INTRODUCTION —
Percutaneous coronary intervention (PCI) with placement of an intracoronary stent requires treatment with a certain duration of dual antiplatelet therapy (DAPT), which may be as short as one month or as long as three years. (See "Long-term antiplatelet therapy after coronary artery stenting in stable patients".)
DAPT improves outcomes by lowering risk of ischemic events, including cardiac mortality and myocardial infarction (MI). Some of the improvement is attributable to a reduction in the incidence of stent thrombosis, a complication often associated with MI and death. However, DAPT is also associated with an increased risk of major bleeding. For patients undergoing PCI who are identified as being at high risk of bleeding, shorter durations of DAPT reduce the bleeding risk; however, the optimal management strategy is not known. This topic will discuss this issue in detail.
Other relevant topics include:
●(See "Noncardiac surgery after percutaneous coronary intervention".)
●(See "Coronary artery disease patients requiring combined anticoagulant and antiplatelet therapy".)
●(See "Gastrointestinal bleeding in patients undergoing percutaneous coronary intervention".)
●(See "Periprocedural bleeding in patients undergoing percutaneous coronary intervention".)
BACKGROUND AND DEFINITIONS
Definition of high bleeding risk — Estimating a patient's risk of bleeding is a complex undertaking requiring a careful assessment by the clinician. To standardize a definition for patients with high bleeding risk (HBR), the Academic Research Consortium developed a consensus definition for HBR (ARC-HBR) in 2019 [1]. The definition states that HBR is present if one major or two minor criteria (risk factors) for major bleeding are present. Major bleeding is defined by the Bleeding Academic Research Consortium (BARC). A patient is considered to be at HBR if the risk of BARC 3 or BARC 5 bleeding (table 1) is predicted to occur at a rate of ≥4 percent at one year or the risk of an intracranial hemorrhage is predicted to occur at ≥1 percent at one year.
The ARC-HBR specifies 20 clinical criteria that predict major bleeding. These criteria are presented in a table (table 2).
The ARC-HBR clinical and biochemical criteria have been validated in two studies of 16,580 "real-world" patients who underwent PCI [2,3]. In both studies, there was a significant, stepwise increase in bleeding risk with the number of criteria present.
Incidence of bleeding after PCI — The incidence of bleeding after PCI in the broad population of patients receiving dual antiplatelet therapy has been well studied [4]. The following studies are representative:
●In the 8582 individuals in the ADAPT-DES study, post-discharge bleeding occurred in 535 (6.2 percent) at a median time of 300 days after discharge [5]. Gastrointestinal bleeding (GI) was the most frequent source (62 percent). (See "Nonresponse and resistance to aspirin", section on 'Observations'.)
●In the EDUCATE registry of 2159 patients who underwent stenting with a second-generation drug-eluting stents (DES), the rate of bleeding by six months was approximately 2 percent [6]. (See 'Prognosis after bleeding' below.)
●In a registry study of 8137 patients who underwent stenting with first-generation DES, 4.8 percent had bleeding-related hospitalization after discharge, and the highest incidence occurred within 30 days of discharge [4]. The most common cause of bleeding was the GI tract. (See "Gastrointestinal bleeding in patients undergoing percutaneous coronary intervention".)
●In a second registry study of 22,798 patients who underwent stenting with first-generation DES, 2.5 percent of patients had bleeding-related hospitalization within 12 months after PCI (56 percent due to GI bleeding) [7].
Assessing individual patient risk — In addition to the ARC-HBR criteria, several risk scores are available to estimate an individual patient's risk of bleeding after PCI (table 2) [8-10].
The PRECISE-DAPT score is a five-item risk score that provides a tool for the prediction of out-of-hospital bleeding during DAPT. The score is calculated from age, creatinine clearance, hemoglobin, white blood cell count, and previous spontaneous bleeding and has moderate ability to predict out-of-hospital Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding (c-index 0.73 derivation cohort, 0.66 to 0.70 validation cohorts). Using a cutoff score of 25 or higher, patients at increased risk of bleeding on longer durations of DAPT are identified [11]. A web-based calculator is available [12].
