CREDO-Kyoto Confirms SYNTAX Findings
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CABG Beats PCI Regardless of SYNTAX Score

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

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Cardiologists devised the SYNTAX score (EuroIntervention 2005;1:219-27) as a tool for quantifying the complexity of coronary anatomy in patients enrolled in the landmark SYNTAX trial (N. Engl. J. Med. 2009;360:961-72).

The SYNTAX investigators recently published the 3-year outcomes results from SYNTAX (Eur. Heart J. 2011;32:2125-34). Those results showed that patients treated with CABG had significantly fewer major adverse coronary and cerebrovascular events (MACCE) than did those who underwent PCI among patients with a high SYNTAX score (greater than 33), including the analysis with all patients, in patients with triple-vessel disease, and in patients with left main coronary disease. Among patients with intermediate SYNTAX scores (23-32), the MACCE rate was significantly lower with CABG than with PCI among all patients and in the subgroup with triple-vessel disease; in those with left main coronary disease, the MACCE rate was similar among patients treated with CABG and those treated with PCI. In patients with low SYNTAX scores (22 or less), the MACCE rates were similar among all CABG and PCI patients, as well as those in the subgroups who had either triple vessel disease or left main coronary disease.

Given this background, it is a big surprise to learn that the Japanese study found a statistically significant advantage for CABG in the 3-year incidence of death, MI, and stroke among patients with a low SYNTAX score who were treated with CABG, compared with those who underwent PCI. This finding needs further examination in future randomized studies.

The CREDO-Kyoto study differed from SYNTAX by being nonrandomized. The current analysis focused exclusively on patients with triple-vessel coronary disease and excluded those with left main coronary disease.

The new Japanese results confirmed the key findings from the SYNTAX study in a large, real-world population. The new results show the usefulness of the SYNTAX score when it is used in clinical practice; however, in this study, the score calculation and the analysis of its relevance to outcomes occurred retrospectively. The ability of the SYNTAX score to help assign patients to optimal treatment with either CABG or PCI needs testing prospectively.

Frans Van de Werf, M.D., is professor and chairman of the department of cardiovascular medicine at University Hospitals Leuven (Belgium). He said that he had no relevant disclosures. This is adapted from the comments he made as the discussant for the study.

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Cardiologists devised the SYNTAX score (EuroIntervention 2005;1:219-27) as a tool for quantifying the complexity of coronary anatomy in patients enrolled in the landmark SYNTAX trial (N. Engl. J. Med. 2009;360:961-72).

The SYNTAX investigators recently published the 3-year outcomes results from SYNTAX (Eur. Heart J. 2011;32:2125-34). Those results showed that patients treated with CABG had significantly fewer major adverse coronary and cerebrovascular events (MACCE) than did those who underwent PCI among patients with a high SYNTAX score (greater than 33), including the analysis with all patients, in patients with triple-vessel disease, and in patients with left main coronary disease. Among patients with intermediate SYNTAX scores (23-32), the MACCE rate was significantly lower with CABG than with PCI among all patients and in the subgroup with triple-vessel disease; in those with left main coronary disease, the MACCE rate was similar among patients treated with CABG and those treated with PCI. In patients with low SYNTAX scores (22 or less), the MACCE rates were similar among all CABG and PCI patients, as well as those in the subgroups who had either triple vessel disease or left main coronary disease.

Given this background, it is a big surprise to learn that the Japanese study found a statistically significant advantage for CABG in the 3-year incidence of death, MI, and stroke among patients with a low SYNTAX score who were treated with CABG, compared with those who underwent PCI. This finding needs further examination in future randomized studies.

The CREDO-Kyoto study differed from SYNTAX by being nonrandomized. The current analysis focused exclusively on patients with triple-vessel coronary disease and excluded those with left main coronary disease.

The new Japanese results confirmed the key findings from the SYNTAX study in a large, real-world population. The new results show the usefulness of the SYNTAX score when it is used in clinical practice; however, in this study, the score calculation and the analysis of its relevance to outcomes occurred retrospectively. The ability of the SYNTAX score to help assign patients to optimal treatment with either CABG or PCI needs testing prospectively.

Frans Van de Werf, M.D., is professor and chairman of the department of cardiovascular medicine at University Hospitals Leuven (Belgium). He said that he had no relevant disclosures. This is adapted from the comments he made as the discussant for the study.

Body

Cardiologists devised the SYNTAX score (EuroIntervention 2005;1:219-27) as a tool for quantifying the complexity of coronary anatomy in patients enrolled in the landmark SYNTAX trial (N. Engl. J. Med. 2009;360:961-72).

The SYNTAX investigators recently published the 3-year outcomes results from SYNTAX (Eur. Heart J. 2011;32:2125-34). Those results showed that patients treated with CABG had significantly fewer major adverse coronary and cerebrovascular events (MACCE) than did those who underwent PCI among patients with a high SYNTAX score (greater than 33), including the analysis with all patients, in patients with triple-vessel disease, and in patients with left main coronary disease. Among patients with intermediate SYNTAX scores (23-32), the MACCE rate was significantly lower with CABG than with PCI among all patients and in the subgroup with triple-vessel disease; in those with left main coronary disease, the MACCE rate was similar among patients treated with CABG and those treated with PCI. In patients with low SYNTAX scores (22 or less), the MACCE rates were similar among all CABG and PCI patients, as well as those in the subgroups who had either triple vessel disease or left main coronary disease.

