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Archive for the ‘Interventional Cardiology’ Category

PCI in the Elderly with NSTEMI

Gnanenthiran et al (http:// dx. doi. org/ 10. 1136/heartjnl- 2017- 311233). report a meta-analysis of randomized clinical trials of percutaneous coronary intervention in the elderly presenting with non ST elevation myocardial infarction.  Reduction in myocardial infarction, repeat revascularization and a trend to reduction in mortality was noted. Bleeding was increased (compared with medical therapy) but appeared to decrease across time.

Abstract

Objective

Whether revascularisation is superior to medical therapy in older populations presenting with non-ST-elevation acute coronary syndromes (NSTEACS) remains contentious, with inconclusive evidence from randomised trials. We aimed to compare routine invasive therapy with initial medical management in the elderly
presenting with NSTEACS.

Methods

MEDLINE, EMBASE and Cochrane Controlled Trial Register were searched for studies comparing routine invasive therapy with initial medical management
in patients ≥75 years old presenting with NSTEACS. Endpoints included long-term mortality, myocardial infarction (MI), revascularisation, rehospitalisation, stroke and major bleeding reported as ORs.

Results

Four randomised trials and three observational studies met inclusion criteria, enrolling a total of 20 540 patients followed up from 6 months to 5 years. Routine invasive therapy reduced mortality (OR 0.67, CI 0.61 to 0.74), MI (OR 0.56, CI 0.45 to 0.70) and stroke (OR 0.53, CI 0.30 to 0.95). Analyses restricted to randomised controlled trials (RCTs) confirmed a reduction in MI (OR 0.51, CI 0.40 to 0.66), revascularisation (OR 0.27, CI 0.13 to 0.56) and a trend to reduced mortality (OR 0.84, CI 0.66 to 1.06) at the expense of major bleeding (OR 2.19, CI 1.12 to 4.28). Differences in major bleeding were unapparent in more recent studies.

Conclusion

Routine invasive therapy reduces MI and repeat revascularisation and may reduce mortality at the expense of major bleeding in elderly patients with NSTEACS. Our findings highlight the need for further RCTs to better determine the effect on mortality and contemporary bleeding risk.

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Scaffold Thrombosis in Routine PCI

Wykrzykowska et al report a randomized clinical trial of metallic stent v bioresorbable vascular scaffold in routine percutaneous coronary intervention. They found significantly higher risk of device thrombosis with BVS. The editorial is available here.

Summary

BACKGROUND

Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drugeluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice.

METHODS

We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events.

RESULTS

The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates,11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P = 0.43); event rates were based on Kaplan–Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and
in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001).

CONCLUSIONS

In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up.

 

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30 Day Myocardial Infarction and Cardiac Death post surgery after previous PCI

Egholm et al report on the 30 day event rates of myocardial infarction/cardiac death/all cause mortality in patients with prior PCI (<1 month, 1-2 month.2-12 month intervals PCI to surgery). Data was from National Registry. The control group was patients without ischemic heart disease. An hazard for myocardial infarction and cardiac death for those with PCI within 1 month of surgery was demonstrated.

ABSTRACT

BACKGROUND

Guidelines recommend postponing surgery for at least 6 months after treatment with a drug-eluting stent by percutaneous coronary intervention (DES-PCI).

OBJECTIVES

The goal of this study was to evaluate the surgical risk associated with DES-PCI compared with that in nonstented patients without ischemic heart disease (IHD).

METHODS

Between 2005 and 2012, a total of 22,590 patients underwent DES-PCI in western Denmark. By
record-linking the Western Denmark Heart Registry and the Danish National Patient Register, we evaluated 4,303 DES-PCI–treated patients with a surgical procedure and compared them with a control group of patients without previous IHD undergoing similar surgical procedures (n ¼ 20,232). Events of interest were myocardial infarction (MI), cardiac death, and all-cause mortality within 30 days after surgery.

RESULTS

Surgery in DES-PCI–treated patients was associated with an increased risk of MI (1.6% vs. 0.2%; odds ratio[OR]: 4.82; 95% confidence interval [CI]: 3.25 to 7.16) and cardiac death (1.0% vs. 0.2%; OR: 5.87; 95% CI: 3.60 to 9.58) but not all-cause mortality (3.1% vs. 2.7%; OR: 1.12; 95% CI: 0.91 to 1.38). When stratified for time from PCI to surgery, only surgery within the first month was associated with a significant increased risk of events.

CONCLUSIONS

Patients requiring surgery within 12 months after DES-PCI had an increased risk of MI and cardiac death compared with patients without IHD. The increased risk was only present within the first month after DES-PCI, suggesting that surgery might be undertaken earlier than currently recommended.

