Duration Of Antiplatelet Therapy Research Articles

Comparison between drug-coated balloons and drug-eluting stents in very small coronary artery interventions

The optimal management of very small vessel (reference diameter from 2.0 to 2.25 mm) in percutaneous coronary interventions (PCIs) is controversial. We aimed to compare the efficacy and safety of drug-coated balloons (DCBs) and drug-eluting stents (DESs) for de-novo very small vessel interventions. We conducted a retrospective analysis of consecutive patients who received very small vessel PCI with a DCB or DES between January 2018 and March 2021. The outcome measures were the incidence of ischemia-driven target lesion revascularization (TLR) and major adverse cardiac and cerebrovascular events (MACCEs) within 1 year after PCI. MACCEs were defined as the composite of ischemia-driven TLR, all-cause death, non-fatal acute coronary syndrome, stroke, or heart failure requiring hospitalization. A total of 205 patients undergoing PCI with a DCB or DES were enrolled in this study. The procedural complication rate was 2.5% in the DES group and 1.7% in the DCB group (P = 1.000). After 1-year of follow-up, the cumulative incidence of TLR was 7.2% in the DCB group and 4.9% in the DES group (P = 0.530). The cumulative incidence of MACCEs was 10.6% in the DCB group and 12.7% in the DES group (P = 0.769). Only female gender, acute coronary syndrome on presentation, and dual antiplatelet therapy duration < 3 months were significantly associated with MACCEs at 1 year, but the use of DCB or DES was not. The use of DCBs or DESs in de novo very small vessel intervention was not associated with different outcomes at 1 year.

Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis

To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

New Insights Into Long- Versus Short-Term Dual Antiplatelet Therapy Duration in Patients After Stenting for Left Main Coronary Artery Disease: Findings From a Prospective Observational Study.

The appropriate duration of dual antiplatelet therapy (DAPT) and risk-benefit ratio for long-term DAPT in patients with left main (LM) disease undergoing percutaneous coronary intervention remains uncertain. Four thousand five hundred sixty-one consecutive patients with stenting of LM disease at a single center from January 2004 to December 2016 were enrolled. Decision to discontinue or remain on DAPT after 12 months was left to an individualized decision-making based on treating physicians by weighing the patient's risks of ischemia versus bleeding and considering patient preference. The primary outcome was a composite of death, myocardial infarction, stent thrombosis, or stroke at 3 years. Key safety outcome was 3-year rate of Bleeding Academic Research Consortium 2, 3, or 5 bleeding. Of 3865 patients free of ischemic and bleeding events at 12 months, 1727 (44.7%) remained on DAPT (mostly clopidogrel based [97.7%]) beyond 12 months after LM percutaneous coronary intervention. DAPT>12-month versus ≤12-month DAPT was associated with a significant reduced risk of 3-year primary outcome (2.6% versus 4.6%; adjusted hazard ratio: 0.59 [95% CI, 0.41-0.84]). The same trend was found for other ischemic end points: death (0.9% versus 3.0%; Plog-rank<0.001), cardiovascular death (0.5% versus 1.7%; Plog-rank=0.001), myocardial infarction (0.8% versus 1.9%; Plog-rank=0.005), and stent thrombosis (0.4% versus 1.1%; Plog-rank=0.017). The key safety end point was not significantly different between 2 regimens (1.8% versus 1.6%; adjusted hazard ratio: 1.07 [95% CI, 0.65-1.74]). The effect of DAPT>12 month on primary and key safety outcomes was consistent across clinical presentations, high bleeding risk, P2Y12 inhibitor, and LM bifurcation percutaneous coronary intervention approach. In a large cohort of patients free from clinical events during the first year after LM percutaneous coronary intervention and at low apparent future bleeding risk, an individualized patient-tailored approach to longer duration (>12 month) of DAPT with aspirin plus a P2Y12 inhibitor (mostly clopidogrel) improved both composite and individual efficacy outcomes by reducing ischemic risk, without a concomitant increase in clinically relevant bleeding.

Management of Artery-Only Digit Replantation: A Systematic Review of the Literature.