Given this background, it is a big surprise to learn that the Japanese study found a statistically significant advantage for CABG in the 3-year incidence of death, MI, and stroke among patients with a low SYNTAX score who were treated with CABG, compared with those who underwent PCI. This finding needs further examination in future randomized studies.

The CREDO-Kyoto study differed from SYNTAX by being nonrandomized. The current analysis focused exclusively on patients with triple-vessel coronary disease and excluded those with left main coronary disease.

The new Japanese results confirmed the key findings from the SYNTAX study in a large, real-world population. The new results show the usefulness of the SYNTAX score when it is used in clinical practice; however, in this study, the score calculation and the analysis of its relevance to outcomes occurred retrospectively. The ability of the SYNTAX score to help assign patients to optimal treatment with either CABG or PCI needs testing prospectively.

Frans Van de Werf, M.D., is professor and chairman of the department of cardiovascular medicine at University Hospitals Leuven (Belgium). He said that he had no relevant disclosures. This is adapted from the comments he made as the discussant for the study.

Title
CREDO-Kyoto Confirms SYNTAX Findings
CREDO-Kyoto Confirms SYNTAX Findings

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

PARIS – Coronary artery bypass grafting surpassed percutaneous coronary intervention in a "real-world," registry of patients with three-vessel coronary disease, largely confirming the findings of the SYNTAX trial in patients with high SYNTAX scores and in those with low scores.

However, because the new data – obtained at 26 Japanese centers during 2005-2007 and involving nearly 3,000 patients – came from a nonrandomized registry, it may have been flawed by selection biases that skewed which patients underwent bypass surgery and which ones had percutaneous revascularization.

Coronary artery bypass grafting (CABG) "remains the standard treatment option for patients with triple-vessel disease, even when their SYNTAX scores are high," Dr. Hiroki Shiomi said at the annual congress of the European society of Cardiology. "Use of PCI [percutaneous coronary intervention] in patients with high SYNTAX scores should be seriously discouraged unless their operative risk is prohibitively high," said Dr. Shiomi, a cardiologist at Kyoto University Hospital, Japan. The registry results "suggested that the clinical outcome of PCI is not comparable with CABG even in patients with low syntax scores."

But the study’s findings also suggested that a selection bias occurred that even the risk-adjusted analysis used by Dr. Shiomi and his associates failed to adequately control, commented Dr. Uwe Zeymer, an interventional cardiologist and professor at the Institute for Myocardial Infarction Research in Ludwigshafen, Germany.

A major clue that selection bias came into play was that all-cause death during the 3-year follow-up of the study was 62% higher among the patients who underwent PCI, compared with those who underwent CABG, a statistically significant difference; in contrast, the rate of cardiac death was not significantly different between the CABG and PCI patients.

This discrepancy "says there was selection bias. Physicians had to decide what to do with patients who had a lot of comorbidities," and most of those patients probably underwent PCI, Dr. Zeymer said in an interview. "If the patients [undergoing PCI and CABG] were the same clinically, you’d expect that with PCI you would at least have the same result" for all-cause mortality. "There seems to have been a selection bias toward using PCI in patients with more comorbidities.

"What we can say is that in this real-world situation, cardiac mortality was the same" with both revascularization methods, "which is reassuring for the use of PCI," he added.

CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) enrolled more than 13,000 patients who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007, a period when all PCIs used a drug-eluting coronary stent. The current analysis focused on 2,981 patients with triple vessel disease and no left main coronary disease or acute MI, and included 1,825 who were treated with CABG and 1,156 treated by PCI. The average age of the PCI patients was 70 years; the CABG patients averaged 68 years old.

After 1 year of follow-up, the combined rate of death, MI, or stroke was 23% higher in the patients treated with PCI, compared with those treated with CABG, a statistically significant difference in an unadjusted analysis for the study’s primary end point. After adjustment for baseline differences between the CABG and PCI patients, the rate of this combined end point was 47% higher among the PCI patients, also a statistically significant difference.

Analysis of several secondary end points showed a mixed pattern of differences between the two treatment groups in the adjusted analyses. A statistically significant difference in favor of fewer events with CABG occurred in the end point of all-cause death, which was 62% higher with PCI, as well as in the end point of MI, which was 2.39-fold higher in the PCI group. The protection against MI by CABG, compared with PCI, was "particularly remarkable," Dr. Shiomi said. But the end points of cardiac death and stroke showed no statistically significant differences between the two treatment groups in either the unadjusted or adjusted analyses.

Dr. Shiomi said that baseline SYNTAX scores were available for 94% of the patients. The mean score was 24 in the PCI patients and 30 for the CABG patients.

Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.

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CABG Beats PCI Regardless of SYNTAX Score
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FROM THE ANNUAL CONGRESS OF THE EUROPEAN SOCIETY OF CARDIOLOGY

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Major Finding: Patients who underwent PCI had a statistically significant 47% increased rate of death, MI, or stroke, compared with patients who underwent CABG in an adjusted analysis.

Data Source: The CREDO-Kyoto study, which reviewed nonrandomized registry data on the adverse event outcomes during 3 years of follow-up of 2,981 patients with triple-vessel coronary disease who underwent coronary revascularization at any of 26 Japanese centers during 2005-2007 by either CABG or PCI.

Disclosures: Dr. Shiomi said he had no disclosures. Dr. Zeymer said that the Institute of MI Research in Germany, where he works, has received research grant support from multiple cardiac-device companies.