Posts Tagged ‘PCI’


Al-Lamee et al report the results of the ORBITA trial in the Lancet ( There is an accompanying editorial. This is a multicentre randomised clinical trial with a sham control group to assess the efficacy of percutaneous coronary intervention in patients with stable angina. It has provoked a significant response in professional and lay literature.



Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.


ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary
endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with, number NCT02062593.


ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and
95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI –8·9 to 42·0, p=0·200).
There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.


In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a
placebo control, as is standard for pharmacotherapy.



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.



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.


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.


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.


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.


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.



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.


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.


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).


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.



Journal Club 20 March 2013


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





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.


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).


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.


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

Supplementary material

Important supplementary material is here.