ESC 2017: Important Trial Results for SIHD

1. PCI Versus CABG in Patients With Type 1 Diabetes and Multivessel Disease1

Presented by Martin J. Holzmann, MD, PhD

Contribution to Literature

Previous studies comparing revascularization strategies in patients with diabetes mellitus (DM) showed that coronary artery bypass graft surgery (CABG) was superior to percutaneous coronary intervention (PCI). However, the proportion of patients with type 1 DM in those trials was either small or not reported. This study, limited to patients with type 1 DM, reports that PCI, compared with CABG, is associated with higher rates and risks of coronary heart disease mortality, myocardial infarction (MI), and repeat revascularizations.

Description

The goal of the study was to determine if patients with type 1 DM and multivessel disease may benefit from CABG compared with PCI.

Study Design

  • Observational cohort study

Inclusion Criteria

All patients with type 1 DM who underwent a first multivessel revascularization with either CABG or PCI over a period of 19 years in Sweden.

Exclusion Criteria

  • Prior cardiothoracic surgery
  • Prior or current left main coronary revascularization
  • Emergency procedure
  • Valvular heart surgery or vascular surgery concurrently with CABG
  • PCI for ST-segment elevation MI
  • Prior single-vessel PCI in the PCI group
  • Type 1 DM diagnosed after the index date

A total of 2,546 patients with type 1 DM underwent a first multivessel revascularization, of which 73% underwent PCI. Patients treated with PCI were older, more often women, had a longer duration of diabetes, and were more likely to have had previous MI and strokes. Three-vessel disease was more common in the CABG group compared with the PCI group.

Principal Findings

The primary outcome, all-cause mortality, occurred in 44.6% patients in the PCI group and 53.3% in the CABG group (hazard ratio [HR] 1.14; 95% confidence interval [CI], 0.99-1.32).

Secondary Outcomes

  • Death from coronary heart disease: 2.9/100 person-years for PCI versus 2.1/100 person years for CABG (HR 1.45; 95% CI, 1.21-1.74).
  • MI: 4.6/100 person-years for PCI versus 2.7/100 person-years for CABG (HR 1.47; 95% CI, 1.23-1.78).
  • Repeat revascularization: 20.1/100 person-years for PCI versus 1.9/100 person-years for CABG (HR 5.64; 95% CI, 4.67-6.82).
  • Stroke: 1.5/100 person-years for PCI versus 1.4/100 person-years for CABG (HR 1.00; 95% CI, 0.76-1.31).
  • Heart failure: 4.6/100 person-years for PCI versus 3.2/100 person-years for CABG (HR 1.10; 95% CI, 0.91-1.32).

Interpretation

Among patients with type 1 DM who underwent a first multivessel revascularization, there was a benefit favoring CABG, with lower rates and risks of coronary heart disease mortality, MI, and repeat revascularization, with no such differences found for all-cause mortality, stroke, and heart failure. This study indicates that CABG may be the preferred strategy in patients with type 1 DM in need of multivessel revascularization. These findings are similar to those reported in previous randomized controlled trials of revascularization strategies in DM and extend those observations to patients with the type 1 form of the disease.

2. Early Strut Coverage in Patients Receiving New-Generation DES and its Implications for DAPT: a Randomized Clinical Trial2

Presented by Myeong-Ki Hong, MD. PhD

Contribution to Literature

This study showed that strut coverage at 3-month follow-up is similar for both everolimus-eluting stent (EES) and biolimus-eluting stent (BES). Ocular coherence tomography (OCT) guided stent implantation results in better strut coverage than angiography-guided drug-eluting stent (DES) implantation at 3-month follow-up. The study also adds to the growing evidence that in selected patients, 3-month dual antiplatelet therapy (DAPT) may be safe after DES implantation.

Description

The goals of the study were to determine 1) if EES would show better strut overage than BES at 3-month follow-up OCT and 2) if OCT-guided stent implantation would show better strut coverage than angiography-guided stent implantation at 3-month follow-up. The study also sought to determine if 3-month DAPT based on a favorable degree of strut coverage would show long-term clinical outcomes similar to 12-month DAPT due to a poor degree of strut coverage.

Study Design

  • Randomized
  • Superiority
  • Two-by-two factorial design

A total of 894 patients requiring DES implantation with two-by-two factorial design was randomized to EES versus BES and OCT versus angiography guidance. Clopidogrel was stopped after 3 months if uncovered strut was ≤6.0% (3-month DAPT); clopidogrel was continued for 12 months if ≥6.0% (12-month DAPT).

