Percutaneous coronary intervention (stents)

A procedure that opens a narrowed or blocked artery of the heart. A catheter carries a balloon to the narrowing, the balloon is inflated to widen the artery, and a small mesh tube called a stent may be left in place to keep it open. In people with stable coronary disease, the ISCHEMIA trial did not find that starting with an invasive strategy beat medicines alone.

Also called PCI · Coronary angioplasty · Stenting

Intervention
In this atlas

Overview

Technical summary

NHLBI says percutaneous coronary intervention, also called coronary angioplasty, opens coronary arteries narrowed or blocked by plaque, and that a stent may be placed to keep the artery from narrowing again. The only trial evidence recorded is ISCHEMIA, whose invasive strategy was angiography with revascularization when feasible, covering PCI and bypass surgery together, in stable coronary disease. It is not evidence about PCI during a heart attack.

About this intervention

Type: Procedure
Mechanism: A small mesh tube (stent) holds a narrowed coronary artery open (NHLBI)

Claims and evidence

Context Adults with stable coronary disease and moderate or severe ischemia (ISCHEMIA)

Recipient: Adult
Population: Patients with stable coronary disease and moderate or severe ischemia (abstract); 5179 were randomly assigned. The registry gives a minimum age of 21 years and all sexes.
Care setting: Open-label strategy trial; the registry records masking as none. Site list not read.
Geography: Multinational: the study record lists every country the registry names
Life stage: Adult, 21 years and older (registry minimum age)
Follow-up: Median follow-up 3.2 years (abstract).

Eligibility: 2 inclusion criteria; exclusion criteria not stated

Included: Stable coronary disease
Moderate or severe ischemia
Excluded: None stated

Effect Interventional Certainty not assessed

ISCHEMIA randomly assigned 5179 patients with stable coronary disease and moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible, plus medical therapy) or an initial conservative strategy of medical therapy alone. Over a median of 3.2 years, there were 318 primary outcome events in the invasive group and 352 in the conservative group. The cumulative event rate at 6 months was 5.3% against 3.4% (difference 1.9 percentage points, 95% CI 0.8 to 3.0), and at 5 years 16.4% against 18.2% (difference -1.8 percentage points, 95% CI -4.7 to 1.0). There were 145 deaths with the invasive strategy and 144 with the conservative strategy (hazard ratio 1.05, 95% CI 0.83 to 1.32). The authors report that they did not find evidence that an initial invasive strategy reduced the risk of ischemic cardiovascular events or death from any cause, and that the findings were sensitive to the definition of myocardial infarction.
Applies to Adult
- Patients with stable coronary disease and moderate or severe ischemia (abstract); 5179 were randomly assigned. The registry gives a minimum age of 21 years and all sexes.
- Open-label strategy trial; the registry records masking as none. Site list not read.
- Multinational: the study record lists every country the registry names
- Adult, 21 years and older (registry minimum age)
Follow-up Median follow-up 3.2 years (abstract).
Certainty method
Not assessed

Limitations
This was a null result for the primary outcome. The invasive strategy was angiography with revascularization when feasible, which covers stents (PCI) and bypass surgery, so the result cannot be read as the effect of PCI alone. The trial was open-label (the registry records masking as none), and the conservative group could cross over to angiography if medical therapy failed. The population was stable coronary disease with moderate or severe ischemia, not people having a heart attack. Abstract only.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (12)
1. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, METHODS, sentence 1, fragment 1 of 2: "We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible)"
  
  How it applies
  Abstract of the paper from PubMed; the full text was not read.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, METHODS, sentence 1, fragment 2 of 2: "and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed."
  
  How it applies
  Conservative strategy definition.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, METHODS, sentence 2: "The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest."
  
  How it applies
  Primary outcome.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, RESULTS, sentence 1: "Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group."
  
  How it applies
  Primary outcome events and follow-up.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
5. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 1 of 3: "At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points;"
  
  How it applies
  Cumulative event rate at 6 months.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
6. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 2 of 3: "95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points;"
  
  How it applies
  Cumulative event rate at 5 years.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
7. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, RESULTS, sentence 2, fragment 3 of 3: "95% CI, -4.7 to 1.0)."
  
  How it applies
  Five-year difference interval.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
8. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, RESULTS, sentence 5: "There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32)."
  
  How it applies
  Deaths in each group.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
9. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, CONCLUSIONS, sentence 1, fragment 1 of 3: "Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy,"
  
  How it applies
  Conclusion, first part.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
10. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, CONCLUSIONS, sentence 1, fragment 2 of 3: "as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2"
  
  How it applies
  Conclusion, second part.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
11. Supports Initial Invasive or Conservative Strategy for Stable Coronary Disease
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. PMC lists a copy (PMC7263833) that is not in the PMC Open Access subset, so the full text was not fetched. The version of record was not fetched. · Published 2020-04-09 · DOI: 10.1056/NEJMoa1915922 · PMID: 32227755 · PMCID: PMC7263833
  
  Locator
  Abstract, CONCLUSIONS, sentence 2: "The trial findings were sensitive to the definition of myocardial infarction that was used."
  
  How it applies
  Sensitivity to the myocardial infarction definition.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d345716db17b186578964e61480700f7459472617841049f0dc4a85125aa3f0e
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
12. Supports International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
  
  Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2023-06-01. · NCT: NCT01471522
  
  Locator
  protocolSection.designModule.enrollmentInfo.count: "5179"
  
  How it applies
  Registry enrollment count, equal to the abstract.
  
  Retrieved
  2026-10-14T18:18:37Z
  
  Source effective date
  2023-06-01
  
  Source state
  Current
  
  Snapshot hash
  aa11fdbe65af845de0cf9cfcbf7b298c3f47057c0d71c36333dbfc9d2bdc8df9
  
  Reuse basis
  Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/cg-ctgov-NCT01471522.json.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Initial invasive strategy compared with medicines alone: Coronary artery disease (Evaluated for)
Applies to Adult
- Patients with stable coronary disease and moderate or severe ischemia (abstract); 5179 were randomly assigned. The registry gives a minimum age of 21 years and all sexes.
- Open-label strategy trial; the registry records masking as none. Site list not read.
- Multinational: the study record lists every country the registry names
- Adult, 21 years and older (registry minimum age)
Follow-up Median follow-up 3.2 years (abstract).
ISCHEMIA randomly assigned 5179 patients with stable coronary disease and moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible, plus medical therapy) or an initial conservative strategy of medical therapy alone. Over a median of 3.2 years, there were 318 primary outcome events in the invasive group and 352 in the conservative group. The cumulative event rate at 6 months was 5.3% against 3.4% (difference 1.9 percentage points, 95% CI 0.8 to 3.0), and at 5 years 16.4% against 18.2% (difference -1.8 percentage points, 95% CI -4.7 to 1.0). There were 145 deaths with the invasive strategy and 144 with the conservative strategy (hazard ratio 1.05, 95% CI 0.83 to 1.32). The authors report that they did not find evidence that an initial invasive strategy reduced the risk of ischemic cardiovascular events or death from any cause, and that the findings were sensitive to the definition of myocardial infarction.
Limitations. This was a null result for the primary outcome. The invasive strategy was angiography with revascularization when feasible, which covers stents (PCI) and bypass surgery, so the result cannot be read as the effect of PCI alone. The trial was open-label (the registry records masking as none), and the conservative group could cross over to angiography if medical therapy failed. The population was stable coronary disease with moderate or severe ischemia, not people having a heart attack. Abstract only.

Record details

Record id: cardio:pci
Content hash: c0d2b932e8ade3f4548947f2e27b274eaa18297418a6ef728f703eef64c12c3e