Artery-only replantation may be necessary in circumstances when venous repair cannot be performed due to their size or vessel injury. Venous congestion of the replanted part is inevitable. A systematic review was performed to identify techniques for mitigating congestion and analyze the outcomes of those techniques. A comprehensive literature search was performed to identify relevant articles related to artery-only replantation. An initial query identified 1286 unique articles. A total of 55 articles were included in the final review. Included studies were categorized by decongestive technique. Data from each article included the number of patients treated, level of amputation, graft use, anticoagulation or antiplatelet therapy, replant viability, and follow-up duration. Weighted averages were determined from studies that reported five or more digits. A total of 1498 individual digital replantations were described. Very rarely did studies report artery-only replantation proximal to the distal interphalangeal joint. An overall survival rate of 78.5 percent was found irrespective of technique but was variable based on each particular study. Studies utilizing medicinal leech therapy were more likely to report use of intravenous anticoagulation, whereas surface bleeding techniques were more likely to report use of topical or local anticoagulant. Lack of a vein for anastomosis should not be regarded as a contraindication to replantation. These digits instead require a method to establish reliable drainage sufficient to allow for low resistance inflow and maintain a physiologic pressure gradient across capillary beds. The surgeon should select a decongestive technique that best suits the patient and their specific injury.

Impact of dual antiplatelet therapy duration on clinical outcome after coronary bifurcation stenting: results from the EuroBifurcation Club registry.

Optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of major adverse cardiac and cardiovascular events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as Bleeding Academic Research Consortium (BARC) ≥3 were evaluated too. Patients were divided into 3 groups: short DAPT (<6-months, N.=375); standard DAPT (≥6-months but ≤12-months, N.=636); prolonged DAPT (>12-months, N.=1273). At 24 months follow-up MACCE-free survival was significantly lower in short DAPT patients (Log-Rank: 45.23, P for trend <0.001). MACCE occurred less frequently in the prolonged DAPT group (148 [11.6%]) as compared with both the short (83 [22.1%] HR: 0.48 [0.37-0.63], P<0.001) and standard DAPT groups (137 [21.5%] HR:0.51 [0.41-0.65], P<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 [0.20-0.36] and HR: 0.44 [0.34-0.57]). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC≥3 bleedings were 0.3% in the standard DAPT, 1.6% in short and 1.9% in prolonged DAPT groups. In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis

BackgroundOptimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. MethodsWe searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. ResultsSix randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. ConclusionsAmong HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.

Antiplatelet therapy after percutaneous coronary intervention: current status and future perspectives.

Antiplatelet therapy after percutaneous coronary intervention(PCI) has been changing in parallel with the development of drug-eluting stents (DES) and antiplatelet agents. The recommendation of dual antiplatelet therapy duration is getting shorter due to the decreased risk of stent thrombosis in new-generation DES, the use of a P2Y12 inhibitor as a monotherapy, and the increasing prevalence of high bleeding risk patients. Antithrombotic therapy after PCI has also changed due to the introduction of direct oral anticoagulants. Aspirin-free P2Y12 inhibitor monotherapy is now being evaluated in several prospective studies as a novel strategy of antiplatelet therapy after PCI. This review shows a current status and provides future perspectives for the antiplatelet therapy after PCI.

Infarto de miocardio con elevación del segmento ST revascularizado. Tendencias temporales de los tratamientos contemporáneos y su impacto en los resultados

Introduction and objectivesTo assess, in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous intervention, the pace of introduction in clinical practice (2010-2017) of drug-eluting stents (DES), ticagrelor, prasugrel, and prolonged dual antiplatelet therapy (DAPT) duration, and their potential impact on the risk of 2-year outcomes. MethodsProspective and exhaustive community-wide cohort of 14 841 STEMI patients undergoing primary percutaneous intervention between 2010 and 2017. Index episodes were obtained from the Catalan Codi IAM Registry, events during follow-up from the Minimum Data Set and DAPT were defined by pharmacy dispensation. Follow-up was 24 months. The temporal trend for exposures and outcomes was assessed using regression models. ResultsAge> 65 years, diabetes, renal failure, previous heart failure, and need for anticoagulation at discharge were more frequent in later periods (P <.001). From 2010 to 2017, the use of DES increased from 31.1% to 69.8%, ticagrelor from 0.1% to 28.6%, prasugrel from 1.5% to 23.8%, and the median consecutive months on DAPT from 2 to 10 (P <.001 for all). Adjusted analysis showed a temporal trend to a lower risk of the main outcome over time: the composite of death, acute myocardial infarction, stroke and repeat revascularization (absolute odds reduction 0.005% each quarter; OR, 0.995; 95%CI, 0.99-0.999; P=.028). The odds of all individual components except stroke were reduced, although significance was only reached for revascularization. ConclusionsDespite a strong increase between 2010 and 2017 in the use and duration of DAPT and the use of ticagrelor, prasugrel and DES, there was no substantial reduction in major cardiovascular outcomes.Full English text available from:www.revespcardiol.org/en