Some studies suggest that up to 45 percent of patients who undergo PCI with current-generation stents may be at high bleeding risk [2,13]. Risk prediction models that incorporate identified risk factors (table 2) are available [8-10]. When applied to an individual patient, differences from model to model in the risk of high bleeding risk (HBR) appear. This is likely attributable to the fact that the scores reflect heterogeneity in the patient populations studied, the variables assessed, and the bleeding definitions used in the development cohorts.
While there is prognostic value to assessing bleeding risk, such an evaluation does not dictate a particular treatment algorithm, in part because of the high correlation between bleeding and ischemic risk [14]. The DAPT score was developed to uncouple the risks of ischemic and bleeding events to separately identify patients more likely to benefit from longer DAPT durations as well as those more likely to be harmed [15]. The score incorporates positive point values for factors that increase ischemic risk (presentation with MI, previous history of MI or PCI, history of diabetes, recent smoking, history of heart failure, PCI of a vein graft, or small stent diameter) and negative point values for increasing age. While not explicitly developed in a high bleeding risk cohort, the score has been demonstrated to separate ischemic and bleeding risks in a number of large cohorts and trials populations [16].
PROGNOSIS
Prognosis after percutaneous coronary intervention — Patients with high bleeding risk have worse outcomes after PCI compared with patients not at high bleeding risk. A 2020 analysis of 10,502 patients who received a current-generation (cobalt-chromium everolimus) drug-eluting stent (DES) in four all-comers postapproval registries evaluated long-term outcomes [13]. Approximately one-third of patients were identified as high bleeding risk if they had one or more of the following risk predictors: age ≥75 years, history of major bleeding, history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Compared with patients not at high bleeding risk, those at high bleeding risk had more comorbidities, higher lesion complexity, and a higher risk of mortality at four years (15.7 versus 3.8 percent; hazard ratio [HR] 4.38, 95% CI 3.76-5.11).
Prognosis after bleeding — Any bleeding, and particularly major bleeding, after PCI is a risk factor for death and MI. The prognosis after gastrointestinal bleeding is discussed separately. (See "Gastrointestinal bleeding in patients undergoing percutaneous coronary intervention", section on 'Outcomes'.)
The poor prognosis in patients who bleed after PCI has been demonstrated in multiple studies:
●In the EDUCATE registry of 2159 patients who underwent stenting with a second generation DES, 9.6 percent reported nonadherence to dual antiplatelet therapy (DAPT). Development of a major bleeding event was the only independent correlate of nonadherence during the first six months (odds ratio 12.83) [6]. The risk for death or MI was significantly higher in patients with drug nonadherence associated with major bleeding (22 patients) than in those with drug nonadherence due to other factors (35 versus 7 percent; p<0.001).
●In the ADAPT-DES study (see 'Incidence of bleeding after PCI' above), post-discharge bleeding was associated with an increased rate of all-cause mortality (13 versus 3.2 percent; p<0.001) [5]. The risk of two-year mortality was increased after adjustment (HR 5.03; p<0.0001).
●In the Dual Antiplatelet Therapy study, the annualized mortality rate after a major bleeding event was 21.5 per 100 person-years, compared with a rate of 12.5 per 100 person-years after a major ischemic event (MI, stroke, or stent thrombosis) [17].
●In a retrospective cohort study of 32,906 patients who underwent PCI and survived the index hospitalization, 530 (1.6 percent) had bleeds between 7 and 365 days after discharge. Bleeding was associated with an increase rate of death (adjusted HR 1.61, 95% CI 1.62-2.25) [18].
●In a registry study of 8137 patients who underwent stenting with first-generation DES, postdischarge bleeding-related hospitalization after stenting was associated with subsequent death or MI (HR 3.09, 95% CI 2.41-3.96) [4]. The highest risk occurred within 60 of bleeding.
●In a second registry study of 22,798 patients who underwent stenting with first-generation DES, post-discharge bleeding was associated with significantly increased risks of death or MI (adjusted HR 2.39 and 3.38) [7].
●In an all-comers postapproval study of 10,502 patients who received DES (see 'Prognosis after percutaneous coronary intervention' above), the risk of death was increased after major bleeding (HR 4.92, 95% CI 3.82-6.35) [13]. The effect was consistent across the spectrum of bleeding risk.
