Archive

Posts Tagged ‘PCI’

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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Journal Club 20 March 2013

Paper

Nonemergency PCI at Hospitals with or without On-Site Cardiac Surgery

Presenter

PJS

Summary

Background

Emergency surgery has become a rare event after percutaneous coronary intervention
(PCI). Whether having cardiac-surgery services available on-site is essential for ensuring
the best possible outcomes during and after PCI remains uncertain.

Methods

We enrolled patients with indications for nonemergency PCI who presented at hospitals
in Massachusetts without on-site cardiac surgery and randomly assigned these
patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that
had cardiac surgery services available. A total of 10 hospitals without on-site cardiac
surgery and 7 with on-site cardiac surgery participated. The coprimary end points
were the rates of major adverse cardiac events — a composite of death, myocardial
infarction, repeat revascularization, or stroke — at 30 days (safety end point) and
at 12 months (effectiveness end point). The primary end points were analyzed according
to the intention-to-treat principle and were tested with the use of multiplicative
noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness).

Results

A total of 3691 patients were randomly assigned to undergo PCI at a hospital without
on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery
(917 patients). The rates of major adverse cardiac events were 9.5% in hospitals
without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at
30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for
noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98;
95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of
death, myocardial infarction, repeat revascularization, and stroke (the components
of the primary end point) did not differ significantly between the groups at either
time point.

Conclusions

Nonemergency PCI procedures performed at hospitals in Massachusetts without
on-site surgical services were noninferior to procedures performed at hospitals
with on-site surgical services with respect to the 30-day and 1-year rates of clinical
events.

Supplementary material

Important supplementary material is here.