Individualizing Dual Antiplatelet Therapy (DAPT) Duration Based on Bleeding Risk, Ischemic Risk, or Both: An Analysis From the DAPT Study

BackgroundGuidelines recommend individualization of dual antiplatelet therapy (DAPT) duration. Whether to guide decisions based on bleeding risk, ischemic risk or a combination is not known. AimsTo compare a bleeding prediction model, an ischemic prediction model, and the DAPT score in guiding DAPT duration. Methods11,648 patients in the DAPT Study were categorized into higher and lower risk using a bleeding model, an ischemic model, and the DAPT score. Effect of 30 vs. 12 months of DAPT on bleeding events, ischemic events, and the combination (net-adverse clinical events [NACE]) was assessed. ResultsAmong patients stratified with the bleeding model, 30 vs. 12 months of DAPT resulted in similar ischemic and bleeding event rates. With the ischemic model, however, higher risk patients had a greater reduction in ischemic events with extended duration of DAPT (difference in risk differences [DRD]: −2.6%, 95% CI: −3.9 to −1.3%; p < 0.01), and a smaller increase in bleeding (DRD: −1.0%, 95% CI: −2.1–0.0%; p = 0.04). Similarly, high DAPT score patients had a greater reduction in ischemic events with extended DAPT duration (DRD: −2.4%, 95%: CI: −3.6 to −1.1%; p < 0.01) and a smaller increase in bleeding (DRD: −1.2%, 95%: CI: −2.2–0.0%; p = 0.02). Although NACE was similar for bleeding risk groups, NACE was significantly reduced with extended DAPT in the higher ischemic risk and high DAPT score groups. ConclusionsIn this low-bleeding risk population, stratifying patients based on predicted ischemic risk and the DAPT score best discerned benefit versus harm of extended DAPT duration on ischemic events, bleeding events, and NACE. Condensed abstractDuration of dual antiplatelet therapy (DAPT) should be guided by an individualized risk assessment. Bleeding risk tools have emerged to identify patients at high bleeding risk for whom truncated DAPT therapy may be safest. In a lower bleeding risk population, however, whether DAPT duration should be guided by bleeding risk, ischemic risk, or a combination is unknown.In this analysis, implementation of a score based on ischemic risk prediction and the DAPT score (a combination of ischemic and bleeding risk) best predicted ischemic events, bleeding events, and net-adverse clinical events (NACE).

Personalisation of DAPT: from ‘bench’ to bedside

The ideal duration of antiplatelet therapy following percutaneous coronary intervention is a topic of much discussion within the cardiology community. Numerous contemporary studies have highlighted benefits of both shortened and prolonged treatment courses within particular patient cohorts. Despite this, there is a delay in seeing such individualised decisions being made within stretched healthcare systems. We aimed to highlight this issue and facilitate discussions on how we can bring this important research from ‘bench’ to ‘bedside’.

615 Characterization of actionable bleeding and thrombotic trade-offs in patients undergoing percutaneous coronary intervention

