Angina After Percutaneous Coronary Intervention: Patient and Procedural Predictors.

BACKGROUND: Twenty percent to 40% of patients are affected by angina after percutaneous coronary intervention (PCI), which is associated with anxiety, depression, impaired physical function, and reduced quality of life. Understanding patient and procedural factors associated with post-PCI angina may inform alternative approaches to treatment. METHODS: Two hundred thirty patients undergoing PCI completed the Seattle Angina Questionnaire (SAQ-7) and European quality of life-5 dimension-5 level (EQ-5D-5L) questionnaires at baseline and 3 months post-PCI. Patients received blinded intracoronary physiology assessments before and after stenting. A post hoc analysis was performed to compare clinical and procedural characteristics among patients with and without post-PCI angina (defined by follow-up SAQ-angina frequency score <100). RESULTS: Eighty-eight of 230 patients (38.3%) reported angina 3 months post-PCI and had a higher incidence of active smoking, atrial fibrillation, and history of previous myocardial infarction or PCI. Compared with patients with no angina at follow-up, they had lower baseline SAQ summary scores (69.48±24.12 versus 50.20±22.59, P<0.001) and EQ-5D-5L health index scores (0.84±0.15 versus 0.69±0.22, P<0.001). Pre-PCI fractional flow reserve (FFR) was lower among patients who had no post-PCI angina (0.56±0.15 versus 0.62±0.13, P=0.003). Percentage change in FFR after PCI had a moderate correlation with angina frequency score at follow-up (r=0.36, P<0.0001). Patients with post-PCI angina had less improvement in FFR (43.1±33.5% versus 67.0±50.7%, P<0.001). There were no between-group differences in post-PCI FFR, coronary flow reserve, or corrected index of microcirculatory resistance. Patients with post-PCI angina had lower SAQ-summary scores (64.01±22 versus 95.16±8.72, P≤0.001) and EQ-5D-5L index scores (0.69±0.26 versus 0.91±0.17, P≤0.001) at follow-up. CONCLUSIONS: Larger improvements in FFR following PCI were associated with less angina and better quality of life at follow-up. In patients with stable symptoms, intracoronary physiology assessment can inform expectations of angina relief and quality of life improvement after stenting and thereby help to determine the appropriateness of PCI. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03259815.

Operator Volumes and In-Hospital Outcomes: An Analysis of 7,740 Rotational Atherectomy Procedures From the BCIS National Database.

OBJECTIVES: The aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes. BACKGROUND: Whether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined. METHODS: Data from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes. RESULTS: In total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p = 0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95% CI: 0.975 to 0.993; p < 0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95% CI: 0.939 to 0.991; p = 0.008), arterial complications (OR: 0.975/case; 95% CI: 0.975 to 0.982; p < 0.001) and in-hospital major bleeding (OR: 0.985/case; 95% CI: 0.977 to 0.993; p < 0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of <4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold. CONCLUSIONS: In-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.

Thin Strut CoCr Biodegradable Polymer Biolimus A9-Eluting Stents versus Thicker Strut Stainless Steel Biodegradable Polymer Biolimus A9-Eluting Stents: Two-Year Clinical Outcomes.

BACKGROUND: While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES). METHODS: In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions. RESULTS: MACE at 2 years occurred in 6.65% CoCr-BP-BES versus 13.23% SS-BP-BES groups (unadjusted HR 0.48 [0.31-0.73]; P=0.0005). Following propensity analysis, 2-year adjusted MACE rates were 7.4% versus 13.3% (HR 0.53 [0.35-0.79]; P=0.004). Definite or probable stent thrombosis, adjudicated using identical criteria in both studies, occurred less frequently with CoCr-BP-BES (1.12% vs. 3.22%; adjusted HR 0.32 [0.11-0.9]; P=0.034). In day-3 landmark analysis, the difference in 2-year MACE was no longer significant but there was a lower patient-orientated composite endpoint (11.7% vs. 18.4%; HR 0.6 [0.43-0.83]; P=0.006) and a trend to lower target vessel failure (5.8% vs. 9.1%; HR 0.63 [0.4-1.00]; P=0.078). CONCLUSION: At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.

AIMS: To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS. METHODS: This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR). RESULTS: Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947). CONCLUSIONS: Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

Vascular Access Site and Outcomes in 58,870 Patients Undergoing Percutaneous Coronary Intervention With a Previous History of Coronary Bypass Surgery: Results From the British Cardiovascular Interventions Society National Database.