Inclusion Criteria

  • Patients at least 20 years old
  • Typical angina and objective evidence of myocardial ischemia
  • Significant coronary artery stenosis (>70% of diameter stenosis by visual estimation)
  • Anticipated 24 mm or shorter stent implantation

The trial was prematurely terminated for

  • low event rate in patients with 3-month DAPT;
  • slow recruitment; and
  • halted production of BES by the manufacturer.

Only 81.3% of 1,100 planned patients were randomly assigned.

Principal Findings

The primary outcome, median percentage of uncovered strut at 3 months, was 8.9% in EES and 8.2% in BES (95% CI, -1.6-2.4, p = 0.69); 7.5% in OCT guidance and 9.9% in angiography guidance (95% CI, 0.8-4.8, p = 0.009).

Secondary Outcomes

  • Cardiac death: 0 in 3-month DAPT versus 0 in 12-month DAPT
  • MI: 0.3% in 3-month DAPT versus 0% in 12-month DAPT (p = 0.4108)
  • Definite or probable stent thrombosis: 0.3% in 3-month DAPT versus 0% in 12-month DAPT (p = 0.4108)
  • Bleeding: 0.3% in 3-month DAPT versus 0.7% in 12-month DAPT (p = 0.5138)
  • Target vessel revascularization: 0.6% in 3-month DAPT versus 0.4% in 12-month DAPT (p = 0.7175)
  • Composite of cardiac death, MI, stent thrombosis, and major bleeding: 0.3% in 3-month DAPT versus 0.2% in 12-month DAPT (p = 0.7967)

Interpretation

Both EES and BES had similar strut coverage on OCT at 3 months. As expected, OCT-guided stent implantation resulted in better strut coverage than angiography-guided implantation. In selected patients, 3-month DAPT based on a favorable degree of strut coverage on OCT was safe.

3. Five-Year Outcome of a Randomized Trial Comparing Second Generation DES Using Either Biodegradable Polymer or Durable Polymer3

Presented by Masahiro Natsuaki, MD
Sponsored by Terumo Japan

Contribution to Literature

This study showed similar safety and efficacy outcomes between a biodegradable polymer (BP) BES and a durable polymer (DP) EES at 5-years after stent implantation.

Description

The goal of the study was to evaluate the 5-year clinical outcomes of BP DES compared with second generation DP DES in the extended follow-up of NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial).

Study Design

  • Randomized
  • Open-label
  • Non-inferiority trial

Inclusion Criteria

Patients scheduled for PCI using DES among the participating centers.

Exclusion Criteria

  • None (all-comer design)

Principal Findings

The primary outcome, death or MI, occurred in 15.1% of the BP BES group versus 16.5% of the DP EES group (p = 0.37). The primary outcome was similar in all pre-specified subgroups.

Secondary Outcomes

  • Death: 11.7% for BP BES versus 12.6% for DP EES (p = 0.51)
  • Cardiac death: 4.4% for BP BES versus 3.9% for DP EES (p = 0.54)
  • MI: 5.2% for BP BES versus 4.8% for DP EES (p = 0.72)
  • Target lesion revascularization: 9.8% for BP BES versus 9.3% for DP EES (p = 0.79)
  • Target vessel revascularization: 14.2% for BP BES versus 12.4% for DP EES (p = 0.22)
  • Stent thrombosis: 0.49% for BP BES versus 0.34% for DP EES (p = 0.52)
  • Stroke: 4.8% for BP BES versus 5.7% for DP EES (p = 0.38)
  • Bleeding TIMI major/minor: 6.5% for BP BES versus 6.4% for DP EES (p = 0.99)
  • Persistent discontinuation of DAPT: 61.5% for BP BES versus 62.8% for DP EES (p = 0.74)

Interpretation

Clinical outcomes after BP BES implantation are similar to those after DP EES implantation through 5 years after stent implantation.

References

  1. Nyström T, Sartipy U, Franzén S, et al. PCI Versus CABG in Patients With Type 1 Diabetes and Multivessel Disease. J Am Coll Cardiol 2017;70:1441-51.
  2. Hong MK. Early strut coverage in patients receiving new-generation drug-eluting stents and its implications for dual antiplatelet therapy: a randomized clinical trial. Presented at ESC Congress 2017, August 26, 2017. Available at: http://www.acc.org/education-and-meetings/image-and-slide-gallery/media-detail?id=97FD35CD4D1244CAAB0A08A130BF98A3.
  3. Natsuaki M. Five-Year Outcome of a Randomized Trial Comparing Second Generation Drug-eluting Stents Using Either Biodegradable Polymer or Durable Polymer. Presented at ESC Congress 2017, August 26, 2017. Available at: http://www.acc.org/education-and-meetings/image-and-slide-gallery/media-detail?id=E568ECC3BD7E4B639CFD03D64E40F741.

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