Abstract Aims Patients undergoing percutaneous coronary intervention (PCI) are at risk of developing bleeding and/or thrombotic complications. Bleeding and thrombotic risk characteristics may overlap in some patients, which makes decision-making for dual antiplatelet therapy duration a clinical challenge. The actual proportion of PCI patients who have an increased bleeding risk and/or an increased thrombotic risk is unclear. The aim of this study is to identify sizeable and actionable proportions of patients at high bleeding risk (HBR) and/or at high thrombotic risk (HTR) in a contemporary cohort of PCI patients. Methods and results We retrospectively included all patients undergoing PCI at our Institution from November 2019 to April 2020 and identified those at HBR or HTR based on criteria from the Academic Research Consortium for High Bleeding Risk (ARC-HBR) or criteria from Giustino et al., respectively. Since belonging to the HBR and HTR groups was non-mutually exclusive, patients were further stratified into four mutually exclusive subgroups: (1) HBR/HTR; (2) HBR, non-HTR; (3) non-HBR, HTR; and (4) non-HBR, non-HTR. In addition, the new ARC-HBR trade-off model (integrating patients’ characteristics to define the individual risks of bleeding and thrombotic events) was applied to rank patients based on their computed risk scores for bleeding and thrombosis. Patients were categorized based on the ratio between the ARC-HBR thrombotic and the bleeding risk scores [i.e. high (1.5), intermediate (0.75–1.5), and low (&amp;lt;0.75)]. A total of 312 patients (mean age 68 ± 11 years, female 29%) were included, of which 93 (30%) presented with HBR and 116 (37%) presented with HTR. Among patients with HBR, 41% presented with HTR. Among patients with HTR, 33% presented with HBR. Overall, 12.2% of patients had HBR/HTR, 17.6% had HBR, non-HTR, 25.0% had non-HBR, HTR, and 45.2% had non-HBR, non-HTR. Based on the ARC-HBR trade off score, 16.3% of patients had a higher risk of thrombosis than the risk of bleeding, 45.9% had similar risks, and 37.8% had a higher risk of bleeding than the risk of thrombosis. Among patients who had HBR/HTR, the trade-off model identified 8% as having a higher risk of thrombosis than the risk of bleeding and 18.4% as having a higher risk of bleeding than the risk of thrombosis. Conclusions Characterizing the risk of bleeding and thrombotic complications is an important prerequisite for tailoring strategies to individual patients, hence minimizing the risks and improving the outcome of PCI. More than half of patients undergoing PCI presented with HBR, HTR, or both. About 40% of patients present with characteristic of high risk, which make them actionable (e.g. by using shorter durations of dual antiplatelet therapy in patients at HBR and non-HTR or using longer durations in patients at non-HBR and HTR). The ARC-HBR trade off model score is an additional useful tool that may be used to identify an additional quarter of actionable patients in the HBR/HTR category.

Revascularized ST-segment elevation myocardial infarction. Temporal trends in contemporary therapies and impact on outcomes

Introduction and objectivesTo assess, in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous intervention, the pace of introduction in clinical practice (2010-2017) of drug-eluting stents (DES), ticagrelor, prasugrel, and prolonged dual antiplatelet therapy (DAPT) duration, and their potential impact on the risk of 2-year outcomes. MethodsProspective and exhaustive community-wide cohort of 14 841 STEMI patients undergoing primary percutaneous intervention between 2010 and 2017. Index episodes were obtained from the Catalan Codi IAM Registry, events during follow-up from the Minimum Data Set and DAPT were defined by pharmacy dispensation. Follow-up was 24 months. The temporal trend for exposures and outcomes was assessed using regression models. ResultsAge> 65 years, diabetes, renal failure, previous heart failure, and need for anticoagulation at discharge were more frequent in later periods (P <.001). From 2010 to 2017, the use of DES increased from 31.1% to 69.8%, ticagrelor from 0.1% to 28.6%, prasugrel from 1.5% to 23.8%, and the median consecutive months on DAPT from 2 to 10 (P <.001 for all). Adjusted analysis showed a temporal trend to a lower risk of the main outcome over time: the composite of death, acute myocardial infarction, stroke and repeat revascularization (absolute odds reduction 0.005% each quarter; OR, 0.995; 95%CI, 0.99-0.999; P=.028). The odds of all individual components except stroke were reduced, although significance was only reached for revascularization. ConclusionsDespite a strong increase between 2010 and 2017 in the use and duration of DAPT and the use of ticagrelor, prasugrel and DES, there was no substantial reduction in major cardiovascular outcomes.

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p<0.0001) and ST (aHR 0.08, 95% CI: 0.03-0.19; p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95% CI: 0.70-1.55; p=0.84) or ST (aHR 0.86, 95% CI: 0.42-1.75; p=0.67). DAPT did not have major effects upon bleeding or death in either period. DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.

