be restarted as soon as possible after surgery I (C-EO)
Management of perioperative antiplatelet therapy should be determined by consensus of treating clinicians and the patient I (C-EO)
BMS , Bare metal stent; CPG, clinical practice guideline; DAPT , dual antiplatelet therapy; DES, drug eluting stent; NCS, noncardiac surgery; PCI, percutaneous coronary intervention.
Adapted from Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circ. 2016;133(11):1135–1147; and Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(22):e77–e137.

TABLE 11.5
Classes IIa and IIb Recommendations for PCI and NCS
Recommendation Class and Evidence
When noncardiac surgery is required in patients taking a P2Y 12 inhibitor, a consensus decision among treating clinicians as to the relative risks of surgery and discontinuation or continuation of antiplatelet therapy can be useful. IIa (C-EO)
Elective noncardiac surgery after DES implantation in patients for whom P2Y 12 inhibitor therapy will need to be discontinued may be considered after 3 months if the risk for further delay of surgery is greater than the expected risks of stent thrombosis. IIb (level C)
DES, Drug-eluting stent; NCS , noncardiac surgery; PCI , percutaneous coronary intervention.
Adapted from Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circ. 2016;133(11):1135–1147; and Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(22):e77–e137.

TABLE 11.6
Class III Recommendations for PCI and NCS
Recommendation Class and Evidence
Elective noncardiac surgery should not be performed within 30 days of BMS implantation or within 3 months after DES implantation in patients whom DAPT will need to be discontinued perioperatively III (B-NR)
DAPT , Dual antiplatelet therapy; DES , drug-eluting stent; NCS , noncardiac surgery; PCI , percutaneous coronary intervention.
Adapted from Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circ. 2016;133(11):1135–1147; and Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(22):e77–e137.

EVIDENCE

Minimize Preoperative Percutaneous Coronary Intervention

Patients with stable 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% received abdominal aortic aneurysm repair and 67% received infrainguinal vascular bypass). 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 MI at 30 days (8.4% versus 8.4%; p = .99) and a similar 27-month survival rate (78% versus 77%; p = .98). Therefore this landmark study suggests that preoperative PCI for stable CAD may not be required before NCS. Further analysis of the CARP data set has also revealed that although postoperative cardiac complications are accurately predicted by the revised cardiac risk index (odds ratio [OR], 1.73; 95% CI, 1.26–2.38; p < .001), preoperative coronary revascularization was unable to reduce these complications in any risk subset (OR, 0.86; 95% CI, 0.50–1.49; p = .60).

The exclusion criteria for CARP included significant left main coronary stenosis, unstable CAD syndromes, aortic stenosis, and severe cardiomyopathy (defined as a left ventricular ejection fraction < 20%). 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 original CARP trial, it was the only subset who demonstrated a survival benefit from preoperative coronary revascularization via coronary artery bypass graft (CABG) surgery in a post hoc analysis of all screened patients. The benefits of CABG also extended to those within the CARP trial among patients with multivessel disease. Although not specifically designed to address this question, those in the CARP trial who underwent surgical revascularization had better protection from subsequent MIs compared with those who underwent PCI (6.6% vs. 16.8%; p = .024). This result was predominantly explained by the completeness of revascularization. An additional retrospective cohort study of patients undergoing NCS within 2 years of PCI found that incomplete revascularization, as defined as residual lesions at the conclusion of PCI, conferred a 19% increase in risk for postoperative MACE compared with those with complete revascularization (OR: 1.19; 95% CI: 1.00–1.41; p = .05). In summary, revascularization should only be performed before NCS according to other general revascularization guidelines, , but not for the direct purpose of decreasing risk from noncardiac surgery. Preoperative PCI is advised only for left main artery disease in patients who are ineligible for CABG or in patients with unstable ACS.

You're Reading a Preview

Become a Clinical Tree membership for Full access and enjoy Unlimited articles

Become membership

If you are a member. Log in here