Twelve-month outcomes of patients unsuitable for prolonged DAPT presenting with an acute coronary syndrome and treated with polymer-free biolimus A9 drug-coated stents.

INTRODUCTION: Prolonged dual anti-platelet therapy (DAPT) is undesirable in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. METHODS: The demographics, procedural data, and clinical outcomes for 505 patients presenting with an ACS to three UK centres and treated with a BA9-DCS stent (PCI-DCS) were collected, and compared to a consecutive ACS cohort of unselected patients treated in the same period with drug-eluting stents (PCI-DES). RESULTS: PCI-DCS patients were older, more often female with hypertension, chronic kidney disease, severe LV dysfunction, and peripheral vascular disease more frequent than the PCI-DES cohort. PCI-DCS patients had a much higher Mehran bleed risk score (21.5 ± 7.7 vs. 15.9 ± 7.7, P < 0.0001). Baseline disease burden was greater in the PCI-DCS cohort with more left main and three vessel disease. During PCI, more stents (1.91 ± 1.1 vs. 1.57 ± 0.94, P < 0.0001), total stent length (38.2 ± 20.8 vs. 31.4 ± 20.3, P < 0.0001) and longer stents (38.2 ± 20.8 vs. 31.4 ± 20.3 mm, P < 0.0001) were used in the PCI-DCS cohort with rotational atherectomy also used more frequently. Physician-recommended DAPT duration was 2.9 ± 3.9 months for PCI-DCS patients and 11.3 ± 2.4 months for PCI-DES patients (P < 0.0001). At 12-month follow-up, definite stent thrombosis (0.6% vs. 1.1%) and TLR (3.2% vs. 2.7%) rates were similar between the two groups. After adjustment for baseline differences, there were no statistically significant differences in death and combined MACE rates at 12 months. CONCLUSIONS: The outcomes of patients treated with polymer-free BA9 drug-coated stent who present with an ACS and who were deemed unsuitable for prolonged DAPT are encouraging. Further studies are warranted.

Baseline anemia in patients undergoing percutaneous coronary intervention after an acute coronary syndrome-A paradox of high bleeding risk, high ischemic risk, and complex coronary disease.

OBJECTIVES: To define more clearly the associations between baseline anemia, bleeding/ischemia risk, coronary disease severity, and outcomes by revascularization completeness. BACKGROUND: Anemia is associated with adverse outcomes in patients presenting with an acute coronary syndrome (ACS). METHODS AND RESULTS: Data was sourced from hospital databases for patients admitted with an ACS to a single center between 2011 and 2014. Using WHO anemia criteria, 468 (26.9%) of 1731 patients were anemic. In anemic patients, the mean CRUSADE score (34.6 ± 16.9 vs 24.6 ± 13.4, P < 0.0001), mean GRACE scores (165.8 ± 44.9 vs 141.6 ± 40.1, P < 0.0001), and percentage of patients with a high/very high CRUSADE score combined with a high GRACE score (69.3 vs 48.3%, P < 0.0001) was much greater than non-anemic patients. Patients with baseline anemia were more likely to have left main or chronic occlusive disease, and more diseased vessels. The percentage of patients with residual disease (41.2 vs 30.7%, P < 0.0001), the number of residual diseased vessels (0.59 ± 0.83 vs 0.42 ± 0.72, P < 0.0001), and the percentage with a residual CTO (62.4 vs 56.4%, P = 0.036) were all higher than in non-anemic patients. The duration of anti-platelet therapy was significantly shorter in anemic patients (7.8 ± 4.3 vs 11.2 ± 2.4 months, P < 0.001). At 12-months, mortality and stent thrombosis were more likely to occur in anemic patients, with the number of residual vessels associated with adverse survival regardless of anemia status. CONCLUSIONS: Patients with anemia present with high ischemia and bleed risk scores, complex coronary disease, and have adverse outcomes. Incomplete revascularization was associated with worse survival regardless of anemia status.

Post-Procedural Bivalirudin Infusion Following Primary PCI to Reduce Stent Thrombosis.

BACKGROUND: Prolonging infusions may abrogate the acute stent thrombosis (ST) associated with bivalirudin use during primary PCI but at an increased cost. We hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end would prevent excess early ST. METHODS: Baseline demographics, procedural data and outcomes were gathered prospectively on 1395 consecutive patients undergoing primary PCI. The choice of bivalirudin versus heparin was at the cardiologist's discretion. Local protocol recommended continuation of the procedural bivalirudin at the PCI dose until infusion end. RESULTS: Patients' mean age was 62.8 ± 13.1years with 11.4% presenting with shock. The majority of patients underwent PCI using bivalirudin with fewer using heparin (87.7 vs. 12.3%, P < 0.0001). Glycoprotein inhibitor bailout rates were 6.1% with bivalirudin and 36.3% with heparin (P < 0.0001). Calculated on an individual patient basis the median intra-procedure duration of the bivalirudin infusion was 30(IQR 21-43) minutes and post-procedure 49(32-66) minutes. The acute (<24-hours) ST rates were 4/1224 with bivalirudin ± GPI (0.3%) and 0/171 with heparin ± GPI (0%, P = 0.41). The sub-acute (24-hours to 30-days) ST rates were 3/1224 for bivalirudin ± GPI (0.3%) and 2/171 with heparin ± GPI (1.2%, P = 0.11). In total the early (<30-days) ST rates were 7/1224 for bivalirudin ± GPI (0.6%) and 2/171 with heparin ± GPI (1.2%, P = 0.31). Acute ST was significantly more likely to occur in clopidogrel-loaded patients than prasugrel/ticagrelor patients (2.7 vs. 0.5%, P = 0.003). CONCLUSION: Continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end combined with potent P2 Y12 inhibitors ameliorates excess early stent thrombosis.

