TBD Meeting (4041-23)

PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.

In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.

Baber_Usman_OKLA_web.jpg

The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).

The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. 

Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.

“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”

The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.

“And then third is that ticagrelor on its own as compared with ticagrelor plus aspirin was equally effective in preventing repeat revascularization events,” he said.
 

Repeat revascularization

The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.

Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.

The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).

The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.

One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.

“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”

Azzalini_Lorenzo_WASH_web.jpg

The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.

“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”

However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”

TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.

“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”

Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.

PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.

In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.

Baber_Usman_OKLA_web.jpg

The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).

The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. 

Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.

“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”

The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.

“And then third is that ticagrelor on its own as compared with ticagrelor plus aspirin was equally effective in preventing repeat revascularization events,” he said.
 

Repeat revascularization

The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.

Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.

The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).

The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.

One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.

“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”

Azzalini_Lorenzo_WASH_web.jpg

The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.

“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”

However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”

TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.

“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”

Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.

PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.

In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.

Baber_Usman_OKLA_web.jpg

The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).

The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. 

Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.

“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”

The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.

“And then third is that ticagrelor on its own as compared with ticagrelor plus aspirin was equally effective in preventing repeat revascularization events,” he said.
 

Repeat revascularization

The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.

Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.

The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).

The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.

One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.

“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”

Azzalini_Lorenzo_WASH_web.jpg

The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.

“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”

However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”

TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.

“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”

Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.

A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).

In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.

Dangas_George_NY_web.jpg

Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.

The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.

“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”

The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.

The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.

This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.

The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.

The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).

“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
 

Critical role

Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.

Brar_Somjat_CALIF_web.jpg

“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”

Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.

A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”

The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.

“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.

Dr. Dangas and Dr. Brar have no relevant financial disclosures.


 

A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).

In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.

Dangas_George_NY_web.jpg

Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.

The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.

“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”

The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.

The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.

This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.

The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.

The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).

“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
 

Critical role

Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.

Brar_Somjat_CALIF_web.jpg

“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”

Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.

A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”

The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.

“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.

Dr. Dangas and Dr. Brar have no relevant financial disclosures.


 

A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).

In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.

Dangas_George_NY_web.jpg

Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.

The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.

“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”

The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.

The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.

This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.

The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.

The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).

“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
 

Critical role

Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.

Brar_Somjat_CALIF_web.jpg

“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”

Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.

A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”

The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.

“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.

Dr. Dangas and Dr. Brar have no relevant financial disclosures.


 

In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.

The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.

“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at  Baylor Scott & White Health, in Plano, Tex., said in an interview.

AlAzizi_Kamir_TEX_web.jpg

Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.

Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”

The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.

The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.

The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).

One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).

Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).

Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.

One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.

The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
 

‘Slow to the party’

U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.

“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”

Some patients who need fine motor hand function would still opt for femoral access, he said.

“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”

Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.

“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”

Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.

In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.

The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.

“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at  Baylor Scott & White Health, in Plano, Tex., said in an interview.

AlAzizi_Kamir_TEX_web.jpg

Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.

Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”

The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.

The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.

The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).

One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).

Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).

Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.

One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.

The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
 

‘Slow to the party’

U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.

“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”

Some patients who need fine motor hand function would still opt for femoral access, he said.

“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”

Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.

“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”

Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.

In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.

The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.

“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at  Baylor Scott & White Health, in Plano, Tex., said in an interview.

AlAzizi_Kamir_TEX_web.jpg

Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.

Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”

The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.

The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.

The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).

One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).

Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).

Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.

One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.

The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
 

‘Slow to the party’

U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.

“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”

Some patients who need fine motor hand function would still opt for femoral access, he said.

“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”

Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.

“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”

Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.

PHOENIX – Marijuana users have an almost four times greater risk of developing peripheral artery disease, compared with nonusers, results of a study of more than 600,000 marijuana users suggest, although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.

marijuana_hand_woman_web.jpg

The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.

Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.

“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.

Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.

“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”

Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.

“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”

The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.

The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.

“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.

“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”

One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”

PHOENIX – Marijuana users have an almost four times greater risk of developing peripheral artery disease, compared with nonusers, results of a study of more than 600,000 marijuana users suggest, although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.

marijuana_hand_woman_web.jpg

The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.

Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.

“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.

Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.

“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”

Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.

“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”

The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.

The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.

“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.

“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”

One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”

PHOENIX – Marijuana users have an almost four times greater risk of developing peripheral artery disease, compared with nonusers, results of a study of more than 600,000 marijuana users suggest, although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.

marijuana_hand_woman_web.jpg

The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.

Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.

“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.

Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.

“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”

Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.

“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”

The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.

The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.

“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.

“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”

One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”