COMPARING BLEEDING AND ISCHEMIC RISK —
Dual antiplatelet therapy (DAPT) is given after percutaneous coronary intervention (PCI) in stable patients to reduce the risk of stent thrombosis. This risk is highest during the first 30 days but is quite low if the patient is taking DAPT. After 30 days, the daily risk continues to fall with time. However, the risk of bleeding due to DAPT and its consequences are relatively constant over time. Thus, the benefit from DAPT is greatest during the first 30 days and is smaller after six months.
The impact of bleeding and ischemic events after PCI was examined in a study of 8582 patients who underwent successful PCI with drug-eluting stents [19]. There were 1060 (12.4 percent of the entire cohort) episodes of definite or possible stent thrombosis (0.9 percent), clinical bleeding (8.1 percent), or MI not related to stent thrombosis (3.4 percent). The risk of death within 30 days of each for these events was 38.5, 7.3, and 7.5 percent, respectively. This is consistent with much higher mortality risk but low frequency for stent thrombosis, whereas overall ischemic (stent thrombosis or MI not related to stent thrombosis) and bleeding occur with similar frequency and carry similar mortality risk.
STENT SPECIFIC CONSIDERATIONS
BMS versus DES — Although bare metal stents (BMS) were previously used preferentially in patients with high bleeding risk due to concerns regarding the safety of short durations of dual antiplatelet therapy (DAPT) for drug-eluting stents (DES), contemporary DES are now preferred over BMS in all circumstances, including in patients with high bleeding risk. The following trials support this concept:
●In the Zotarolimus-eluting Endeavor sprint stent in Uncertain DES candidates (ZEUS) trial, 1606 patients (with stable or unstable symptoms) for whom it was not clear whether DES or BMS was a superior choice (eg, high bleeding risk, low restenosis risk, or high stent thrombosis risk) were randomly assigned to a zotarolimus-eluting stent (ZES) or BMS and treated with DAPT for at least 30 days, after which they received either aspirin or P2Y12 monotherapy [20]. The total duration of DAPT was prespecified based on the reason for inclusion, and the mean duration was 32 days. The primary end point of 12-month major adverse cardiovascular events (including death, MI, or target vessel revascularization) occurred less often with ZES (17.5 versus 22.1 percent; hazard ratio [HR] 0.76, 95% CI 0.61-0.95). This was driven by lower rates of MI and target vessel revascularization. The rate of definite or probable stent thrombosis was significantly reduced in ZES patients (2 versus 4.1 percent).
A prespecified analysis evaluated outcomes in 828 patients at high bleeding risk who had at least one of the following: age older than 80 years, clinical indication for treatment with oral anticoagulant agents, recent bleeding episodes that required medical attention or hospitalization, systemic conditions associated with increased bleeding risk, known anemia, and the need for long-term treatment with steroids or nonsteroidal antiinflammatory drugs (NSAIDs) [21]. The primary end point occurred less often with ZES (22.6 versus 29 percent; HR 0.75, 95% CI 0.57-0.98).
●In the LEADERS FREE trial, 2466 patients who were candidates for a BMS rather than a DES due to high bleeding risk were randomly assigned to a polymer- and carrier-free drug-coated stent that transfers umirolimus (biolimus A9) into the vessel wall over one month or a similar BMS [22] (see "Intracoronary stents: Stent types", section on 'Bioresorbable polymer drug-eluting stents'). All patients received DAPT for one month followed by aspirin alone. The primary safety end point (a composite of cardiac death, MI, or stent thrombosis) occurred less often in the drug-coated group at 390 days (9.4 versus 12.9 percent; p = 0.005 for superiority), owing to a difference in spontaneous and type 4C (restenosis-related) MI during follow-up. The primary efficacy end point of target lesion revascularization occurred less often in the DES group (5.1 versus 9.8 percent; p<0.001).