Abstract 9914: Three Months vs 12-Months Dual Antiplatelet Therapy Duration in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Introduction: Recent American Heart Association/American College of Cardiology guidelines on duration of dual antiplatelet therapy (DAPT) recommend DAPT for 12 months in patients presenting with an acute coronary syndrome (ACS) who underwent percutaneous intervention (PCI) (grade IIb recommendation). With the advent of newer generation stents, multiple randomized controlled trials (RCTs) have studied the role of short term -3 months DAPT compared to the guideline-indicated12 months DAPT. We aim to assess the evidence using a meta-analytic approach. Methods: PubMed, Embase and Cochrane Central databases were searched from inception until May 31, 2021. RCTs comparing short term (3 months) vs extended (12 months) DAPT in patients with ACS undergoing PCI were included. Outcomes assessed were MACE, cardiovascular mortality, all-cause mortality, myocardial infarction, stent thrombosis and bleeding events. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI). Results: We included 5 trials comprising 16,781 patients with an acute coronary syndrome that underwent percutaneous intervention. There was no significant difference in MACE (RR 0.92; 95% CI, 0.76-1.11), cardiovascular mortality (RR 1.26; 95% CI, 0.38-4.17), or all-cause mortality (RR 0.92; 95% CI, 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of myocardial infarction (RR 0.98; 95% CI, 0.74-1.30), or stent thrombosis (RR 1.30; 95% CI, 0.55-3.05) between short-term and extended DAPT. However, compared with extended DAPT, 3-month DAPT showed significantly reduced risk of major bleeding (RR 0.53; 95% CI, 0.43-0.64). Conclusions: In patients with acute coronary syndrome undergoing PCI, short term DAPT may be reasonable for some patients, while extended DAPT may be appropriate for select others. An individualized approach on optimal DAPT duration should be used considering the risks of ischemic events and bleeding.

Abstract 12811: Dual Antiplatelet Therapy Duration and Long-Term Risks of Adverse Outcomes After Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents

Introduction: Randomized trials show that short dual antiplatelet (DAPT) regimens have similar adverse events to longer regimens in patients treated by percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES2). However, these studies are underpowered for death. Hypothesis: After PCI with DES2, patients discontinuing DAPT before six months had higher risks of adverse ischemic outcomes than patients continuing DAPT for longer durations. Methods: We assessed adverse outcomes in patients having PCI between 2008-2016 in the Veterans Affairs Clinical Assessment Report and Tracking (CART) database. DAPT use was determined from the VA Pharmacy database. Outcomes after PCI were all-cause death (from the VA death index), and myocardial infarction, recurrent coronary revascularization, and major bleeding from ICD 9, ICD 10 and CPT codes in VA and Medicare/Medicaid records. Hazard ratios (HR) and 95% confidence intervals (95%CI) from Cox proportional hazards models weighted with a stabilized inverse probability of treatment weight were used to assess the risk of outcomes from stopping DAPT in 4 time intervals after PCI (1-5, 6-9, 10-12, and 13-18 months). Results: After exclusions, there were 40,871 PCIs with DES2 during the study period. Outcomes were followed for an average of 4.6 years. Compared to continuing DAPT, the risks for death were significantly higher for stopping DAPT 1-5 months after PCI (HR=2.04, 95%CI=1.82, 2.29) and stopping DAPT 6-9 months after PCI (HR=2.2, 95%CI=1.98, 2.44). There was no significant increase in death from stopping DAPT more than 10 months after PCI. Stopping DAPT 10 or more months after the index PCI associated with lower rates of myocardial infarction (HR=0.74, 95%CI=0.68, 0.81) and major bleeding (HR=0.81, 95%CI 0.73, 0.91), and lower repeat revascularization at all time periods. There was no interaction of effects with acute coronary syndrome at index PCI. Conclusion: Among Veterans having PCI with DES2, stopping DAPT less than 10 months after PCI was associated with a higher risk of death but no increased risk in myocardial infarction or major bleeding. Short DAPT regimens after PCI may increase the risk of death. Clinical trials of short DAPT duration should powered to assess this endpoint.

Evaluation of Optimal Dual Antiplatelet Therapy Duration for High-Risk Patients with Diabetes Following PCI