Early Clinical Experience with a Polymer-Free Biolimus A9 Drug-Coated Stent in DES-Type Patients Who Are Poor Candidates for Prolonged Dual Anti-Platelet Therapy.

INTRODUCTION: Prolonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding. BACKGROUND AND METHODS: The demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES). RESULTS: Operator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts. CONCLUSIONS: This early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.

Comparison of the Effects of Incomplete Revascularization on 12-Month Mortality in Patients <80 Compared With ≥80 Years Who Underwent Percutaneous Coronary Intervention.

Although randomized trial data suggest that complete revascularization improves outcomes after percutaneous coronary intervention (PCI), the impact of differing revascularization strategies in octogenarians is not well defined. We performed a retrospective analysis, which was conducted of 9,628 consecutive patients who underwent PCI at a large UK center. Octogenarians were more likely to have significant co-morbidity, a higher Mehran bleed risk score (24.5 ± 6.8 vs 13.3 ± 7.4, p <0.0001), and more complex disease (baseline SYNTAX score 18.7 ± 11.0 vs 13.1 ± 8.9, p = 0.002) than younger patients. During PCI, octogenarians were more likely to undergo left main or proximal LAD intervention, but despite this, significantly less likely to receive drug-eluting stents (66.5% vs 80.1%, p <0.001). Postprocedurally, octogenarians had greater residual disease burden (residual SYNTAX score 10.1 ± 8.7 vs 1.6 ± 3.3, p <0.0001). At 12 months, adverse outcomes (definite stent thrombosis 3.3% vs 1.1%, p <0.001, clinically driven in-stent restenosis PCI 3.7% vs 2.6%, p = 0.005, and 12-month mortality 12.8% vs 4.2%, p <0.0001) were all more frequent in octogenarians. Although age, shock, diabetes, and BMS use were independently predictive of increased 12-month mortality, incomplete revascularization was not. In conclusion, octogenarians are a complex group to treat balancing high-risk bleeding profile and complex coronary disease. However, in multivariate analysis, incomplete revascularization was not independently predictive of adverse outcomes. These data support a conservative target lesion-only DES-driven revascularization strategy.

Complex Disease, Partial Revascularization, and Adverse Outcomes in Patients Treated With Long-Term Warfarin Therapy Who Underwent Percutaneous Coronary Intervention.

Patients treated with warfarin who undergo percutaneous coronary intervention (PCI) present a difficult therapeutic problem. Their baseline demographics, procedural characteristics, and 12-month outcomes are poorly defined. We conducted a retrospective analysis of all patients who underwent PCI at a major UK Cardiac Center from 2012 to 2013. Of the 2,675 patients who underwent PCI, 155 were on long-term warfarin treatment (5.8%). Patients on warfarin were older and more likely to have significant co-morbidity than those not on warfarin. The modified Mehran bleed score was higher in patients treated with warfarin versus those not treated (19.0 ± 5.8 vs 15.4 ± 8.0, p = 0.004). Baseline SYNTAX scores were higher in the patients treated with warfarin (18.5 ± 9.1 vs 12.4 ± 3.8, p = 0.0006) as were residual SYNTAX scores (8.3 ± 1.1 vs 3.8 ± 5.9, p = 0.001). Bare metal stents were more frequently used in warfarin-treated patients than those not treated (44.8% vs 26.3%, p <0.0001). Antiplatelet monotherapy was prescribed after PCI in 14.4% of patients treated with warfarin and 0.7% of non-warfarin (p <0.0001), whereas average dual anti-platelet therapy duration was also significantly shorter (4.3 vs 10.7 months, p <0.0001). At 1-year follow-up, target-vessel revascularization (6.5% vs 3.3%, p <0.05), stent thrombosis (5.0% vs 2.6%, p = 0.14), death (10.1% vs 4.6%, p <0.01), and target-vessel revascularization/stent thrombosis/death (21.6% vs 10.5%, p = 0.004) were all more common in the warfarin cohort. In conclusion, patients treated with warfarin who need PCI are a complex cohort, more likely to receive incomplete revascularization, less intense, and shorter durations of antiplatelet therapy, and have adverse 1-year outcomes. More trials of both current DES and newer DES technologies in warfarin-treated patients are needed.