Revascularisation or medical therapy in elderly patients with acute anginal syndromes: the RINCAL randomised trial.

BACKGROUND: Historically the elderly have been under-represented in non-ST-elevation myocardial infarction (NSTEMI) management trials. AIMS: The aim of this trial was to demonstrate that an intervention-guided strategy is superior to optimal medical therapy (OMT) alone for treating NSTEMI in elderly individuals. METHODS: Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an intervention-guided strategy plus OMT versus OMT alone. The primary endpoint was a composite of all-cause mortality and non-fatal myocardial reinfarction at 1 year. Ethics approval was obtained by the institutional review board of every recruiting centre. RESULTS: From May 2014 to September 2018, 251 patients (n=125 invasive vs n=126 conservative) were enrolled. Almost 50% of participants were female. The trial was terminated prematurely due to slow recruitment. A Kaplan-Meier estimate of event-free survival revealed no difference in the primary endpoint at 1 year (invasive 18.5% [23/124] vs conservative 22.2% [28/126]; p=0.39). No significant difference persisted after Cox proportional hazards regression analysis (hazard ratio 0.79, 95% confidence interval 0.45-1.35; p=0.39). There was greater freedom from angina at 3 months (p<0.001) after early intervention but this was similar at 1 year. Both non-fatal reinfarction (invasive 9.7% [12/124] vs conservative 14.3% [18/126]; p=0.22) and unplanned revascularisation (invasive 1.6% [2/124] vs conservative 6.4% [8/126]; p=0.10) occurred more frequently in the OMT alone cohort. CONCLUSIONS: An intervention-guided strategy was not superior to OMT alone to treat very elderly NSTEMI patients. The trial was underpowered to demonstrate this definitively. Early intervention resulted in fewer cases of reinfarction and unplanned revascularisation but did not improve survival.

Clinical outcomes with 6 months dual antiplatelet therapy after implantation of biolimus-A9 drug eluting coronary stents.

INTRODUCTION: Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate. AIMS: We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation. METHODS: 692 patients (77.2% male), aged 65.6 ± 12.5 years received biolimus-eluting DES (March 2008 -November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres). RESULTS: Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0-6 months, 1.0% at 6-12 months and 0.9% at >12 months. Of the 7 deaths between 6 and 12 months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months. CONCLUSIONS: After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.

Prospective peer review of regional percutaneous interventional procedures: a tool for quality control and revalidation.

AIMS: Current quality measures of percutaneous coronary intervention (PCI) procedures are based on the incidence of major adverse cardiac events (MACE). This crude marker ignores the many clinical nuances that make for sound decision making in PCI. We have established a prospective peer review audit tool to determine the quality of PCI within our cardiac network, which consists of five PCI hospitals serving a population of 1.4 million people in Sussex, UK. METHODS AND RESULTS: Analysis of 10% of all PCI cases selected at random each month by a non-clinical audit manager is made by a rotating panel of two PCI operators and one cardiac surgeon. Each PCI case is assessed for anatomical suitability, lesion severity, strategic appropriateness and final outcome. Panel findings were reported back to the operator and the audit manager. A total of 326 cases were assessed by the review committee. Results were disseminated to individual operators. Coronary anatomy and lesion severity were considered appropriate for PCI in 94.2% and 96.0% of cases, respectively. Appropriateness of strategy was confirmed in 86.2% and the outcome considered satisfactory in 90.8%. A total of 242 subsequent cases were analysed to assess practice trends. This analysis demonstrated a statistically significant improvement in clinical decision making with respect to appropriateness of strategy (from 86.2% to 92.6%; p=0.004). CONCLUSIONS: Prospective peer review of percutaneous coronary intervention cases by a rotating regional committee is valuable in ensuring procedural quality.

Rescue angioplasty for failed fibrinolysis--long-term follow-up of a large cohort.

BACKGROUND: Fibrinolysis remains an important treatment for ST-elevation myocardial infarction, but fails to achieve adequate reperfusion in a significant proportion of cases. "Rescue" angioplasty is seen as the preferred treatment strategy in most contemporary centers although the literature provides conflicting evidence. METHODS: We retrospectively reviewed all cases of rescue angioplasty performed at our cardiothoracic center from July 1999 to June 2008. The diagnosis of failed lysis was made on the basis of an ECG demonstrating failure of ST segment resolution >50% at 90 min. Periprocedural data was taken from a dedicated procedural database and mortality data obtained from the UK Office of National Statistics. RESULTS: A total of 316 cases were performed. Patients were aged 61 ± 11 years. Thirty-day mortality was 8.9%. Thirty-day mortality in those presenting with cardiogenic shock was 50%, and in those requiring blood transfusion was also 50%. Thirty day mortality in those with TIMI III flow at the end of the procedure was significantly less than in those in whom this was not the case (6.6% vs. 23.3%; P < 0.001). One year mortality for the entire cohort was 10.1%. Longer-term follow-up revealed after 5.2 ± 2.3 years, survival in this cohort was 83%. Significant bleeding requiring blood transfusion occurred in 2.5% of cases. CONCLUSIONS: We have shown that rescue angioplasty can be performed with good procedural success rates and excellent long-term results. Limiting bleeding complications and achieving TIMI III flow appear to be major determinants of achieving good long term results.