OBJECTIVES: Using the British Cardiovascular Intervention Society percutaneous coronary intervention (PCI) database, access site choice and outcomes of patients undergoing PCI with previous coronary artery bypass grafting (CABG) were studied. BACKGROUND: Given the influence of access site on outcomes, use of radial access in PCI-CABG warrants further investigation. METHODS: Data were analyzed from 58,870 PCI-CABG procedures performed between 2005 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. RESULTS: The number of PCI-CABG cases and the percentage of total PCI increased significantly during the study period. Femoral artery (FA) utilization fell from 90.8% in 2005 to 57.6% in 2014 (p < 0.001), with no differences in the rate of change of left versus right radial use. In contemporary study years (2012 to 2014), female sex, acute coronary syndrome presentation, chronic total occlusion intervention, and lower operator volume were independently associated with FA access. Length of stay was shortened in the radial cohort. Unadjusted outcomes including an access site complication (1.10% vs. 0.30%; p < 0.001), blood transfusion (0.20% vs. 0.04%; p < 0.001), major bleeding (1.30% vs. 0.40%; p < 0.001), and in-hospital death (1.10% vs. 0.60%; p = 0.001) were more likely to occur with FA access compared with radial access. After adjustment, although arterial complications, transfusion, and major bleeding remained more common with FA use, short- and longer-term mortality and major adverse cardiac event rates were similar. CONCLUSIONS: In contemporary practice, FA access remains predominant during PCI-CABG with case complexity associated with it use. FA use was associated with longer length of stay, and higher rates of vascular complications, major bleeding, and transfusion.

Coronary Perforation Complicating Percutaneous Coronary Intervention in Patients With a History of Coronary Artery Bypass Surgery: An Analysis of 309 Perforation Cases From the British Cardiovascular Intervention Society Database.

BACKGROUND: The evidence base for coronary perforation (CP) occurring during percutaneous coronary intervention in patients with a history of coronary artery bypass surgery (PCI-CABG) is limited and the long-term effects unclear. Using a national PCI database, the incidence, predictors, and outcomes of CP during PCI-CABG were defined. METHODS AND RESULTS: Data were analyzed on all PCI-CABG procedures performed in England and Wales between 2005 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. During the study period, 309 CPs were recorded during 59 644 PCI-CABG procedures with the incidence rising from 0.32% in 2005 to 0.68% in 2013 (P<0.001 for trend). Independent associates of perforation in native vessels included age, chronic occlusive disease intervention, rotational atherectomy use, number of stents, hypertension, and female sex. In graft PCI, predictors of perforation were history of stroke, New York Heart Association class, and number of stents used. In-hospital clinical complications including Q-wave myocardial infarction (2.9% versus 0.2%; P<0.001), major bleeding (14.0% versus 0.9%; P<0.001), blood transfusion (3.7% versus 0.2%; P<0.001), and death (10.0% versus 1.1%; P<0.001) were more frequent in patients with CP. A continued excess mortality occurred after perforation, with an odds ratio for 12-month mortality of 1.35 for perforation survivors compared with matched nonperforation survivors without a CP (P<0.0001). CONCLUSIONS: CP is an infrequent event during PCI-CABG but is closely associated with adverse clinical outcomes. A legacy effect of perforation on 12-month mortality was observed.

Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial.

BACKGROUND: The randomized, LEADERS FREE trial showed superior safety and efficacy of a polymer-free DCS vs. a bare metal stent in high-bleeding risk patients with only one month dual antiplatelet treatment. We report characteristics and outcomes of the pre-specified group of elderly patients (aged ≥75). METHODS: Age >75 was one of the trial's inclusion criteria. The main additional criteria were: need for oral anticoagulants, recent bleeding, anemia, chronic renal failure and cancer. All patients received 1month DAPT only. Both primary endpoints (efficacy: clinically driven TLR and safety: composite of cardiac death, MI and stent thrombosis) as well as bleeding were recorded up to 390days. RESULTS: 1564 elderly patients (63.4% of the population) were enrolled with a mean of 2 inclusion criteria/patient. The primary safety endpoint was reached less frequently in DCS than BMS patients (10.7 vs. 14.3%, p=0.03), as was the primary efficacy endpoint (5.8 vs. 10.8% p=0.0003). Major bleeding rates were high and similar in both groups (7.3 vs. 8.2%, p=0.55). For the 562 (23.4%) patients with age as sole entry criterion, trends were similar for DCS and BMS patients respectively: safety endpoint (7.3%vs.11.4% p=0.10) and Cd TLR (4.7 vs. 13.2% p=0.0003), but for both groups, major bleeding occurred less frequently than for elderly patients with more comorbid conditions (3.6%vs. 2.8%). CONCLUSION: Compared to a BMS, use of a DCS together with a short one-month DAPT course was associated with significant safety and efficacy benefits for the elderly patients enrolled in LEADERS FREE.