The efficacy and safety of prolonged (>1-year) dual antiplatelet therapy (DAPT) duration in high-risk patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain unknown. All patients undergoing PCI at Fuwai hospital between January 2013 and December 2013 were prospectively enrolled into the Fuwai PCI registry. A total of 3,696 high-risk diabetics patients with at least one additional atherothrombotic risk factor were screened for inclusion. The primary efficacy outcome was the composite of all-cause mortality, myocardial infarction, or stroke. The median follow-up duration was 887 days. 69.8% of DM patients were on DAPT at 1 year without discontinuation. Based on multivariate Cox regression model and inverse probability of treatment weighting (IPTW) analysis, long-term (>1-year) DAPT reduced the risk of primary efficacy outcome (1.7% vs 4.1%; adjusted hazard ratio [adjHR]: 0.382, 95% confidence interval [CI]: 0.252 to 0.577; IPTW-HR: 0.362 [0.241 to 0.542]), as well as cardiovascular death and definite/probable stent thrombosis, compared with short-course (≤ 1-year) DAPT. Risk of the safety end point of clinically relevant bleeding (adjHR: 0.920 [0.467 to 1.816]; IPTW-HR: 0.969 [0.486 to 1.932]) was comparable between longer DAPT and shorter DAPT. A lower number of net clinical benefit adverse outcomes was observed with >1year DAPT versus ≤ 1-year DAPT (adjHR: 0.471 [0.331 to 0.671]; IPTW-HR: 0.462 [0.327 to 0.652]), which appeared increasingly favorable in those with multiple atherothrombotic risk characteristics. In high-risk patients with DM receiving PCI who were event free at 1 year, DAPT prolongation resulted in significant reduction in the risk of ischemic events not offset by increase of clinically meaningful bleeding events, thereby achieving a net clinical benefit. Extending DAPT beyond the period mandated by guidelines seems reasonable in high-risk DM patients not deemed at high bleeding risk.

Twelve months results from a prospective real-world multicenter clinical practice of CAS using the CGuard Embolic Prevention System (EPS): the IRONGUARD 2 study

Abstract Objectives When compared to carotid endarterectomy, carotid artery stenting (CAS) has been associated to a higher rate of post procedural neurologic events, potentially related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual layered mesh covered carotid stent systems (DLS). However, recent reports demonstrated that these devices are also associated with a not-negligible restenosis rate among the studies. Aim of this registry was to evaluate 1-year safety and efficacy of DLS for CAS in the clinical practice. Methods From January 2017 to June 2019 a physician-initiated, prospective, multispecialty, registry enrolled 733 consecutive patients undergoing CAS using the CGuard Embolic Prevention System (EPS) in 20 centres. The primary endpoint was the occurrence of death and stroke at 1 year; secondary endpoints were transient ischemic attack (TIA), acute myocardial infarction (AMI), restenosis rate and in-stent thrombosis, ECA occlusion at 1 year. Results Among all enrolled subjects, late results were collected for 726 patients (99.04%). Dual antiplatelet therapy was maintained for at least 30 days post-procedurally in all patients, and for 3 months in 295 (40.63%), according with each center routine practice. After 30th post-operative day, new neurological adverse event was detected in 5 patients (0.68%), accounting for 1 minor stroke (0.13%), and 4 (0.55%) transient ischemic attacks. Eight patients (1.10%) died during the study period: 2 fatal acute myocardial infarctions (0.27%), 4 malignancies (0.55%), 1 suicide (0.13%), 1 undefined complication in Guillain-Barré Syndrome (0.13%). At duplex ultrasound examination, internal carotid artery was found patent in all but two patients (0.27%), and 2 asymptomatic in-stent restenosis (0.27%) were judged to be severe (&amp;gt;70%, peak systolic velocity &amp;gt;450cm/sec) and successfully treated by stent-in-stent. External carotid artery patency rate was 98.8% (718/726). At univariate analysis, post-dilatation (p=0.62; OR: 0.67; CI95%: 0.13–3.34), and dual antiplatelet therapy duration (p=0.97; OR: 0.96; CI95%: 0.11–8.31) were found to be not statistically related to occlusion and/or restenosis occurrence. Conclusion This real-world registry suggests that use of EPS in clinical practice is safe and associated to a minimal occurrence of adverse neurological events up to 12 months follow up. Funding Acknowledgement Type of funding sources: None.