●The SENIOR trial randomly assigned 1200 patients aged 75 years or older scheduled to undergo PCI to either a bioresorbable polymer DES or similar thin-strut BMS [23]. DAPT was given for one month in stable patients and six months in those with an acute coronary syndrome. The composite primary end point (all-cause mortality, MI, stroke, or ischemia–driven target lesion revascularization at one year) occurred less often in the DES group (12 versus 16 percent; relative risk [RR] 0.71, 95% CI 0.52-0.94).
The ZEUS, LEADERS FREE, and SENIOR trials suggest that even in patients who receive DAPT for as short as 30 days, outcomes are better with some DES compared with BMS. The trials have several limitations including varying definitions of high bleeding risk, lack of power to detect differences in individual endpoints (including stent thrombosis), and heterogeneous study populations. We believe that, despite trial limitations, current-generation, thin-strut DES with biocompatible durable or bioresorbable polymers should be favored over BMS in patients at high bleeding risk even when DAPT may be limited to 30 days [24].
DES and DAPT duration — Studies suggest that for high-bleeding-risk patients treated with current-generation DES platforms, short DAPT durations of one to three months, with continuation of a single antiplatelet (aspirin or ticagrelor) out to 12 months, reduce bleeding risk without increasing risk of ischemic events, even among patients with acute coronary syndromes.
Definitions of DAPT regimens are as follows:
●Abbreviated – One to <3 months DAPT followed by a single antiplatelet therapy.
●Nonabbreviated DAPT – DAPT for six months or longer.
A number of trials and meta-analyses suggest that among high-bleeding-risk patients undergoing current-generation DES implantation, abbreviated DAPT reduces bleeding without an increased risk of death or MI compared with nonabbreviated DAPT:
●In the MASTER DAPT trial, 4434 patients with high bleeding risk were randomly assigned at 30 to 44 days after index PCI to either immediate deescalation of DAPT to single antiplatelet agent (aspirin or P2Y12) or continued DAPT for at least five additional months [25]. Abbreviated DAPT was found to be noninferior to nonabbreviated DAPT at 12 months with regard to net adverse clinical events (composite of all-cause death, MI, stroke, or major bleeding [7.5 versus 7.7 percent; p<0.001 for noninferiority]) and major adverse cardiac or cerebral events (composite of all-cause death, MI, or stroke [6.1 versus 5.9 percent; p<0.001 for noninferiority]). The individual rates of MI and stent thrombosis were also similar among the two groups. This was associated with a significantly lower risk of major and clinically relevant nonmajor bleeding at 12 months in the abbreviated DAPT group (6.5 versus 9.4 percent; p<0.001 for superiority).
●In TWILIGHT-HBR (a prespecified analysis of the TWILIGHT trial), 1064 patients with high bleeding risk undergoing PCI were randomly assigned after three months of DAPT with aspirin and ticagrelor to either single antiplatelet therapy with ticagrelor for an additional 12 months or continued DAPT for 12 months [26]. Patients who received ticagrelor monotherapy after three months had a lower incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with those who continued DAPT (6.3 versus 11.4 percent; HR 0.53, 95% CI 0.35-0.82). There was no difference in the risk of all-cause death, MI, or stroke. (6.5 versus 5.6 percent; HR 1.16, 95% CI 0.71-1.90).
●In the STOP-DAPT 2 trial, 3045 patients who underwent staged PCI were randomly assigned at the completion of the procedure to either one month of DAPT followed by clopidogrel monotherapy or 12 months of DAPT with aspirin and clopidogrel. In a subgroup analysis of patients with high bleeding risk (n = 1054), there was no interaction between the high bleeding risk status and treatment strategy, suggesting that the results are consistent among patients with high bleeding risk. Clopidogrel monotherapy after one month was noninferior to 12 months of DAPT with regard to the primary composite endpoint of cardiovascular death, MI, definite stent thrombosis, stroke, or Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding. There was no difference in the incidence of ischemic events between the two treatment strategies among patients with high bleeding risk [27].
