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Percutaneous coronary intervention with second-generation everolimus-eluting stents is associated with a similar risk of death but a higher risk of myocardial infarction and repeat revascularization than is coronary-artery bypass grafting.
An observational registry study of 34,819 patients with multivessel coronary artery disease who underwent one or the other procedure showed a similar risk of death at a mean follow-up of 2.9 years between patients who underwent PCI with everolimus-eluting stents and those who underwent CABG (3.1% and 2.9% per year, hazard ratio, 1.04; P = .50).
However, those in the percutaneous coronary intervention (PCI) group had a 51% greater risk of MI (95% confidence interval, 1.29-1.77; P < .001).
This increase in risk was significant only in patients who had incomplete revascularization and not in those with complete revascularization. In addition, the increase in risk largely was tied to spontaneous myocardial infarction, according to the findings.
“Randomized trials comparing PCI with CABG have not been typically powered to evaluate differences in the rates of myocardial infarction, stroke, and death from any cause; instead, they have been based on composite outcomes that include repeat revascularization,” wrote Dr. Sripal Bangalore of the cardiovascular clinical research center at the New York University, and his coauthors.
Patients undergoing PCI with everolimus-eluting stents also had a greater than twofold increase in the risk of repeat revascularization (hazard ratio, 2.35; 95% CI, 2.14-2.58; P < .001), but particularly in patients with three-vessel as opposed to two-vessel disease.
However, those in the PCI group also had a 58% lower risk of stroke than did those in the CABG group (95% CI, 0.50-0.76; P < .001), which was driven largely by a reduced risk in the first 30 days after the procedure (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMoa1412168]).
In the short term – in the hospital or within 30 days of the procedure – patients who underwent PCI showed significantly lower risk of death and stroke but no significant differences in MI risk.
“Thus, the choice between CABG and PCI with everolimus-eluting stents may depend on whether complete revascularization can be achieved with PCI,” the authors wrote. “If the answer is yes, the choice between PCI and CABG should be made on the basis of weighing the short-term risk of death and stroke against the long-term risk of revascularization with PCI.”
The authors acknowledged limitations of the study. It was a nonrandomized, observational trial; it did not examine variables such as smoking and other comorbidities; and it did not capture other neurologic events, such as transient ischemic attack.
The study was supported by Abbott Vascular. Dr. Bangalore has received consultant fees or honoraria from Abbott Vascular, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Pfizer, and Unique Pharmaceuticals.
CABG previously has been shown to be associated with fewer repeat vascularizations than has PCI, but questions have been raised about incremental improvements in stent technology that might narrow this gap.
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Dr. Robert A. Harrington |
However, data from this and the BEST study show there are clearly trade-offs between the two revascularization strategies that need to be discussed with patients as part of the shared decision-making process.
The early risk of stroke with CABG may be unacceptable to some, while others may want to avoid the risk of a later myocardial infarction or repeat procedure associated with PCI.
Dr. Robert A. Harrington is Arthur L. Bloomfield Professor of Medicine at Stanford (Calif.) University. These comments are taken from an editorial (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMe1501045]) accompanying this and the BEST study, which was also presented at the annual meeting of the American College of Cardiology in San Diego (N. Engl. J. Med. 2015 March 15 [doi:10.1056/NEJMoa1415447]). Dr. Harrington has received consultant fees and/or research grants from numerous pharmaceutical and device companies, including Amgen, Medtronic, Merck, Novartis, GlaxoSmithKline, and the Medicines Company. He is a principal or has ownership interest in Element Science and MyoKardia.
CABG previously has been shown to be associated with fewer repeat vascularizations than has PCI, but questions have been raised about incremental improvements in stent technology that might narrow this gap.
|
Dr. Robert A. Harrington |
However, data from this and the BEST study show there are clearly trade-offs between the two revascularization strategies that need to be discussed with patients as part of the shared decision-making process.
The early risk of stroke with CABG may be unacceptable to some, while others may want to avoid the risk of a later myocardial infarction or repeat procedure associated with PCI.
Dr. Robert A. Harrington is Arthur L. Bloomfield Professor of Medicine at Stanford (Calif.) University. These comments are taken from an editorial (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMe1501045]) accompanying this and the BEST study, which was also presented at the annual meeting of the American College of Cardiology in San Diego (N. Engl. J. Med. 2015 March 15 [doi:10.1056/NEJMoa1415447]). Dr. Harrington has received consultant fees and/or research grants from numerous pharmaceutical and device companies, including Amgen, Medtronic, Merck, Novartis, GlaxoSmithKline, and the Medicines Company. He is a principal or has ownership interest in Element Science and MyoKardia.
CABG previously has been shown to be associated with fewer repeat vascularizations than has PCI, but questions have been raised about incremental improvements in stent technology that might narrow this gap.
|
Dr. Robert A. Harrington |
However, data from this and the BEST study show there are clearly trade-offs between the two revascularization strategies that need to be discussed with patients as part of the shared decision-making process.
The early risk of stroke with CABG may be unacceptable to some, while others may want to avoid the risk of a later myocardial infarction or repeat procedure associated with PCI.
Dr. Robert A. Harrington is Arthur L. Bloomfield Professor of Medicine at Stanford (Calif.) University. These comments are taken from an editorial (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMe1501045]) accompanying this and the BEST study, which was also presented at the annual meeting of the American College of Cardiology in San Diego (N. Engl. J. Med. 2015 March 15 [doi:10.1056/NEJMoa1415447]). Dr. Harrington has received consultant fees and/or research grants from numerous pharmaceutical and device companies, including Amgen, Medtronic, Merck, Novartis, GlaxoSmithKline, and the Medicines Company. He is a principal or has ownership interest in Element Science and MyoKardia.