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AHA 2016: Initial Look

BIO-RESORT Trial

von-Birgelen et al report the results of the BIO-RESORT trial. This was a 3 armed randomized clinical trial of thin strut biodegradable polymer EES, thin strut biodegradable polymer SES, thin strut durable polymer ZES. Both devices were within non-inferiority margin.

Abstract

Background

In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the
life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which
leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers
the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but
never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers.

Methods

The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised,
BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged
18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with
drug-eluting stent implantation according to clinical guidelines or the operators’ judgment. Exclusion criteria were:
participation in another randomised drug or device study before reaching the primary endpoint of that study;
planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance
to components of the investigational product or medication required; uncertainty about the adherence to follow-up
procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated
allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer
everolimus-eluting or sirolimus-eluting stents (which diff er substantially in type, amount, distribution, and
resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary
endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target
vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either
everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents,
analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov,
number NCT01674803.

Findings

From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute
coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of
3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%)
of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%)
of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting
stents compared with zotarolimus-eluting stents was confirmed (both –0·7% absolute risk difference, 95% CI
–2·4 to 1·1; upper limit of one sided 95% CI 0·8%, p non-inferiority<0·0001). Definite stent thrombosis (defined by the
Academic Research Consortium) occurred in four (0·3%) of 1172 patients who were allocated to everolimus-eluting
stents, four (0·3%) of 1169 patients who were allocated to sirolimus-eluting stents, and three (0·3%) of 1173 patients
who were allocated to zotarolimus-eluting stents (log-rank p=0·70 for both comparisons with zotarolimus-eluting
stents).

Interpretation

At 12 month follow-up, both very thin strut drug-eluting stents with dissimilar biodegradable polymer
coatings (eluting either everolimus or sirolimus) were non-inferior to the durable polymer stent (eluting zotarolimus)
in treating allcomers with a high proportion of patients with acute coronary syndromes. The absence of a loss of
1 year safety and efficacy with the use of these two biodegradable polymer-coated stents is a prerequisite before
assessing their potential longer-term benefits.

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ABSORB II 3 year Outcome

Serruys et al report the 3 year outcome of the ABSORB II trial. The bioresorbable scaffold had higher device related outcomes and was similar with respect to patient related outcomes. Late loss was significantly lower in the EES.

The editorial is available here.

Abstract

Background

No medium-term data are available on the random comparison between everolimus-eluting
bioresorbable vascular scaff olds and everolimus-eluting metallic stents. The study aims to demonstrate two
mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered
vasomotion of the scaffolded vessel. Vasomotion was not improved with the scaffold.

Methods

The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group,
multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and
one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive
treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or
treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation
was stratifi ed by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was
superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity
after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late
luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of
late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of
0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281.

Findings

Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb
group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years
was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; p superiority=0·49),
whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs
0·25 mm [0·25]; p non-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound
assessment of the minimum lumen area (4·32 mm² [SD 1·48] vs 5·38 mm² [1·51]; p<0·0001). The secondary
endpoints of patient-oriented composite endpoint, Seattle Angina Questionnaire score, and exercise testing were not
statistically different in both groups. However, a device-oriented composite endpoint was significantly different
between the Absorb group and the Xience group (10% vs 5%, hazard ratio 2·17 [95% CI 1·01–4·70]; log-rank
test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural
myocardial infarction (4% vs 1%; p=0·16).

Interpretation

The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late
luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have
significantly lower late luminal loss than the Absorb scaffold. A higher rate of device-oriented composite endpoint due
to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb
group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different
between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging
in sizing the device and in optimising the scaffold implantation. The benefit and need for prolonged dual antiplatelet
therapy after bioresorbable scaffold implantation could also become a topic for future clinical research.

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Ilumien III Trial

Ali et al report the results of the ILUMEN III trial. This randomized clinical trial compared OCT guided stent implantation with IVUS and angiography guided intervention. The minimum post procedural stent area was used as end-point. OCT met non-inferiority against IVUS-guided intervention. It did not meet superiority against angiography guided intervention. The editorial is available here.

Abstract

Background

Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular
ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI,
principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence
tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest
that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel
OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with
IVUS guidance and better than that achieved with angiography guidance alone.

Methods

In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from
29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25–3·50 mm and a length of less than 40 mm. We excluded
patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of
enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was
procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of
1·0 mm²), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance,
in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586.

Findings

Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to
IVUS, and 146 [32%] to angiography), with 415 fi nal OCT acquisitions analysed for the primary endpoint (140 [34%]
in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The fi nal median minimum
stent area was 5·79 mm² (IQR 4·54–7·34) with OCT guidance, 5·89 mm² (4·67–7·80) with IVUS guidance, and
5·49 mm² (4·39–6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance
(one-sided 97·5% lower CI –0·70 mm²; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to
angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group,
one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT
vs angiography p=0·37).

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OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation
strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a largescale
randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography
guidance.

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