●A meta-analysis of DAPT duration in 16,848 high-bleeding-risk PCI patients compared abbreviated DAPT (≤3 months) followed by aspirin or P2Y12 inhibitor monotherapy with nonabbreviated DAPT (6 to 12 months). Six randomized trials and three propensity-matched studies were included. People who received abbreviated DAPT had a lower rate of major bleeding compared with nonabbreviated DAPT (odds ratio [OR] 0.68, 95% CI 0.51-0.89). Those receiving abbreviated DAPT had a similar risk of MI as those receiving nonabbreviated DAPT [OR 1.16, 95% CI 0.94-1.44]. There were also no differences in risks of death, stroke, or stent thrombosis between those receiving abbreviated versus nonabbreviated DAPT [28].
●Another meta-analysis of 11 randomized trials including 9006 patients with high bleeding risk compared abbreviated DAPT (≤3 months) with nonabbreviated DAPT (≥6 months). Compared with nonabbreviated DAPT, abbreviated DAPT was associated with a lower risk of major or clinically relevant non-major bleeding (RR 0.76, 95% CI 0.61-0.94) and cardiovascular death (RR 0.79, 95% CI 0.65-0.95). There was no difference in the incidence of all-cause death, MI, or stent thrombosis. These findings were consistent using PRECISE-DAPT and ARC-HBR bleeding risk definitions [29].
●Abbreviated DAPT results in lower incidence of BARC 2 to 5 bleeding and comparable ischemic outcomes regardless of sex. A prespecified subanalysis within the XIENCE Short DAPT Program included 3364 high-bleeding-risk patients (34.3 percent female) undergoing PCI with everolimus DES who received one- or three-month DAPT [30]. For both female and male participants, there were no significant differences in the risk of ischemic and bleeding events between the one- and three-month DAPT groups.
POBA — While it is theoretically possible that performance of plain old balloon angioplasty (POBA) might be a reasonable revascularization strategy to stenting for patients who cannot take DAPT for more than brief periods of time, this approach has not been evaluated. We perform POBA only in rare cases where a stent cannot be delivered or when DAPT cannot be administered for a minimum of 30 days.
Drug-coated balloon angioplasty — Percutaneous coronary intervention using a drug-coated balloon (DCB) is used (primarily in Europe but increasingly in the United States) for the treatment of in-stent restenosis or de novo lesions in small coronary arteries. (See "Percutaneous coronary intervention of specific coronary lesions", section on 'Small coronary arteries' and "Intracoronary stent restenosis", section on 'Management'.)
The DEBUT trial is the first study to evaluate the use of paclitaxel drug-coated balloon (DCB) angioplasty in patients with large coronary arteries [31]. DEBUT randomly assigned 208 patients with de-novo lesions in a native coronary artery (measuring between 2.5 and 4.0 mm) or bypass graft and risk factors for bleeding to a paclitaxel- and iopromide-coated balloon or a bare metal stent. Exclusion criteria included (but were not limited to) ST-elevation MI, cardiogenic shock, bifurcation lesion requiring a two-stent technique, in-stent restenosis, left main coronary artery disease, or flow-limiting (TIMI blood flow <3) (table 3) dissection or substantial recoil (>30 percent) of the target lesion after predilation. Both groups received clopidogrel 75 mg and aspirin 100 mg daily for one month in both stable and acute coronary syndrome (ACS) patients.
The primary end point of major cardiovascular adverse events (composite of cardiovascular mortality, non-fatal MI, or ischemia drive target-lesion revascularization at nine months) occurred less often with DCB (1 versus 14 percent, respectively; risk ratio 0.07 percent, 95% CI 0.01-0.52). At nine months, target-lesion revascularization occurred significantly less often with DCB (0 and 6 percent, respectively). Although more patients with diabetes were randomized to the bare metal stent group, adjusted cardiovascular mortality remained lower in the DCB group. Limitations of the trial include premature termination due to slow recruitment, a lower-than-predicted rate of major adverse cardiovascular events, use of bare metal stents as the comparator, and imbalance of randomization with regard to patients with diabetes.
In the BASKET-SMALL 2 trial, 758 patients with de novo stenosis of small native coronary vessels (<3 mm) were randomly assigned to either paclitaxel DCB or second-generation DES and were followed for three years [32]. DAPT was recommended for one month in the DCB group and for six months in the DES group, except among those with ACS. In a prespecified analysis of patients with high bleeding risk (defined by ARC-HBR), there was no difference in the incidence of major bleeding events at three years with DCB compared with DES (4.5 versus 3.4 percent) [33]. Additionally, there was similar risk of the composite of cardiac death, nonfatal MI, and target-vessel revascularization at three years (RR 1.16, 95% CI 0.51-2.62).