Percutaneous coronary intervention with second-generation everolimus-eluting stents is associated with a similar risk of death but a higher risk of myocardial infarction and repeat revascularization than is coronary-artery bypass grafting.
An observational registry study of 34,819 patients with multivessel coronary artery disease who underwent one or the other procedure showed a similar risk of death at a mean follow-up of 2.9 years between patients who underwent PCI with everolimus-eluting stents and those who underwent CABG (3.1% and 2.9% per year, hazard ratio, 1.04; P = .50).
However, those in the percutaneous coronary intervention (PCI) group had a 51% greater risk of MI (95% confidence interval, 1.29-1.77; P < .001).
This increase in risk was significant only in patients who had incomplete revascularization and not in those with complete revascularization. In addition, the increase in risk largely was tied to spontaneous myocardial infarction, according to the findings.
“Randomized trials comparing PCI with CABG have not been typically powered to evaluate differences in the rates of myocardial infarction, stroke, and death from any cause; instead, they have been based on composite outcomes that include repeat revascularization,” wrote Dr. Sripal Bangalore of the cardiovascular clinical research center at the New York University, and his coauthors.
Patients undergoing PCI with everolimus-eluting stents also had a greater than twofold increase in the risk of repeat revascularization (hazard ratio, 2.35; 95% CI, 2.14-2.58; P < .001), but particularly in patients with three-vessel as opposed to two-vessel disease.
However, those in the PCI group also had a 58% lower risk of stroke than did those in the CABG group (95% CI, 0.50-0.76; P < .001), which was driven largely by a reduced risk in the first 30 days after the procedure (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMoa1412168]).
In the short term – in the hospital or within 30 days of the procedure – patients who underwent PCI showed significantly lower risk of death and stroke but no significant differences in MI risk.
“Thus, the choice between CABG and PCI with everolimus-eluting stents may depend on whether complete revascularization can be achieved with PCI,” the authors wrote. “If the answer is yes, the choice between PCI and CABG should be made on the basis of weighing the short-term risk of death and stroke against the long-term risk of revascularization with PCI.”
The authors acknowledged limitations of the study. It was a nonrandomized, observational trial; it did not examine variables such as smoking and other comorbidities; and it did not capture other neurologic events, such as transient ischemic attack.
The study was supported by Abbott Vascular. Dr. Bangalore has received consultant fees or honoraria from Abbott Vascular, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Pfizer, and Unique Pharmaceuticals.
Percutaneous coronary intervention with second-generation everolimus-eluting stents is associated with a similar risk of death but a higher risk of myocardial infarction and repeat revascularization than is coronary-artery bypass grafting.
An observational registry study of 34,819 patients with multivessel coronary artery disease who underwent one or the other procedure showed a similar risk of death at a mean follow-up of 2.9 years between patients who underwent PCI with everolimus-eluting stents and those who underwent CABG (3.1% and 2.9% per year, hazard ratio, 1.04; P = .50).
However, those in the percutaneous coronary intervention (PCI) group had a 51% greater risk of MI (95% confidence interval, 1.29-1.77; P < .001).
This increase in risk was significant only in patients who had incomplete revascularization and not in those with complete revascularization. In addition, the increase in risk largely was tied to spontaneous myocardial infarction, according to the findings.
“Randomized trials comparing PCI with CABG have not been typically powered to evaluate differences in the rates of myocardial infarction, stroke, and death from any cause; instead, they have been based on composite outcomes that include repeat revascularization,” wrote Dr. Sripal Bangalore of the cardiovascular clinical research center at the New York University, and his coauthors.
Patients undergoing PCI with everolimus-eluting stents also had a greater than twofold increase in the risk of repeat revascularization (hazard ratio, 2.35; 95% CI, 2.14-2.58; P < .001), but particularly in patients with three-vessel as opposed to two-vessel disease.
However, those in the PCI group also had a 58% lower risk of stroke than did those in the CABG group (95% CI, 0.50-0.76; P < .001), which was driven largely by a reduced risk in the first 30 days after the procedure (N. Engl. J. Med. 2015 March 16 [doi:10.1056/NEJMoa1412168]).
In the short term – in the hospital or within 30 days of the procedure – patients who underwent PCI showed significantly lower risk of death and stroke but no significant differences in MI risk.
“Thus, the choice between CABG and PCI with everolimus-eluting stents may depend on whether complete revascularization can be achieved with PCI,” the authors wrote. “If the answer is yes, the choice between PCI and CABG should be made on the basis of weighing the short-term risk of death and stroke against the long-term risk of revascularization with PCI.”
The authors acknowledged limitations of the study. It was a nonrandomized, observational trial; it did not examine variables such as smoking and other comorbidities; and it did not capture other neurologic events, such as transient ischemic attack.
The study was supported by Abbott Vascular. Dr. Bangalore has received consultant fees or honoraria from Abbott Vascular, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Pfizer, and Unique Pharmaceuticals.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: PCI with second-generation everolimus-eluting stents is associated with a similar risk of death but a higher risk of MI and repeat revascularization than does CABG.
Major finding: PCI was associated with a 51% greater risk of MI at 2.9 years of follow-up, compared with CABG.
Data source: An observational registry study of 34,819 patients with multivessel coronary artery disease.
Disclosures: The study was supported by Abbott Vascular. Dr. Bangalore has received consultant fees or honoraria from Abbott Vascular, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Pfizer, and Unique Pharmaceuticals.