Characterization of actionable bleeding and thrombotic risk trade-offs in patients undergoing percutaneous coronary intervention

Abstract Background Patients undergoing percutaneous coronary intervention (PCI) are at risk of developing bleeding and/or thrombotic complications. Bleeding and thrombotic risk characteristics may overlap in some patients, which makes decision-making for dual antiplatelet therapy duration a clinical challenge. The actual proportion of PCI patients who have an increased bleeding risk and/or an increased thrombotic risk is unclear. Purpose Aim of this study is to identify sizeable and actionable proportions of patients at high bleeding risk (HBR) and/or at high thrombotic risk (HTR) in a contemporary cohort of PCI patients. Methods We retrospectively included all patients undergoing PCI at our Institution from November 2019 to April 2020 and identified those at HBR or HTR based on criteria from the Academic Research Consortium for High Bleeding Risk (ARC-HBR) or criteria from Giustino and colleagues, respectively. Since belonging to the HBR and HTR groups was non-mutually exclusive, patients were further stratified into 4 mutually exclusive subgroups: 1) HBR/HTR; 2) HBR, non-HTR; 3) non-HBR, HTR; and 4) non-HBR, non-HTR. In addition, the new ARC-HBR trade-off model (integrating patients' characteristics to define the individual risks of bleeding and thrombotic events) was applied to rank patients based on their computed risk scores for bleeding and thrombosis. Patients were categorized based on the ratio between the ARC-HBR thrombotic and the bleeding risk scores (i.e., high [1.5], intermediate [0.75–1.5], low [&amp;lt;0.75]). Results A total of 312 patients were included, of which 93 (30%) presented with HBR and 116 (37%) with HTR. Among patients with HBR, 41% presented with HTR. Among patients with HTR, 33% presented with HBR. Overall, 12.2% of patients had HBR/HTR, 17.6% had HBR, non-HTR, 25.0% had non-HBR, HTR, and 45.2% had non-HBR, non-HTR. Based on the ARC-HBR trade off score, 16.3% of patients had a higher risk of thrombosis than the risk of bleeding, 45.9% had similar risks, and 37.8% had a higher risk of bleeding than the risk of thrombosis. Among patients who had HBR/HTR, the trade-off model identified 8% as having a higher risk of thrombosis than the risk of bleeding and 18.4% as having a higher risk of bleeding than the risk of thrombosis. Conclusions Characterizing the risk of bleeding and thrombotic complications is an important prerequisite for tailoring strategies to individual patients, hence minimizing the risks and improving the outcome of PCI. More than half of patients undergoing PCI presented with HBR, HTR, or both. About 40% of patients presented with characteristics of high risk, which make them actionable (e.g., by using shorter durations of dual antiplatelet therapy in patients at HBR and non-HTR or using longer durations in patients at non-HBR and HTR). The ARC-HBR trade off model score is an additional useful tool that may be used to identify an additional quarter of actionable patients in the HBR/HTR category. Funding Acknowledgement Type of funding sources: None.

Is meta-analysis the optimal method to decide the duration of antiplatelet therapy in diabetic patients treated with drug‑eluting stenting?

Is meta-analysis the optimal method to decide the duration of antiplatelet therapy in diabetic patients treated with drug‑eluting stenting?

Safety and efficacy of the polymer-free and polymer-coated drug-eluting stents in patients undergoing percutaneous coronary intervention.

The relative safety and efficacy of polymer-free (PF) versus polymer-coated (PC) drug-eluting stents (DES) in patients with angina or acute coronary syndrome (ACS) undergoing percutaneous coronary intervention has received limited study. Digital databases were queried to identify relevant studies. Major adverse cardiovascular events (MACE) and secondary outcomes were compared using a random effect model to calculate unadjusted odds ratios (OR). A total of 28 studies consisting of 23,198 patients were included in the final analysis. On pooled analysis, there was no significant difference in the odds of MACE (OR 0.98, 95% CI 0.91-1.08) and major bleeding (OR 0.87, 95% CI 0.61-1.24) between patients undergoing PF-DES versus PC-DES. Similarly, the odds of myocardial infarction, stroke, stent thrombosis, cardiovascular mortality and need for target vessel revascularization was similar between the two groups. PF-DES was favored due to significantly lower odds of non-cardiac death (OR 0.78, 95% CI 0.68-89) and all-cause mortality (OR 0.87, 95% CI 0.80-0.95), but had a higher need for target lesion revascularization (OR 1.2, 95% CI 1.02-1.42). A subgroup analysis based on follow up duration, clinical presentation, presence of diabetes and class of eluting drugs mirrored the net estimates for all outcomes with a few exceptions. A sensitivity and meta-regression analysis showed no influence of single-study and duration of antiplatelet therapy on pooled outcomes. In patients presenting with angina or ACS, PF-DES might be favored due to lower all-cause mortality and equal risk of ischemic adverse cardiovascular and major bleeding events compared with PC-DES.