Deescalation of antiplatelet therapy may reduce the risk of bleeding after DCB without worsening cardiovascular outcomes. Such an approach was evaluated in the REC-CAGEFREE II trial, in which 1948 patients with ACS treated with paclitaxel DCBs were randomly assigned to a stepwise de-escalation (ie, aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, followed by six months of aspirin monotherapy) or standard DAPT (ie, aspirin plus ticagrelor for 12 months) [34]. At 12 months, the rate of the primary composite endpoint (ie, death, stroke, myocardial infarction, revascularization, and Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) was similar between the groups. Those who had a stepwise de-escalation of therapy had a lower risk of BARC type 3 or 5 bleeding (-0.4 versus 1.6 percent). These data suggest that shorter DAPT regimens (ie, one month) are reasonable for patients at high risk of bleeding who are treated with DCB; this approach is already used for patients undergoing DES placement.
MANAGEMENT OF BLEEDING —
This issue is discussed separately. (See "Gastrointestinal bleeding in patients undergoing percutaneous coronary intervention", section on 'Treatment' and "Periprocedural bleeding in patients undergoing percutaneous coronary intervention", section on 'Management'.)
OUR APPROACH —
For patients undergoing PCI with stenting who are assessed to be at high bleeding risk (see 'Definition of high bleeding risk' above) for reasons other than long-term use of oral anticoagulant, we pay particular attention to the following issues: the choice of P2Y12 receptor blocker, duration of dual antiplatelet therapy (DAPT), timing of PCI in stable patients, and optimization of the procedure to minimize the risks associated with early cessation of DAPT.
Our recommendations for patients receiving oral anticoagulant therapy for an indication such as atrial fibrillation, who are by definition at high risk, are found elsewhere. (See "Coronary artery disease patients requiring combined anticoagulant and antiplatelet therapy", section on 'Summary and recommendations'.)
In practically all clinical scenarios, we choose drug-eluting stents to bare metal stents. (See 'BMS versus DES' above.)
P2Y12 receptor blocker — In patients at high bleeding risk, the specific P2Y12 receptor blocker (and dose) and the duration of DAPT need to be considered carefully. As there is no strong evidence on which to make recommendations, we individualize decision making based on patient characteristics and preferences. As the risk of bleeding increases, we tend to shorten the duration of DAPT. (See "Long-term antiplatelet therapy after coronary artery stenting in stable patients", section on 'Summary and recommendations'.)
Agent — In the broad population of patients with stable disease undergoing PCI, clopidogrel (75 mg daily) is the preferred P2Y12 receptor blocker. (See "Coronary artery disease patients requiring combined anticoagulant and antiplatelet therapy", section on 'Summary and recommendations'.)
In the broad population of patients with acute coronary syndrome (ACS), a more potent P2Y12 inhibitor (ticagrelor or prasugrel) is preferred to clopidogrel due to the higher ischemic risk of these patients compared with stable patients. However, in these patients with ACS, the rate of non-coronary artery bypass graft surgery major bleeding with these more potent agents was higher in the PLATO and TRITON-TIMI 38 trials. In patients with ACS at high bleeding risk (see 'Assessing individual patient risk' above) due to use of oral anticoagulants, most of our contributors choose clopidogrel over a more potent P2Y12 inhibitor, typically in the context of concomitant aspirin use. (See "Coronary artery disease patients requiring combined anticoagulant and antiplatelet therapy", section on 'Summary and recommendations'.)
Duration — In the broad population of patients with either stable disease or ACS undergoing PCI, we typically continue DAPT 6 to 12 months, with the option to extend to longer durations among patients with high ischemic and low bleeding risk (eg, patients with high DAPT scores). (See "Long-term antiplatelet therapy after coronary artery stenting in stable patients", section on 'Duration and Type of Antiplatelet Treatment'.)