Feasibility, safety, and efficacy of a novel polymeric pimecrolimus-eluting stent: traditional pre-clinical safety end points failed to predict 6-month clinical angiographic results.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial. BACKGROUND: Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization. METHODS: We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis. RESULTS: At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients. CONCLUSIONS: Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls.

Very late changes in the dilated lesion following coronary balloon angioplasty: a 17 year serial quantitative angiographic study.

AIMS: Limited data are available on the changes that occur at the dilated site many years after coronary balloon angioplasty. The development of bioabsorbable stents may increase the importance of understanding the long term changes that occur in an unscaffolded coronary artery following balloon-mediated injury. METHODS AND RESULTS: This study evaluated, by serial quantitative angiography, the natural history of changes that occurred in the dilated segment between early (mean seven months), late (mean 4.5 years) and very late (mean 17 years) follow-up after balloon angioplasty. Of 127 consecutive patients (174 lesions) with successful coronary angioplasty, 125 underwent early, 84 late and 47 very late angiographic follow-up (75% of eligible survivors). The mean lesion diameter stenosis decreased from 36+/-11% at early to 26+/-15% at late follow-up (p<0.0001), and then increased again to 35+/-25% by very late follow-up (p=0.003). Although stenosis severity at early follow-up angiography predicted lesion regression at late follow-up, there was no significant correlation between late and very late follow-up lesion severity. CONCLUSIONS: After coronary angioplasty, lesion regression at the dilated site from 7 months to 4.5 years is followed by slow lesion progression over the next 12 years.

The "crush" technique for coronary artery bifurcation stenting: insights from micro-computed tomographic imaging of bench deployments.

OBJECTIVES: This study provides insights into "crush" coronary bifurcation stenting through imaging of bench deployments. BACKGROUND: Although the strategy of provisional side-branch stenting is widely accepted for suitable bifurcation lesions, there is no consensus on the best option for elective stenting with 2 stents. The crush technique has the potential to scaffold and apply the drug to the side-branch ostium where restenosis is most common. METHODS: Sequential steps of crush stent deployment and post-dilation were undertaken in silicone phantoms and recorded on cine angiography and microcomputed tomography. We assessed the effect of deployment strategies, post-dilation strategies, and cell size on side-branch ostial area. RESULTS: Side-branch ostial coverage by metal struts was 53% (95% confidence interval [CI]: 46 to 59) after 1-step kissing post-dilation and was reduced by 2-step kissing post-dilation to 33% (95% CI: 28 to 37; p < 0.0001). Although the residual stenosis after the classical crush strategy was 47% (95% CI: 39 to 53), it was 36% (95% CI: 31 to 40; p = 0.002) after mini-crush deployment. Stents with larger cell size (>3.5 mm diameter) had a residual stenosis of 37% (95% CI: 32 to 42) after crush deployment that was less than the residual stenosis for stents with smaller cell size (52%; 95% CI: 44 to 60; p < 0.0001). CONCLUSIONS: Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size. It is unknown if optimizing stent deployment at bifurcation lesions will reduce clinical stent thrombosis and restenosis.

Extensive coronary thrombus causing full thickness myocardial infarction.

A young male presented 22 h following onset of symptoms with an anterior ST-elevation myocardial infarction. He was transferred for rescue angioplasty after failing to reperfuse with thrombolytic therapy. On arrival, his symptoms had settled. Following administration of intracoronary abciximab and passage of an angioplasty wire into the distal LAD, extensive thrombus was demonstrated in the left anterior descending artery extending from the ostium to the distal vessel Figure 1(a). Further intervention with attempted thrombectomy was considered but it was postponed pending a viability study because of the risks of displacing thrombus down the circumflex. A cardiac MRI scan with delayed gadolinium hyper-enhancement demonstrated the classical appearance of full-thickness infarction in the LAD territory Figure 1(b). No further intervention was therefore indicated. At one-year follow-up, the patient remains free of angina with NYHA Class 1 symptoms of heart failure.