In stable patients with high bleeding risk, we consider limiting DAPT to as short as one to three months. A longer course of DAPT in patients with high bleeding risk may be considered in complex anatomy such as left main or bifurcation stenting. After this period, either aspirin or P2Y12 inhibitor is discontinued. Our contributors believe the evidence is not sufficiently robust to allow for a recommendation that chooses between the two, although growing evidence supports the safety and effectiveness of P2Y12 inhibitor monotherapy in a broad population of patients.
For patients with high bleeding risk with ACS, we believe it is reasonable to consider extending the duration to six months based on the evidence that even unstented patients with ACS derive benefit from longer durations of DAPT. However, careful consideration should be made to truncate the duration of DAPT further in the patients with high bleeding risk, given the low rates of stent thrombosis of contemporary drug-eluting stents. (See "Acute non-ST-elevation acute coronary syndromes: Initial antiplatelet therapy", section on 'Other aspects of antiplatelet therapy'.)
Timing of percutaneous coronary intervention — Bleeding risk may decrease with time. Examples include patients who are taking oral anticoagulant for a limited period of time or the removal of upcoming surgery as a risk factor. For patients scheduled for elective PCI, consideration should be given to postponing PCI.
PCI optimization — Given the shorter DAPT duration and the need to mitigate the risk of stent failure and subsequent need for revascularization in patients with high bleeding risk, we recommend the routine use advanced intravascular imaging techniques in this population. This strategy is recommended to optimize stent placement and improve procedural outcomes. (See "Intravascular ultrasound, optical coherence tomography, and angioscopy of coronary circulation".)
RECOMMENDATIONS OF OTHERS —
The 2016 American College of Cardiology/American Heart Association Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease makes the following recommendations for patients treated with percutaneous coronary intervention at high bleeding risk [35]:
●Clopidogrel is the P2Y12 receptor blocker of choice in patients taking an oral anticoagulant.
●For patients with chronic coronary syndrome at high bleeding risk, discontinuation of P2Y12 receptor blocker at three months may be reasonable.
●For patients with an acute coronary syndrome at high bleeding risk, discontinuation of P2Y12 receptor blocker at six months may be reasonable.
The 2015 European guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation states that P2Y12 inhibitor administration for a shorter duration (than 12 months) of three to six months after drug-eluting stent implantation may be considered in patients deemed at high bleeding risk [36,37].
SOCIETY GUIDELINE LINKS —
Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Percutaneous coronary intervention".)
SUMMARY AND RECOMMENDATIONS
●Background – Multiple risk factors for bleeding after percutaneous coronary intervention (PCI) have been identified. Although we evaluate each patient for the presence of these risk factors, we do not use a formal bleeding risk score to guide therapy. (See 'Definition of high bleeding risk' above and 'Assessing individual patient risk' above.)
●Acute management in patients with high bleeding risk
•In the broad population of patients with stable disease undergoing PCI, clopidogrel (75 mg daily) is the preferred P2Y12 receptor blocker.
•In patients with acute coronary syndrome (ACS) at high bleeding risk (see 'Assessing individual patient risk' above) due to use of oral anticoagulants, most of our contributors choose clopidogrel over a more potent P2Y12 inhibitor (ticagrelor or prasugrel). (See 'Agent' above.)
•In other patients with high bleeding risk, the risks of ischemia and bleeding must be considered when deciding on the potency and duration of the P2Y12 inhibitor. However, age alone is rarely used as a deciding factor. (See 'Agent' above.)
•In stable patients with high bleeding risk, we consider limiting dual antiplatelet therapy (DAPT) to as short as one to three months. After this period, either aspirin or P2Y12 inhibitor is discontinued. Our contributors believe the evidence is not sufficiently robust to allow for a recommendation that chooses between the two. For patients with an ACS, we believe it is reasonable to extend the duration to six months based on the evidence that even unstented ACS patients derive benefit from one year of DAPT. (See 'Our approach' above.)
●Long-term management in patients with high bleeding risk – Our approach to antithrombotic therapy in stented patients receiving long-term oral anticoagulant therapy is presented separately. (See "Coronary artery disease patients requiring combined anticoagulant and antiplatelet therapy", section on 'Our approach'.)